Bupropion Oral - BUPROPION SUSTAINED - RELEASE

Warnings Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially children/teenagers) who take antidepressants for any condition may experience 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 (especially for children/teenagers), even if treatment is not for a mental/mood condition.

Tell the doctor immediately 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.

Uses This medication is used to treat depression. It can improve your mood and feelings of well-being. It works by helping to restore the balance of natural chemicals (neurotransmitters) in your brain. Bupropion is also used to help people quit smoking by decreasing cravings and nicotine withdrawal effects.

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 be used to treat attention-deficit hyperactivity disorder (ADHD). It may also be used in combination with other mood stabilizers to treat bipolar disorder (depressive phase).

How to use Bupropion Oral Read the Medication Guide and Patient Information Leaflet available from 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 nausea occurs, you may take this drug 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 having a seizure. This medication must be swallowed whole. Do not crush, chew or break the tablets. Doing so will destroy the slow release of the drug and may increase your risk of side effects, including seizures. You may have trouble sleeping when you start taking bupropion. Do not take your evening dose too close to bedtime. Let your doctor know if sleeplessness becomes a problem. Your dosage is based on your medical condition and response to therapy. Your dose should be slowly increased to limit side effects such as sleeplessness and decrease the risk of seizures. Do not take more or less medication than prescribed. Taking more than the recommended dose will increase your risk of having a seizure. The usual maximum dose is 300-400 milligrams per day (maximum single dose 150-200 milligrams). Do not stop taking this medication without notifying your doctor. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It may take 4 weeks or more before the full effects of this medication are noticed. Talk to your doctor if your condition persists or worsens.

Precautions

See also 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 medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: seizures, eating disorders (e.g., 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 can cause a higher risk of seizures.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide thoughts/attempts, head injury, brain tumor, liver problems, heart problems, high blood pressure, kidney problems, diabetes, alcohol/drug dependence, intention to quit smoking.
This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery.
Limit or avoid consumption of alcoholic beverages. Alcohol can increase your risk of dizziness and seizures.
Do not take this medicine with any other product containing bupropion (e.g., drugs to help quit smoking) since large doses of bupropion are more likely to cause seizures.
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.
Bupropion passes into breast milk. Because of the potential risk to the infant, breast-feeding is not recommended while using this drug.

Additional Information

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, severe confusion, hallucinations, rapid heart rate, loss of consciousness.

NOTES:
Psychiatric/medical checkups (and possibly laboratory and/or medical tests such as blood pressure monitoring) must be done periodically to monitor your progress and check for side effects. Consult your doctor for more details.
Do not share this medication with others.

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. Taking too much of this medication can increase your chance of having a seizure.

STORAGE:
Store at room temperature between 68-77 degrees F (20-25 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.
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.

MEDICAL ALERT:
Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Side Effects

See also the Warning section.

Dry mouth, sore throat, nausea, vomiting, stomach/abdominal pain, flushing, headache, loss of appetite, constipation, trouble sleeping, increased sweating, strange taste in mouth, muscle/joint aches, dizziness, or blurred vision 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 do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, chest pain, fast heartbeat, severe headache, uncontrolled movements (tremor), unusual weight loss or gain, ringing in the ears, mental/mood changes (e.g., agitation, anxiety, hallucinations, nervousness, confusion, restlessness).

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 have a seizure while taking bupropion. If you have a seizure while taking bupropion, you should not take this drug again.

A severe allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a severe allergic reaction include: rash, itching, swelling, 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.

Interactions

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious interactions may occur: MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine, procarbazine, selegiline, isocarboxazid, tranylcypromine), certain x-ray dyes such as iomeprol, sibutramine, thioridazine.
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting bupropion.
If you are currently using or have recently stopped taking an MAO inhibitor within the last 14 days, tell your doctor or pharmacist before starting bupropion.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: amantadine, diabetes medications (e.g., hypoglycemic drugs such as glyburide, glipizide, or insulin), HIV drugs (e.g., efavirenz, nelfinavir, ritonavir), levodopa, nicotine products (e.g., patches, gum, or spray), regular use of sedatives (e.g., alcohol, alprazolam), stimulants (e.g., amphetamine, cocaine, ecstasy, ephedrine), warfarin.
Also tell your doctor if you are taking any drugs which are affected by certain liver enzymes, such as antidepressants (e.g., desipramine, paroxetine, fluoxetine), antipsychotics (e.g., haloperidol), beta-blockers (e.g., metoprolol), antiarrhythmics (e.g., propafenone, flecainide), orphenadrine, cyclophosphamide, thiotepa, carbamazepine, phenobarbital, or phenytoin.
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 document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.