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    Pregabalin

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    May.24.2024

    Pregabalin

    Indications/Dosage

    Labeled

    • diabetic neuropathy
    • fibromyalgia
    • neuropathic pain
    • partial seizures
    • postherpetic neuralgia
    • spinal cord injury

    Off-Label

    • generalized anxiety disorder (GAD)
    • social phobia (social anxiety disorder)
    • trigeminal neuralgia
    † Off-label indication

    For the treatment of neuropathic pain due to diabetic neuropathy, postherpetic neuralgia, spinal cord injury, and trigeminal neuralgia†

    for the treatment of peripheral diabetic neuropathy

    Oral dosage (immediate-release)

    Adults

    50 mg PO 3 times daily, initially. May increase dose to 100 mg PO 3 times daily after 1 week based on efficacy and tolerability. Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated; therefore, doses above 300 mg/day are not recommended. To discontinue, gradually taper the dose over a minimum of 1 week.[31493]

    Oral dosage (extended-release) in treatment-naive patients

    Adults

    165 mg PO once daily, initially. May increase dose to 330 mg PO once daily after 1 week based on efficacy and tolerability. After 2 to 4 weeks, may further increase dose to 660 mg PO once daily for patients who have ongoing pain and are tolerating 330 mg/day. Max dose: 660 mg once daily. To discontinue, gradually taper the dose over a minimum of 1 week.[62506]

    Oral dosage (extended-release) in patients switching from immediate-release products

    Adults

    82.5 mg/day of extended-release for 75 mg/day of immediate-release, 165 mg/day of extended-release for 150 mg/day of immediate-release, 247.5 mg of extended-release for 225 mg/day of immediate-release, 330 mg/day of extended-release for 300 mg/day immediate-release, 495 mg/day of extended-release for 450 mg/day immediate-release dose, or 660 mg/day of extended-release for 600 mg/day of immediate-release. To discontinue, gradually taper the dose over a minimum of 1 week.[62506]

    for the treatment of postherpetic neuralgia (PHN)

    Oral dosage (immediate-release)

    Adults

    75 mg PO twice daily or 50 mg PO 3 times daily, initially. May increase dose to 150 mg PO twice daily or 100 mg PO 3 times daily after 1 week based on efficacy and tolerability. After 2 to 4 weeks, may further increase dose to 300 mg PO twice daily or 200 mg PO 3 times daily for patients who have ongoing pain and are tolerating 300 mg/day. To discontinue, gradually taper the dose over a minimum of 1 week.[31493]

    Oral dosage (extended-release) in treatment-naive patients

    Adults

    165 mg PO once daily, initially. May increase dose to 330 mg PO once daily after 1 week based on efficacy and tolerability. After 2 to 4 weeks, may further increase dose to 660 mg PO once daily for patients who have ongoing pain and are tolerating 330 mg/day. Max dose: 660 mg once daily. To discontinue, gradually taper the dose over a minimum of 1 week.[62506]

    Oral dosage (extended-release) in patients switching from immediate-release products

    Adults

    82.5 mg/day of extended-release for 75 mg/day of immediate-release, 165 mg/day of extended-release for 150 mg/day of immediate-release, 247.5 mg of extended-release for 225 mg/day of immediate-release, 330 mg/day of extended-release for 300 mg/day immediate-release, 495 mg/day of extended-release for 450 mg/day immediate-release dose, or 660 mg/day of extended-release for 600 mg/day of immediate-release. To discontinue, gradually taper the dose over a minimum of 1 week.[62506]

    for the treatment of neuropathic pain due to spinal cord injury

    Oral dosage (immediate-release)

    Adults

    75 mg PO twice daily, initially. May increase dose to 150 mg PO twice daily after 1 week based on efficacy and tolerability. After 2 to 3 weeks, may further increase dose to 300 mg PO twice daily for patients who have ongoing pain and are tolerating 300 mg/day. To discontinue, gradually taper the dose over a minimum of 1 week.[31493]

    for the treatment of trigeminal neuralgia†

    Oral dosage (immediate-release)

    Adults

    75 mg PO twice daily for 1 week, then 150 mg PO twice daily for 1 week, then 300 mg PO twice daily.[68023] [68024]

    For the adjunctive treatment of partial seizures (with or without secondary generalization)

    Oral dosage (immediate-release)

    Adults

    150 mg/day PO divided 2 or 3 times daily, initially. May increase dose weekly based on efficacy and tolerability. Max: 600 mg/day.[31493]

    Adolescents 17 years

    150 mg/day PO divided 2 or 3 times daily, initially. May increase dose weekly based on efficacy and tolerability. Max: 600 mg/day.[31493]

    Children and Adolescents 4 to 16 years weighing 30 kg or more

    2.5 mg/kg/day PO divided 2 or 3 times daily, initially. May increase dose weekly based on efficacy and tolerability. Max: 10 mg/kg/day or 600 mg/day.[31493]

    Children and Adolescents 4 to 16 years weighing less than 30 kg

    3.5 mg/kg/day PO divided 2 or 3 times daily, initially. May increase dose weekly based on efficacy and tolerability. Max: 14 mg/kg/day.[31493]

    Infants and Children 1 month to 3 years

    3.5 mg/kg/day PO divided 3 times daily, initially. May increase dose weekly based on efficacy and tolerability. Max: 14 mg/kg/day.[31493]

    For the treatment of fibromyalgia

    Oral dosage (immediate-release)

    Adults

    75 mg PO twice daily, initially. May increase dose to 150 mg PO twice daily after 1 week based on efficacy and tolerability. May further increase the dose to 225 mg PO twice daily for patients who do not experience sufficient benefit on 300 mg/day. Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated; therefore, doses above 450 mg/day are not recommended. To discontinue, gradually taper the dose over a minimum of 1 week.[31493] 

    For the treatment of social phobia (social anxiety disorder)†

    Oral dosage (immediate-release)

    Adults

    200 mg PO 3 times daily. Doses are usually titrated to the target dose over 1 week.[30765] [58411]

    For the treatment of generalized anxiety disorder (GAD)†

    Oral dosage (immediate-release)

    Adults

    50 mg PO twice daily for 2 days, then 100 mg PO twice daily for 2 days, and then 150 mg PO twice daily, initially, or alternately, 75 mg PO twice daily, initially; may increase the dose by 150 mg/day at weekly intervals as needed. Usual dose: 150 to 600 mg/day in 2 to 3 divided doses. Max: 600 mg/day.[58300] [58301] [58302]

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

    • Adults

      600 mg/day PO for immediate-release formulations; 660 mg/day PO for extended-release tablets.

    • Geriatric

      600 mg/day PO for immediate-release formulations; 660 mg/day PO for extended-release tablets.

    • Adolescents

      17 years: 600 mg/day PO for immediate-release formulations.

      13 to 16 years weighing 30 kg or more: 10 mg/kg/day PO (Max: 600 mg/day) for immediate-release formulations.

      13 to 16 years weighing less than 30 kg: 14 mg/kg/day PO for immediate-release formulations.

    • Children

      weighing 30 kg or more: 10 mg/kg/day PO (Max: 600 mg/day) for immediate-release formulations.

      weighing less than 30 kg: 14 mg/kg/day PO for immediate-release formulations.

    • Infants

      14 mg/kg/day PO for immediate-release formulations.

    • Neonates

      Safety and efficacy have not been established.

    Patients with Hepatic Impairment Dosing

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing

    Adult patients

    CrCl 60 mL/minute or more: No dose adjustment needed.

    CrCl 30 to 60 mL/minute: 75 to 300 mg/day PO divided 2 or 3 times daily for immediate-release formulations; reduce dose by 50% for extended-release tablets.

    CrCl 15 to 30 mL/minute: 25 to 150 mg/day PO divided once or twice daily for immediate-release formulations. Use of the extended-release tablet is not recommended.

    CrCl 15 mL/minute or less: 25 to 75 mg PO once daily for immediate-release formulations. Use of the extended-release tablet is not recommended.[31493][62506]

     

    Pediatric patients

    Based on pharmacokinetic modeling, the following maximum daily doses have been recommended in pediatric patients with renal impairment:[69121]

    Pediatric patients weighing 30 kg or more

    CrCl 60 mL/minute/1.73 m2 or more: No dose adjustment needed.

    CrCl 30 to 60 mL/minute/1.73 m2: 5 mg/kg/day PO divided twice daily

    CrCl 15 to 30 mL/minute/1.73 m2: 2.5 mg/kg/day PO divided twice daily.

    CrCl less than 15 mL/minute/1.73 m2: 1 mg/kg/day PO divided once or twice daily.

     

    Pediatric patients weighing less than 30 kg

    CrCl 60 mL/minute/1.73 m2 or more: No dose adjustment needed.

    CrCl 30 to 60 mL/minute/1.73 m2: 7 mg/kg/day PO divided twice daily.

    CrCl 15 to 30 mL/minute/1.73 m2: 3.5 mg/kg/day PO divided twice daily.

    CrCl less than 15 mL/minute/1.73 m2: 1.4 mg/kg/day PO divided once or twice daily.

     

    Intermittent hemodialysis

    Use of extended-release tablets is not recommended; use immediate-release formulations.[62506] Pregabalin is effectively removed by hemodialysis. Each 4-hour hemodialysis session removes 50% to 60% of the amount of drug initially present in the circulation in patients on 3 times weekly hemodialysis, who were administered pregabalin roughly 24 hours prior to next scheduled dialysis session.[30770] For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, give a supplemental dose immediately after every 4-hour hemodialysis treatment.[31493]

    Adult patients

    • For patients receiving the 25 mg once daily regimen: 1 supplemental dose of 25 or 50 mg
    • For patients receiving the 25 to 50 mg once daily regimen: 1 supplemental dose of 50 or 75 mg
    • For patients receiving 50 to 75 mg once daily regimen: 1 supplemental dose of 75 or 100 mg
    • For patients receiving the 75 mg once daily regimen: 1 supplemental dose of 100 or 150 mg

     

    Pediatric patients

    • Pediatric-specific recommendations are not available.
    † Off-label indication
    Revision Date: 05/24/2024, 01:33:00 AM

    References

    30765 - Pande AC, Feltner DE, Jefferson JW, et al. Efficacy of the novel anxiolytic pregabalin in social anxiety disorder: a placebo-controlled, multicenter study. J Clin Psychopharmacol 2004;24:141-9.30770 - Randinitis EJ, Posvar EL, Alvey CW, et al. Pharmacokinetics of pregabalin in subjects with various degrees of renal function. J Clin Pharmacol 2003;43:277-83.31493 - Lyrica (pregabalin) package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.58300 - Rickels K, Shiovitz TM, Ramey TS, et al. Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment. Int Clin Psychopharmacol 2012;27:142-50.58301 - Kasper S, Herman B, Nivoli G, et al. Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. Int Clin Psychopharmacol 2009;24:87-96.58302 - Montgomery S, Chatamra K, Pauer L, et al. Efficacy and safety of pregabalin in elderly people with generalized anxiety disorder. BJP 2008;193:389-94.58411 - Feltner DE, Liu-Dumaw M, Schweizer E, et al. Efficacy of pregabalin in generalized social anxiety disorder: results of a double-blind, placebo-controlled, fixed-dose study. Int Clin Psychopharmacol 2011;26:213-20.62506 - Lyrica CR (pregabalin) extended-release tablets package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.68023 - Bendtsen L, Zakrzewska JM, Abbott J, et al. European Academy of Neurology guideline on trigeminal neuralgia. Eur J Neurol. 2019 Jun;26:831-849.68024 - Rustagi A, Roychoudhury A, Bhutia O, et ah. Lamotrigine Versus Pregabalin in the Management of Refractory Trigeminal Neuralgia: A Randomized Open Label Crossover Trial. J Maxillofac Oral Surg. 2014 Dec;13:409-18.69121 - Ke C, You X, Lin C, et al. Development of Physiologically Based Pharmacokinetic Model for Pregabalin to Predict the Pharmacokinetics in Pediatric Patients with Renal Impairment and Adjust Dosage Regimens: PBPK Model of Pregabalin in Pediatric Patients with Renal Impairment. J Pharm Sci 2022;111:542-551.

    How Supplied

    Pregabalin Oral capsule

    Lyrica 25mg Capsule (71610-0071) (Aphena Pharma Solutions - Tennessee, LLC) null

    Pregabalin Oral capsule

    Lyrica 25mg Capsule (00071-1012) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (62332-0119) (Alembic Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (60687-0473) (American Health Packaging) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (69238-1310) (Amneal Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (60505-3793) (Apotex Corp) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (67877-0462) (Ascend Laboratories, LLC a Subsidiary of Alkem Laboratories Ltd) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (65862-0758) (Aurobindo Pharma USA Inc.) nullPregabalin 25mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (72162-1541) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (31722-0610) (Camber Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (69097-0954) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (69097-0677) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (43598-0291) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (76420-0117) (Enovachem Manufacturing) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (76282-0568) (Exelan Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (51407-0509) (Golden State Medical Supply, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (59762-1342) (Greenstone Ltd) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (00904-6991) (Major Pharmaceuticals Inc, a Harvard Drug Group Company) nullPregabalin 25mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (72205-0011) (Novadoz Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (71205-0869) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (64980-0410) (Rising Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (50228-0350) (ScieGen Pharmaceuticals, Inc) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (43547-0506) (Solco Healthcare US LLC) nullPregabalin 25mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (47335-0686) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (00093-7622) (Teva Pharmaceuticals USA) (off market)

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (00228-2856) (Teva/Actavis US) (off market)

    Pregabalin Oral capsule

    Pregabalin 25mg Capsule (69367-0324) (Westminster Pharmaceuticals, LLC) nullPregabalin 25mg Capsule package photo

    Pregabalin Oral capsule

    Lyrica 50mg Capsule (43353-0263) (Aphena Pharma Solutions - Tennessee, LLC) null

    Pregabalin Oral capsule

    Lyrica 50mg Capsule (63629-3367) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Lyrica 50mg Capsule (52959-0891) (HJ Harkins Co Inc) null

    Pregabalin Oral capsule

    Lyrica 50mg Capsule (55289-0969) (PD-Rx Pharmaceuticals, Inc.) (off market)

    Pregabalin Oral capsule

    Lyrica 50mg Capsule (00071-1013) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Lyrica 50mg Capsule (00071-1013) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (62332-0120) (Alembic Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (60687-0484) (American Health Packaging) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (69238-1311) (Amneal Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (71610-0619) (Aphena Pharma Solutions - Tennessee, LLC) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (60505-3794) (Apotex Corp) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (67877-0463) (Ascend Laboratories, LLC a Subsidiary of Alkem Laboratories Ltd) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (65862-0759) (Aurobindo Pharma USA Inc.) nullPregabalin 50mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (72162-1542) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (31722-0611) (Camber Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (72606-0005) (Celltrion USA, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (62135-0444) (Chartwell RX LLC) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (69097-0955) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (69097-0678) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (43598-0292) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (43598-0292) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (76282-0569) (Exelan Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (51407-0510) (Golden State Medical Supply, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (59762-1344) (Greenstone Ltd) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (00904-6992) (Major Pharmaceuticals Inc, a Harvard Drug Group Company) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (72205-0012) (Novadoz Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (71205-0870) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (64980-0411) (Rising Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (50228-0351) (ScieGen Pharmaceuticals, Inc) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (43547-0507) (Solco Healthcare US LLC) nullPregabalin 50mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (47335-0687) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (00093-7623) (Teva Pharmaceuticals USA) (off market)

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (00228-2857) (Teva/Actavis US) (off market)

