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Thiamine, Vitamin B1

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Sep.03.2023

Thiamine, Vitamin B1

Indications/Dosage

Labeled

  • beriberi
  • maple syrup urine disease (MSUD)
  • nutritional supplementation
  • Wernicke encephalopathy prophylaxis
  • Wernicke/Korsakoff syndrome

Off-Label

    † Off-label indication

    For nutritional supplementation

    Oral dosage

    Adult Males

    1.2 mg/day PO.[69401]

    Adult Females

    1.1 mg/day PO.[69401]

    Pregnant or Lactating Persons

    1.4 mg/day PO.[69401]

    Adolescent Males 14 to 17 years

    1.2 mg/day PO.[69401]

    Adolescent Females 14 to 17 years

    1 mg/day PO.[69401]

    Children 9 to 13 years

    0.9 mg/day PO.[69401]

    Children 4 to 8 years

    0.6 mg/day PO.[69401]

    Children 1 to 3 years

    0.5 mg/day PO.[69401]

    Infants 7 to 11 months

    0.3 mg/day PO is the recommended Adequate Intake. No RDA has been established.[69401]

    Infants 1 to 6 months

    0.2 mg/day PO is the recommended Adequate Intake. No RDA has been established.[69401]

    Neonates

    0.2 mg/day PO is the recommended Adequate Intake. No RDA has been established.[69401]

    for nutritional supplementation to prevent thiamine deficiency in persons receiving parenteral nutrition

    Intravenous dosage

    Adults

    3 to 6 mg/day IV.[43369]

    for nutritional supplementation after bariatric surgery

    Oral dosage

    Adults

    12 mg or more PO once daily; preferably 50 to 100 mg PO once daily from a vitamin B-complex supplement or high-potency multivitamin.[69358]

    For the treatment of beriberi (thiamine deficiency)

    for the treatment of mild berberi (including in breast-feeding persons at risk of inadequate intake)

    Oral dosage

    Adults

    10 mg PO once daily for 1 week, then 3 to 5 mg PO once daily for 6 weeks.[69373] [69390]

    Infants, Children, and Adolescents

    10 mg PO once daily for 1 week, then 3 to 5 mg PO once daily for 6 weeks.[69373] [69390]

    for the treatment of berberi with critical illness

    Intravenous dosage

    Adults

    50 to 100 mg IV as a single dose, followed by oral thiamine for at least 6 weeks.[69373] [69390]

    Oral dosage

    Adults

    3 to 5 mg PO once daily for at least 6 weeks after initial parenteral therapy.[69373] [69390]

    for the treatment of infantile berberi with severe heart failure, convulsions, or coma

    Intravenous or Intramuscular dosage

    Infants

    25 to 50 mg IV as a single dose, then 10 mg IM once daily for 10 days, and followed by oral thiamine for at least 6 weeks.[69373] [69390]

    Oral dosage

    Infants

    3 to 5 mg PO once daily for at least 6 weeks after initial parenteral therapy.[69373] [69390]

    for the treatment of berberi in infants and children with heart failure due to thiamine deficiency

    Intravenous or Intramuscular dosage

    Infants and Children

    25 mg IV and 25 mg IM concurrently as single doses, then 25 mg IV or IM once daily until the child can eat, and followed by oral thiamine for 2 to 3 weeks. Treat the mother at the same time until the mother can eat a more diverse diet.[69373]

    Oral dosage

    Breast-feeding Persons

    100 mg PO twice daily for 1 month until the mother can eat a more diverse diet.[69373]

    Infants and Children

    10 mg PO once daily for 2 to 3 weeks after initial parenteral therapy.[69373]

    for the treatment of beriberi in persons after bariatric surgery

    Oral dosage

    Adults

    100 mg PO 2 to 3 times daily until symptoms resolve.[69358]

    Intravenous dosage

    Adults

    200 mg IV 3 times daily to 500 mg IV once or twice daily for 3 to 5 days, then 250 mg IV once daily for 3 to 5 days or until symptoms resolve. Consider treatment with oral thiamine indefinitely or until risk factors have been resolved.[69358]

