Naltrexone and bupropion (Oral)

Naltrexone and bupropion combination is used along with a reduced-calorie diet and regular exercise to help with weight loss and maintenance. This medicine is for people who are overweight or very overweight and have weight-related health issues.

This medicine is only available with a doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly and to watch for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to avoid getting pregnant during therapy. If you think you might be pregnant while using this medicine, tell your doctor right away.

Do not take naltrexone and bupropion combination with a monoamine oxidase (MAO) inhibitor (for example, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking naltrexone and bupropion combination during the 2 weeks after you stop a MAO inhibitor. Wait 2 weeks after stopping naltrexone and bupropion combination before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may experience confusion, agitation, restlessness, stomach or bowel symptoms, a sudden high body temperature, extremely high blood pressure, or severe seizures.

Do not use naltrexone and bupropion combination if you are also using Zyban® to quit smoking or Aplenzin® or Wellbutrin® for depression, because they also contain bupropion. Also, do not take this medicine if you are using or have used narcotic drugs (for example, buprenorphine, methadone, or other habit-forming painkillers) within the past 7 to 10 days.

This medicine may cause some people to feel agitated, irritable, or show other unusual behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure your doctor knows if you have trouble sleeping, get upset easily, have a significant increase in energy, or start to act recklessly. Also inform the doctor if you have sudden or intense feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

You have a higher risk of accidental overdose, serious injury, or death if you use heroin or any other narcotic medicine while being treated with naltrexone and bupropion combination. Additionally, naltrexone prevents you from feeling the effects of heroin if you use it.

Do not stop taking this medicine without first consulting your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to reduce the chance of certain side effects when you stop the medicine, such as agitation, anxiety, dizziness, a feeling of constant movement of yourself or your surroundings, headaches, increased sweating, nausea, trembling or shaking, trouble sleeping or walking, or unusual tiredness.

Your blood pressure might become too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain.

Serious skin reactions (for example, Stevens-Johnson syndrome) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you experience blurred vision, eye pain, or any other change in vision during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

This medicine may increase the risk of hypoglycemia (low blood sugar) in patients with diabetes. Low blood sugar must be treated before it causes you to lose consciousness. People may experience different symptoms of low blood sugar. It is important to learn which symptoms you usually have so you can treat it quickly. You should check your blood sugar before starting treatment and while taking this medicine.

Drinking alcoholic beverages should be limited or avoided, if possible, while using this medicine.

Before having any medical tests, inform the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your clinician will make. For this medicine, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other medications. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of naltrexone and bupropion combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naltrexone and bupropion combination in the elderly. Nevertheless, elderly patients may be more sensitive to the effects of this drug and are more likely to have age-related kidney issues, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to using this drug while breastfeeding.

Interactions with Medicines

Although certain drugs should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially important that your healthcare professional know if you are using any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medications is not advised. Your physician may decide not to treat you with this medication or change some of the other medicines you take.

• Alfentanil
• Alphaprodine
• Anileridine
• Benzhydrocodone
• Bromopride
• Buprenorphine
• Butorphanol
• Codeine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Eliglustat
• Ethylmorphine
• Fentanyl
• Furazolidone
• Hydrocodone
• Hydromorphone
• Iproniazid
• Isocarboxazid
• Ketobemidone
• Levorphanol
• Linezolid
• Meperidine
• Methadone
• Methylene Blue
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nialamide
• Nicomorphine
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Ozanimod
• Papaveretum
• Paregoric
• Phenelzine
• Piritramide
• Procarbazine
• Propoxyphene
• Rasagiline
• Remifentanil
• Selegiline
• Sufentanil
• Tapentadol
• Tilidine
• Tramadol
• Tranylcypromine

Using this medication with any of the following drugs is usually not advised, but may be required in some cases. If both drugs are prescribed together, your doctor may change the dose or how frequently you use one or both of the medicines.