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (27808-0235) (Tris Pharma, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 50mg Capsule (69367-0325) (Westminster Pharmaceuticals, LLC) nullPregabalin 50mg Capsule package photo

    Pregabalin Oral capsule

    Lyrica 75mg Capsule (61919-0504) (Direct Rx) null

    Pregabalin Oral capsule

    Lyrica 75mg Capsule (55289-0569) (PD-Rx Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Lyrica 75mg Capsule (00071-1014) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Lyrica 75mg Capsule (00071-1014) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (62332-0121) (Alembic Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (60687-0495) (American Health Packaging) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (69238-1312) (Amneal Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (60505-3795) (Apotex Corp) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (67877-0464) (Ascend Laboratories, LLC a Subsidiary of Alkem Laboratories Ltd) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (65862-0760) (Aurobindo Pharma USA Inc.) nullPregabalin 75mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (72162-1543) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (31722-0612) (Camber Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (72606-0006) (Celltrion USA, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (62135-0445) (Chartwell RX LLC) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (69097-0956) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (69097-0679) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (43598-0293) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (43598-0293) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (76282-0570) (Exelan Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (51407-0511) (Golden State Medical Supply, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (59762-1346) (Greenstone Ltd) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (00904-7000) (Major Pharmaceuticals Inc, a Harvard Drug Group Company) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (72205-0013) (Novadoz Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (71205-0871) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (71205-0298) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (64980-0412) (Rising Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (50228-0352) (ScieGen Pharmaceuticals, Inc) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (43547-0508) (Solco Healthcare US LLC) nullPregabalin 75mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (60760-0485) (St. Mary's Medical Park Pharmacy) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (47335-0688) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (00093-7624) (Teva Pharmaceuticals USA) (off market)

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (00228-2858) (Teva/Actavis US) (off market)

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (27808-0236) (Tris Pharma, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 75mg Capsule (69367-0326) (Westminster Pharmaceuticals, LLC) nullPregabalin 75mg Capsule package photo

    Pregabalin Oral capsule

    Lyrica 100mg Capsule (43353-0413) (Aphena Pharma Solutions - Tennessee, LLC) null

    Pregabalin Oral capsule

    Lyrica 100mg Capsule (61919-0505) (Direct Rx) null

    Pregabalin Oral capsule

    Lyrica 100mg Capsule (55289-0257) (PD-Rx Pharmaceuticals, Inc.) (off market)

    Pregabalin Oral capsule

    Lyrica 100mg Capsule (00071-1015) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Lyrica 100mg Capsule (00071-1015) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (62332-0122) (Alembic Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (60687-0506) (American Health Packaging) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (69238-1313) (Amneal Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (60505-3796) (Apotex Corp) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (67877-0465) (Ascend Laboratories, LLC a Subsidiary of Alkem Laboratories Ltd) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (65862-0761) (Aurobindo Pharma USA Inc.) nullPregabalin 100mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (72162-1544) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (31722-0613) (Camber Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (72606-0007) (Celltrion USA, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (62135-0446) (Chartwell RX LLC) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (69097-0957) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (69097-0681) (Cipla USA, Inc) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (43598-0294) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (43598-0294) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (76282-0571) (Exelan Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (51407-0512) (Golden State Medical Supply, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (59762-1348) (Greenstone Ltd) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (00904-7001) (Major Pharmaceuticals Inc, a Harvard Drug Group Company) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (72205-0014) (Novadoz Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (71205-0872) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (71205-0872) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (64980-0413) (Rising Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (50228-0353) (ScieGen Pharmaceuticals, Inc) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (43547-0509) (Solco Healthcare US LLC) nullPregabalin 100mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (47335-0689) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (00093-7625) (Teva Pharmaceuticals USA) (off market)

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (00228-2859) (Teva/Actavis US) (off market)

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (27808-0237) (Tris Pharma, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 100mg Capsule (69367-0327) (Westminster Pharmaceuticals, LLC) nullPregabalin 100mg Capsule package photo

    Pregabalin Oral capsule

    Lyrica 150mg Capsule (43353-0414) (Aphena Pharma Solutions - Tennessee, LLC) null

    Pregabalin Oral capsule

    Lyrica 150mg Capsule (55289-0214) (PD-Rx Pharmaceuticals, Inc.) (off market)

    Pregabalin Oral capsule

    Lyrica 150mg Capsule (00071-1016) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Lyrica 150mg Capsule (00071-1016) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (62332-0123) (Alembic Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (60687-0517) (American Health Packaging) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (69238-1314) (Amneal Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (60505-3797) (Apotex Corp) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (67877-0466) (Ascend Laboratories, LLC a Subsidiary of Alkem Laboratories Ltd) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (65862-0762) (Aurobindo Pharma USA Inc.) nullPregabalin 150mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (72162-1545) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (63629-4181) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (31722-0614) (Camber Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (72606-0008) (Celltrion USA, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (62135-0447) (Chartwell RX LLC) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (69097-0958) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (69097-0682) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (43598-0295) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (43598-0295) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (76282-0572) (Exelan Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (51407-0513) (Golden State Medical Supply, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (59762-1351) (Greenstone Ltd) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (00904-7002) (Major Pharmaceuticals Inc, a Harvard Drug Group Company) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (72205-0015) (Novadoz Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (71205-0873) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (64980-0414) (Rising Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (50228-0354) (ScieGen Pharmaceuticals, Inc) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (43547-0510) (Solco Healthcare US LLC) nullPregabalin 150mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (47335-0690) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (00093-7626) (Teva Pharmaceuticals USA) (off market)

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (00228-2860) (Teva/Actavis US) (off market)

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (27808-0238) (Tris Pharma, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 150mg Capsule (69367-0328) (Westminster Pharmaceuticals, LLC) nullPregabalin 150mg Capsule package photo

    Pregabalin Oral capsule

    Lyrica 200mg Capsule (43353-0675) (Aphena Pharma Solutions - Tennessee, LLC) null

    Pregabalin Oral capsule

    Lyrica 200mg Capsule (00071-1017) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (62332-0124) (Alembic Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (69238-1315) (Amneal Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (60505-3798) (Apotex Corp) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (67877-0467) (Ascend Laboratories, LLC a Subsidiary of Alkem Laboratories Ltd) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (65862-0763) (Aurobindo Pharma USA Inc.) nullPregabalin 200mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (72162-1546) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (71335-1822) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (31722-0615) (Camber Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (69097-0959) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (69097-0683) (Cipla USA, Inc) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (43598-0296) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (76420-0122) (Enovachem Manufacturing) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (76282-0573) (Exelan Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (51407-0514) (Golden State Medical Supply, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (59762-1354) (Greenstone Ltd) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (00904-7003) (Major Pharmaceuticals Inc, a Harvard Drug Group Company) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (72205-0016) (Novadoz Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (71205-0874) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (64980-0415) (Rising Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (50228-0355) (ScieGen Pharmaceuticals, Inc) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (43547-0511) (Solco Healthcare US LLC) nullPregabalin 200mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (47335-0691) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (00093-7627) (Teva Pharmaceuticals USA) (off market)

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (00228-2861) (Teva/Actavis US) (off market)

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (27808-0239) (Tris Pharma, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 200mg Capsule (69367-0329) (Westminster Pharmaceuticals, LLC) nullPregabalin 200mg Capsule package photo

    Pregabalin Oral capsule

    Lyrica 225mg Capsule (43353-0876) (Aphena Pharma Solutions - Tennessee, LLC) null

    Pregabalin Oral capsule

    Lyrica 225mg Capsule (00071-1019) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (62332-0125) (Alembic Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (69238-1316) (Amneal Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (71610-0358) (Aphena Pharma Solutions - Tennessee, LLC) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (60505-3799) (Apotex Corp) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (67877-0468) (Ascend Laboratories, LLC a Subsidiary of Alkem Laboratories Ltd) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (65862-0764) (Aurobindo Pharma USA Inc.) nullPregabalin 225mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (72162-1547) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (31722-0616) (Camber Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (69097-0961) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (69097-0684) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (43598-0297) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (76420-0101) (Enovachem Manufacturing) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (76282-0574) (Exelan Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (51407-0516) (Golden State Medical Supply, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (59762-1360) (Greenstone Ltd) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (00904-7004) (Major Pharmaceuticals Inc, a Harvard Drug Group Company) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (72205-0017) (Novadoz Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (71205-0875) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (71205-0875) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (64980-0416) (Rising Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (50228-0356) (ScieGen Pharmaceuticals, Inc) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (43547-0512) (Solco Healthcare US LLC) nullPregabalin 225mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (47335-0692) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (00093-7628) (Teva Pharmaceuticals USA) (off market)

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (00228-2862) (Teva/Actavis US) (off market)

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (27808-0240) (Tris Pharma, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 225mg Capsule (69367-0330) (Westminster Pharmaceuticals, LLC) nullPregabalin 225mg Capsule package photo

    Pregabalin Oral capsule

    Lyrica 300mg Capsule (43353-0840) (Aphena Pharma Solutions - Tennessee, LLC) null

    Pregabalin Oral capsule

    Lyrica 300mg Capsule (55289-0255) (PD-Rx Pharmaceuticals, Inc.) (off market)

    Pregabalin Oral capsule

    Lyrica 300mg Capsule (00071-1018) (Pfizer Inc.) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (62332-0126) (Alembic Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (69238-1317) (Amneal Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (60505-3800) (Apotex Corp) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (67877-0469) (Ascend Laboratories, LLC a Subsidiary of Alkem Laboratories Ltd) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (65862-0765) (Aurobindo Pharma USA Inc.) nullPregabalin 300mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (72162-1548) (Bryant Ranch Prepack, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (31722-0617) (Camber Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (69097-0962) (Cipla USA, Inc) (off market)

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (69097-0685) (Cipla USA, Inc) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (43598-0298) (Dr. Reddy's Laboratories, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (76282-0575) (Exelan Pharmaceuticals, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (51407-0515) (Golden State Medical Supply, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (59762-1364) (Greenstone Ltd) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (00904-7005) (Major Pharmaceuticals Inc, a Harvard Drug Group Company) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (72205-0018) (Novadoz Pharmaceuticals LLC) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (71205-0876) (Proficient Rx LP) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (64980-0417) (Rising Pharmaceuticals Inc) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (50228-0357) (ScieGen Pharmaceuticals, Inc) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (43547-0513) (Solco Healthcare US LLC) nullPregabalin 300mg Capsule package photo

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (47335-0693) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (00093-7621) (Teva Pharmaceuticals USA) (off market)

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (00228-2863) (Teva/Actavis US) (off market)

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (27808-0241) (Tris Pharma, Inc.) null

    Pregabalin Oral capsule

    Pregabalin 300mg Capsule (69367-0331) (Westminster Pharmaceuticals, LLC) nullPregabalin 300mg Capsule package photo

    Pregabalin Oral solution

    Lyrica 20mg/mL Solution (00071-1020) (Pfizer Inc.) null

    Pregabalin Oral solution

    Pregabalin 20mg/mL Solution (67877-0457) (Ascend Laboratories, LLC a Subsidiary of Alkem Laboratories Ltd) null

    Pregabalin Oral solution

    Pregabalin 20mg/mL Solution (59762-1576) (Greenstone Ltd) null

    Pregabalin Oral solution

    Pregabalin 20mg/mL Solution (39328-0090) (Patrin Pharma Inc) null

    Pregabalin Oral tablet, extended release

    Lyrica CR 82.5mg Extended-Release Tablet (00071-1026) (Pfizer Inc.) null

    Pregabalin Oral tablet, extended release

    Pregabalin 82.5mg Extended-Release Tablet (72888-0049) (AdvaGen Pharma Ltd.) nullPregabalin 82.5mg Extended-Release Tablet package photo

    Pregabalin Oral tablet, extended release

    Pregabalin 82.5mg Extended-Release Tablet (47781-0379) (Alvogen, Inc.) null

    Pregabalin Oral tablet, extended release

    Pregabalin 82.5mg Extended-Release Tablet (72205-0077) (Novadoz Pharmaceuticals LLC) nullPregabalin 82.5mg Extended-Release Tablet package photo

    Pregabalin Oral tablet, extended release

    Pregabalin 82.5mg Extended-Release Tablet (63304-0047) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral tablet, extended release

    Lyrica CR 165mg Extended-Release Tablet (00071-1027) (Pfizer Inc.) null

    Pregabalin Oral tablet, extended release

    Pregabalin 165mg Extended-Release Tablet (72888-0050) (AdvaGen Pharma Ltd.) nullPregabalin 165mg Extended-Release Tablet package photo

    Pregabalin Oral tablet, extended release

    Pregabalin 165mg Extended-Release Tablet (47781-0380) (Alvogen, Inc.) null

    Pregabalin Oral tablet, extended release

    Pregabalin 165mg Extended-Release Tablet (72205-0078) (Novadoz Pharmaceuticals LLC) nullPregabalin 165mg Extended-Release Tablet package photo

    Pregabalin Oral tablet, extended release

    Pregabalin 165mg Extended-Release Tablet (63304-0048) (Sun Pharmaceutical Industries, Inc.) null

    Pregabalin Oral tablet, extended release

    Lyrica CR 330mg Extended-Release Tablet (00071-1029) (Pfizer Inc.) null

    Pregabalin Oral tablet, extended release

    Pregabalin 330mg Extended-Release Tablet (72888-0051) (AdvaGen Pharma Ltd.) nullPregabalin 330mg Extended-Release Tablet package photo

    Pregabalin Oral tablet, extended release

    Pregabalin 330mg Extended-Release Tablet (47781-0381) (Alvogen, Inc.) null

    Pregabalin Oral tablet, extended release

    Pregabalin 330mg Extended-Release Tablet (72205-0079) (Novadoz Pharmaceuticals LLC) nullPregabalin 330mg Extended-Release Tablet package photo

    Pregabalin Oral tablet, extended release

    Pregabalin 330mg Extended-Release Tablet (63304-0049) (Sun Pharmaceutical Industries, Inc.) null

    Description/Classification

    Description

    Pregabalin is an oral compound that is chemically and structurally similar to gabapentin, with antiepileptic, analgesic, and anxiolytic properties. It is indicated for neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia in adult patients and adjunctive therapy for partial onset seizures in adult and pediatric patients. Antiepileptic drugs, including pregabalin, are associated with an increased risk of suicidal thoughts and behaviors; patients should be monitored for new or worsening depression, suicidal thoughts and/or behaviors, and changes in mood or behavior.[31493]

    Classifications

    • Central Nervous System
      • Analgesics
        • Neuropathic Pain and Peripheral Neuropathy Agents
      • Anticonvulsants
        • Anticonvulsants, Gabapentinoids
    Revision Date: 05/24/2024, 01:33:00 AM

    References

    31493 - Lyrica (pregabalin) package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.

    Administration Information

    General Administration Information

    For storage information, see the specific product information within the How Supplied section.

    Route-Specific Administration

    Oral Administration

    • When discontinuing pregabalin, taper the dose gradually over a minimum of 1 week.[31493][62506]

     

    Immediate-release capsules and oral solution

    • Both capsules and oral solution may be administered without regard to meals.
    • Missed doses: Advise patients that if they miss a dose, then they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at their regularly scheduled time. Instruct patients not to take 2 doses at the same time.[31493]

     

    Extended-release tablets

    • Administer after evening meal.
    • Do not split, crush, or chew the tablet.
    • When switching from immediate-release to extended-release pregabalin, on the day of the switch, instruct patients to take their morning dose of immediate-release pregabalin as prescribed and initiate extended-release pregabalin therapy after the evening meal.
    • Missed doses: Advise patients that if they miss taking their dose of extended-release pregabalin after an evening meal, then they should take their usual dose before bedtime after a snack. If they miss taking the dose before bedtime, then they should take their usual dose after a morning meal. If they miss taking the dose after the morning meal, then they should take their usual dose at the usual time that evening after an evening meal.[62506]

    Clinical Pharmaceutics Information

    From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database
      Revision Date: 05/24/2024, 01:33:00 AM

      References

      31493 - Lyrica (pregabalin) package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.62506 - Lyrica CR (pregabalin) extended-release tablets package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.

