GENERIC NAME: BUPROPION SUSTAINED-RELEASE (SMOKING DETERRENT) - ORAL (bue-PROE-pee-on)
BRAND NAME(S): Zyban
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. Tell your doctor right away if you have any of these symptoms after stopping treatment.
USES: This medication is used in combination with a stop-smoking program (e.g., support group, counseling) to help you quit smoking. Bupropion can decrease your nicotine withdrawal symptoms (e.g., irritability, anxiety, restlessness) and your urge to smoke. Quitting smoking decreases your risk of heart and lung disease, as well as cancer.This medication belongs to a class of medications known as antidepressants. It is not known exactly how bupropion works to reduce smoking urges. It may work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain.Discuss the risks and benefits of this medication, as well as other ways to quit smoking (such as nicotine replacement treatment), with your doctor.OTHER 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 other mental/mood disorders such as depression and attention deficit hyperactivity disorder (ADHD). It may be used to prevent autumn-winter seasonal depression (seasonal affective disorder). It is also used with other mood stabilizers to treat bipolar disorder.
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using bupropion and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Take this medication by mouth, usually twice daily with or without food. If stomach upset occurs, take with food. It is important to take your doses at least 8 hours apart or as directed by your doctor to decrease your risk of seizure.You may have trouble sleeping when you start taking this drug. Do not take your evening dose too close to bedtime.Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects, including seizures. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.Your dosage is based on your medical condition and response to therapy. Your dose may be slowly increased to limit side effects. Do not take more or less medication than prescribed. Do not take more than 150 milligrams in a single dose. Do not take more than 300 milligrams per day. Taking more than the recommended dose of this medication may increase your risk of having a seizure.It is recommended that you do not try to quit smoking until you have been taking bupropion for 1 week so that the drug can reach a high enough level in your blood. Set a date for quitting, and stop smoking sometime in the second week of taking the drug.If necessary, this medication may be combined with nicotine patches or gum to help you quit smoking. Ask your doctor for more information. The combination of nicotine and this medication may increase your blood pressure. Your doctor may need to monitor your blood pressure closely. Do not smoke at any time if using any nicotine products with this drug. Too much nicotine can cause serious side effects.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.Tell your doctor if you are not able to stop smoking after 7 to 12 weeks on this medication.
SIDE EFFECTS: Dry mouth and trouble sleeping may occur as your body gets used to the drug. Dizziness, drowsiness, nausea, diarrhea, fatigue, constipation, blurred vision, increased sweating, strange taste in mouth, or stomach pain may also 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 heartbeat, irregular heartbeat, mental/mood changes (e.g., anxiety, agitation, confusion, memory loss), muscle aches, ringing in the ears, severe headache, 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 rarely 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.An empty tablet shell may appear in your stool. This is harmless.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 Warnings section.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, which may increase your risk of seizures.Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol/drug dependence, diabetes, heart disease (e.g., congestive heart failure, recent heart attack), high blood pressure, kidney problems, liver problems (e.g., cirrhosis), mental/mood disorders (e.g., bipolar disorder, thoughts of suicide).This drug may make you dizzy, drowsy, or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages. Alcohol can increase your risk of dizziness or seizures.Do not take this medicine with any other product that contains bupropion (e.g., antidepressants) since large doses of bupropion are more likely to cause seizures.Older adults may be more sensitive to the side effects of this drug, especially dizziness and memory loss. Dizziness can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. Behavioral therapy and stop-smoking education is preferred for pregnant women who desire to stop smoking. Discuss the risks and benefits with your doctor.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.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, 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.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, ticlopidine), 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 medical/laboratory tests (including brain scan for Parkinson's disease), 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.
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OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. 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, severe confusion, hallucinations, rapid heart rate, and loss of consciousness.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., blood pressure monitoring, liver function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
STORAGE: Store the US product at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture.Store the Canadian product 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 safe 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 March 2014. Copyright(c) 2014 First Databank, Inc.
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