• Acetophenazine
• Aclidinium
• Acrivastine
• Acyclovir
• Alcaftadine
• Alfentanil
• Amantadine
• Ambenonium
• Amdinocillin
• Amdinocillin Pivoxil
• Amiloride
• Amineptine
• Aminophylline
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amphotericin B
• Ampicillin
• Anisotropine
• Antazoline
• Aripiprazole
• Astemizole
• Atomoxetine
• Atovaquone
• Atropine
• Azatadine
• Azelastine
• Azlocillin
• Aztreonam
• Bacampicillin
• Baclofen
• Balofloxacin
• Belladonna Alkaloids
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Bepotastine
• Besifloxacin
• Betamethasone
• Bornaprine
• Bremelanotide
• Brexpiprazole
• Bromodiphenhydramine
• Bromperidol
• Brompheniramine
• Buclizine
• Budesonide
• Bupivacaine
• Buprenorphine
• Buspirone
• Busulfan
• Butorphanol
• Butriptyline
• Butylscopolamine
• Carbamazepine
• Carbenicillin
• Carbimazole
• Carbinoxamine
• Carvedilol
• Chlorambucil
• Chloroquine
• Chlorotrianisene
• Chlorpheniramine
• Chlorphenoxamine
• Chlorpromazine
• Chlorprothixene
• Cimetidine
• Cimetropium
• Cinnarizine
• Ciprofloxacin
• Citalopram
• Clemastine
• Clemizole
• Clidinium
• Clobetasone
• Clomipramine
• Clopidogrel
• Clothiapine
• Clovoxamine
• Cloxacillin
• Clozapine
• Cocaine
• Codeine
• Conjugated Estrogens
• Corticotropin
• Cortisone
• Cosyntropin
• Cyclacillin
• Cyclizine
• Cyclopentolate
• Cyclosporine
• Cyproheptadine
• Dabrafenib
• Dalfampridine
• Danazol
• Darifenacin
• Deflazacort
• Delavirdine
• Demecarium
• Desipramine
• Desonide
• Desvenlafaxine
• Deutetrabenazine
• Dexamethasone
• Dexbrompheniramine
• Dexchlorpheniramine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Dicloxacillin
• Dicyclomine
• Dienestrol
• Diethylstilbestrol
• Difenoxin
• Dihydroartemisinin
• Dihydrocodeine
• Dimenhydrinate
• Dimethindene
• Diphenhydramine
• Diphenoxylate
• Diphenylpyraline
• Distigmine
• Dixyrazine
• Donepezil
• Dopamine
• Dothiepin
• Doxepin
• Doxofylline
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Doxylamine
• Droperidol
• Duloxetine
• Ebastine
• Echothiophate
• Edrophonium
• Efavirenz
• Emedastine
• Enflurane
• Enoxacin
• Epinastine
• Escitalopram
• Esterified Estrogens
• Estradiol
• Estramustine
• Estriol
• Estrone
• Estropipate
• Ethinyl Estradiol
• Ethopropazine
• Etomidate
• Famotidine
• Femoxetine
• Fenfluramine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Flavoxate
• Flecainide
• Floxacillin
• Fludrocortisone
• Flumequine
• Flunarizine
• Flunisolide
• Fluoxetine
• Fluphenazine
• Fluticasone
• Fluvoxamine
• Foscarnet
• Fosphenytoin
• Galantamine
• Ganciclovir
• Gatifloxacin
• Glycopyrrolate
• Guanidine
• Halofantrine
• Haloperidol
• Hetacillin
• Homatropine
• Hydrocodone
• Hydrocortisone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxyzine
• Hyoscyamine
• Ifosfamide
• Imipenem
• Imipramine
• Indalpine