      Adverse Reactions

      Moderate

      • amblyopia
      • amnesia
      • anemia
      • aphasia
      • ascites
      • ataxia
      • balanitis
      • blepharitis
      • blurred vision
      • bullous rash
      • cervicitis
      • chest pain (unspecified)
      • cholelithiasis
      • colitis
      • confusion
      • conjunctivitis
      • constipation
      • contact dermatitis
      • crystalluria
      • delirium
      • depression
      • dysarthria
      • dyskinesia
      • dyspareunia
      • dysphagia
      • dyspnea
      • dystonic reaction
      • dysuria
      • edema
      • ejaculation dysfunction
      • elevated hepatic enzymes
      • encephalopathy
      • eosinophilia
      • esophagitis
      • euphoria
      • exophthalmos
      • fluid retention
      • gastritis
      • glycosuria
      • hallucinations
      • hematuria
      • hostility
      • hyperacusis
      • hyperalgesia
      • hyperesthesia
      • hypertension
      • hypertonia
      • hypoglycemia
      • hypotension
      • hypotonia
      • impotence (erectile dysfunction)
      • infertility
      • iritis
      • leukopenia
      • lymphadenopathy
      • mania
      • melena
      • memory impairment
      • myasthenia
      • myoclonia
      • myopathy
      • neuritis
      • nystagmus
      • oral ulceration
      • orthostatic hypotension
      • palpitations
      • peripheral edema
      • peripheral neuropathy
      • phlebitis
      • photophobia
      • physiological dependence
      • polycythemia
      • proteinuria
      • psychosis
      • respiratory depression
      • sinus tachycardia
      • skin ulcer
      • stomatitis
      • thrombocytopenia
      • trismus
      • urinary incontinence
      • urinary retention
      • wheezing
      • withdrawal

      Mild

      • abdominal pain
      • agitation
      • alopecia
      • amenorrhea
      • anxiety
      • appetite stimulation
      • arthralgia
      • asthenia
      • back pain
      • breast enlargement
      • chills
      • cough
      • diarrhea
      • diplopia
      • dizziness
      • drowsiness
      • dysgeusia
      • dysmenorrhea
      • ecchymosis
      • fatigue
      • fever
      • flatulence
      • gynecomastia
      • headache
      • hiccups
      • hirsutism
      • hyperkinesis
      • hypersalivation
      • hypoesthesia
      • increased urinary frequency
      • infection
      • insomnia
      • irritability
      • lethargy
      • leukocytosis
      • leukorrhea
      • libido decrease
      • libido increase
      • malaise
      • menorrhagia
      • miosis
      • muscle cramps
      • musculoskeletal pain
      • myalgia
      • mydriasis
      • nausea
      • orgasm dysfunction
      • paranoia
      • paresthesias
      • parosmia
      • pelvic pain
      • pharyngitis
      • photosensitivity
      • pruritus
      • psychomotor impairment
      • ptosis
      • purpura
      • rash
      • sinusitis
      • syncope
      • tinnitus
      • tremor
      • urticaria
      • vertigo
      • vesicular rash
      • vomiting
      • weight gain
      • xerophthalmia
      • xerosis
      • xerostomia
      • yawning

      Severe

      • acute cerebellar syndrome
      • anaphylactoid reactions
      • angioedema
      • apnea
      • cholecystitis
      • coma
      • epididymitis
      • esophageal ulceration
      • exfoliative dermatitis
      • GI bleeding
      • Guillain-Barre syndrome
      • heart failure
      • increased intracranial pressure
      • keratitis
      • keratoconjunctivitis
      • laryngeal edema
      • laryngospasm
      • new primary malignancy
      • night blindness
      • ocular hemorrhage
      • oliguria
      • optic atrophy
      • pancreatitis
      • papilledema
      • pulmonary edema
      • pulmonary fibrosis
      • renal failure (unspecified)
      • retinal edema
      • retroperitoneal fibrosis
      • rhabdomyolysis
      • skin atrophy
      • skin necrosis
      • Stevens-Johnson syndrome
      • suicidal ideation
      • torticollis
      • uveitis
      • ventricular fibrillation
      • visual impairment

      Anticonvulsants, including pregabalin, are thought to carry an increased risk of depression (2%) and suicidal ideation/behavior. An analysis by the FDA of previously gathered drug data showed that patients receiving anticonvulsants had approximately twice the risk of suicidal behavior or ideation (0.43%) as patients receiving placebo (0.24%). The relative risk was higher in patients with epilepsy compared to those with other conditions. Age was not a determining factor. The increased risk of suicidal ideation and behavior occurred between 1 and 24 weeks after therapy initiation. However, a longer duration of therapy should not preclude the possibility of an association to the drug since most studies included in the analysis did not continue beyond 24 weeks. All patients beginning treatment with anticonvulsants or currently receiving such treatment should be closely monitored for emerging or worsening suicidal thoughts/behavior or depression. Patients and caregivers should be informed of the increased risk of suicidal thoughts and behaviors and should be advised to immediately report the emergence or worsening of depression, the emergence of suicidal thoughts or behavior, thoughts of self-harm, or other unusual changes in mood or behavior.[31493]

      Peripheral edema occurred in roughly 27% of patients taking pregabalin doses of immediate-release pregabalin 300 to 600 mg/day and in 17% of those taking 150 mg/day.[30759] Lower incidences (3% to 16%) of peripheral edema, edema (1% to 8.2%), and fluid retention (2% to 3%) have been reported; 0.5% of pregabalin patients withdrew from therapy due to fluid retention vs. 0.2% of those on placebo.[31493] Across all clinical trials of the controlled-release tablets for pain indications, peripheral edema occurred in 5.3% of patients during single-blind phase. Peripheral edema (3.8% to 4.9%) and edema (0.4% to 1.4%) occurred during a randomized trial of the controlled-release tablets in patients with postherpetic neuralgia. Peripheral edema led to pregabalin discontinuation in 0.5% to 0.8% of patients.[62506] Pregabalin-induced edema did not appear to be associated with cardiovascular complications or renal or hepatic deterioration in short-term studies in patients without these complications. However, higher rates of peripheral edema (up to 19%) and an increase in weight (up to 7.5%) may occur in patients who concomitantly take a thiazolidinedione antidiabetic agent with pregabalin. As the thiazolidinedione class of antidiabetic drugs can cause gain in weight and/or fluid retention, possibly exacerbating or leading to heart failure, care should be taken when coadministering pregabalin and these agents.[31493] Dyspnea, which may or may not be associated with edema, has also been infrequently reported (2% vs. 1% placebo).

      Adverse events not listed elsewhere that have been reported during pregabalin clinical trials in more than 1% of patients included anxiety (2%), arthralgia (3% to 6%), chest pain (unspecified) (1% to 4%), muscle spasms (2% to 4%), speech disorder or dyspraxia (1% to 7%), hypotension (2.2% or less), hypertension (2.2%), and urinary incontinence (1% to 2.7%). Other adverse reactions occurring in 1% or more of pregabalin-treated patients during clinical trials included fever, impotence (erectile dysfunction), increased urinary frequency, libido decrease, leg muscle cramps, myalgia, orgasm dysfunction (anorgasmia), and tinnitus. Infrequent (0.1% to 1%) adverse events reported during pregabalin clinical trials included albuminuria, amenorrhea, arthrosis, chills, dysmenorrhea, dysuria, ejaculation dysfunction, heart failure, hematuria, hyperacusis, leukorrhea, libido increase, menorrhagia, metrorrhagia, nephritis, oliguria, urinary retention, pelvic pain, joint stiffness, syncope, thrombo-phlebitis, orthostatic hypotension, palpitations, chest pain (unspecified), and facial edema. Rare reactions (less than 0.1%) during clinical trials included apnea, ascites, atelectasis, balanitis, bronchiolitis, cervicitis, coma, crystalluria, dyspareunia, epididymitis, granuloma, hiccups, increased intracranial pressure, lactation, laryngismus or laryngospasm, glomerulitis, ovarian disorder, parosmia, pulmonary edema, pulmonary fibrosis, pyelonephritis, renal failure (unspecified), retroperitoneal fibrosis, shock, ST depression, ventricular fibrillation, sinus tachycardia, facial pain, glycosuria, increased lipase, increased neutrophil count, proteinuria, coccydynia, myokymia, and yawning. Causality between pregabalin and these adverse events has not been definitively established.[31493] [62506] During a randomized trial of the controlled-release tablets in patients with postherpetic neuralgia, elevated hepatic enzymes (ALT 0.2% to 1.4%; AST 0.2% to 1%), arthralgia (0.7% to 1%), joint swelling (0% to 1.9%), cough (0.2% to 1%), and impotence (erectile dysfunction) (0.6% to 1.4%) occurred in pregabalin-treated patients.[62506] Although pregabalin treatment was associated with mild cardiac PR interval prolongation, no adverse events or AV heart block have been reported due to this effect. Additionally, subgroup analyses indicate that patients with baseline PR prolongation taking other PR prolonging medications do not appear to be at greater risk than the normal population, but numbers of patients in these groups were small.[31493]

      In clinical trials of immediate-release pregabalin, headaches were reported in neuropathic pain studies at an incidence of 5% to 9% in pregabalin groups vs. 5% in placebo groups. In clinical trials for fibromyalgia, headache occurred more frequently in pregabalin-treated patients (10% to 14%) than in those receiving placebo (12%), leading to discontinuation in about 1% of patients.[31493] Headaches occurred in 1.9% to 3.9% of patients during a randomized trial of the controlled-release tablets in patients with postherpetic neuralgia.[62506]

      In clinical trials, amnesia (1% to 6%) and memory impairment (1% to 4%) were reported by recipients of immediate-release pregabalin therapy.[31493] Across all clinical trials with immediate- and controlled-release pregabalin, amnesia was observed in 0.1% to 1% of patients.[62506]

      In pregabalin clinical trials for fibromyalgia, fatigue occurred more frequently in pregabalin-treated patients (5% to 8%) than in those receiving placebo (4%), leading to discontinuation in about 1% of patients. Fibromyalgia patients receiving treatment with pregabalin also experienced a higher incidence of lethargy (1% to 2%) when compared with patients receiving placebo (0%). During clinical trials for neuropathic pain associated with spinal cord injury, fatigue was reported more frequently in pregabalin-treated patients (11%) than placebo-treated patients (4%).[31493] Fatigue (1.4% to 3.9%) also occurred during a randomized trial of the controlled-release tablets in patients with postherpetic neuralgia.[62506]

      Gastrointestinal adverse events have been reported in pregabalin trials. Xerostomia, or dry mouth, is dose-related with an incidence ranging from 1% up to 15% with higher doses of immediate-release pregabalin (more than 300 mg/day). Other adverse reactions affecting the gastrointestinal tract include abdominal pain or distension (2%), appetite stimulation (2% to 7%), constipation (1% to 10%), flatulence (1% to 3%), gastroenteritis (1%), and nausea with or without vomiting (1% to 4.9%).[31493] During a clinical trial of the controlled-release tablets in patients with postherpetic neuralgia, pregabalin-treated patients experienced xerostomia (0.5% to 3.7%), nausea (3% to 3.4%), constipation (0% to 2.7%), diarrhea (1% to 1.4%), and vomiting (1.1% to 1.4%).[62506] During a placebo-controlled study in pediatric patients with partial onset seizures, increased appetite occurred in 8% of pregabalin-treated patients (n = 201) compared to 4% of placebo-treated patients (n = 94). Increased appetite occurred in 7% of patients who received a pregabalin dose of 2.5 mg/kg/day (n = 104) and 10% of patients who received a dose of 10 mg/kg/day (n = 97). Additionally, hypersalivation occurred in 2% of pregabalin-treated patients vs. 0% of placebo-treated patients. Hypersalivation occurred in 1% of patients who received a pregabalin dose of 2.5 mg/kg/day and 4% of patients who received a dose of 10 mg/kg/day.[31493] Adverse reactions infrequently (0.1% to 1%) reported by recipients of pregabalin during clinical trials included ageusia and dysgeusia, abdominal pain or distension, cholecystitis, cholelithiasis, colitis, dysphagia, esophagitis, gastritis, GI bleeding, melena, oral ulceration, pancreatitis, and rectal bleeding. Rare (less than 0.1%) reactions included aphthous stomatitis, esophageal ulceration, and periodontal abscesses. Nausea and diarrhea were reported during postmarketing use.[31493] [62506]

      Myoclonus (myoclonia) has been observed in patients being treated with pregabalin for focal epilepsy and appears to be dose-related. The frequency and intensity of myoclonic jerks decreased after dose reduction of pregabalin. In some cases, the myoclonus was subtle and did not require dose reduction. Four of 19 patients in 1 review developed myoclonus, which is a similar rate to myoclonus reported in patients receiving the structurally similar anticonvulsant gabapentin. Several patients who have developed myoclonic jerks were also taking carbamazepine, which is also associated with myoclonus. Additionally, rapid dose titration of pregabalin may result in a higher frequency of myoclonus.[30761] Myoclonus was reported to occur at a mean incidence of 2% in all dose groups combined for pregabalin and 0% for placebo groups during clinical trials. In the groups receiving 150, 300, or 600 mg/day of pregabalin, myoclonus occurred at a rate of 1%, 0%, and 4%, respectively. Additionally, recipients of pregabalin have also experienced tremor (1% to 11%) and twitching (4% to 5%) during clinical trials.[31493]

      Recipients of pregabalin treatment during clinical trials reported experiencing impairments in movement and sensation. These neurologic adverse reactions included ataxia (1% to 20%), abnormal gait (1% to 8%), asthenia (2% to 7%), hypertonia (1% or more), hypoesthesia (2% to 3%), incoordination (1% to 6%), myasthenia (1% to 4.9%), paresthesias (1% or more), and peripheral neuropathy (2% to 9%). Infrequent (0.1% to 1%) cases of hyperalgesia, hyperesthesia, hyperkinesis, hypokinesia, hypotonia, and neuralgia were also reported with pregabalin therapy. Balance disorders were a reason for drug discontinuation in roughly 1% of patients. Acute cerebellar syndrome, cogwheel rigidity, dysautonomia, dyskinesia, dystonic reaction, extrapyramidal syndrome, peripheral neuritis, torticollis, and trismus were rarely (less than 0.1%) reported during pregabalin clinical trials. Other musculoskeletal effects or pain symptoms reported more frequently in pregabalin-treated patients than placebo-treated patients include arthredema (2.2% vs. 0%) and musculoskeletal pain, such as back pain (1% to 4% vs. 3%), unspecified pain (3.3% vs. 1.1%), extremity pain (3.3% vs. 2.3%), and neck pain (2.7% vs. 1.1%).[31493] During studies of controlled-release pregabalin, pregabalin-treated patients experienced balance disorder (0.5% to 2.6% vs. 0% placebo). Across all clinical trials, bradykinesia, psychomotor impairment, and psychomotor hyperactivity occurred in less than 0.1% of pregabalin recipients.[62506]

