Bupropion/Naltrexone, Oral

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KEY POINTS

• This medicine is taken by mouth to help people lose weight and keep the weight off. It is used along with exercise and a reduced calorie diet. Take the medicine exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidepressant/narcotic (opioid) antagonist

Generic and brand names: bupropion/naltrexone, oral; Contrave

What is this medicine used for?

This medicine is taken by mouth to help people lose weight and keep the weight off. It is used along with exercise and a reduced calorie diet.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Do not take this medicine if you:

• Have high blood pressure that is not well controlled
• Have ever had a seizure disorder
• Have or have had an eating disorder such as bulimia or anorexia nervosa
• Are taking any other medicine that contains bupropion (Do not take this medicine if you are also taking Aplenzin, Forfivo XL, Wellbutrin, Wellbutrin XL, or Wellbutrin SR, Buproban, or Zyban. They contain one of the same ingredients as this medicine, and can increase the risk of an overdose or seizures.)
• Are taking an MAO inhibitor medicine (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Take narcotic pain medicines, have recently stopped taking narcotics, or use medicines such as methadone or buprenorphine to help stop taking narcotics
• Drink a lot of alcohol and suddenly stop drinking
• Have been taking sedatives, benzodiazepines, stimulants, or antiseizure medicines and suddenly stop taking them

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A brain tumor or infection, or if you have recently had a head injury
• A stroke or transient ischemic attack (TIA)
• Diabetes
• Glaucoma
• Heart disease or a heart attack
• High blood pressure
• Kidney or liver disease
• Low levels of sodium in your blood
• Mental health problems such as depression, bipolar disorder, or thoughts of suicide
• Problems with alcohol or drug abuse

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Take this medicine exactly as your healthcare provider prescribes. Your provider will change your dose if needed. Do not change your dose without your provider’s approval. Do not take more or less or take it longer than prescribed. Follow the diet and exercise program recommended by your healthcare provider.

This medicine is not approved for use in children. Check with your healthcare provider before using this medicine in children under age 18.

Do not take this medicine with high-fat meals. It may increase your risk of seizures. Do not cut, crush, or chew the tablets. Swallow them whole. Tell your provider is you cannot swallow whole tablets.

Do not take more than 2 tablets at the same time or more than 4 tablets in 1 day.

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: dizziness, vomiting, seizures, tremors, hallucinations (seeing or hearing things that are not there), muscle stiffness, fainting, fast or irregular heartbeat, trouble breathing, coma.

What should I watch out for?

This medicine contains bupropion, an ingredient used to treat depression or help people quit smoking. Antidepressant medicines may increase suicidal thoughts or actions within the first few months of treatment, especially in children, teens, and young adults. Some people have had changes in mood or behavior such as becoming irritable or anxious while taking this medicine to help quit smoking. These symptoms can start during treatment or after you stop treatment with this medicine. Call your healthcare provider right away if you or your family members notice any of these symptoms.

You must not take any kind of narcotic for at least 7 to 10 days before starting this medicine. This includes street drugs, prescription pain medicines, cough, cold, or diarrhea medicines, buprenorphine, or methadone. Using narcotics in the 7 to 10 days before you start taking this medicine may cause you to suddenly have symptoms of withdrawal when you take it. This medicine may affect how narcotics work, even after you’ve stopped taking it. Talk with your healthcare provider about this.

You need regular checkups to see how this medicine affects you. Keep all appointments.

This medicine may trigger angle-closure glaucoma. Contact your provider right away if you have eye pain, vision changes, or redness and swelling in or around your eye.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves. If you drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having a seizure.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. This medicine may affect the results of certain drug tests.

If you have diabetes: Weight loss can cause low blood sugar, especially if you are also taking medicines to treat diabetes. This may change the amount of diabetes medicines you may need. Talk with your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Seizures; fast or irregular heartbeat; chest pain; severe dizziness or fainting; thoughts of suicide; changes in mood or behavior; new or worsening depression; hallucinations; confusion; yellowing of eyes or skin; dark urine; light-colored bowel movements; severe headache; eye pain, swelling, or redness; vision changes; slow or shallow breathing; severe drowsiness; severe skin redness, blisters, or peeling; unexplained muscle or joint pain; fever with a rash; tremors.

Other: Trouble sleeping, abnormal dreams, dry mouth, mild anxiety, dizziness, mild headache, constipation, diarrhea, change in sense of taste, loss of appetite, ringing in the ears, cough, runny nose, nausea, vomiting, stomach pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Amantadine (Symmetrel)
• Amiloride
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), and others
• Antidepressants such as citalopram (Celexa), fluoxetine (Prozac), nortriptyline (Pamelor), sertraline (Zoloft), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and others
• Antipsychotic medicines such as haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), thioridazine, and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), primidone (Mysoline), valproic acid (Depacon, Depakene, Depakote), and others
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir (Technivie) and ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira)
• Atomoxetine (Strattera)
• Atropine/diphenoxylate (Lomotil)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), and others
• Bupropion (Aplenzin, Buproban, Forfivo, Wellbutrin, Zyban)
• Cancer medicines such as crizotinib (Xalkori), cyclophosphamide (Cytoxan), doxorubicin (Doxil), oxaliplatin (Eloxatin), and others
• Corticosteroids such as dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), and others
• Dextromethorphan, an ingredient in many allergy, cold, or cough medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as glyburide (Glynase) and metformin (Fortamet, Glucophage, Riomet)
• Disulfiram (Antabuse)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Heart medicines such as flecainide, mexiletine, procainamide, and propafenone (Rythmol)
• HIV medicines such efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Linezolid (Zyvox)
• Lorcaserin (Belviq)
• Malaria medicines such as chloroquine, mefloquine, primaquine, quinine, and others
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), famotidine (Pepcid), and ranitidine (Zantac)
• Medicines to treat narcotic dependence such as buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv) and naltrexone (ReVia, Vivitrol)
• Medicines to treat or prevent blood clots such as clopidogrel (Plavix) and warfarin (Coumadin)
• Memantine (Namenda)
• Muscle relaxants such as carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), orphenadrine (Norflex), and others
• Narcotic allergy, cold, or cough medicines such as guaifenesin/codeine (Robitussin AC, Tussi-Organidin), hydrocodone/chlorpheniramine (Tussionex), hydrocodone/homatropine, promethazine, promethazine with codeine (Phenergan with codeine), and others
• Natural remedies such as kava, SAMe, St. John's wort, valerian, and others
• Other nonprescription or herbal weight-loss medicines
• Pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), oxycodone (OxyContin, Roxicodone), and others
• Parkinson’s disease medicines such as entacapone (Comtan), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), ropinirole (Requip), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rifampin (Rifadin)
• Sleeping pills such as temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Stimulants such as amphetamine/dextroamphetamine (Adderall), dexmethylphenidate (Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), and others
• Tedizolid (Sivextro)
• Tetrabenazine (Xenazine)
• Theophylline
• Varenicline (Chantix)

Drinking alcohol while you are taking this medicine may increase its side effects. Ask your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.