    Intramuscular dosage

    Adults

    250 mg IM once daily for 3 to 5 days or 100 to 250 mg IM once monthly.[69358]

    For the treatment of Wernicke/Korsakoff syndrome

    Intravenous or Intramuscular dosage

    Adults

    200 to 500 mg IV every 8 hours for at least 3 days.[58002] [58003] [66512] [68419] [68439] [69373] [69391] The FDA-approved dosage is 100 mg IV as a single dose, followed by 50 to 100 mg IM once daily until normal dietary intake is established.[15317]

    For Wernicke encephalopathy prophylaxis†

    Oral dosage

    Adults

    100 mg PO once daily for 3 to 5 days.[66512]

    Intravenous or Intramuscular dosage

    Adults

    100 mg IV or IM once daily for 3 to 5 days.[66512]

    For the treatment of metabolic disorders including necrotizing encephalomyelopathy, maple syrup urine disease (MSUD), and lactic acidosis associated with pyruvate carboxylase deficiency

    Oral dosage

    Adults

    10 to 20 mg/day PO as a single dose. Up to 4 g/day in divided doses has been used.

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

      Patients with Hepatic Impairment Dosing

      It appears that no dosage adjustments are needed.

      Patients with Renal Impairment Dosing

      It appears that no dosage adjustments are needed.

       

      Intermittent hemodialysis

      Patients on dialysis may have increased needs for thiamine.

       

      Peritoneal dialysis

      Patients on dialysis may have increased needs for thiamine.

      † Off-label indication
      Revision Date: 09/03/2023, 07:21:27 PM

      References

      15317 - Thiamine Hydrochloride injection package insert. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2013 Oct.43369 - Mirtallo J, Canada T, Johnson D, et al. Safe practices for parenteral nutrition. J Parenter Enteral Nutr 2004;28(6):S39-S70.58002 - Galvin R, Brathen G, Ivashynka A, et al. EFNS guidelines for diagnosis, therapy, and prevention of Wernicke encephalopathy. Eur J Neurol 2010;17:1408-1418.58003 - Thomson AD, Cook CH, Touquet R, et al. The Royal College of Physicians report on alcohol: guidelines for managing Wernicke's Encephalopathy in the accident and emergency department. Alcohol Alcohol 2002;37:513-521.66512 - American Society of Addiction Medicine’s (ASAM) Quality Improvement Council (QIC). The ASAM Clinical Practice Guideline on Alcohol Withdrawal Management. J Addict Med. 2020;14(3S Suppl 1):1-72. Erratum in: J Addict Med. 2020;14:e280.68419 - Long D, Long B, Koyfman A. The emergency medicine management of severe alcohol withdrawal. Am J Emerg Med. 201768439 - Flannery AH, Adkins DA, Cook AM. Unpeeling the Evidence for the Banana Bag: Evidence-Based Recommendations for the Management of Alcohol-Associated Vitamin and Electrolyte Deficiencies in the ICU. Crit Care Med. 2016 Aug;44:1545-52.69358 - Mechanick JI, Apovian C, Brethauer S, et al. Clinical practice guidelines for the perioperative nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures - 2019 update. Endocr Pract 2019;25:1346-1359.69373 - Smith TJ, Johnson CR, Koshy R, et al. Thiamine deficiency disorders: a clinical perspective. Ann N Y Acad Sci 2021;1498:9-28.69390 - World Health Organization. Thiamine deficiency and its prevention and control in major emergencies. Geneva, Switzerland: World Health Organization, 1999.69391 - Smith H, McCoy M, Varughese K, et al. Thiamine Dosing for the Treatment of Alcohol-Induced Wernicke's Encephalopathy: A Review of the Literature. J Pharm Technol 2021;37:107-113.69401 - National Institute of Health Office of Dietary Supplements. Dietary Supplement Fact Sheet: Thiamin. Updated Feb 9, 2023. Available on the World Wide Web at https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/#h2.