      In pregabalin clinical trials of immediate-release formulations of up to 14 weeks, a gain of 7% or more over baseline weight was observed in 9% of pregabalin-treated patients and 2% of placebo-treated patients. From 1% to 16% of pregabalin-treated patients experienced weight gain during clinical trials compared to 1% for placebo.[31493] Across all clinical trials of the controlled-release tablets for pain indications, weight gain occurred in 4% of patients during single-blind phase. During the double-blind phase of a randomized trial of the controlled-release tablets in patients with postherpetic neuralgia (n = 413), weight gain occurred more frequently in pregabalin-treated patients than in placebo-treated patients (3.7% vs. 1%).[62506] Few patients treated with immediate-release pregabalin (0.3%) withdrew from controlled trials due to weight gain. Increased appetite was reported in epilepsy trials (5% vs. 1% placebo) as well as trials for fibromyalgia. Pregabalin-associated weight gain was related to dose and duration of exposure, but did not appear to be associated with baseline body mass index (BMI), gender, or age. During a placebo-controlled study in pediatric patients with partial onset seizures, weight gain occurred in 8% of pregabalin-treated patients (n = 201) compared to 4% of placebo-treated patients (n = 94). Weight gain occurred in 4% of patients who received a pregabalin dose of 2.5 mg/kg/day (n = 104) and 13% of patients who received a dose of 10 mg/kg/day (n = 97). In a cohort of 333 diabetic patients who received pregabalin for at least 2 years, the average weight gain was 5.2 kg. While the effects of pregabalin-associated weight gain on glycemic control have not been systematically assessed, pregabalin treatment did not appear to be associated with loss of glycemic control (as measured by A1C) in controlled and longer-term open label clinical trials with diabetic patients. Hypoglycemia was reported in 1% to 3% of pregabalin recipients and 1% of placebo recipients during a clinical trial for diabetic peripheral neuropathy.[31493]

      Hypersensitivity reactions including redness, blisters, hives or urticaria (0.1% to 1%), rash (0.1% to 1%), dyspnea (2% to 3%), and wheezing have been reported during clinical and postmarketing use of pregabalin. Angioedema of the face, mouth (lips, tongue, and gums), throat, and larynx (laryngeal edema) has occurred in up to 1% to 3% of pregabalin recipients during clinical trials. In addition, life-threatening angioedema with respiratory compromise and anaphylactoid reactions (less than 0.1%) have also been reported.[31493] [62506]

      During clinical trials, pruritus (1% or more) was among the most frequent dermatologic adverse events reported by recipients of pregabalin. During clinical trials for the treatment of neuropathic pain associated with spinal cord injury, skin ulcer occurred in 2.7% of pregabalin-treated patients and 1.1% of placebo-treated patients. Skin ulcer was reported less frequently in other clinical trial evaluations (0.1% to 1%). Other less common dermatologic adverse events (0.1% to 1%) occurring during pregabalin clinical trials included alopecia, cellulitis, dry skin (xerosis), eczema, hirsutism, photosensitivity, and vesicular rash. Mucosal dryness, exfoliative dermatitis, lichenoid dermatitis, melanosis, nail disorder, petechial rash, purpuric rash, pustular rash, skin atrophy, skin necrosis, skin nodule, and Stevens-Johnson syndrome were reported rarely (less than 0.1%) by persons treated with pregabalin. Bullous rash (bullous pemphigoid) has been reported with pregabalin during postmarketing experience.[31493] [62506] Contact dermatitis occurred in 0% to 1% of patients receiving controlled-release pregabalin in a clinical trial for postherpetic neuralgia.[62506]

      In controlled studies, a higher proportion of patients treated with immediate-release pregabalin reported blurred vision (1% to 12%) than did patients treated with placebo (1% to 4%), which resolved in a majority of cases with continued dosing. In epilepsy trials, blurred vision and diplopia occurred at an incidence of 12% in the 600 mg/day groups. However, less than 1% of patients discontinued pregabalin treatment due to vision-related events (primarily blurred vision).[31493] Across all clinical trials of the controlled-release tablets for pain indications, blurred vision occurred in 4.8% of patients in the single-blind phase. Blurred vision occurred in 0.5% to 3.7% of pregabalin patients during a randomized trial of the controlled-release tablets in patients with postherpetic neuralgia. Blurred vision led to pregabalin discontinuation in less than 1% of patients.[62506] Blurred vision appears to be a dose-related effect. Diplopia (double vision) has been reported in 2% to 12% of patients receiving immediate-release pregabalin and 0.5% to 1% of patients receiving controlled-release pregabalin vs. 0% to 4% of placebo-treated patients.[31493] [62506] Amblyopia (distorted vision) (1% to 12%), abnormal vision, conjunctivitis (1% or more), nystagmus (1% or more), and visual impairment (1% to 5%) have also been reported.[30759] Visual acuity and visual field changes were evaluated in clinical trials, but compared to placebo, differences appeared minor. Less frequent (0.1% to 1%) adverse reactions reported during clinical trials included accommodation abnormalities, blepharitis, ocular hemorrhage, photophobia, retinal edema, periorbital edema, and xerophthalmia or dry eyes. Anisocoria, blindness, corneal ulcer, exophthalmos, iritis, keratitis, keratoconjunctivitis, miosis, mydriasis, night blindness, ophthalmoplegia, optic atrophy, papilledema, ptosis, and uveitis were also reported rarely (less than 0.1%) with pregabalin use during clinical trials. If visual disturbance persists, further assessment should be considered. More frequent assessment should be considered for patients who are already routinely monitored for ocular conditions.[31493] [62506]

      Pregabalin treatment has been associated with creatine kinase elevations. Mean changes in creatine kinase from baseline to the maximum value were 60 units/L for pregabalin-treated patients and 28 units/L for the placebo patients. During clinical trials for the treatment of neuropathic pain associated with spinal cord injury, elevated creatine phosphokinase occurred in 2.7% of patients receiving pregabalin and no patients treated with placebo. In clinical trials overall, roughly 1.5% of pregabalin patients and 0.7% of placebo patients had a value of creatine kinase at least 3 times the upper limit of normal. Three pregabalin treated subjects had events reported as rhabdomyolysis in premarketing clinical trials. The relationship between these myopathy events and pregabalin is not completely known. Prescribers should instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or pyrexia. Pregabalin treatment should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase concentrations occur.[31493]

      Pregabalin treatment has been associated with a decrease in platelet count. Pregabalin-treated subjects experienced a mean maximal decrease in platelet count of 20 x 103/microliters, compared to 11 x 103/microliters in placebo patients during clinical trials of immediate-release formulations.[31493] During studies of controlled-release pregabalin, pregabalin-treated subjects experienced median changes from platelet baseline of 11 x 103/mm3 (postherpetic neuralgia) and 14 x 103/mm3 (fibromyalgia), compared to 1 x 103/mm3 for all placebo-treated populations.[62506] In the overall database of controlled trials, 3% of pregabalin patients and 2% of placebo patients experienced a potentially clinically significant decrease in platelets, defined as 20% below baseline value and less than 150 x 103/microliters. One patient developed severe thrombocytopenia with a platelet count less than 20 x 103/microliters. Additionally, ecchymosis occurred in 1% or more of pregabalin recipients. Other hematologic adverse events reported in 0.1% to 1% of pregabalin-treated patients during clinical trials included anemia and hypochromic anemia, eosinophilia, leukocytosis, leukopenia, and lymphadenopathy. Rare (less than 0.1%) hematologic adverse events included myelofibrosis, polycythemia, decrease in prothrombin, purpura, and thrombocythemia. In randomized controlled trials, pregabalin was not associated with an increase in bleeding-related adverse events.[31493] [62506]

      During clinical trials for fibromyalgia, patients receiving treatment with pregabalin experienced a higher incidence of sinusitis (4% to 7%) when compared with patients receiving placebo (4%). During clinical trials for neuropathic pain associated with spinal cord injury, pharyngitis (nasopharyngitis) occurred more frequently in pregabalin-treated patients (8.2%) than placebo-treated patients (4.6%). Infection (3% to 14%), bronchitis (1% to 3%), and otitis media (1% or more) were reported among pregabalin-treated patients. In pediatric trials for partial onset seizures, viral infection (4%) and pneumonia (4%) were reported in patients 1 month to 3 years.[31493] During studies of controlled-release pregabalin, pregabalin-treated patients experienced nasopharyngitis (1.4% to 1.5% vs. 0% placebo), bronchitis (0.5% to 1.4% vs. 1%), viral respiratory tract infection (0.4% to 1.4% vs. 0.5%), sinusitis (0.4% to 1% vs. 0%), urinary tract infection (1.4% vs. 0.5%), and viral gastroenteritis (0.2% to 1% vs. 0%). Across all adult clinical trials, otitis media (0.1% to 1%) and pneumonia (0.1% to 1%) were reported in pregabalin recipients.[62506]

      Addiction or physiological dependence to pregabalin may develop in certain individuals. In a study of recreational drug users (n = 15) of sedative/hypnotic drugs (including alcohol), pregabalin (450 mg, single dose) received subjective ratings of 'good drug effect,' 'high,' and 'liking' to a degree that was similar to 30 mg of diazepam. In controlled clinical studies (n more than 5,500), 4% of pregabalin-treated patients and 1% of placebo-treated patients overall reported euphoria as an adverse event; however, in some patients, this reporting rate was higher and ranged from 1% to 12%. In clinical studies, after abrupt or rapid discontinuation of pregabalin, some patients reported withdrawal or a discontinuation syndrome consisting of sleeplessness, nausea, headache, or diarrhea.[31493] Pregabalin should be tapered over a week if treatment is to be stopped.

      Central nervous system (CNS) adverse effects are the most common adverse effects reported with pregabalin therapy. In the majority of clinical studies of immediate-release pregabalin, the most commonly reported CNS adverse events were dizziness (8% to 45%) and somnolence (drowsiness) (4% to 35.7%). The majority (85%) of these adverse events were mild to moderate in intensity and dose dependent. Dizziness and drowsiness may not be transient drug effects. The incidence of dizziness ranges from 23% to 45% with pregabalin doses of 300 to 600 mg/day and 8% and 9% with 75 mg/day and 150 mg/day, respectively. Somnolence or drowsiness occurs in 13% to 28% with higher doses and 4% to 13% with the lower dose of pregabalin.[30759] [31493] Dizziness and somnolence are the adverse events most frequently leading to withdrawal (4% for dizziness and 3% for somnolence) from controlled studies. In pregabalin-treated patients reporting these adverse events in short-term, controlled studies, dizziness persisted until the last dose in 30% and somnolence persisted until the last dose in 42% of patients.[31493] [62506] During the single-blind phase of clinical trials of controlled-release pregabalin for pain indications, 24% of pregabalin-treated patients experienced dizziness and 15.8% of patients experienced drowsiness. Study withdrawal due to dizziness or drowsiness during a single-blind phase occurred in 2.4% and 1.2% of controlled-release pregabalin-treated patients, respectively. Dizziness and somnolence generally began shortly after treatment initiation and occurred more frequently with higher doses. During a randomized trial of controlled-release pregabalin in patients with postherpetic neuralgia, dizziness was observed in 3.4% to 17.1% of patients, and drowsiness in 0.5% to 11.4% of patients.[62506] In pediatric trials, somnolence (including the terms lethargy, sluggishness, hypersomnia) was reported in 15% to 21% of patients and occurred more frequently at higher doses. Drowsiness led to pregabalin discontinuation in 3 pediatric patients, and hallucination and worsening of epilepsy also each resulted in pregabalin discontinuation in a single patient.[31493] Other CNS adverse events reported during pregabalin clinical trials included abnormal thinking (1% to 9%), confusion (1% to 7%), insomnia (3.8%), disturbance in attention (3.8%), depersonalization (1%), disorientation (1% to 2%), drunk or hungover feeling (0.1% to 2%), nervousness (1%), stupor (1% or more), and vertigo (1% to 4%). Adverse events infrequently (0.1% to 1%) reported included abnormal dreams, agitation, apathy, aphasia, cognitive disorder, dysarthria (change in speech), hallucinations, hostility, irritability, malaise, sciatica, and sleep phase rhythm disturbance. Delirium, delusion, depressed level of consciousness, altered state of consciousness, encephalopathy, Guillain-Barre syndrome, mania, paranoia, psychosis, schizophrenic reactions, and sleep disorders were rarely (less than 0.1%) reported in recipients of pregabalin during clinical trials.[31493] [62506]

      In carcinogenicity studies of pregabalin in mice, an unexpectedly high incidence of hemangiosarcoma was identified. Clinical experience during pregabalin premarketing development provides no direct means to assess its potential for inducing tumors in humans. In clinical studies covering more than 6,300 patient-years of exposure in patients 12 years and older, new or worsening pre-existing tumors were reported in 57 patients. The clinical significance of these findings is unknown; however, health care providers are advised to be aware of the potential for a new primary malignancy following treatment with pregabalin.[31493]

      Breast enlargement and gynecomastia have been reported during postmarketing use of pregabalin. The frequencies are unknown and causality to the drug has not been established.[31493]

      Men may experience decreased sperm concentrations and potential reproductive risk, such as infertility, with pregabalin therapy. In a randomized, double-blind, placebo-controlled, non-inferiority study to examine the effect of pregabalin on sperm characteristics, healthy male subjects received pregabalin at a daily dose of 600 mg or less (n = 111) or placebo (n = 109) for 13 weeks followed by a 13-week washout period. In the per protocol population (pregabalin, n = 65; placebo, n = 62), approximately 9% of the pregabalin group vs. 3% of the placebo group had a 50% or more reduction in mean sperm concentrations from baseline at week 26. The difference between pregabalin and placebo was within the pre-specified non-inferiority margin of 20%. Sperm concentrations were no longer reduced by 50% or more after an additional 3 months off pregabalin. However, at 9-month and 12-month follow-up visits, 1 subject did demonstrate reductions in sperm concentrations of 50% or more. There were no adverse effects on sperm morphology, sperm motility, or serum follicle-stimulating hormone or testosterone concentrations compared to placebo. The clinical significance of these data is uncertain.[31493]

      Respiratory depression can occur with pregabalin alone or in combination with other central nervous system (CNS) depressants or in patients with underlying respiratory impairment. Over approximately 6 years, 49 postmarketing reports of respiratory depression with gabapentinoids were identified; gabapentin accounted for 15 cases and pregabalin for 34 cases. A respiratory risk factor, including age-related loss of lung function, or the use of a CNS depressant was reported in 92% of cases. Death occurred in 12 patients (24%). All death cases reported at least 1 risk factor for developing respiratory depression or concomitant use of a CNS depressant. Exposure to preoperative gabapentinoids increases the risk of postoperative respiratory depression. In a case-control study of more than 11,000 arthroplasty patients, the risk of respiratory depression, defined as apnea, hypopnea, oxyhemoglobin desaturation, or an episode of severe pain despite moderate to profound sedation (i.e., pain-sedation mismatch), during recovery in the postanesthesia care unit was increased 60% for patients using regional anesthesia (OR 1.60, 95% CI 1.27, 2.02) and 47% for those using general anesthesia (OR 1.47, 95% CI 1.26, 1.70) when the preoperative anesthesia regimen included gabapentin doses more than 300 mg compared to no preoperative gabapentin exposure. Preoperative gabapentin increased the risk of postoperative respiratory depression by 26% (OR 1.26, 95% CI 1.02, 1.58) compared to no preoperative exposure in another case-control study of more than 8,000 laparoscopy patients. Respiratory depression was defined as apnea, hypopnea, oxyhemoglobin desaturation, pain-sedation mismatch, naloxone administration, failure to extubate, need to reintubate, or non-invasive positive pressure ventilation (NIPPV) use in patients who were not previously prescribed such a device. Initiate pregabalin at the lowest recommended dose and monitor for symptoms of respiratory depression and sedation in elderly patients, patients with underlying pulmonary disease, or during coadministration with other CNS depressants. Management of respiratory depression should include observation, necessary supportive measures, and reduction or withdrawal of CNS depressants, including pregabalin. Taper the dose of pregabalin used for analgesia or seizure control before discontinuation.[64848]

      Revision Date: 05/24/2024, 01:33:00 AM

      References

      30759 - Frampton JE, Scott LJ. Pregabalin: in the treatment of painful diabetic peripheral neuropathy. Drugs 2004;64:2813-20.30761 - Huppertz HJ, Feuerstein TJ, Schulze-Bonhage A. Myoclonus in epilepsy patients with anticonvulsive add-on therapy with pregabalin. Epilepsia 2001;42:790-2.31493 - Lyrica (pregabalin) package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.62506 - Lyrica CR (pregabalin) extended-release tablets package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.64848 - Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR). https://www.fda.gov/media/133681/download. Retrieved December 19, 2019.

