Naltrexone; Bupropion Extended-Release Tablets

NALTREXONE; BUPROPION (nal TREX one; byoo PROE pee on) promotes weight loss. It may also be used to maintain weight loss. It works by decreasing appetite. Changes to diet and exercise are often combined with this medication.

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. You can take it with or without food. Do not take with high-fat meals as this may increase your risk of seizures. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Fast or irregular heartbeat
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Seizures
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Dizziness
• Dry mouth
• Fatigue
• Headache
• Nausea
• Trouble sleeping
• Vomiting

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

They need to know if you have any of these conditions:

• An eating disorder, such as anorexia or bulimia
• Diabetes
• Depression
• Frequently drink alcohol
• Glaucoma
• Head injury
• Heart disease
• High blood pressure
• History of a tumor or infection of your brain or spine
• History of heart attack or stroke
• History of irregular heartbeat
• History of substance use disorder or alcohol use disorder
• Kidney disease
• Liver disease
• Low levels of sodium in the blood
• Mental health condition
• Seizures
• Suicidal thoughts, plans, or attempt by you or a family member
• Taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
• An unusual or allergic reaction to bupropion, naltrexone, other medications, foods, dyes, or preservatives
• Breast-feeding
• Pregnant or trying to become pregnant

Do not take this medication with any of the following:

• Any medications used to stop taking opioids, such as methadone or buprenorphine
• Linezolid
• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methylene blue (injected into a vein)
• Opioid medications
• Other medications that contain bupropion, such as Zyban or Wellbutrin

This medication may also interact with the following:

• Alcohol
• Certain medications for blood pressure, such as metoprolol, propranolol
• Certain medications for depression, anxiety, or mental health conditions
• Certain medications for HIV or hepatitis
• Certain medications for irregular heart beat, such as propafenone, flecainide
• Certain medications for Parkinson disease, such as amantadine, levodopa
• Certain medications for seizures, such as carbamazepine, phenytoin, phenobarbital
• Certain medications for sleep
• Cimetidine
• Clopidogrel
• Cyclophosphamide
• Digoxin
• Disulfiram
• Furazolidone
• Isoniazid
• Nicotine
• Orphenadrine
• Procarbazine
• Steroid medications, such as prednisone or cortisone
• Stimulant medications for attention disorders, weight loss, or to stay awake
• Tamoxifen
• Theophylline
• Thiotepa
• Ticlopidine
• Tramadol
• Warfarin

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

Visit your care team for regular checks on your progress.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

This medication may affect blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes.

Patients and their families should watch out for new or worsening depression or thoughts of suicide. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

Avoid alcoholic drinks while taking this medication. Drinking large amounts of alcoholic beverages, using sleeping or anxiety medications, or quickly stopping the use of these agents while taking this medication may increase your risk for a seizure.

Do not drive or use heavy machinery until you know how this medication affects you. This medication can impair your ability to perform these tasks.

Inform your care team if you wish to become pregnant or think you might be pregnant. Losing weight while pregnant is not advised and may cause harm to the unborn child. Talk to your care team for more information.