What is bupropion and naltrexone?
Bupropion and naltrexone is a combination medicine used to help manage weight in obese or overweight adults with weight-related medical problems. bupropion and naltrexone is used together with diet and exercise.
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Bupropion and naltrexone will not treat any weight-related medical condition, such as high blood pressure, diabetes, or high cholesterol.
Contrave is not approved to treat depression or other psychiatric conditions, or to help you quit smoking.
Bupropion and naltrexone may also be used for purposes not listed in this medication guide.
Important Information
You should not use this medicine if you have uncontrolled high blood pressure, seizures, an eating disorder, opioid addiction, if you are pregnant, if you take narcotic medicine or other forms of bupropion, or if you have suddenly stopped using alcohol, seizure medication, or a sedative.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with bupropion and naltrexone, and some drugs should not be used together.
Some young people have thoughts about suicide when first taking bupropion. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Before taking this medicine
Do not use bupropion and naltrexone if you are pregnant. Weight loss during pregnancy can harm an unborn baby, even if you are overweight. Tell your doctor right away if you become pregnant.
You should not use this medicine if you are allergic to bupropion or naltrexone, or if you have:
- untreated or uncontrolled high blood pressure;
- an eating disorder (anorexia or bulimia);
- a history of seizures;
- opioid addiction or withdrawal (or if you take methadone or buprenorphine);
- if you take other forms of bupropion (Wellbutrin, Aplenzin, Budeprion, Forfivo, Zyban, and others); or
- if you have suddenly stopped using alcohol, seizure medication, or a sedative such as Xanax, Valium, Fiorinal, Klonopin, and others).
Do not use an MAO inhibitor within 14 days before or 14 days after you take bupropion and naltrexone. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
Tell your doctor if you have ever had:
- depression, bipolar disorder, or mental illness;
- suicidal thoughts or actions;
- a head injury;
- a tumor or infection in your brain or spinal cord;
- diabetes or low blood sugar;
- low sodium levels;
- liver or kidney disease;
- heart disease, high blood pressure, heart attack, or stroke; or
- drug addiction, or if you normally drink a lot of alcohol.
Some young people have thoughts about suicide when first taking bupropion. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
You should not breast-feed while using this medicine.
This medicine is not approved for use by anyone younger than 18 years old.
How should I take bupropion and naltrexone?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Swallow the tablet whole and do not crush, chew, or break it.
Do not take more than 2 tablets at once.
Do not take this medicine with a high-fat meal, or you may be more likely to have a seizure.
If you need to use narcotic medicine for any reason (such as pain, surgery, or treatment for drug addiction) you may need to stop taking bupropion and naltrexone for a short time. Follow your doctor’s dosing instructions very carefully.
Store at room temperature away from moisture and heat.
If you have not lost at least 5% of your starting weight after 16 weeks of treatment, this medicine may not be right for you.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Do not take more than 4 tablets in 1 day.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of bupropion and naltrexone can be fatal, especially if you also take a narcotic (opioid medicine).
What should I avoid while taking bupropion and naltrexone?
Drinking alcohol with bupropion may increase your risk of seizures. If you drink alcohol regularly, talk with your doctor before changing the amount you drink. Bupropion can also cause seizures in a regular drinker who suddenly stops drinking.
Follow your doctor’s instructions about any restrictions on food, beverages, or activity. Do not take other weight-loss products or diet pills unless your doctor has told you to.
Do not use narcotic medication, methadone, heroin, or other street drugs while you are taking bupropion and naltrexone. Doing so could result in dangerous effects, including coma and death.
Bupropion and naltrexone side effects
Get emergency medical help if you have signs of an allergic reaction: fever, swollen glands, mouth sores, muscle or joint pain; hives, rash or itching; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.
A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, severe drowsiness, or if you are hard to wake up.
Stop taking bupropion and naltrexone and call your doctor right away if you have:
- a seizure (convulsions);
- blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- changes in mood or behavior–anxiety, depression, panic attacks, trouble sleeping, agitation, thoughts about suicide or hurting yourself;
- a manic episode–racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative;
- liver problems–upper stomach pain, tiredness, dark urine, jaundice (yellowing of the skin or eyes);
- increased blood pressure–severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
- severe skin reaction–fever, mouth or throat pain, burning eyes, skin pain, red or purple rash that spreads and causes blisters and peeling.
Older adults may be more likely to have certain side effects.
Common side effects may include:
- nausea, vomiting, diarrhea, constipation;
- headache, dizziness;
- dry mouth; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Weight Loss:
Each extended-release tablet contains naltrexone 8 mg/bupropion 90 mg:
Initial dose:
-Week 1: One tablet orally once a day in the morning
-Week 2: One tablet orally 2 times a day (morning and evening)
-Week 3: Two tablets orally once a day in the morning and 1 tablet orally once a day in the evening
-Week 4: Two tablets orally 2 times a day (morning and evening)
Maintenance dose: 2 tablets orally 2 times a day (morning and evening)
Maximum dose: 4 tablets/day (naltrexone 32 mg/Bupropion 360 mg)
Comments:
-Discontinue therapy if a patient has not lost at least 5% of baseline body weight after 12 weeks at maintenance dose.
Uses: As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
What other drugs will affect bupropion and naltrexone?
When you start or stop taking bupropion and naltrexone, your doctor may need to adjust the doses of other medicines you take on a regular basis.
Tell your doctor about all your current medicines and any you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
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