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • abrupt discontinuation
      • angioedema
      • breast-feeding
      • chronic obstructive pulmonary disease (COPD)
      • CNS depression
      • coadministration with other CNS depressants
      • depression
      • diabetes mellitus
      • driving or operating machinery
      • ethanol intoxication
      • geriatric
      • heart failure
      • infertility
      • male-mediated teratogenicity
      • ocular disease
      • pregnancy
      • pulmonary disease
      • renal failure
      • renal impairment
      • reproductive risk
      • respiratory depression
      • substance abuse
      • suicidal ideation

      Pregabalin is contraindicated in patients with known pregabalin hypersensitivity or with product specific ingredient hypersensitivity. It is not known if cross-hypersensitivity exists between gabapentin and pregabalin; however, the drugs are chemically and structurally similar. Use with caution in patients with a known hypersensitivity to gabapentin. There are postmarketing reports of hypersensitivity reactions (i.e., erythema, blisters, hives, rash, dyspnea, and wheezing) and life-threatening angioedema. Discontinue treatment with pregabalin immediately if these reactions occur. Caution is advised during use of pregabalin in patients with a history of angioedema. Concurrent use of other medications known to cause angioedema may increase the risk of this complication with use of pregabalin.[31493]

      Antiepileptic drugs (AEDs), including pregabalin, increase the risk of suicidal ideation, thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to 1 of the AEDs had approximately twice the risk (adjusted RR 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients taking placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately 1 case of suicidal thinking or behavior for every 530 patients treated. There were 4 suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior was observed as early as 1 week after starting drug treatment and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years of age) in the clinical trials analyzed. The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Closely monitor patients for emerging or worsening depression or suicidal thoughts/behavior. Inform patients and caregivers of the increased risk of suicidal thoughts and behaviors and advise them to immediately report the emergence or worsening of depression, the emergence of suicidal thoughts or behavior, thoughts of self-harm, or other unusual changes in mood or behavior.[31493]

      Pregabalin commonly causes CNS depression, including dizziness and drowsiness. Patients should be advised to use caution when driving or operating machinery, or performing other tasks that require mental alertness, until they are aware of whether pregabalin adversely affects their mental and/or motor performance. Advise patients to avoid the concomitant use of ethanol and ethanol intoxication while receiving pregabalin due to the potential for additive drowsiness.[31493]

      Pregabalin may cause physical and psychological dependence and should be used with extreme caution in patients with known, suspected, or a history of substance abuse. Pregabalin is not known to be active at receptor sites associated with drugs of abuse; however, as with any CNS active drug, carefully evaluate patients for history of drug abuse and observe them for signs of pregabalin misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).[31493]

      Avoid abrupt discontinuation of pregabalin after prolonged use to reduce the risk for withdrawal seizures or adverse effects such as insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea. Withdraw pregabalin slowly, using a gradual dose-tapering schedule over a minimum of 1 week.[31493]

      Use pregabalin with caution in patients with renal impairment or renal failure. Pregabalin is excreted unchanged in the urine and can accumulate with decreased renal function. Dosage adjustments are recommended in patients with renal impairment.[31493]

      Initiate pregabalin at the lowest recommended dose and monitor for symptoms of respiratory depression and sedation in elderly patients, patients with underlying pulmonary disease, such as chronic obstructive pulmonary disease (COPD), and during coadministration with other CNS depressants. Serious, life-threatening, and fatal respiratory depression has been reported with pregabalin. Most cases involved coadministration of another CNS depressant, particularly opioids, in patients with underlying respiratory impairment or advanced age. Respiratory depression, if left untreated, may cause respiratory arrest and death. Management of respiratory depression may include observation, necessary supportive measures, and reduction or withdrawal of CNS depressants, including pregabalin. Taper the dose of pregabalin used for analgesia or seizure control before discontinuation.[64848]

      Initiate pregabalin at the lowest recommended dose and monitor for symptoms of respiratory depression and sedation in geriatric adults. Serious, life-threatening, and fatal respiratory depression has been reported with pregabalin. Most cases involved coadministration of another CNS depressant, particularly opioids, in patients with underlying respiratory impairment or advanced age. Respiratory depression, if left untreated, may cause respiratory arrest and death. Management of respiratory depression should include observation, necessary supportive measures, and reduction or withdrawal of CNS depressants, including pregabalin. Taper the dose of pregabalin used for analgesia or seizure control before discontinuation. During clinical trials for fibromyalgia, geriatric subjects more frequently reported neurologic reactions such as dizziness, blurred vision, balance disorder, tremor, confusional state, abnormal coordination, and lethargy. Pregabalin is known to be almost exclusively excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Adjust dosing based on estimated creatinine clearance; it may be useful to monitor renal function.[31493] [64848] According to the Beers Criteria, anticonvulsants such as pregabalin are considered potentially inappropriate medications (PIMs) in geriatric adults with a history of falls or fractures and should be avoided in these patient populations, except for treating seizure and mood disorders, since anticonvulsants can produce ataxia, impaired psychomotor function, syncope, and additional falls. If pregabalin must be used, consider reducing the use of other CNS-active medications that increase the risk of falls and fractures and implement strategies to reduce fall risk.[63923]

      Pregabalin treatment may cause peripheral edema. Higher frequencies of weight gain and peripheral edema were observed in diabetes mellitus patients taking both pregabalin and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone. As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, exercise caution when coadministering pregabalin and these agents. Because there are limited data on congestive heart failure patients with New York Heart Association (NYHA) Class III or IV cardiac status, exercise caution when using pregabalin in these patients.[31493]

      In controlled studies, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo, which resolved in most cases with continued dosing. Advise patients to notify their health care provider if changes in vision occur. If visual disturbance persists, consider further assessment. Consider more frequent assessment for patients who are already routinely monitored for ocular disease or conditions.[31493]

      Data from observational studies of pregabalin use during human pregnancy suggest a possible small increase in the incidence of overall major birth defects; there was no consistent or specific pattern of major birth defects identified. A database study reported a prevalence ratio for major malformations overall of 1.14 (95% CI: 0.96 to 1.35) for 2,700 pregnancies exposed to pregabalin monotherapy during the first trimester compared to 3,063,251 pregnancies not exposed to antiepileptic drugs (AEDs). Study limitations include the inability to control for underlying disease states or other potential confounders, in addition to a lack of verification of compliance with the AED regimen. A second database study showed no increase in the risk of major birth defects for 353 pregnancies with first trimester pregabalin monotherapy exposure when compared to 368,489 pregnancies with no AED exposure (adjusted relative risk 0.87 [95% CI 0.53 to 1.42]). A third database study suggested a small increase in the risk of major birth defects for 118 pregnancies with first trimester pregabalin monotherapy exposure when compared to 380,347 pregnancies with no AED exposure (adjusted relative risk 1.26 [95% CI 0.64 to 2.49]). Limitations consistent with previous database studies were present. Available postmarketing data on miscarriage and other maternal, fetal, and long-term developmental adverse effects were insufficient to identify risk associated with pregabalin. Pregabalin has been shown to cause animal developmental toxicity (e.g., fetal structural abnormalities and growth retardation) in rats and rabbits given oral pregabalin at doses that produced pregabalin AUC exposures 18 times or more the human exposure at the maximum recommended dose of 660 mg/day. In a study of rats given pregabalin throughout gestation and lactation, offspring growth was reduced at doses of 100 mg/kg or more, and offspring survival decreased at doses of 250 mg/kg or more. When offspring were tested as adults, neurobehavioral abnormalities (i.e., decreased auditory startle response) were observed at doses of 250 mg/kg or more, and decreased fertility and litter size were seen at doses of 1,250 mg/kg. In a prenatal-postnatal study in rats, pregabalin prolonged gestation and induced dystocia at exposures of 50 times or more the mean human exposure. There is a pregnancy exposure registry that monitors outcomes in pregnant patients exposed to pregabalin; information about the registry can be obtained at www.aedpregnancyregistry.org or by calling 1-888-233-2334.[31493] [62506]

      Use caution with pregabalin while breast-feeding due to a potential risk of tumorigenicity. Animal data demonstrate a potential association of tumorigenicity with pregabalin exposure from breast milk, and there is not a clear conclusion regarding the risk from available human clinical studies. Small amounts of pregabalin have been found in the milk of breast-feeding women, with average breast milk steady-state concentrations of approximately 76% of those in maternal plasma. Assuming a mean milk consumption of 150 mL/kg/day, the estimated average daily infant dose of pregabalin from breast-milk was 0.31 mg/kg/day, which would be approximately 7% of the maternal dose. The effects of pregabalin on milk production or the breast-fed infant are unknown.[31493] Alternative treatment options may be preferred, including carbamazepine, divalproex, gabapentin, lamotrigine, oxcarbazepine, phenytoin, or valproic acid.[70364]

      Pregabalin may be associated with reproductive risk. Advise men who plan to father a child of the potential risk of male-mediated teratogenicity. In animal fertility studies, pregabalin was associated with an increased risk of male-mediated teratogenicity; adverse reproductive and developmental effects were observed. Additionally, males may experience decreased sperm concentrations and infertility. In a randomized, double-blind, placebo-controlled, non-inferiority study to examine the effect of pregabalin on sperm characteristics, healthy male subjects received pregabalin at a daily dose of 600 mg or less (n = 111) or placebo (n = 109) for 13 weeks followed by a 13-week washout period. In the per protocol population (pregabalin, n = 65; placebo, n = 62), approximately 9% of the pregabalin group vs. 3% of the placebo group had a 50% or more reduction in mean sperm concentrations from baseline at week 26. The difference between pregabalin and placebo was within the pre-specified non-inferiority margin of 20%. Sperm concentrations were no longer reduced by 50% or more after an additional 3 months off pregabalin. However, at 9-month and 12-month follow-up visits, 1 subject did demonstrate reductions in sperm concentration of 50% or more. There were no adverse effects on sperm morphology, sperm motility, or serum follicle-stimulating hormone (FSH) or testosterone concentrations vs. placebo. The clinical significance of these data is uncertain.[31493]

      Revision Date: 05/24/2024, 01:33:00 AM

      References

      31493 - Lyrica (pregabalin) package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.62506 - Lyrica CR (pregabalin) extended-release tablets package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.63923 - 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71:2052-208164848 - Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR). https://www.fda.gov/media/133681/download. Retrieved December 19, 2019.70364 - Drugs and Lactation Database (LactMed) [e-book]. Bethesda (MD): National Institute of Child Health and Human Development; 2006- . Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/. Accessed February 21, 2024.

      Mechanism of Action

      Pregabalin is a structural analogue of gamma-aminobutyric acid (GABA) and has anxiolytic, analgesic, and antiepileptic properties. Pregabalin is structurally related to gabapentin, but pregabalin has shown greater potency than gabapentin in pain and seizure disorders (3- to 10-times more potent in animal studies).[30743][31493] The exact mechanism of action of pregabalin as an antiseizure agent has not been determined. Pregabalin does not show direct GABA-mimetic effects, but increases neuronal GABA levels as well as produces a dose-dependent increase in glutamic acid decarboxylase activity.[30744] Pregabalin reduces neuronal calcium currents by binding to the alpha-2-delta subunit of calcium channels, and this particular mechanism may be responsible for effects in neuropathic pain, anxiety, and other pain syndromes.[30745] Pregabalin does not bind directly to GABAA, GABAB, or benzodiazepine receptors, does not block sodium channels, is not active at opioid receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake.[31493]

      Revision Date: 05/24/2024, 01:33:00 AM

      References

      30743 - Czuczwar SJ, Patsalos PN. The new generation of GABA enhancers: potential in the treatment of epilepsy. CNS Drugs 2001;15:339-50.30744 - Willmore LJ. Clinical pharmacology of the new antiepileptic drugs. Neurology 2000;55(Suppl 3):S17-24.30745 - Huppertz HJ, Feuerstein TJ, Schulze-Bonhage A. Myoclonus in epilepsy patients with anticonvulsive add-on therapy with pregabalin. Epilepsia 2001;42(6):790-2.31493 - Lyrica (pregabalin) package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.

      Pharmacokinetics

      Pregabalin is administered orally. Pregabalin does not bind to plasma proteins and shows negligible hepatic metabolism. The volume of distribution is 0.5 L/kg. Pregabalin has been shown to cross into the blood-brain barrier and placenta in animal studies. Small amounts of pregabalin have been detected in the breast milk of lactating women. The primary route of elimination is renal excretion, with 90% to 98% of an administered dose eliminated unchanged in the urine. Pregabalin clearance by the kidneys is directly proportional to CrCl in patients not on dialysis. Mean renal clearance is roughly 67 to 81 mL/minute in young, healthy subjects. Because pregabalin is not bound to plasma proteins, this clearance rate indicates that renal tubular reabsorption is involved. Pregabalin undergoes minimal metabolism. The elimination half-life has been reported to be roughly 6 hours.[30759][31493]

       

      Affected cytochrome P450 isoenzymes: none

      In vitro studies suggest that pregabalin does not inhibit CYP isoenzymes including 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4 or induce isoenzymes 1A2 or 3A4.[31493]

      Route-Specific Pharmacokinetics

      Oral Route

      Oral bioavailability of pregabalin is roughly 90% and is independent of dose. Oral formulations are rapidly absorbed. The immediate-release oral solution and capsules are bioequivalent dissolving at a rate of more than 85% within 30 minutes.[38104] Pregabalin displays linear pharmacokinetics. The median Tmax for immediate-release formulations is 0.7 hours (0.7 to 1.5 hours), and for extended-release tablets is 8 hours (5 to 12 hours). After multiple oral doses, steady state concentrations are achieved within 1 to 2 days for immediate-release formulations and 2 to 3 days for extended-release formulations.[62506] Food delays the rate but not the extent of absorption of immediate-release formulations.[31493] Administration of the extended-release tablets once daily after an evening meal has an equivalent AUC and lower Cmax compared to administration of immediate-release formulations without food twice daily.[62506]

      Special Populations

      Renal Impairment

      Pregabalin clearance is nearly proportional to CrCl. Pregabalin is effectively removed by hemodialysis. Each 4-hour hemodialysis session removes 50% of the amount of drug initially present in the circulation.[31493]

      Pediatrics

      Cmax was attained 0.5 to 2 hours after oral administration in the fasted state. Apparent clearance and Vd increase as body weight increases. When normalized by body weight, clearance is approximately 40% higher in patients weighing less than 30 kg compared to those weighing 30 kg or more. The mean half-life is 3 to 4 hours in patients 3 months to 6 years and 4 to 6 hours in patients 7 to 17 years.[31493]

      Geriatric

      Oral clearance of pregabalin tends to decrease with increasing age, consistent with age-related decreases in CrCl.[31493]

      Gender Differences

      The relationship between daily dose and pregabalin exposure is similar between genders.[31493]

      Ethnic Differences

      The pharmacokinetics of pregabalin were not significantly affected by race.[31493]

      Revision Date: 05/24/2024, 01:33:00 AM

      References

      30759 - Frampton JE, Scott LJ. Pregabalin: in the treatment of painful diabetic peripheral neuropathy. Drugs 2004;64:2813-20.31493 - Lyrica (pregabalin) package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.38104 - Personal communication Pfizer Inc., January 2010.62506 - Lyrica CR (pregabalin) extended-release tablets package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.

