Bupropion is an antidepressant medicine that can also decrease appetite. Naltrexone is usually given to block the effects of opioids or alcohol in people with addiction problems. Naltrexone may also curb hunger and food cravings.

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.

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.

You should not use bupropion and naltrexone if you have uncontrolled high blood pressure, seizures, an eating disorder, opioid addiction, if you are pregnant, if you take opioid 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. 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 bupropion and naltrexone with a high-fat meal, or you may be more likely to have a seizure.

If you need to use opioid 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.

This medicine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use bupropion and naltrexone.

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.

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 in the morning and 1 tablet orally 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:
-Therapy should be discontinued if a patient has not lost at least 5% of baseline body weight after 12 weeks at maintenance dose as it is unlikely that clinically meaningful weight loss will occur with continued treatment.
-The effect of this drug on cardiovascular morbidity and mortality has not been established.
-The safety and effectiveness of this drug in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

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).

Do not use this medicine 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 opioid medication for a minimum of 7 to 10 days before starting bupropion and naltrexone.

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 breastfeed while using this medicine.

This medicine is not approved for use by anyone younger than 18 years old.

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.

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 an opioid medicine.

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 opioid 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.

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 this medicine and call your doctor right away if you have:

• severe headache, blurred vision, pounding in your neck or ears, fast heartbeats;

• 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); or

• severe skin reaction--fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling.

Older adults may be more likely to have certain side effects.

Common side effects of bupropion and naltrexone 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

When you start or stop taking bupropion and naltrexone, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can affect bupropion and naltrexone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.