• Iobenguane I 123
• Iobenguane I 131
• Iprindole
• Isoflurane
• Isoflurophate
• Isoniazid
• Isopropamide
• Ketamine
• Ketotifen
• Lemborexant
• Levocabastine
• Levodopa
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lidocaine
• Lindane
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lomefloxacin
• Lopinavir
• Loxapine
• Maprotiline
• Mebeverine
• Mebhydrolin
• Meclizine
• Mefenamic Acid
• Mefloquine
• Melitracen
• Melperone
• Memantine
• Mepenzolate
• Meperidine
• Meropenem
• Mesoridazine
• Mestranol
• Metformin
• Methadone
• Methamphetamine
• Methantheline
• Methdilazine
• Methenolone
• Methicillin
• Methimazole
• Methixene
• Methotrimeprazine
• Methylphenidate
• Methylprednisolone
• Methyltestosterone
• Metoclopramide
• Metopimazine
• Metronidazole
• Mexiletine
• Mezlocillin
• Midostaurin
• Milnacipran
• Mirtazapine
• Mizolastine
• Morphine
• Moxifloxacin
• Nadifloxacin
• Nafcillin
• Nalbuphine
• Naldemedine
• Nalidixic Acid
• Naloxegol
• Nandrolone
• Nebivolol
• Nefazodone
• Neostigmine
• Nevirapine
• Niaprazine
• Norfloxacin
• Nortriptyline
• Ofloxacin
• Olanzapine
• Olopatadine
• Ondansetron
• Opipramol
• Oxacillin
• Oxaliplatin
• Oxandrolone
• Oxatomide
• Oxybutynin
• Oxycodone
• Oxymetholone
• Oxymorphone
• Paramethasone
• Paroxetine
• Pazufloxacin
• Pefloxacin
• Penicillin G
• Penicillin V
• Pentazocine
• Perazine
• Periciazine
• Perphenazine
• Phenindamine
• Pheniramine
• Phenobarbital
• Phenylpropanolamine
• Phenyltoloxamine
• Phenytoin
• Physostigmine
• Pimozide
• Pinaverium
• Pindolol
• Pipamperone
• Piperacillin
• Piperaquine
• Pipotiazine
• Pirenzepine
• Pitolisant
• Pivampicillin
• Pizotyline
• Polyestradiol Phosphate
• Prednisolone
• Prednisone
• Procainamide
• Procaine
• Prochlorperazine
• Proguanil
• Promazine
• Promestriene
• Promethazine
• Propafenone
• Propantheline
• Propicillin
• Propiverine
• Propizepine
• Propofol
• Propoxyphene
• Propranolol
• Protriptyline
• Prulifloxacin
• Pyrilamine
• Quetiapine
• Quinacrine
• Quinestrol
• Ranitidine
• Remifentanil
• Rifampin
• Rimexolone
• Risperidone
• Ritonavir
• Rivastigmine
• Rufloxacin
• Safinamide
• Scopolamine
• Sertraline
• Sevoflurane
• Sibutramine
• Solifenacin
• Sparfloxacin
• Sparsentan
• Stanozolol
• Sufentanil
• Sulbenicillin
• Sultamicillin
• Sumatriptan
• Tacrine
• Tapentadol
• Temocillin
• Terfenadine
• Testosterone
• Theophylline
• Thiethylperazine
• Thiopropazate
• Thioproperazine
• Thioridazine
• Thiotepa
• Thiothixene
• Thonzylamine
• Tianeptine
• Tibolone
• Ticarcillin
• Ticlopidine
• Timiperone
• Timolol
• Tolterodine
• Tramadol
• Trifluoperazine
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tripelennamine
• Triprolidine
• Tropicamide
• Trospium
• Umeclidinium
• Valbenazine
• Valethamate
• Varenicline
• Venlafaxine
• Vortioxetine
• Zidovudine
• Zuclopenthixol