      Pregnancy/Breast-feeding

      pregnancy

      Data from observational studies of pregabalin use during human pregnancy suggest a possible small increase in the incidence of overall major birth defects; there was no consistent or specific pattern of major birth defects identified. A database study reported a prevalence ratio for major malformations overall of 1.14 (95% CI: 0.96 to 1.35) for 2,700 pregnancies exposed to pregabalin monotherapy during the first trimester compared to 3,063,251 pregnancies not exposed to antiepileptic drugs (AEDs). Study limitations include the inability to control for underlying disease states or other potential confounders, in addition to a lack of verification of compliance with the AED regimen. A second database study showed no increase in the risk of major birth defects for 353 pregnancies with first trimester pregabalin monotherapy exposure when compared to 368,489 pregnancies with no AED exposure (adjusted relative risk 0.87 [95% CI 0.53 to 1.42]). A third database study suggested a small increase in the risk of major birth defects for 118 pregnancies with first trimester pregabalin monotherapy exposure when compared to 380,347 pregnancies with no AED exposure (adjusted relative risk 1.26 [95% CI 0.64 to 2.49]). Limitations consistent with previous database studies were present. Available postmarketing data on miscarriage and other maternal, fetal, and long-term developmental adverse effects were insufficient to identify risk associated with pregabalin. Pregabalin has been shown to cause animal developmental toxicity (e.g., fetal structural abnormalities and growth retardation) in rats and rabbits given oral pregabalin at doses that produced pregabalin AUC exposures 18 times or more the human exposure at the maximum recommended dose of 660 mg/day. In a study of rats given pregabalin throughout gestation and lactation, offspring growth was reduced at doses of 100 mg/kg or more, and offspring survival decreased at doses of 250 mg/kg or more. When offspring were tested as adults, neurobehavioral abnormalities (i.e., decreased auditory startle response) were observed at doses of 250 mg/kg or more, and decreased fertility and litter size were seen at doses of 1,250 mg/kg. In a prenatal-postnatal study in rats, pregabalin prolonged gestation and induced dystocia at exposures of 50 times or more the mean human exposure. There is a pregnancy exposure registry that monitors outcomes in pregnant patients exposed to pregabalin; information about the registry can be obtained at www.aedpregnancyregistry.org or by calling 1-888-233-2334.[31493] [62506]

      breast-feeding

      Use caution with pregabalin while breast-feeding due to a potential risk of tumorigenicity. Animal data demonstrate a potential association of tumorigenicity with pregabalin exposure from breast milk, and there is not a clear conclusion regarding the risk from available human clinical studies. Small amounts of pregabalin have been found in the milk of breast-feeding women, with average breast milk steady-state concentrations of approximately 76% of those in maternal plasma. Assuming a mean milk consumption of 150 mL/kg/day, the estimated average daily infant dose of pregabalin from breast-milk was 0.31 mg/kg/day, which would be approximately 7% of the maternal dose. The effects of pregabalin on milk production or the breast-fed infant are unknown.[31493] Alternative treatment options may be preferred, including carbamazepine, divalproex, gabapentin, lamotrigine, oxcarbazepine, phenytoin, or valproic acid.[70364]

      Revision Date: 05/24/2024, 01:33:00 AM

      References

      31493 - Lyrica (pregabalin) package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.62506 - Lyrica CR (pregabalin) extended-release tablets package insert. Morgantown, WV: Viatris Specialty LLC; 2023 Dec.70364 - Drugs and Lactation Database (LactMed) [e-book]. Bethesda (MD): National Institute of Child Health and Human Development; 2006- . Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/. Accessed February 21, 2024.

      Interactions

      Level 2 (Major)

      • Acetaminophen; Caffeine; Dihydrocodeine
      • Acetaminophen; Codeine
      • Acetaminophen; Hydrocodone
      • Acetaminophen; Oxycodone
      • Acrivastine; Pseudoephedrine
      • Alfentanil
      • Alprazolam
      • Amitriptyline
      • Amobarbital
      • Amoxapine
      • Apomorphine
      • Aspirin, ASA; Butalbital; Caffeine
      • Aspirin, ASA; Caffeine; Orphenadrine
      • Aspirin, ASA; Carisoprodol; Codeine
      • Aspirin, ASA; Oxycodone
      • Azelastine
      • Azelastine; Fluticasone
      • Baclofen
      • Barbiturates
      • Belladonna; Opium
      • Benzhydrocodone; Acetaminophen
      • Benzodiazepines
      • Brexpiprazole
      • Buprenorphine
      • Buprenorphine; Naloxone
      • Butalbital; Acetaminophen
      • Butalbital; Acetaminophen; Caffeine
      • Butalbital; Acetaminophen; Caffeine; Codeine
      • Butalbital; Aspirin; Caffeine; Codeine
      • Butorphanol
      • Calcium, Magnesium, Potassium, Sodium Oxybates
      • Capsaicin; Metaxalone
      • Carbidopa; Levodopa
      • Carbidopa; Levodopa; Entacapone
      • Carisoprodol
      • Celecoxib; Tramadol
      • Chlordiazepoxide
      • Chlordiazepoxide; Amitriptyline
      • Chlordiazepoxide; Clidinium
      • Chlorpheniramine; Codeine
      • Chlorpheniramine; Hydrocodone
      • Chlorpromazine
      • Chlorzoxazone
      • Clobazam
      • Clomipramine
      • Clonazepam
      • Clonidine
      • Clorazepate
      • Clozapine
      • Codeine
      • Codeine; Guaifenesin
      • Codeine; Guaifenesin; Pseudoephedrine
      • Codeine; Phenylephrine; Promethazine
      • Codeine; Promethazine
      • COMT inhibitors
      • Cyclobenzaprine
      • Dantrolene
      • Desipramine
      • Diazepam
      • Doxepin
      • Droperidol
      • Entacapone
      • Estazolam
      • Eszopiclone
      • Ethanol
      • Etomidate
      • Fentanyl
      • Flurazepam
      • food
      • Gabapentin
      • General anesthetics
      • Haloperidol
      • Homatropine; Hydrocodone
      • Hydrocodone
      • Hydrocodone; Ibuprofen
      • Hydromorphone
      • Hydroxyzine
      • Ibuprofen; Oxycodone
      • Imipramine
      • Isoflurane
      • Ketamine
      • Levodopa
      • Levorphanol
      • Lorazepam
      • Maprotiline
      • Meperidine
      • Metaxalone
      • Methadone
      • Methocarbamol
      • Methohexital
      • Midazolam
      • Mirtazapine
      • Morphine
      • Morphine; Naltrexone
      • Nalbuphine
      • Nefazodone
      • Nortriptyline
      • Oliceridine
      • Opicapone
      • Orphenadrine
      • Oxazepam
      • Oxycodone
      • Oxymorphone
      • Pentazocine; Naloxone
      • Pentobarbital
      • Perphenazine; Amitriptyline
      • Phenobarbital
      • Phenobarbital; Hyoscyamine; Atropine; Scopolamine
      • Pramipexole
      • Primidone
      • Prochlorperazine
      • Promethazine
      • Promethazine; Dextromethorphan
      • Promethazine; Phenylephrine
      • Propofol
      • Protriptyline
      • Quazepam
      • Quetiapine
      • Rasagiline
      • Remifentanil
      • Remimazolam
      • Risperidone
      • Ropinirole
      • Rotigotine
      • Safinamide
      • Secobarbital
      • Sevoflurane
      • Sodium Oxybate
      • Sufentanil
      • Tapentadol
      • Temazepam
      • Thalidomide
      • Thioridazine
      • Tizanidine
      • Tolcapone
      • Tramadol
      • Tramadol; Acetaminophen
      • Trazodone
      • Triazolam
      • Tricyclic antidepressants
      • Trimipramine
      • Zaleplon
      • Zolpidem
      • Zuranolone

      Level 3 (Moderate)