      How Supplied

      Calcium, Vitamin B1 (Thiamine) Oral tablet

      Leader Vitamin B-1 100mg Tablet (null) (Cardinal Health, Inc.) (off market)

      Calcium, Vitamin B1 (Thiamine) Oral tablet

      Vitamin B-1 100mg Tablet (null) (Mason Vitamins) null

      Calcium, Vitamin B1 (Thiamine) Oral tablet

      Today's Health Vitamin B1 100mg Tablet (null) (Today's Health, Inc.) null

      Calcium, Vitamin B1 (Thiamine) Oral tablet

      Vitamin B-1 100mg Tablet (null) (Mason Vitamins) (off market)

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 100mg/ml Solution for Injection (00641-0610) (Baxter Anesthesia/Critical Care) (off market)

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 100mg/ml Solution for Injection (00074-2174) (Hospira Worldwide, Inc., a Pfizer Company) (off market)

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 100mg/ml Solution for Injection (00684-0148) (Primedics Laboratories) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2ml Solution for Injection (00641-6228) (Hikma Pharmaceuticals USA Inc.) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2ml Solution for Injection (67457-0196) (Mylan Institutional LLC ) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2ml Solution for Injection (25021-0500) (Sagent Pharmaceuticals) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2mL Solution for Injection (72485-0507) (Armas Pharmaceuticals, Inc.) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2mL Solution for Injection (43598-0050) (Dr. Reddy's Laboratories, Inc.) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2mL Solution for Injection (55150-0273) (Eugia US LLC fka AuroMedics Pharma LLC) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2mL Solution for Injection (63323-0013) (Fresenius Kabi AG) nullThiamine Hydrochloride 200mg/2mL Solution for Injection package photo

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2mL Solution for Injection (70748-0347) (Lupin Pharmaceuticals, Inc.) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2mL Solution for Injection (72603-0139) (NorthStar Rx LLC) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2ml Solution for Injection (NOVAPLUS) (63323-0013) (Fresenius Kabi USA, LLC ) null

      Vitamin B1 (Thiamine Hydrochloride) Solution for injection

      Thiamine Hydrochloride 200mg/2mL Solution for Injection (PREMIER ProRx) (63323-0013) (Fresenius Kabi AG) null

      Description/Classification

      Description

      Description: Thiamine, or vitamin B1, is a water-soluble vitamin found in such foods as yeast, cereal grains, legumes, peas, nuts, pork, and beef. Thiamine deficiency causes beriberi. Thiamine is also used to prevent peripheral neuritis associated with pellagra and pregnancy. This vitamin is also beneficial in treating metabolic disorders associated with subacute necrotizing encephalomyelopathy, branched-chain aminoacidopathy, and lactic acidosis associated with pyruvate carboxylase deficiency. Thiamine is considered a standard agent in the treatment of a patient with undiagnosed coma. Thiamine was approved by the FDA at its inception in 1938.

      Classifications

      • Vitamins, Minerals, and Dietary or Nutritional Supplements
        • Vitamin and Mineral Supplements
          • Vitamin B Supplements
            • Vitamin B1 (Thiamine) Supplements
      Revision Date: 02/07/2009, 03:03:04 AM

      References

      Administration Information

      General Administration Information

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

      Route-Specific Administration

      Oral Administration

      • Thiamine, vitamin B1 may be administered without regard to meals.

      Injectable Administration

      • Administer intramuscularly or intravenously. Parenteral therapy is usually reserved for patients for which oral thiamine is not feasible.
      • Prior to intravenous administration, an intradermal test dose should be administered to patients in whom a sensitivity might be suspected.
      • Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

      Intravenous Administration

      Direct IV injection:

      • No dilution is necessary.
      • Inject each 100 mg thiamine, vitamin B1 via slow IV push.

       

      Continuous IV infusion:

      • Dilute thiamine, vitamin B1 in a compatible infusion solution.
      • Administer at a rate prescribed by the physician.

      Intramuscular Administration

      • Inject thiamine, vitamin B1 deeply into a large muscle.
      • Tenderness and induration may occur at the injection site. Discomfort may be reduced by applying cool compresses.

