NALTREXONE/BUPROPION EXTENDED-RELEASE - ORAL

NALTREXONE/BUPROPION EXTENDED-RELEASE - ORAL

PHONETIC PRONUNCIATION: (nal-TREX-one/bue-PROE-pee-on)

COMMON BRAND NAME(S): Contrave

GENERIC NAME(S): naltrexone HCl/bupropion HCl

Uses

USES: This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. Naltrexone belongs to a class of drugs known as opiate antagonists, and bupropion is an antidepressant that may help restore the balance of certain natural chemicals (neurotransmitters) in your brain. These two medications work together on separate parts of the brain to reduce appetite and how much you eat. Most opiates should not be used for 7 to 10 days before starting naltrexone, but some opiate drugs (such as methadone) should not be used for 10 to 14 days before starting naltrexone. Ask your doctor or pharmacist for more details. Other forms of naltrexone or bupropion are used to treat a variety of conditions including depression, other mental/mood disorders, smoking cessation, addiction to narcotic medication, and alcohol abuse. This combination product is not approved for these other uses. Discuss the risks and benefits of this medication, as well as other ways to lose weight, with your doctor.


How to use NALTREXONE/BUPROPION EXTENDED-RELEASE - ORAL

HOW TO USE: Read the Medication Guide if available from your pharmacist before you start taking naltrexone/bupropion and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with a low-fat meal as directed by your doctor, usually twice daily. You may have trouble sleeping when you start taking this drug. Do not take your evening dose too close to bedtime. Swallow the tablets whole. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects such as seizures. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Your dose will be slowly increased to lower the risk of seizures and to limit side effects such as sleeplessness, symptoms of withdrawal from opiates, and high blood pressure. Do not increase your dose, take it more often, or stop taking it without your doctor's approval. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Tell your doctor if you have not lost weight after 16 weeks on this medication.

Side Effects

SIDE EFFECTS: See also Warning, How to Use, and Precautions sections. Nausea, vomiting, constipation, stomach pain, headache, dizziness, trouble sleeping, increased sweating, flushing, and dry mouth or strange taste in the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (anxiety, agitation, confusion, memory loss), uncontrolled movements (tremor), ringing in the ears, fainting, severe headache, fast/pounding/irregular heartbeat, chest pain. Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbow around lights at night). If you have been taking opioid medications regularly, you could have withdrawal symptoms within minutes after taking naltrexone. Tell your doctor right away if you have any of the following symptoms of narcotic withdrawal: mental/mood changes (such as anxiety/irritability), fast breathing, yawning, sweating, watering eyes, goose bumps, muscle twitching. This drug may rarely cause seizures. Get medical help right away if you have a seizure. If you have a seizure while taking bupropion, you should not take this drug again. Naltrexone may rarely cause serious (possibly fatal) liver disease. The risk is increased when larger doses are used. Discuss the risks and benefits with your doctor. Stop using this medication and tell your doctor right away if you have symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), painful sores in the mouth/around the eyes, severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: See also Warning section. Before taking naltrexone/bupropion, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (such as congestive heart failure/recent heart attack), mental/mood disorders (such as bipolar disorder/thoughts of suicide), diabetes, current or recent use (in the last 7-14 days) of any type of opioid drug (such as morphine/methadone/buprenorphine), kidney disease, liver disease (such as cirrhosis), high pressure in the eye (glaucoma), use/abuse of drugs/alcohol, seizures or conditions that increase your risk of seizures (including brain/head injury, brain tumors, arteriovenous malformation, eating disorders such as bulimia/anorexia nervosa). This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Alcohol may also increase your risk of seizures. After stopping treatment with this medication, you may be more sensitive to opioids, increasing your risk of possibly life-threatening side effects from narcotics (such as decreased breathing, loss of consciousness). This medication blocks the effects of opiate drugs (including heroin) and similar drugs (opioids). However, large doses of heroin or narcotics can overcome this block. Trying to overcome this block is very dangerous and may cause serious injury, loss of consciousness, and death. Follow your doctor's instructions closely. Do not take this product with any other product that contains bupropion (such as antidepressants or smoking cessation drugs) since large doses of bupropion are more likely to cause seizures. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially dizziness. Dizziness can increase the risk of falling. This medication must not be used during pregnancy. Weight loss during pregnancy is not recommended and may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: narcotic medications (such as codeine, hydrocodone), disulfiram, cough medications (such as dextromethorphan), diarrhea medications (such as diphenoxylate), pimozide, tamoxifen. Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication. This medication may interfere with certain medical/laboratory tests (including urine tests for amphetamine, narcotic drug tests, and brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures, hallucinations, fast/slow/irregular heart rate, loss of consciousness.

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Faq for NALTREXONE/BUPROPION EXTENDED-RELEASE - ORAL

Naltrexone/bupropion extended-release is a medication that combines two drugs, naltrexone and bupropion, to help with weight loss. It is taken orally in the form of a once-daily tablet.

Naltrexone/bupropion extended-release works by targeting multiple neurotransmitter systems in the brain involved in regulating appetite and body weight. Naltrexone helps reduce food cravings, while bupropion helps increase feelings of fullness and satiety.

Naltrexone is primarily used to treat alcohol and opioid dependence. However, in naltrexone/bupropion extended-release, it serves a different purpose by helping to reduce food cravings and the desire to overeat.

Bupropion is commonly prescribed as an antidepressant and smoking cessation aid. In naltrexone/bupropion extended-release, it is used to help increase feelings of fullness and decrease appetite.

Yes, naltrexone/bupropion extended-release is FDA-approved for chronic weight management in individuals with obesity or overweight who have at least one weight-related comorbidity such as type 2 diabetes or high blood pressure.

Clinical trials have shown that naltrexone/bupropion extended-release can lead to significant weight loss when combined with a reduced-calorie diet and increased physical activity. On average, participants in these trials achieved a weight loss of 5-10% of their initial body weight.

Common side effects of naltrexone/bupropion extended-release include nausea, constipation, headache, vomiting, dizziness, insomnia, and dry mouth. It may also increase the risk of suicidal thoughts or behaviors in some individuals.

No, naltrexone/bupropion extended-release is not suitable for everyone. It should not be used by individuals with uncontrolled high blood pressure, seizure disorders, eating disorders, or a history of bipolar disorder, among other conditions. It is important to consult with a healthcare provider to determine if this medication is appropriate for you.

The full effects of naltrexone/bupropion extended-release on weight loss may take time to manifest. It is recommended to continue taking the medication as prescribed for at least 12 weeks to evaluate the response.


Warning

WARNING: This medication is a combination of bupropion and naltrexone. Bupropion is an antidepressant used to treat a variety of conditions, including depression and other mental/mood disorders. It can also be prescribed to help with smoking cessation or weight loss. Antidepressants can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition. Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed. If you are using naltrexone/bupropion to lose weight, stop taking this medication and tell your doctor right away if you have any of the symptoms listed above. Tell your doctor right away if you have any of these symptoms after stopping treatment.


Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.