Naltrexone and Bupropion
(nal trex' one) (byoo proe' pee on)
This medication contains bupropion, the same active ingredient as some antidepressant medications (Wellbutrin, Aplenzin) and a medication used to help people stop smoking (Zyban). A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as bupropion during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. The combination of naltrexone and bupropion is not approved for use in children under 18 years of age.
You should know that your mental health may change in unexpected ways when you take the combination of naltrexone and bupropion even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; anxiety or panic attacks; difficulty falling asleep or staying asleep; aggressive, angry, or violent behavior; irritability; acting without thinking; severe restlessness; abnormal thoughts or sensations; feeling that people are against you; hallucinations (seeing things or hearing voices that do not exist); feeling confused; frenzied abnormal excitement; or any other sudden or unusual changes in behavior. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
Your healthcare provider will want to see you often while you are taking the combination of naltrexone and bupropion, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with the combination of naltrexone and bupropion and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking the combination of naltrexone and bupropion.
WHY is this medicine prescribed?
The combination of naltrexone and bupropion is used along with a reduced calorie diet and exercise plan to help adults who are obese, or who are overweight and have weight-related medical problems, to lose weight and then to keep from gaining back that weight. Naltrexone is in a class of medications called opiate antagonists. Bupropion is in a class of medications called antidepressants. These medications work together on two areas of the brain, the hunger center and the reward system, to reduce appetite and help control cravings.
HOW should this medicine be used?
The combination of naltrexone and bupropion comes as an extended-release (long-acting) tablet to take by mouth. It is usually taken twice a day. Do not take this medication with a high-fat meal. Take naltrexone and bupropion at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take naltrexone and bupropion exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the extended-release tablets whole; do not split, chew, or crush them.
Your doctor will probably start you on a low dose of the combination of naltrexone and bupropion and gradually increase your dose, not more than once every week, for 4 weeks. After 16 weeks of treatment, your doctor will check to see how much weight you have lost. If you have not lost a certain amount of weight, your doctor may tell you to stop taking the combination of naltrexone and bupropion as it is unlikely that you will benefit from continuing your treatment.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking the combination of naltrexone and bupropion,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
The combination of naltrexone and bupropion may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING and SPECIAL PRECAUTIONS sections, stop taking the combination of naltrexone and bupropion and call your doctor immediately or get emergency medical treatment:
The combination of naltrexone and bupropion may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom)
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking the combination of naltrexone and bupropion.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: April 15, 2019.
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