      Clinical Pharmaceutics Information

      From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database

      Thiamine hydrochloride

      pH Range
      pH 2.5 to 4.5
      ReferencesAnon. Manufacturer's information and labeling. (Package insert).
      Osmolality/Osmolarity
      Thiamine hydrochloride injection 100 mg/mL is hypertonic having an osmolality of 777 mOsm/kg.
      ReferencesTrissel LA. Drug information- osmolalities. Data on file.
      Stability
      Thiamine hydrochloride injection in intact containers stored as directed by the manufacturer is stable until the labeled expiration date. Infusion Solutions: Kirkland et al. reported that thiamine hydrochloride is physically compatible with most common infusion solutions. Martens reported thiamine hydrochloride (from multiple vitamins) was stable in dextrose 5% and also sodium chloride 0.9% in polyvinyl chloride (PVC) and in Clearflex non-PVC at room temperature of 23 degree C exposed to and protected from light. HPLC analysis found losses about 11% or lower in 24 hours. Dupertuis et al. reported loss of thiamine hydrochloride from Cernevit in a 3-in-1 parenteral nutrition admixture was approximately 25% in ethylene vinyl acetate bags but only 10% in multilayer bags over 24 hours at temperatures ranging from 4, 21, and 40 degree C. Presumably the multilayer bags afforded better protection against oxygen transfer than the EVA bags. Vazquez et al. (2 reports) reported the stability of multiple vitamins injection (Cernevit, Baxter) diluted in three parenteral nutrition admixtures. Except for ascorbic acid, all of the vitamins, including thiamine hydrochloride, retained nearly 100% of the initial concentrations for 48 hours at ambient conditions. Thiamine hydrochloride in solutions is highly unstable in the presence of a sufficient concentration of sulfite and bisulfite antioxidants. Numerous studies have documented the rapid and extensive loss of thiamine hydrochloride in a variety of parenteral nutrition admixtures in which the vitamin was found to be much more stable without the antioxidant present. A degree of variability of the losses has been reported; losses in sulfite-containing parenteral nutrition admixtures have ranged from about 40 or 50% up to 97% in 24 hours at room temperature. Bowman and Nguyen reported that if the sulfite concentration is sufficiently low (0.05%) the loss of thiamine hydrochloride is much less. Packaged in Syringes: Nolly et al. reported that thiamine hydrochloride 100 mg/mL packaged in Becton Dickinson Glaspak glass syringes, Hy-Pod glass syringes, and Stylex plastic syringes was stable stored at room temperature 22 to 24 degree C protected from exposure to light with UV absorbing amber plastic bags. HPLC analysis found no loss of thiamine hydrochloride and no change in color or pH after storage for 84 days. Paramedic Vehicles: Valenzuela et al. reported the stability of thiamine hydrochloride injection exposed to temperatures ranging from 26 to 38 degree C under simulated summer conditions in paramedic vehicles over 4 weeks. Gas chromatography coupled with mass spectrometry found no change in the drug over 4 weeks under these simulated use conditions. Gammon et al. reported on the stability of a number of drugs used by paramedics when exposed to the temperature range that is found in ambulances as documented by Brown et al. and Allegra et al. Undiluted adenosine 3 mg/mL injection was stored at temperatures that cycled every 24 hours from -6 to 54 degree C (2.12 to 129.2 degree F) for 28 days. The drug was exposed to a total of 336 hours at each of the temperature extremes. The mean kinetic temperature was 33 degree C. HPLC and ultraviolet spectrophotometry found little or no loss of drug occurred over the 28-day test period.
      ReferencesAllegra JR, Brennan J, Lanier V, et al. Storage temperatures of out-of-hospital medications. Acad Emerg Med. 1999; 6
      ReferencesBowman BB, Nguyen P. Stability of thiamine in parenteral nutrition solutions. J Parenter Enter Nutr. 1983; 7
