Generic Name: naltrexone (nal-TREX-one & bue-PROE-pee-on)
Brand Name: Contrave
Naltrexone is not approved to treat depression or other mental or mood problems. Naltrexone contains bupropion, which is in some medicines used to treat depression. Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using naltrexone outweigh the risks.
Although naltrexone is not used to help patients stop smoking, a certain brand of medicine that contains bupropion is approved for this use. Serious mental or mood problems, including depression and suicidal thoughts or actions, have been reported in some patients using bupropion to help them stop smoking.
Family and caregivers must closely watch patients who take naltrexone. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if new, worsened, or sudden symptoms such as agitation, hostility, depressed mood, or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. Discuss any questions with the patient's doctor.
Naltrexone is not approved for use in children. Talk with the doctor.
Naltrexone is used for:
Managing weight in certain patients when used in combination with exercise and diet.
Naltrexone is a combination of 2 medicines used to control appetite. Exactly how it works is not known, but it is thought to help to release certain chemicals in the brain that control appetite.
Do NOT use naltrexone if:
- you are allergic to any ingredient in naltrexone
- you are pregnant
- you have end-stage kidney disease or high blood pressure that is not controlled, or you are going through withdrawal from opioid medicines (eg, oxycodone)
- you are taking any other medicine that contains bupropion
- you have a history of an eating disorder (eg, anorexia, bulimia) or seizures
- you are suddenly stopping the use of alcohol, benzodiazepines (eg, alprazolam), sedatives (medicines that make you sleepy), or seizure medicines (eg, phenobarbital) after long-term use
- you are taking carbamazepine, efavirenz, lopinavir, phenobarbital, phenytoin, or ritonavir
- you have been taking an opioid medicine (eg, morphine) for a long time or you take certain medicines to help you stop taking opioids (eg, methadone, buprenorphine)
- you are taking or have taken linezolid or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using naltrexone:
Some medical conditions may interact with naltrexone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic depression), other mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or substance abuse or dependence
- if you have diabetes, low blood oxygen levels, kidney problems, high blood pressure, or increased eye pressure or glaucoma
- if you have a history of a condition that may increase the risk of seizures (eg, certain blood vessel problems in the brain, head injury, a tumor or infection in the brain or spinal cord, stroke), heart problems (eg, heart attack), low blood sugar levels, low blood sodium levels, or liver problems
- if you drink alcohol
- if you are taking a medicine that contains methylene blue
Some MEDICINES MAY INTERACT with naltrexone. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Antipsychotics (eg, haloperidol, risperidone), corticosteroids (eg, prednisone), insulin or oral medicines to treat diabetes (eg, glipizide), theophylline, tricyclic antidepressants (eg, amitriptyline), or other medicine that contains bupropion because the risk of seizures may be increased
- Amantadine, clopidogrel, levodopa, linezolid, MAOIs (eg, phenelzine), or ticlopidine because they may increase the risk of naltrexone's side effects
- Opioid medicines (eg, methadone) or partial opioid agonists (eg, buprenorphine) because their effectiveness may be decreased by naltrexone
- Carbamazepine, efavirenz, lopinavir, phenobarbital, phenytoin, or ritonavir because they may decrease naltrexone's effectiveness
- Amiloride, beta-blockers (eg, metoprolol, pindolol), certain antiarrhythmics (eg, flecainide, procainamide, propafenone), cimetidine, dopamine, famotidine, lorcaserin, memantine, metformin, oxaliplatin, phenothiazines (eg, thioridazine), ranitidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), tricyclic antidepressants (eg, nortriptyline), or varenicline because the risk of their side effects may be increased by naltrexone
This may not be a complete list of all interactions that may occur. Ask your health care provider if naltrexone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use naltrexone:
Use naltrexone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Naltrexone comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get naltrexone refilled.
- Take naltrexone by mouth with or without food. Avoid taking naltrexone with high-fat meals.
