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.
BUPROPION – ORAL
COMMON BRAND NAME(S): Wellbutrin
WARNING: Bupropion is an antidepressant used to treat a variety of conditions, including depression, other mental/mood disorders, and smoking cessation. 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 new or 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, even if treatment is not for a mental/mood condition. Tell the doctor immediately if you notice new or 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 bupropion to quit smoking, stop taking bupropion and contact your doctor immediately if you experience any of the symptoms listed above or if you have any of these symptoms after stopping treatment.
USES: Bupropion is used to treat depression. It can improve your mood and feelings of well-being. It may work by helping to restore the balance of certain natural chemicals (neurotransmitters) in your brain.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. Bupropion may also be used to treat attention deficit hyperactivity disorder (ADHD), or to help people quit smoking by decreasing cravings and nicotine withdrawal effects. It may be used to prevent autumn-winter seasonal depression (seasonal affective disorder). This drug may also be used with other medications to treat bipolar disorder (depressive phase).
HOW TO USE: Read the Patient Information Leaflet and Medication Guide available from your pharmacist before you start using bupropion and each time you get a refill. Consult your doctor or pharmacist if you have any questions. Take this medication by mouth, with or without food, usually three times daily. If stomach upset occurs, you may take this drug with food. It is important to take your doses at least 6 hours apart or as directed by your doctor to decrease your risk of having a seizure. Do not take more or less medication or take it more frequently than prescribed. Taking more than the recommended dose of bupropion may increase your risk of having a seizure. Do not take more than 150 milligrams as a single dose, and do not take more than 450 milligrams per day. Your dosage is based on your medical condition and response to therapy. Your dose may be slowly increased to limit side effects such as sleeplessness, and to decrease the risk of seizures. To avoid trouble sleeping, do not take this medication too close to bedtime. Let your doctor know if sleeplessness becomes a problem. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. It may take 4 or more weeks before you notice the full benefit of this drug. Continue to take this medication as directed by your doctor even after you feel better. Talk to your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also the How to Use, Precautions, and Warning sections. Nausea, vomiting, dry mouth, headache, constipation, increased sweating, joint aches, sore throat, blurred vision, strange taste in the mouth, or dizziness may occur. If any of these effects persist or worsen, notify 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 immediately if any of these unlikely but serious side effects occur: chest pain, fainting, fast/pounding/irregular heartbeat, hearing problems, ringing in the ears, severe headache, mental/mood changes (e.g., agitation, anxiety, confusion, hallucinations), uncontrolled movements (tremor), unusual weight loss or gain. Tell your doctor immediately if any of these rare but very serious side effects occur: muscle pain/tenderness/weakness, change in the amount of urine. This drug may infrequently cause seizures. Seek immediate medical attention if you experience a seizure. If you have a seizure while taking bupropion, you should not take this drug again. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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. 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: See also the How to Use and Warning sections. Before taking 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have or have had: 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 medication should not be used if you are suddenly stopping regular use of sedatives (e.g., benzodiazepines such as lorazepam) or alcohol. Doing so may increase your risk of seizures. Large amounts of alcohol may also increase your risk of seizures and dizziness. Discuss your use of these products with your doctor. Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol/drug dependence (including benzodiazepines, narcotic pain medicines, cocaine and stimulants), diabetes, heart disease (e.g., congestive heart failure, high blood pressure, recent heart attack), kidney problems, liver problems (e.g., cirrhosis), personal or family history of psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide thoughts/attempts, intent to quit smoking. Though uncommon, depression can lead to thoughts or attempts of suicide. Tell your doctor immediately if you have any suicidal thoughts, worsening depression, or any other mental/mood changes (including new or worsening anxiety, agitation, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, rapid speech, unusual behavior changes). Keep all medical appointments so your doctor can monitor your progress closely and adjust or change your medication if needed. This drug may make you dizzy or affect your coordination. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid or limit alcoholic beverages. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug and to side effects. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infrequently, newborns whose mothers have used certain newer antidepressants during the last 3 months of pregnancy may develop symptoms including persistent feeding or breathing difficulties, jitteriness, seizures or constant crying. Promptly report any such symptoms to the doctor. However, do not stop taking this medication unless your doctor directs you to do so. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor’s approval. Some products that may interact with this drug include: amantadine, certain x-ray dyes (including iomeprol), levodopa, nicotine products (such as patches, gum, or spray), regular use of sedatives (such as alprazolam), stimulants, tamoxifen, warfarin. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication and for two weeks before and after treatment. In some cases a serious (possibly fatal) drug interaction may occur. Other medications can affect the removal of bupropion from your body, which may affect how bupropion works. Examples include cyclophosphamide, orphenadrine, thiotepa, antiplatelet drugs (including clopidogrel, ticlodipine), anti-seizure drugs (such as carbamazepine, phenobarbital, phenytoin), HIV drugs (such as efavirenz, ritonavir), rifamycins (such as rifampin), among others. Bupropion can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include citalopram, antiarrhythmics (such as propafenone, flecainide), antidepressants (such as desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (such as haloperidol, thioridazine), beta-blockers (such as metoprolol), among others. Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with bupropion, such as antipsychotics (e.g., chlorpromazine), tricyclic antidepressants (e.g., amitriptyline), corticosteroids (e.g., prednisone) or theophylline, among others. Consult your doctor or pharmacist for details. Large amounts of caffeine and other stimulants, such as those found in weight loss and cold/sinus medications, can increase the chance of seizures with this drug. Check all nonprescription/prescription/herbal drug labels for caffeine and other stimulants (e.g., ephedra). Consult your doctor or pharmacist. This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: seizures, hallucinations, fast or slow heart rate, loss of consciousness.
NOTES: Do not share this medication with others. Psychiatric/medical checkups or tests such as blood pressure monitoring may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Bupropion tablets may have a strange odor. This is normal and the medication is still okay to use. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised September 2012. Copyright(c) 2012 First Databank, Inc.