      ReferencesBrown LH, Bailey LC, Medwick T, et al. Medication storage on US ambulances: a prospective multi-center observational study. Pharm Forum. 2003; 29
      ReferencesChen MF, Boyce HW, Triplett L. Stability of B vitamins in mixed parenteral nutrition solution. J Parenter Enter Nutr. 1983; 7
      ReferencesDahl GB, Jeppsson RI, Tengborn HJ. Vitamin stability in a TPN mixture stored in an EVA plastic bag. J Clin Hosp Pharm. 1986; 1
      ReferencesDupertuis YM, Morch A, Fathi M, et al. Physical characteristics of total parenteral nutrition bags significantly affect the stability of vitamins C and B1: A controlled prospective study. J Parenter Enter Nutr. 2002; 26
      ReferencesGammon DL, Su S, Huckfeldt R, et al. Alteration in prehospital drug concentration after thermal exposure. Am J Emerg Med. 2008; 26
      ReferencesKearney MCJ, Allwood MC, Neale T, et al. The stability of thiamine in total parenteral nutrition mixtures stored in EVA and in multi-layered bags. Clin Nutr. 1995; 14
      ReferencesKirkland WD, Jones RW, Ellis JR, et al. Compatibility studies of parenteral admixtures. Am J Hosp Pharm. 1961; 18
      ReferencesMartens HJ. Stabilitat wasserloslicher vitamine in verschieden infusionsbenteln. [Stability of water soluble vitamins in different infusions.]. Krankenhauspharmazie. 1989; 10
      ReferencesMurata A, Okamoto Y, Sasa Y, et al. Effect of light and sodium bisulfite on the stability of thiamine in TPN fluids and integrated dose in period values. Jpn J Pharm Health Care Sci. 2004; 30
      ReferencesNolly RJ, Stach PE, Latiolais CJ, et al. Stability of thiamine hydrochloride repackaged in disposable syringes. Am J Hosp Pharm. 1982; 39
      ReferencesScheiner JM, Araujo MM, DeRitter E. Thiamine destruction by sodium bisulfite in infusion solutions. Am J Hosp Pharm. 1981; 38
      ReferencesShine B, Farwell JA. Stability and compatibility in parenteral nutrition solutions. Br J Parenter Ther. 1984; 5
      ReferencesSmith JL, Canham JE, Wells PA. Effect of phototherapy light, sodium bisulfite, and pH on vitamin stability in total parenteral nutrition admixtures. J Parenter Enter Nutr. 1988; 12
      ReferencesSmith JL, Canham JE, Kirkland WD, et al. Effect of Intralipid, amino acids, container, temperature, and duration of storage on vitamin stability in total parenteral nutrition admixtures. J Parenter Enter Nutr. 1988; 12
      ReferencesValenzuela TD, Criss EA, Hammargen WM, et al. Thermal stability of prehospital medications. Ann Emerg Med. 1989; 18
      ReferencesVazquez R, Hoang ML, Martin J, et al. Simultaneous quantification of water-soluble and fat-soluble vitamins in parenteral nutrition admixtures by HPLC-UV-MS/MS. Eur J Hosp Pharm Sci. 2009; 15
      ReferencesVazquez R, Rotival R, Calvez S, et al. Stability indicating assay method on vitamins: Application to their stability study in aprenetral nutrition admixtures. Chromatographia. 2009; 69
      pH Effects
      Thiamine hydrochloride is stable at acidic pH. Decomposition proceeds very slowly at pH 4 and lower with maximum stability variously reported to be at pH 2 (Connors et al.) and pH 3.5 (El-Khawas and Boraie). However, the vitamin is less stable at neutral and alkaline pH including solutions of alkaline drugs such as barbiturates and those with carbonates or bicarbonates in the formulation.
      ReferencesAnon. Manufacturer's information and labeling. (Package insert).
      ReferencesAmmar HO. Stability of injection solutions of vitamin B1. Pharmazie. 1976; 31
      ReferencesEl-Khawas M, Boraie NA. Stability and compatibility of thiamine hydrochloride in liquid dosage forms at various temperatures. Acta Pharm. 2000; 50
      ReferencesMcEvoy GK (ed). AHFS Drug Information (current edition). Bethesda, MD: American Society of Health-System Pharmacists.
      ReferencesConnors KA, Amidon GL, Stella VJ. Chemical stability of pharmaceuticals, A handbook for pharmacists. New York: John Wiley & Sons, 1986. 1986;