- Swallow naltrexone whole. Do not break, crush, divide, or chew before swallowing. If you cannot swallow naltrexone whole, contact your doctor.
- Continue to take naltrexone even if you feel well. Do not miss any doses.
- If you miss a dose of naltrexone, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use naltrexone.
Important safety information:
- Follow the diet and exercise program given to you by your health care provider.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking naltrexone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Naltrexone may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you use a lot of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking naltrexone.
- If you already drink alcohol or if you take barbiturates (eg, phenobarbital), benzodiazepines (eg, alprazolam), sedatives (medicines that make you sleepy), or seizure medicines, do not suddenly stop them without first checking with your doctor. Suddenly stopping them may increase your seizure risk.
- The risk of seizures may be greater if you take naltrexone in high doses or for a long time. Do NOT take more than the recommended dose, change your dose, or use naltrexone for longer than prescribed without checking with your doctor.
- If your doctor tells you to stop taking naltrexone, you will need to wait at least 14 days before beginning to take certain other medicines (eg, MAOIs). Ask your doctor when you should start to take your new medicines after you have stopped taking naltrexone.
- Children, teenagers, and young adults who take naltrexone may be at increased risk of suicidal thoughts or actions. Watch all patients who take naltrexone closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Talk with your doctor before you take opioid medicines (eg, certain cough and cold products, certain diarrhea medicines, certain pain relievers) while you are using naltrexone; you will not receive as much effect from these medicines. Do not try to overcome this effect by taking large doses of opioid medicines. Taking large doses of opioid medicines may cause serious injury, coma, or death. Discuss any questions or concerns with your doctor.
- Patients who no longer take naltrexone may be more sensitive to opioids. Even low doses of opioids may cause serious and life-threatening effects in these patients. Discuss any questions or concerns with your doctor.
- If you have been taking an opioid medicine for a long time, you may need to be opioid-free for at least 7 to 10 days before you start naltrexone. Discuss any questions or concerns with your doctor.
- Some people may be at risk for eye problems from naltrexone. Your doctor may want you to have an eye exam to see if you are at risk for these eye problems. Call your doctor right away if you have eye pain, vision changes, or swelling or redness in or around the eye.
- Naltrexone may increase blood pressure or heart rate. Your doctor will monitor your blood pressure and heart rate while you are taking naltrexone.
- A very bad skin reaction (Stevens-Johnson syndrome) has happened with naltrexone. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have symptoms like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Diabetes patients - Naltrexone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Naltrexone may interfere with certain lab tests, including urine screenings for amphetamines. Be sure your doctor and lab personnel know you are taking naltrexone.
- Use naltrexone with caution in the ELDERLY; they may be more sensitive to its effects.
- Naltrexone should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use naltrexone if you are pregnant. It may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. Naltrexone is found in breast milk. Do not breast-feed while taking naltrexone.
Possible side effects of naltrexone:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; dry mouth; headache; nausea; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; painful sores in the mouth or around the eyes; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; swollen lymph glands; unusual hoarseness); chest pain; confusion; delusions; fainting; fast or irregular heartbeat; hallucinations; muscle or joint pain; new or worsening mental, mood, or behavior changes (eg, concentration problems, depression, panic attacks, aggressiveness, agitation, anxiety, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); seizures; severe or persistent headache, dizziness, or drowsiness; severe or persistent nervousness, restlessness, or trouble sleeping; shortness of breath; slow or shallow breathing; suicidal thoughts or attempts; symptoms of liver problems (eg, dark urine, pale stools, nausea, persistent loss of appetite, severe stomach pain, yellowing or the skin or eyes).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of naltrexone:
Store naltrexone at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), away from heat, moisture, and light. Do not store in the bathroom. Keep naltrexone out of the reach of children and away from pets.
- If you have any questions about naltrexone, please talk with your doctor, pharmacist, or other health care provider.
- Naltrexone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take naltrexone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about naltrexone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to naltrexone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using naltrexone.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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