contrave

Contrave contains a combination of bupropion and naltrexone. Bupropion is an antidepressant medicine. Naltrexone blocks the effects of narcotic medicines and alcohol.

Contrave is used to help manage weight in obese or overweight adults with weight-related medical problems. This medicine is used together with diet and exercise.

Contrave is for use only to help you manage your weight. This medicine will not treat any weight-related medical condition, such as high blood pressure, diabetes, or high cholesterol.

Although bupropion is an antidepressant and is sometimes used to help people quit smoking, Contrave is not approved to treat depression or other psychiatric conditions, or to help you quit smoking.

Important information

You should not use Contrave if you have uncontrolled high blood pressure, seizures, an eating disorder, kidney failure, if you are pregnant or breast-feeding, or if you have recently stopped using seizure medicine. Do not take this medicine if you also take narcotic medicine or other forms of bupropion (such as Wellbutrin or Zyban), or if you are going through withdrawal from alcohol or drug addiction.

Do not use Contrave if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Do not use Contrave if you are pregnant.

Some young people have thoughts about suicide when first taking bupropion. Your doctor will need to check your progress at regular visits while you are using Contrave. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Before taking this medicine

You should not use Contrave 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;

• kidney failure (end-stage kidney disease);

• if you are pregnant or breast-feeding;

• if you have recently stopped using seizure medicine suddenly;

• if you have taken any narcotic (opioid) medicine within the past 10 days (including tramadol, Vicodin, OxyContin, and many others);

• if you are going through withdrawal from alcohol or drug addiction; or

• if you also take bupropion (Wellbutrin, Aplenzin, Budeprion, Forfivo, Zyban, and others).

Do not use Contrave if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

To make sure Contrave is safe for you, tell your doctor if you have:

• past or present depression, mental illness, or suicidal thoughts or actions;

• bipolar disorder (or a family history of bipolar disorder, depression, or suicide);

• a history of addiction to drugs or alcohol;

• narrow-angle glaucoma;

• diabetes (treated with insulin or oral medicine);

• heart disease, high blood pressure, history of stroke or blood clot;

• liver or kidney disease;

• a history of low blood sugar or low levels of sodium in your blood;

• a history of head injury;

• a history of tumor or infection in your brain or spinal cord;

• if you normally drink a lot of alcohol;

• if you have taken buprenorphine or methadone in the past 14 days; or

• if you also take clopidogrel (Plavix) or ticlopidine (Ticlid).

Some young people have thoughts about suicide when first taking bupropion. Your doctor will need to check your progress at regular visits while you are using Contrave. Your family or other caregivers should also be alert to changes in your mood or symptoms.

This medicine can harm an unborn baby or cause birth defects. Do not use Contrave if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control to prevent pregnancy while you are using Contrave.

Bupropion and naltrexone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Contrave.

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

How should I take Contrave?

Take Contrave exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medicine is usually taken in the morning and evening. Do not take more than 2 tablets at once.

Do not take Contrave with a high-fat meal, or you may be more likely to have a seizure. If you have a seizure while taking Contrave, you may never be able to take it again.

Do not crush, chew, or break an extended-release Contrave tablet. Swallow the tablet whole.

Your pulse and blood pressure will need to be checked often. If you have diabetes, your blood sugar will also need to be checked often.

Your doctor will need to check your progress while you are using this medicine. 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.

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 Contrave for a short time. You also may need to use a lower dose of any narcotic medicine you have used in the past. Follow your doctor"s dosing instructions very carefully.

Store at room temperature away from moisture and heat.

Contrave dosing information

Usual Adult Dose of Contrave for Weight Loss:

Initial dose:
-Week 1: One tablet (8 mg naltrexone/90 mg bupropion) orally once in the morning; then
-Week 2: One tablet orally twice a day (once in the morning and once in the evening); then
-Week 3: Two tablets orally in the morning and one tablet orally in the evening
Maintenance dose: Week 4 and onward: Two tablets orally twice a day (morning and evening)
Maximum dose: Two tablets orally twice a day

Comments:
-Discontinue therapy if a patient has not lost at least 5% of baseline body weight after 12 weeks at the maintenance dose.
-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.

Use:
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 happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not take more than 4 Contrave 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 this medicine can be fatal, especialy if you also take a narcotic (opioid medicine).

Overdose symptoms may include confusion, extreme drowsiness, fainting, and weak or shallow breathing (breathing may stop).

What should I avoid while taking Contrave?

Avoid drinking alcohol. It may increase your risk of seizures. Tell your doctor if you have recently stopped drinking alcohol or have suddenly changed your drinking habits.

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.

Contrave side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Contrave: 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.

Stop taking this medicine and call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, depression, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Stop using this medicine and call your doctor at once if you have:

• seizure (convulsions);

• fast heart rate;

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• dangerously high blood pressure - severe headache, pounding in your neck or ears, severe chest pain, shortness of breath; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

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

Common Contrave 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.

See also: Side effects (in more detail)

What other drugs will affect Contrave?

Many drugs can interact with bupropion and naltrexone, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Contrave. Give a list of all your medicines to any healthcare provider who treats you.