      Light Exposure
      Thiamine hydrochloride should be protected from exposure to light during long-term storage. Martens reported thiamine hydrochloride (from multiple vitamins) was stable in dextrose 5% and also sodium chloride 0.9% in polyvinyl chloride (PVC) and in Clearflex non-PVC at room temperature of 23 degree C exposed to and protected from light. HPLC analysis found losses of 11% or lower in 24 hours. Smith et al. reported that exposure of a parenteral nutrition admixture containing thiamine hydrochloride to intense phototherapy light did not adversely affect the stability of thiamine hydrochloride.
      ReferencesAnon. Manufacturer's information and labeling. (Package insert).
      ReferencesMartens HJ. Stabilitat wasserloslicher vitamine in verschieden infusionsbenteln. [Stability of water soluble vitamins in different infusions.]. Krankenhauspharmazie. 1989; 10
      ReferencesSmith JL, Canham JE, Wells PA. Effect of phototherapy light, sodium bisulfite, and pH on vitamin stability in total parenteral nutrition admixtures. J Parenter Enter Nutr. 1988; 12
      Freezing
      Thiamine hydrochloride injection should be protected from freezing.
      ReferencesAnon. Manufacturer's information and labeling. (Package insert).
      Filtration
      Nolly et al. reported that thiamine hydrochloride 100 mg/mL unfiltered and also passed through Extemp filter pins having 5-micron stainless steel depth filters and packaged in syringes was stable stored at room temperature of 22 to 24 degree C protected from exposure to light by UV absorbing amber plastic bags. HPLC analysis found no loss of thiamine hydrochloride over 84 days of storage with no difference between the filtered and unfiltered samples.
      ReferencesNolly RJ, Stach PE, Latiolais CJ, et al. Stability of thiamine hydrochloride repackaged in disposable syringes. Am J Hosp Pharm. 1982; 39
      Sorption Leaching
      Moorhatch and Chiou reported that thiamine hydrochloride did not undergo sorption to polyvinyl chloride (PVC) plastic test strips.
      ReferencesMoorhatch P, Chiou WL. Interactions between drugs and plastic intravenous fluid bags, part I: sorption studies on 17 drugs. Am J Hosp Pharm. 1974; 31
      Other Information
      Thiamine hydrochloride is incompatible with oxidizing and reducing compounds. Oxidation yields thiochrome, an inactive intensely blue colored compound. Antibiotics: Thiamine hydrochloride has been shown to impair the antibiotic activity of erythromycin, kanamycin sulfate, streptomycin sulfate. Sulfites: Thiamine hydrochloride is sensitive to sulfites and bisulfite antioxidants in the formulations of other drugs and solutions undergoing rapid decomposition.
      ReferencesAsahara K, Goda Y, Shimomura Y, et al. Stability of thiamine in intravenous hyperalimentation containing multivitamins. Jpn J Hosp Pharm. 1995; 21
      ReferencesColes CLJ, Lees KA. Additives to intravenous fluids. Pharm J. 1971; 206
      ReferencesConnors KA, Amidon GL, Stella VJ. Chemical stability of pharmaceuticals, A handbook for pharmacists. New York: John Wiley & Sons, 1986. 1986;
      ReferencesEl-Nakeeb MA, Souccar N, Yousef RT. Inactivation of various antibiotics by some vitamins. Can J Pharm Sci. 1976; 11
      ReferencesMcEvoy GK (ed). AHFS Drug Information (current edition). Bethesda, MD: American Society of Health-System Pharmacists.
      ReferencesNolly RJ, Stach PE, Latiolais CJ, et al. Stability of thiamine hydrochloride repackaged in disposable syringes. Am J Hosp Pharm. 1982; 39
      Stability Max
      Maximum reported stability periods: In D5W- 24 hours at room temperature (11% loss) In NS- 24 hours at room temperature (11% loss)
      ReferencesMartens HJ. Stabilitat wasserloslicher vitamine in verschieden infusionsbenteln. [Stability of water soluble vitamins in different infusions.]. Krankenhauspharmazie. 1989; 10
      Revision Date: 09/18/2018, 07:47:46 AMCopyright 2004-2024 by Lawrence A. Trissel. All Rights Reserved.

