Naltrexone-Bupropion

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. 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.

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 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 (cannabis) 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 (cannabis). 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 opioids (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 opioids 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.

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 last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 opioid 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: nausea/vomiting that doesn't stop, 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), 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.

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