      • Acetaminophen; Aspirin; Diphenhydramine
      • Acetaminophen; Caffeine; Pyrilamine
      • Acetaminophen; Chlorpheniramine
      • Acetaminophen; Chlorpheniramine; Dextromethorphan
      • Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
      • Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
      • Acetaminophen; Chlorpheniramine; Phenylephrine
      • Acetaminophen; Dextromethorphan; Doxylamine
      • Acetaminophen; Diphenhydramine
      • Acetaminophen; Pamabrom; Pyrilamine
      • Alogliptin; Pioglitazone
      • Amlodipine; Benazepril
      • Angiotensin-converting enzyme inhibitors
      • Aripiprazole
      • Asenapine
      • Atropine
      • Atropine; Difenoxin
      • Benazepril
      • Benazepril; Hydrochlorothiazide, HCTZ
      • Brompheniramine
      • Brompheniramine; Dextromethorphan; Phenylephrine
      • Brompheniramine; Phenylephrine
      • Brompheniramine; Pseudoephedrine
      • Brompheniramine; Pseudoephedrine; Dextromethorphan
      • Cannabidiol
      • Captopril
      • Captopril; Hydrochlorothiazide, HCTZ
      • Carbinoxamine
      • Cariprazine
      • Cenobamate
      • Cetirizine
      • Cetirizine; Pseudoephedrine
      • Chlophedianol; Dexbrompheniramine
      • Chlophedianol; Dexchlorpheniramine; Pseudoephedrine
      • Chlorcyclizine
      • Chlorpheniramine
      • Chlorpheniramine; Dextromethorphan
      • Chlorpheniramine; Dextromethorphan; Phenylephrine
      • Chlorpheniramine; Dextromethorphan; Pseudoephedrine
      • Chlorpheniramine; Ibuprofen; Pseudoephedrine
      • Chlorpheniramine; Phenylephrine
      • Chlorpheniramine; Pseudoephedrine
      • Clemastine
      • Cyproheptadine
      • Deutetrabenazine
      • Dexbrompheniramine
      • Dexbrompheniramine; Dextromethorphan; Phenylephrine
      • Dexbrompheniramine; Pseudoephedrine
      • Dexchlorpheniramine
      • Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine
      • Dexmedetomidine
      • Dextromethorphan; Diphenhydramine; Phenylephrine
      • Difelikefalin
      • Dimenhydrinate
      • Diphenhydramine
      • Diphenhydramine; Ibuprofen
      • Diphenhydramine; Naproxen
      • Diphenhydramine; Phenylephrine
      • Diphenoxylate; Atropine
      • Doxylamine
      • Doxylamine; Pyridoxine
      • Dronabinol
      • Enalapril, Enalaprilat
      • Enalapril; Hydrochlorothiazide, HCTZ
      • Esketamine
      • Fenfluramine
      • Flibanserin
      • Fluphenazine
      • Fosinopril
      • Fosinopril; Hydrochlorothiazide, HCTZ
      • Guanfacine
      • Hydrochlorothiazide, HCTZ; Moexipril
      • Hydroxychloroquine
      • Iloperidone
      • Isocarboxazid
      • Lasmiditan
      • Lemborexant
      • Levocetirizine
      • Lisinopril
      • Lisinopril; Hydrochlorothiazide, HCTZ
      • Lofexidine
      • Loxapine
      • Lumateperone
      • Lurasidone
      • Meclizine
      • Melatonin
      • Meprobamate
      • Methyldopa
      • Metoclopramide
      • Moexipril
      • Molindone
      • Monoamine oxidase inhibitors
      • Nabilone
      • Olanzapine
      • Olanzapine; Fluoxetine
      • Olanzapine; Samidorphan
      • Paliperidone
      • Perampanel
      • Perindopril
      • Perindopril; Amlodipine
      • Perphenazine
      • Phenelzine
      • Phentermine; Topiramate
      • Pimavanserin
      • Pimozide
      • Pioglitazone
      • Pioglitazone; Glimepiride
      • Pioglitazone; Metformin
      • Pseudoephedrine; Triprolidine
      • Quinapril
      • Quinapril; Hydrochlorothiazide, HCTZ
      • Ramelteon
      • Ramipril
      • Rosiglitazone
      • Scopolamine
      • Selegiline
      • Stiripentol
      • Suvorexant
      • Tasimelteon
      • Tetrabenazine
      • Thiazolidinediones
      • Thiothixene
      • Topiramate
      • Trandolapril
      • Trandolapril; Verapamil
      • Tranylcypromine
      • Trifluoperazine
      • Triprolidine
      • Valerian, Valeriana officinalis
      • Valproic Acid, Divalproex Sodium
      • Ziprasidone
      Acetaminophen; Aspirin; Diphenhydramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of diphenhydramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [56616] [64848] Acetaminophen; Caffeine; Dihydrocodeine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30282] [31493] [58572] [61143] [63923] [64848] Acetaminophen; Caffeine; Pyrilamine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of pyrilamine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64883] Acetaminophen; Chlorpheniramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Acetaminophen; Chlorpheniramine; Dextromethorphan: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Acetaminophen; Chlorpheniramine; Phenylephrine : (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Acetaminophen; Codeine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] Acetaminophen; Dextromethorphan; Doxylamine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of doxylamine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [52061] [64848] Acetaminophen; Diphenhydramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of diphenhydramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [56616] [64848] Acetaminophen; Hydrocodone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30379] [31493] [43291] [61691] [63923] [64848] Acetaminophen; Oxycodone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [43906] [57407] [57732] [61143] [61897] [63923] [64848] Acetaminophen; Pamabrom; Pyrilamine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of pyrilamine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64883] Acrivastine; Pseudoephedrine: (Major) Avoid coadministration of acrivastine with pregabalin because of the risk of additive CNS depression. If concurrent use cannot be avoided, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [64848] [64878] Alfentanil: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of alfentanil with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. The magnitude and duration of CNS and cardiovascular effects of alfentanil may be enhanced. Monitor patients for hypotension or prolonged respiratory depression and sedation. The respiratory depressant effect of alfentanil may persist longer than the measured analgesic effect; consider the total dose of all opioid agonists before ordering opioid analgesics during recovery from anesthesia. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30072] [31493] [61143] [63923] [64848] Alogliptin; Pioglitazone: (Moderate) Higher rates of peripheral edema and weight gain may occur in patients who concomitantly use thiazolidinediones with pregabalin. As the thiazolidinediones and pregabalin can both cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, care should be taken when co-administering these agents. [31493] Alprazolam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Amitriptyline: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Amlodipine; Benazepril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Amobarbital: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Amoxapine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and amoxapine. Concomitant use of pregabalin with amoxapine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [28558] [31493] [64848] Angiotensin-converting enzyme inhibitors: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Apomorphine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and apomorphine. Concomitant use of pregabalin with apomorphine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Dopaminergic agents, such as apomorphine, have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. [28661] [31493] [64848] Aripiprazole: (Moderate) Monitor for respiratory depression and sedation during concomitant aripiprazole and pregabalin use; consider starting pregabalin at a low dose. Concomitant use increases the risk for additive CNS depression. [31493] [42845] [64848] Asenapine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of asenapine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [36343] [64848] Aspirin, ASA; Butalbital; Caffeine: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Aspirin, ASA; Caffeine; Orphenadrine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and orphenadrine. Concomitant use of pregabalin with orphenadrine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [29244] [31493] [64848] Aspirin, ASA; Carisoprodol; Codeine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and carisoprodol. Concomitant use of pregabalin with carisoprodol may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31110] [31493] [64848] Aspirin, ASA; Oxycodone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [43906] [57407] [57732] [61143] [61897] [63923] [64848] Atropine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of atropine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [63228] [64848] Atropine; Difenoxin: (Moderate) Concurrent administration of diphenoxylate/difenoxin with pregabalin can potentiate the CNS-depressant effects of diphenoxylate/difenoxin. Use caution during coadministration. [30269] [7523] [8284] (Moderate) Monitor for excessive sedation and somnolence during coadministration of atropine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [63228] [64848] Azelastine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and azelastine. Concomitant use of pregabalin with azelastine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [43712] [63556] [64848] Azelastine; Fluticasone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and azelastine. Concomitant use of pregabalin with azelastine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [43712] [63556] [64848] Baclofen: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and baclofen. Concomitant use of pregabalin with baclofen may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [27986] [57272] [64848] Barbiturates: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Belladonna; Opium: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [57409] [61143] [63923] [64848] Benazepril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Benazepril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Benzhydrocodone; Acetaminophen: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [61143] [62889] [63923] [64848] Benzodiazepines: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Brexpiprazole: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and brexpiprazole. Concomitant use of pregabalin with brexpiprazole may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [59949] [64848] Brompheniramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of brompheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [47262] [64848] Brompheniramine; Dextromethorphan; Phenylephrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of brompheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [47262] [64848] Brompheniramine; Phenylephrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of brompheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [47262] [64848] Brompheniramine; Pseudoephedrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of brompheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [47262] [64848] Brompheniramine; Pseudoephedrine; Dextromethorphan: (Moderate) Monitor for excessive sedation and somnolence during coadministration of brompheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [47262] [64848] Buprenorphine: (Major) Concomitant use of buprenorphine with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of buprenorphine with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [41235] [41453] [61143] [64848] Buprenorphine; Naloxone: (Major) Concomitant use of buprenorphine with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of buprenorphine with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [41235] [41453] [61143] [64848] Butalbital; Acetaminophen: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Butalbital; Acetaminophen; Caffeine: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Butalbital; Acetaminophen; Caffeine; Codeine: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] Butalbital; Aspirin; Caffeine; Codeine: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] Butorphanol: (Major) Concomitant use of butorphanol with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of butorphanol with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [29174] [31493] [61143] [64848] Calcium, Magnesium, Potassium, Sodium Oxybates: (Major) Concomitant use of sodium oxybate with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28528] [31493] [64848] Cannabidiol: (Moderate) Monitor for excessive sedation and somnolence during coadministration of cannabidiol and pregabalin. Concurrent use may result in additive CNS depression. [31493] [63309] [64848] Capsaicin; Metaxalone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and metaxalone. Concomitant use of pregabalin with metaxalone may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [27986] [30830] [64848] Captopril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Captopril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Carbidopa; Levodopa: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and levodopa. Concomitant use of pregabalin with levodopa may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Dopaminergic agents, such as levodopa, have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. [31493] [63854] [64848] Carbidopa; Levodopa; Entacapone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and COMT inhibitors. Concomitant use of pregabalin with COMT inhibitors may cause additive CNS depression. COMT inhibitors have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them. [28845] [31493] [42112] [64848] [65338] (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and levodopa. Concomitant use of pregabalin with levodopa may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Dopaminergic agents, such as levodopa, have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. [31493] [63854] [64848] Carbinoxamine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of carbinoxamine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64879] Cariprazine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of cariprazine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [60164] [64848] Carisoprodol: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and carisoprodol. Concomitant use of pregabalin with carisoprodol may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31110] [31493] [64848] Celecoxib; Tramadol: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [32475] [51440] [61143] [63923] [64848] Cenobamate: (Moderate) Monitor for excessive sedation and somnolence during coadministration of cenobamate and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64768] [64848] Cetirizine: (Moderate) Monitor for unusual drowsiness and sedation during coadministration of cetirizine and pregabalin due to the risk for additive CNS depression. [31493] [40972] [64848] Cetirizine; Pseudoephedrine: (Moderate) Monitor for unusual drowsiness and sedation during coadministration of cetirizine and pregabalin due to the risk for additive CNS depression. [31493] [40972] [64848] Chlophedianol; Dexbrompheniramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of dexbrompheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64881] Chlophedianol; Dexchlorpheniramine; Pseudoephedrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of dexchlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64882] Chlorcyclizine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorcyclizine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64880] Chlordiazepoxide: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Chlordiazepoxide; Amitriptyline: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Chlordiazepoxide; Clidinium: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Chlorpheniramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Chlorpheniramine; Codeine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Chlorpheniramine; Dextromethorphan: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Chlorpheniramine; Dextromethorphan; Phenylephrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Chlorpheniramine; Hydrocodone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30379] [31493] [43291] [61691] [63923] [64848] (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Chlorpheniramine; Phenylephrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Chlorpheniramine; Pseudoephedrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of chlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43437] [64848] Chlorpromazine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and chlorpromazine. Concomitant use of pregabalin with chlorpromazine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [28997] [31493] [64848] Chlorzoxazone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and chlorzoxazone. Concomitant use of pregabalin with chlorzoxazone may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [27986] [51369] [64848] Clemastine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of clemastine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [47268] [64848] Clobazam: (Major) Concomitant use of clobazam with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [46370] [64848] Clomipramine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Clonazepam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Clonidine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and clonidine. Concomitant use of pregabalin with clonidine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [28290] [31493] [42062] [42063] [64848] Clorazepate: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Clozapine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and clozapine. Concomitant use of pregabalin with clozapine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [28262] [31493] [64848] Codeine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] Codeine; Guaifenesin: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] Codeine; Guaifenesin; Pseudoephedrine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] Codeine; Phenylephrine; Promethazine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and promethazine. Concomitant use of pregabalin with promethazine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [63555] [64848] Codeine; Promethazine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33654] [34883] [61143] [63923] [64848] (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and promethazine. Concomitant use of pregabalin with promethazine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [63555] [64848] COMT inhibitors: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and COMT inhibitors. Concomitant use of pregabalin with COMT inhibitors may cause additive CNS depression. COMT inhibitors have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them. [28845] [31493] [42112] [64848] [65338] Cyclobenzaprine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and cyclobenzaprine. Concomitant use of pregabalin with cyclobenzaprine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [27986] [28425] [64848] Cyproheptadine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of cyproheptadine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [59577] [64848] Dantrolene: (Major) Concomitant use of dantrolene with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [49509] [64848] Desipramine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Deutetrabenazine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of deutetrabenazine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [61845] [64848] Dexbrompheniramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of dexbrompheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64881] Dexbrompheniramine; Dextromethorphan; Phenylephrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of dexbrompheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64881] Dexbrompheniramine; Pseudoephedrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of dexbrompheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64881] Dexchlorpheniramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of dexchlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64882] Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of dexchlorpheniramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64848] [64882] Dexmedetomidine: (Moderate) Monitor for excessive sedation, somnolence, and respiratory depression during coadministration of dexmedetomidine and pregabalin. Concurrent use may result in additive CNS and respiratory depression. [29112] [31493] [64848] Dextromethorphan; Diphenhydramine; Phenylephrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of diphenhydramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [56616] [64848] Diazepam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Difelikefalin: (Moderate) Monitor for dizziness, somnolence, mental status changes, and gait disturbances if concomitant use of difelikefalin with CNS depressants is necessary. Concomitant use may increase the risk for these adverse reactions. [66926] Dimenhydrinate: (Moderate) Monitor for excessive sedation and somnolence during coadministration of dimenhydrinate and pregabalin. Concurrent use may result in additive CNS depression. [31493] [48650] [64848] Diphenhydramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of diphenhydramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [56616] [64848] Diphenhydramine; Ibuprofen: (Moderate) Monitor for excessive sedation and somnolence during coadministration of diphenhydramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [56616] [64848] Diphenhydramine; Naproxen: (Moderate) Monitor for excessive sedation and somnolence during coadministration of diphenhydramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [56616] [64848] Diphenhydramine; Phenylephrine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of diphenhydramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [56616] [64848] Diphenoxylate; Atropine: (Moderate) Concurrent administration of diphenoxylate/difenoxin with pregabalin can potentiate the CNS-depressant effects of diphenoxylate/difenoxin. Use caution during coadministration. [30269] [7523] [8284] (Moderate) Monitor for excessive sedation and somnolence during coadministration of atropine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [63228] [64848] Doxepin: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Doxylamine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of doxylamine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [52061] [64848] Doxylamine; Pyridoxine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of doxylamine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [52061] [64848] Dronabinol: (Moderate) Concomitant use of dronabinol with other CNS depressants can potentiate the effects of dronabinol on respiratory depression. Pregabalin can cause considerable somnolence and the combined use of ethanol or other CNS depressants with pregabalin may lead to an additive drowsy effect. [30431] [30760] Droperidol: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and droperidol. Concomitant use of pregabalin with droperidol may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51289] [64848] Enalapril, Enalaprilat: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Enalapril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Entacapone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and COMT inhibitors. Concomitant use of pregabalin with COMT inhibitors may cause additive CNS depression. COMT inhibitors have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them. [28845] [31493] [42112] [64848] [65338] Esketamine: (Moderate) Closely monitor patients receiving esketamine and pregabalin for sedation and other CNS depressant effects. Instruct patients who receive a dose of esketamine not to drive or engage in other activities requiring alertness until the next day after a restful sleep. [31493] [63989] Estazolam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Eszopiclone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and eszopiclone. Concomitant use of pregabalin with eszopiclone may cause additive CNS depression and complex sleep-related behaviors (e.g., driving, talking, eating, or performing other activities while not fully awake). Educate patients about the risks and symptoms of excessive CNS depression. Instruct patients to contact their provider immediately if sleep-related symptoms or behaviors occur. [30571] [31493] [64848] Ethanol: (Major) Advise patients to avoid alcohol consumption while taking CNS depressants. Alcohol consumption may result in additive CNS depression. [61143] [62827] Etomidate: (Major) Concomitant use of general anesthetics with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of excessive respiratory depression. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28970] [31036] [31493] [43431] [49500] [49614] [64848] Fenfluramine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of fenfluramine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [65634] Fentanyl: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [29623] [29763] [31493] [32731] [40944] [44875] [48165] [59568] [61143] [63923] [64848] Flibanserin: (Moderate) Monitor for excessive sedation and somnolence during coadministration of flibanserin and pregabalin. Concurrent use may result in additive CNS depression. [31493] [60099] [64848] Fluphenazine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of fluphenazine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43067] [64848] Flurazepam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Food: (Major) Advise patients to avoid cannabis use while taking CNS depressants due to the risk for additive CNS depression and potential for other cognitive adverse reactions. [67473] Fosinopril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Fosinopril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Gabapentin: (Major) Concomitant use of gabapentin with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate both pregabalin and gabapentin at the lowest recommended doses and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [27986] [31493] [64848] General anesthetics: (Major) Concomitant use of general anesthetics with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of excessive respiratory depression. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28970] [31036] [31493] [43431] [49500] [49614] [64848] Guanfacine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of guanfacine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43566] [50446] [64848] Haloperidol: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and haloperidol. Concomitant use of pregabalin with haloperidol may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [42938] [64848] Homatropine; Hydrocodone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30379] [31493] [43291] [61691] [63923] [64848] Hydrochlorothiazide, HCTZ; Moexipril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Hydrocodone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30379] [31493] [43291] [61691] [63923] [64848] Hydrocodone; Ibuprofen: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Avoid prescribing opioid cough medications in patients taking pregabalin. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30379] [31493] [43291] [61691] [63923] [64848] Hydromorphone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [39635] [49619] [49620] [61143] [63923] [64848] Hydroxychloroquine: (Moderate) Monitor persons with epilepsy for seizure activity during concomitant pregabalin and hydroxychloroquine use. Hydroxychloroquine can lower the seizure threshold; therefore, the activity of antiepileptic drugs may be impaired with concomitant use. [41806] Hydroxyzine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and hydroxyzine. Reduce the pregabalin dose by 50% or more when used with hydroxyzine intramuscular injection. Concomitant use of pregabalin with hydroxyzine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [47140] [61470] [64848] Ibuprofen; Oxycodone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [43906] [57407] [57732] [61143] [61897] [63923] [64848] Iloperidone: (Moderate) Monitor for excessive sedation and somnolence during coadministration of iloperidone and pregabalin. Concurrent use may result in additive CNS depression. [31493] [36146] [64848] Imipramine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Isocarboxazid: (Moderate) Monitor for respiratory depression and sedation during concomitant monoamine oxidase inhibitor (MAOI) and pregabalin use; consider starting pregabalin at a low dose. Concomitant use increases the risk for additive CNS depression. [27957] [30438] [31493] [64848] Isoflurane: (Major) Concomitant use of general anesthetics with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of excessive respiratory depression. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28970] [31036] [31493] [43431] [49500] [49614] [64848] Ketamine: (Major) Concomitant use of general anesthetics with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of excessive respiratory depression. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28970] [31036] [31493] [43431] [49500] [49614] [64848] Lasmiditan: (Moderate) Monitor for excessive sedation and somnolence during coadministration of lasmiditan and pregabalin. Concurrent use may result in additive CNS depression. [31493] [64685] [64848] Lemborexant: (Moderate) Monitor for excessive sedation and somnolence during coadministration of lemborexant and pregabalin. Dosage adjustments of lemborexant and pregabalin may be necessary when administered together because of potentially additive CNS effects. The risk of next-day impairment, including impaired driving, is increased if lemborexant is taken with other CNS depressants. [31493] [64870] Levocetirizine: (Moderate) Monitor for unusual drowsiness and sedation during coadministration of cetirizine and pregabalin due to the risk for additive CNS depression. [31493] [40972] [64848] Levodopa: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and levodopa. Concomitant use of pregabalin with levodopa may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Dopaminergic agents, such as levodopa, have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. [31493] [63854] [64848] Levorphanol: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Reduce the initial dose of levorphanol by approximately 50% or more. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [60958] [61143] [63923] [64848] Lisinopril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Lisinopril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Lofexidine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of lofexidine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [63161] [64848] Lorazepam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Loxapine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of loxapine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43462] [64848] Lumateperone: (Moderate) Monitor for excessive sedation and somnolence during coadministration of lumateperone and pregabalin. Concurrent use may result in additive CNS depression. [31493] [63877] [64885] Lurasidone: (Moderate) Monitor for excessive sedation and somnolence during coadministration of lurasidone and pregabalin. Concurrent use may result in additive CNS depression. [31493] [42227] [64848] Maprotiline: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and maprotiline. Concomitant use of pregabalin with maprotiline may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51740] [64848] Meclizine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of meclizine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43856] [64848] Melatonin: (Moderate) Monitor for excessive sedation and somnolence during coadministration of melatonin and pregabalin. Concurrent use may result in additive CNS depression. [25471] [31493] [60032] [64848] Meperidine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30988] [31493] [61143] [63923] [64848] Meprobamate: (Moderate) Monitor for excessive sedation and somnolence during coadministration of meprobamate and pregabalin. Concurrent use may result in additive CNS depression. [31493] [41973] [64848] Metaxalone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and metaxalone. Concomitant use of pregabalin with metaxalone may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [27986] [30830] [64848] Methadone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [33136] [52650] [61143] [63923] [64848] Methocarbamol: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and methocarbamol. Concomitant use of pregabalin with methocarbamol may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [30831] [31493] [64848] Methohexital: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Methyldopa: (Moderate) Monitor for excessive sedation and somnolence during coadministration of methyldopa and pregabalin. Concurrent use may result in additive CNS depression. [29252] [31493] [64848] Metoclopramide: (Moderate) Monitor for excessive sedation and somnolence during coadministration of metoclopramide and pregabalin. Concurrent use may result in additive CNS depression. [31493] [57877] [64848] Midazolam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Mirtazapine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and mirtazapine. Concomitant use of pregabalin with mirtazapine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [40942] [64848] Moexipril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Molindone: (Moderate) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and molindone. Concomitant use of pregabalin with molindone may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [28820] [31493] [64848] Monoamine oxidase inhibitors: (Moderate) Monitor for respiratory depression and sedation during concomitant monoamine oxidase inhibitor (MAOI) and pregabalin use; consider starting pregabalin at a low dose. Concomitant use increases the risk for additive CNS depression. [27957] [30438] [31493] [64848] Morphine: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. For extended-release morphine tablets (MS Contin and Morphabond), start with 15 mg every 12 hours. Morphine; naltrexone should be initiated at 1/3 to 1/2 the recommended starting dosage. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [35890] [40951] [46350] [60209] [61143] [63923] [64848] Morphine; Naltrexone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. For extended-release morphine tablets (MS Contin and Morphabond), start with 15 mg every 12 hours. Morphine; naltrexone should be initiated at 1/3 to 1/2 the recommended starting dosage. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [35890] [40951] [46350] [60209] [61143] [63923] [64848] Nabilone: (Moderate) Concomitant use of nabilone with other CNS depressants can potentiate the effects of nabilone on respiratory depression. Pregabalin can cause considerable somnolence and the combined use of ethanol or other CNS depressants with pregabalin may lead to an additive drowsy effect. [30760] [32226] Nalbuphine: (Major) Concomitant use of nalbuphine with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of nalbuphine with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30030] [31493] [61143] [64848] Nefazodone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and nefazodone. Concomitant use of pregabalin with nefazodone may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [47267] [64848] Nortriptyline: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Olanzapine: (Moderate) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and olanzapine. Concomitant use of pregabalin with olanzapine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [28785] [31493] [64848] Olanzapine; Fluoxetine: (Moderate) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and olanzapine. Concomitant use of pregabalin with olanzapine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [28785] [31493] [64848] Olanzapine; Samidorphan: (Moderate) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and olanzapine. Concomitant use of pregabalin with olanzapine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [28785] [31493] [64848] Oliceridine: (Major) Concomitant use of oliceridine with pregabalin may cause excessive sedation and somnolence. Limit the use of oliceridine with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. [31493] [63877] [65809] Opicapone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and COMT inhibitors. Concomitant use of pregabalin with COMT inhibitors may cause additive CNS depression. COMT inhibitors have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them. [28845] [31493] [42112] [64848] [65338] Orphenadrine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and orphenadrine. Concomitant use of pregabalin with orphenadrine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [29244] [31493] [64848] Oxazepam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Oxycodone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [43906] [57407] [57732] [61143] [61897] [63923] [64848] Oxymorphone: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use an initial dose of oxymorphone at 1/3 to 1/2 the usual dosage and titrate to clinical response. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [32438] [51201] [61143] [63923] [64848] Paliperidone: (Moderate) Monitor for excessive sedation and somnolence during coadministration of paliperidone and pregabalin. Concurrent use may result in additive CNS depression. [31493] [32936] [64848] Pentazocine; Naloxone: (Major) Concomitant use of pentazocine with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of pentazocine with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30029] [30219] [31493] [61143] [64848] Pentobarbital: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Perampanel: (Moderate) Monitor for excessive sedation and somnolence during coadministration of perampanel and pregabalin. Concurrent use may result in additive CNS depression. [31493] [52140] [64848] Perindopril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Perindopril; Amlodipine: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Perphenazine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of perphenazine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43070] [64848] Perphenazine; Amitriptyline: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] (Moderate) Monitor for excessive sedation and somnolence during coadministration of perphenazine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43070] [64848] Phenelzine: (Moderate) Monitor for respiratory depression and sedation during concomitant monoamine oxidase inhibitor (MAOI) and pregabalin use; consider starting pregabalin at a low dose. Concomitant use increases the risk for additive CNS depression. [27957] [30438] [31493] [64848] Phenobarbital: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] (Moderate) Monitor for excessive sedation and somnolence during coadministration of atropine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [63228] [64848] (Moderate) Monitor for excessive sedation and somnolence during coadministration of scopolamine and pregabalin. Concurrent use may result in additive CNS depression. [30354] [31493] [64848] Phentermine; Topiramate: (Moderate) Monitor for respiratory depression and sedation during concomitant topiramate and pregabalin use; consider starting pregabalin at a low dose. Concomitant use increases the risk for additive CNS depression. [28378] [31493] [56847] Pimavanserin: (Moderate) Monitor for excessive sedation and somnolence during coadministration of pimavanserin and pregabalin. Concurrent use may result in additive CNS depression. [31493] [60748] [64848] Pimozide: (Moderate) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and pimozide. Concomitant use of pregabalin with pimozide may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [43463] [64848] Pioglitazone: (Moderate) Higher rates of peripheral edema and weight gain may occur in patients who concomitantly use thiazolidinediones with pregabalin. As the thiazolidinediones and pregabalin can both cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, care should be taken when co-administering these agents. [31493] Pioglitazone; Glimepiride: (Moderate) Higher rates of peripheral edema and weight gain may occur in patients who concomitantly use thiazolidinediones with pregabalin. As the thiazolidinediones and pregabalin can both cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, care should be taken when co-administering these agents. [31493] Pioglitazone; Metformin: (Moderate) Higher rates of peripheral edema and weight gain may occur in patients who concomitantly use thiazolidinediones with pregabalin. As the thiazolidinediones and pregabalin can both cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, care should be taken when co-administering these agents. [31493] Pramipexole: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and pramipexole. Concomitant use of pregabalin with pramipexole may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Dopaminergic agents, such as pramipexole, have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. [31493] [41505] [64848] Primidone: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Prochlorperazine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and prochlorperazine. Concomitant use of pregabalin with prochlorperazine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Concurrent administration of prochlorperazine is contraindicated in patients receiving large doses of CNS depressants. [31493] [62305] [64848] Promethazine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and promethazine. Concomitant use of pregabalin with promethazine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [63555] [64848] Promethazine; Dextromethorphan: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and promethazine. Concomitant use of pregabalin with promethazine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [63555] [64848] Promethazine; Phenylephrine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and promethazine. Concomitant use of pregabalin with promethazine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [63555] [64848] Propofol: (Major) Concomitant use of general anesthetics with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of excessive respiratory depression. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28970] [31036] [31493] [43431] [49500] [49614] [64848] Protriptyline: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Pseudoephedrine; Triprolidine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of triprolidine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [48444] [64848] Quazepam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Quetiapine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and quetiapine. Concomitant use of pregabalin with quetiapine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [33360] [64848] Quinapril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Quinapril; Hydrochlorothiazide, HCTZ: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Ramelteon: (Moderate) Monitor for excessive sedation and somnolence during coadministration of ramelteon and pregabalin. Concurrent use may result in additive CNS depression. [31359] [31493] [64848] Ramipril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Rasagiline: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and rasagiline. Concomitant use of pregabalin with rasagiline may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Dopaminergic agents, such as rasagiline, have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. [31493] [32223] [64848] Remifentanil: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of remifentanil with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28897] [31493] [61143] [63923] [64848] Remimazolam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Risperidone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and risperidone. Concomitant use of pregabalin with risperidone may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [27986] [28414] [31493] [64848] Ropinirole: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and ropinirole. Concomitant use of pregabalin with ropinirole may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Dopaminergic agents, such as ropinirole, have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. [31241] [31493] [64848] Rosiglitazone: (Moderate) Higher rates of peripheral edema and weight gain may occur in patients who concomitantly use thiazolidinediones with pregabalin. As the thiazolidinediones and pregabalin can both cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, care should be taken when co-administering these agents. [31493] Rotigotine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and rotigotine. Concomitant use of pregabalin with rotigotine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Dopaminergic agents, such as rotigotine, have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. [31493] [49557] [64848] Safinamide: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and safinamide. Concomitant use of pregabalin with safinamide may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. Dopaminergic agents, such as safinamide, have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. [31493] [61825] [64848] Scopolamine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of scopolamine and pregabalin. Concurrent use may result in additive CNS depression. [30354] [31493] [64848] Secobarbital: (Major) Concomitant use of barbiturates with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28597] [29787] [31493] [49229] [49236] [49352] [52119] [52120] [64848] Selegiline: (Moderate) Monitor for excessive sedation and somnolence during coadministration of selegiline and pregabalin. Concurrent use may result in additive CNS depression. [31493] [32026] [32436] Sevoflurane: (Major) Concomitant use of general anesthetics with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of excessive respiratory depression. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28970] [31036] [31493] [43431] [49500] [49614] [64848] Sodium Oxybate: (Major) Concomitant use of sodium oxybate with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [28528] [31493] [64848] Stiripentol: (Moderate) Monitor for excessive sedation and somnolence during coadministration of stiripentol and pregabalin. Concurrent use may result in additive CNS depression. [31493] [63456] [64848] Sufentanil: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of sufentanil with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. The use of sufentanil with CNS depressants may result in decreased pulmonary artery pressure and hypotension. As postoperative analgesia, concomitant use increases the risk for hypotension, respiratory depression, profound sedation, coma, and death. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30966] [31493] [61143] [63923] [64848] Suvorexant: (Moderate) Monitor for excessive sedation and somnolence during coadministration of suvorexant and pregabalin. Concurrent use may result in additive CNS depression. [31493] [57780] [64848] Tapentadol: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [45480] [61143] [63923] [64848] Tasimelteon: (Moderate) Monitor for excessive sedation and somnolence during coadministration of tasimelteon and pregabalin. Concurrent use may result in additive CNS depression. [31493] [56665] [64848] Temazepam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Tetrabenazine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of tetrabenazine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [34389] [64848] Thalidomide: (Major) Avoid coadministration of thalidomide with pregabalin because of the risk of additive CNS depression. If concurrent use cannot be avoided, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [60079] [64848] Thiazolidinediones: (Moderate) Higher rates of peripheral edema and weight gain may occur in patients who concomitantly use thiazolidinediones with pregabalin. As the thiazolidinediones and pregabalin can both cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, care should be taken when co-administering these agents. [31493] Thioridazine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and thioridazine. Concomitant use of pregabalin with thioridazine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [28293] [31493] [64848] Thiothixene: (Moderate) Monitor for excessive sedation and somnolence during coadministration of thiothixene and pregabalin. Concurrent use may result in additive CNS depression. [31493] [46957] [64848] Tizanidine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tizanidine. Concomitant use of pregabalin with tizanidine may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [27986] [52430] [64848] Tolcapone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and COMT inhibitors. Concomitant use of pregabalin with COMT inhibitors may cause additive CNS depression. COMT inhibitors have also been associated with sudden sleep onset during activities of daily living such as driving, which has resulted in accidents in some cases. Reassess patients for drowsiness or sleepiness regularly throughout treatment, especially since events may occur well after the start of treatment. Patients should be advised to avoid driving or other tasks requiring mental alertness until they know how the combination affects them. [28845] [31493] [42112] [64848] [65338] Topiramate: (Moderate) Monitor for respiratory depression and sedation during concomitant topiramate and pregabalin use; consider starting pregabalin at a low dose. Concomitant use increases the risk for additive CNS depression. [28378] [31493] [56847] traMADol: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [32475] [51440] [61143] [63923] [64848] Tramadol; Acetaminophen: (Major) Concomitant use of opioid agonists with pregabalin may cause excessive sedation, somnolence, and respiratory depression. Limit the use of opioid pain medications with pregabalin to only patients for whom alternative treatment options are inadequate. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Use the lowest effective doses and minimum treatment durations needed to achieve the desired clinical effect. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [31493] [32475] [51440] [61143] [63923] [64848] Trandolapril: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Trandolapril; Verapamil: (Moderate) Monitor for signs and symptoms of angioedema during concomitant angiotensin-converting enzyme inhibitor and pregabalin use. Concomitant use may increase the risk of developing angioedema. [31493] Tranylcypromine: (Moderate) Monitor for respiratory depression and sedation during concomitant monoamine oxidase inhibitor (MAOI) and pregabalin use; consider starting pregabalin at a low dose. Concomitant use increases the risk for additive CNS depression. [27957] [30438] [31493] [64848] Trazodone: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and trazodone. Concomitant use of pregabalin with trazodone may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [38831] [64848] Triazolam: (Major) Concomitant use of benzodiazepines with pregabalin may cause excessive sedation, somnolence, and respiratory depression. If concurrent use is necessary, initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of respiratory depression and sedation. Educate patients about the risks and symptoms of excessive CNS depression and respiratory depression. [30413] [31493] [40309] [41533] [41537] [41538] [41541] [41542] [41543] [41554] [41582] [43931] [44859] [57258] [63616] [64848] Tricyclic antidepressants: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Trifluoperazine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of trifluoperazine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [43071] [64848] Trimipramine: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and tricyclic antidepressants. Concomitant use of pregabalin with tricyclic antidepressants may cause additive CNS depression. Educate patients about the risks and symptoms of excessive CNS depression. [31493] [51356] [64848] Triprolidine: (Moderate) Monitor for excessive sedation and somnolence during coadministration of triprolidine and pregabalin. Concurrent use may result in additive CNS depression. [31493] [48444] [64848] Valerian, Valeriana officinalis: (Moderate) Monitor for excessive sedation and somnolence during coadministration of valerian and pregabalin. Concurrent use may result in additive CNS depression. [28209] [28832] [28833] [31493] [64848] Valproic Acid, Divalproex Sodium: (Moderate) Monitor for excessive sedation and somnolence during coadministration of valproic acid and pregabalin. Concurrent use may result in additive CNS depression. [31493] [44726] [64848] Zaleplon: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and zaleplon. Concomitant use of pregabalin with zaleplon may cause additive CNS depression and complex sleep-related behaviors (e.g., driving, talking, eating, or performing other activities while not fully awake). Educate patients about the risks and symptoms of excessive CNS depression. Instruct patients to contact their provider immediately if sleep-related symptoms or behaviors occur. [29887] [31493] [64848] Ziprasidone: (Moderate) Monitor for excessive sedation and somnolence during coadministration of ziprasidone and pregabalin. Concurrent use may result in additive CNS depression. [28233] [31493] [64848] Zolpidem: (Major) Initiate pregabalin at the lowest recommended dose and monitor patients for symptoms of sedation and somnolence during coadministration of pregabalin and zolpidem. The recommended dose of sublingual zolpidem tablets is 1.75 mg/night in patients receiving concomitant CNS depressants. Concomitant use of pregabalin with zolpidem may cause additive CNS depression and complex sleep-related behaviors (e.g., driving, talking, eating, or performing other activities while not fully awake). Educate patients about the risks and symptoms of excessive CNS depression. Instruct patients to contact their provider immediately if sleep-related symptoms or behaviors occur. [31493] [46915] [57789] [64848] Zuranolone: (Major) Avoid the use of multiple sedating agents due to the risk for additive CNS depression. If use is necessary, consider a downward dosage adjustment of either or both medications, especially in patients with additional risk factors for sedation-related harm. [69264]
      Revision Date: 05/24/2024, 01:33:00 AM

      References

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      Monitoring Parameters

      • laboratory monitoring not necessary

      US Drug Names

      • Lyrica
      • Lyrica CR
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