      References

      Adverse Reactions

      Mild

      • diaphoresis
      • injection site reaction
      • nausea
      • pruritus
      • restlessness
      • sneezing
      • urticaria
      • weakness

      Severe

      • anaphylactoid reactions
      • angioedema
      • cyanosis
      • GI bleeding
      • pulmonary edema

      Thiamine is relatively free from adverse reactions. The incidence of severe reactions to parenteral thiamine is estimated to be < 0.1%, even with undiluted IV push administration. In rare cases, thiamine hypersensitivity, including urticaria, anaphylactoid reactions, collapse, and death have occurred, primarily following repeated parenteral administration. Symptoms of sneezing or generalized pruritus may preceed more severe reactions. Pruritus appears to occur in approximately 1% of individuals receiving parenteral thiamine.[25500] There have also been reports of a feeling of warmth, urticaria, weakness, diaphoresis, nausea, restlessness, tightness of the throat, angioedema, cyanosis, pulmonary edema, and GI bleeding with parenteral administration.[15317]

      The most common adverse reaction to parenteral thiamine administration is an injection site reaction. Pain, induration, and tenderness after IM injection can occur. Patients receiving IV thiamine may experience transient burning or pain immediately after injection into the IV site or IV line. Reactions related to IV thiamine administration can be minimized by slow IV administration into larger, more proximal veins with high flow rates. Injection site reactions are usually mild and transient, with no permanent consequence.[15317]

      Revision Date: 03/27/2011, 04:23:36 AM

      References

      15317 - Thiamine Hydrochloride injection package insert. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2013 Oct.25500 - Wrenn KD, Murphy F, Slovis CM, et al. A toxicity study of parenteral thiamine hydrochloride. Ann Emerg Med 1989;18:867-70.

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • breast-feeding
      • encephalopathy
      • pregnancy

      Wernicke's encephalopathy may be precipitated or worsened if intravenous glucose is administered to a thiamine-deficient patient. Thiamine (vitamin B1) should be administered prior to glucose. Clinicians should note that parenteral glucose should never be administered to a comatose patient without the prior administration of thiamine.

      Thiamine is classified as FDA pregnancy risk category A. Appropriate maternal thiamine (vitamin B1) intake is encouraged during pregnancy, and no maternal or fetal complications associated with maternal dietary intake or supplementation to achieve adequate intake goals have been reported. As with other water-soluble vitamins, the pregnancy risk factor increases to FDA risk category C if the vitamin is used in dosages exceeding the Recommended Dietary Allowance (RDA) during pregnancy.[49220]

      According to the manufacturer, caution should be exercised when thiamine is administered during breast-feeding.[15317] However, while thiamine is excreted in human milk, appropriate maternal intake of thiamine (vitamin B1) is important during lactation, and no maternal or fetal complications have been identified with maternal supplementation to achieve adequate intake goals during breast-feeding. Seizures have occurred in nursing infants of mothers with thiamine deficiency, although causality has not been established.[49220] Supplementation with thiamine is recommended in lactating women whose diets do not provide adequate amounts of thiamine. The American Academy of Pediatrics classifies thiamine as compatible with breast-feeding.[27500] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

      Revision Date: 03/19/2012, 04:55:47 PM

      References

      15317 - Thiamine Hydrochloride injection package insert. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2013 Oct.27500 - American Academy of Pediatrics (AAP) Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics 2001;108(3):776-789.49220 - Briggs GG, Freeman RK, Yaffee SJ. Thiamine. In: Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. 8th ed. Philadelphia: Lippincott Williams & Wilkins: 2008;1792-3.

      Mechanism of Action

      Mechanism of Action: Thiamine combines with adenosine triphosphate (ATP) in the liver, kidneys, and leukocytes to produce thiamine diphosphate. Thiamine diphosphate acts as a coenzyme in carbohydrate metabolism, in transketolation reactions, and in the utilization of hexose in the hexose-monophosphate shunt. Without adequate thiamine, pyruvic acid does not undergo conversion to acetyl-CoA and cannot enter the Krebs cycle. Pyruvic acid accumulates in the blood and is subsequently converted to lactic acid, with the potential development of lactic acidosis. Diminished production of NADH in the Krebs cycle also results in lactic acid production through facilitation of anaerobic glycolysis.

