Dextromethorphan and Bupropion

IMPORTANT WARNING:

This medication contains bupropion, the same active ingredient as some antidepressant medications (Aplenzin, Forfivo, Wellbutrin). 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 dextromethorphan 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 dextromethorphan 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.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Your healthcare provider will want to see you often while you are taking the combination of dextromethorphan 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 dextromethorphan 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.

WHY is this medicine prescribed?

Dextromethorphan and bupropion is used to treat depression. Dextromethorphan is in a class of medications called NMDA receptor antagonists. The way it works in the brain to treat depression is not known. Bupropion is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dextromethorphan and bupropion comes as a tablet to take by mouth with or without food. Initially, it is usually taken once a day for 3 days. After 3 days, it is usually taken twice a day (at least 8 hours apart). Take dextromethorphan and bupropion at around the same time(s) 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 dextromethorphan 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 tablets whole; do not split, chew, or crush them.

Dextromethorphan and bupropion controls depression but does not cure it. Do not stop taking dextromethorphan and bupropion without talking to your doctor. If you suddenly stop taking dextromethorphan and bupropion, you may experience serious side effects such as mood changes, agitation, irritability, dizziness, ringing in the ears, shock-like sensations, anxiety, confusion, tiredness, difficulty falling asleep or staying asleep, numbness or tingling in the arms, legs, hands, or feet, headache, increased sweating, seizures, or nausea.

What SPECIAL PRECAUTIONS should I follow?

Before taking dextromethorphan and bupropion,

• tell your doctor and pharmacist if you are allergic to dextromethorphan, bupropion, any other medications, or any of the ingredients in dextromethorphan and bupropion tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate) or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take the combination of dextromethorphan and bupropion. If you stop taking the combination of dextromethorphan and bupropion, your doctor will tell you that you should wait at least 14 days before you start to take an MAO inhibitor.

• do not take more than one product containing bupropion (Aplenzin, Forfivo, Wellbutrin) or dextromethorphan (in Nuedexta, in cough and cold products) at a time. You could receive too much bupropion or dextromethorphan and experience severe side effects.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had seizures, anorexia nervosa (an eating disorder) or bulimia (an eating disorder). Also tell your doctor if you drink large amounts of alcohol but expect to suddenly stop drinking or you take sedatives but expect to suddenly stop taking them. Your doctor will probably tell you not to take dextromethorphan and bupropion.

• tell your doctor if you drink large amounts of alcohol, use street drugs, or overuse prescription medications and if you have or ever had a heart attack; a stroke; a head injury; a tumor in your brain or spine; high blood pressure; low sodium levels in the blood; problems with low blood sugar; diabetes; glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) or other eye problems; problems walking or falling down; or liver, kidney, or heart disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking dextromethorphan and bupropion, call your doctor.

• tell your doctor if you are breast-feeding. You should not breastfeed while you are taking dextromethorphan and bupropion and for 5 days after your last dose.

• you should know that dextromethorphan and bupropion may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.

• talk to your doctor about the safe use of alcoholic beverages while you are taking dextromethorphan and bupropion. Alcohol can make the side effects from dextromethorphan and bupropion worse.

• you should know that bupropion may cause an increase in your blood pressure. Your doctor may check your blood pressure before starting treatment and regularly while you are taking dextromethorphan and bupropion, especially if you also are using nicotine replacement therapy.

• you should know that the combination of dextromethorphan and bupropion may cause angle-closure glaucoma (condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure, which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication to see if you are at risk for this condition. If you have eye pain, changes in vision, or swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

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?

Dextromethorphan and bupropion may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• tiredness
• dizziness
• nervousness
• restlessness
• headache
• nausea
• diarrhea
• constipation
• dry mouth
• excessive sweating
• loss of appetite
• stomach pain
• joint pain
• numbness or tingling in the arms, legs, hands, or feet
• difficulty falling asleep or staying asleep
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• seizures
• agitation, fever, sweating, shivering, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• coma (loss of consciousness for a period of time)
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• rash, itching, hives, fever, chest pain, shortness of breath, or muscle or joint pain

Dextromethorphan 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 at https://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:

• nausea
• vomiting
• drowsiness
• unresponsiveness
• changes in vision
• seizures
• hallucinating (seeing things or hearing voices that do not exist)
• coma (loss of consciousness for a period of time)
• rapid or pounding heartbeat
• loss of coordination

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dextromethorphan 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.