Using this medicine with any of the following medications may cause an increased risk of certain adverse effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your clinician may change the dose or how frequently you use one or both of the medications.

• Aripiprazole Lauroxil
• Digoxin
• Isavuconazonium Sulfate
• Lofexidine
• Metoprolol
• Nirmatrelvir
• St John's Wort
• Tipranavir
• Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may as well cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is normally not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medication. Make sure you inform your doctor if you have any other medical issues, especially:

• Alcohol use, if stopped suddenly, or
• Eating disorders (eg, anorexia, bulimia), history of or
• Hypertension (high blood pressure), uncontrolled or
• Seizure medication use, if stopped suddenly (eg, carbamazepine (Tegretol®), phenobarbital, phenytoin (Dilantin®)), or
• Seizures, or history of or
• Sleeping or anxiety medication use, if stopped suddenly (eg, alprazolam (Xanax®), lorazepam (Ativan®), temazepam (Restoril®), triazolam (Halcion®))—Should not be used in patients with these conditions.

• Arteriovenous malformation (circulation issue) or
• Brain tumor or infection or
• Diabetes or
• Drug or alcohol abuse or
• Head injury or
• Hypoglycemia (low blood sugar) or
• Hyponatremia (low sodium in the blood) or
• Hypoxia (low oxygen in the blood) or
• Liver disease, serious or
• Stroke, severe or history of—May increase chance for seizures.

• Bipolar disorder (type of depression), or chance of or
• Glaucoma, angle closure or
• Hypertension (high blood pressure) or
• Mania or hypomania (type of mental disease), history of or
• Psychosis (type of mental disease)—Use with caution. May make these conditions worse.

• End-stage kidney disease or
• Liver disease, severe—Use is not advised in patients with these conditions.

• Kidney disease, moderate or serious or
• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medication from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blurred vision
• discouragement
• dizziness
• fear or nervousness
• feeling sad or empty
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• pounding in the ears
• slow or fast heartbeat
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness

Less common

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• fast, irregular, pounding, or racing heartbeat or pulse
• frequent urge to urinate
• lower back or side pain
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

Less common or rare

• Chest pain or discomfort
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• sweating
• vomiting

Rare

• Changes in behavior
• thoughts of killing oneself

Incidence not known

• Aggressive or angry
• anxiety
• blistering, peeling, or loosening of the skin
• chills
• clay colored stools
• cough
• dark urine
• delusions of persecution, mistrust, suspiciousness, or combativeness
• diarrhea
• difficulty with moving
• difficulty with swallowing
• dry mouth
• false beliefs that cannot be changed by facts
• feeling that others are watching you or controlling your behavior
• feeling, seeing, or hearing things that are not there
• fever
• hives, itching, or rash
• hyperventilation
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle stiffness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• restlessness
• severe mood or mental changes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain or tenderness
• swelling of the feet or lower legs
• tightness in the chest
• unusual behavior
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blue lips, fingernails, or skin
• change in or loss of consciousness
• confusion
• decreased awareness or responsiveness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• muscle cramps or spasms
• severe sleepiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty having a bowel movement

Less common

• Change or loss of taste
• continuing ringing or buzzing or other unexplained noise in the ears
• feeling of warmth
• hearing loss
• increased sweating
• redness of the face, neck, arms, and occasionally, upper chest
• stomach pain

Rare

• Feeling of constant movement of self or surroundings
• indigestion
• sensation of spinning
• severe nausea or vomiting
• thinning of the hair or hair loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Contrave

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Antiobesity Agent

Pharmacologic Class: Naltrexone

Chemical Class: Bupropion

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Follow your doctor's instructions carefully on a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.

Swallow the tablet whole. Do not crush, break, or chew it.

Take this medicine with food. However, do not take it with high-fat meals. This may increase your risk of seizures.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):For weight loss: Adults—At first, one tablet in the morning taken on week 1. Your doctor will increase your dose to one tablet in the morning and one tablet in the evening on week 2. Then, two tablets in the morning and one tablet in the evening on week 3. On week 4, two tablets in the morning and two tablets in the evening. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Does naltrexone cause weight gain?