      Thiamine deficiency appears as a nonspecific syndrome: headache, nausea, malaise, myalgias. Severe thiamine deficiency causes beriberi. Beriberi can affect the cardiovascular system (wet beriberi) and the nervous system (dry beriberi and the Wernicke-Korsakoff syndrome). Cardiovascular manifestations include peripheral vasodilation, biventricular failure, and edema. Neurologic symptoms include neuropathy, ataxia, retrograde amnesia, impaired ability to learn, and confabulation. Once Korsakoff's syndrome appears, thiamine supplementation is successful in only half of the patients.

      Revision Date: 02/07/2009, 03:03:04 AM

      References

      Pharmacokinetics

      Thiamine is administered orally and by intramuscular or intravenous injection.  Thiamine is widely distributed. Body storage of thiamine is limited to about 30 mg. Thiamine is distributed into breast milk at a rate of about 100—200 mcg daily from normal dietary intake. There is little excretion of thiamine or its metabolites at physiologic doses. Following large doses, saturation occurs, with subsequent renal excretion as pyrimidine.

      Route-Specific Pharmacokinetics

      Oral Route

      Small oral doses are readily absorbed from the GI tract, but absorption of large doses is limited. Administration with food reduces the rate of absorption.

      Intramuscular Route

      Following IM administration of thiamine, vitamin B1, absorption is rapid and complete.

      Special Populations

      Hepatic Impairment

      Patients with cirrhosis have a decreased extent of absorption of thiamine, vitamin B1.

      Other

      Alcoholism

      Alcoholics have a decreased extent of absorption of thiamine, vitamin B1.

       

      Malabsorption

      Patients with malabsorption have a decreased extent of absorption of thiamine, vitamin B1.

      Revision Date: 04/09/2010, 02:13:54 PM

      Pregnancy/Breast-feeding

      pregnancy

      Thiamine is classified as FDA pregnancy risk category A. Appropriate maternal thiamine (vitamin B1) intake is encouraged during pregnancy, and no maternal or fetal complications associated with maternal dietary intake or supplementation to achieve adequate intake goals have been reported. As with other water-soluble vitamins, the pregnancy risk factor increases to FDA risk category C if the vitamin is used in dosages exceeding the Recommended Dietary Allowance (RDA) during pregnancy.[49220]

      breast-feeding

      According to the manufacturer, caution should be exercised when thiamine is administered during breast-feeding.[15317] However, while thiamine is excreted in human milk, appropriate maternal intake of thiamine (vitamin B1) is important during lactation, and no maternal or fetal complications have been identified with maternal supplementation to achieve adequate intake goals during breast-feeding. Seizures have occurred in nursing infants of mothers with thiamine deficiency, although causality has not been established.[49220] Supplementation with thiamine is recommended in lactating women whose diets do not provide adequate amounts of thiamine. The American Academy of Pediatrics classifies thiamine as compatible with breast-feeding.[27500] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

      Revision Date: 03/19/2012, 04:55:47 PM

      References

      15317 - Thiamine Hydrochloride injection package insert. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2013 Oct.27500 - American Academy of Pediatrics (AAP) Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics 2001;108(3):776-789.49220 - Briggs GG, Freeman RK, Yaffee SJ. Thiamine. In: Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. 8th ed. Philadelphia: Lippincott Williams & Wilkins: 2008;1792-3.

      Interactions

      Level 3 (Moderate)

      • Patiromer
      Patiromer: (Moderate) Separate the administration of patiromer and oral thiamine by at least 3 hours if concomitant use is necessary. Simultaneous oral coadministration may reduce gastrointestinal absorption of thiamine and reduce its efficacy. Patiromer has been observed to bind some oral medications when given at the same time and separating administration by at least 3 hours has effectively mitigated this risk. [60237]
      Revision Date: 09/29/2023, 01:50:00 AM

      References

      60237 - Veltassa (patiromer) package insert. Redwood City, CA: Vifor Pharma, Inc.; 2023 Oct.

      Monitoring Parameters

      • laboratory monitoring not necessary
      ;