Bupropion IR

USES:
Wellbutrin is a pharmaceutical prescription antidepressant which acts directly on the brain and other nerve cells. It is also used to treat ADHD (Attention Deficit Disorder), Bipolar depression, chronic fatigue syndrome, cocaine addiction, nicotine addiction, and lower back pain. Also, aids in quitting smoking (identical to Zyban). It is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents.

HOW TO USE
This medication may be taken with food if stomach upset occurs. Take doses at regularly scheduled times each day. Do not take more or less medication than prescribed and follow your doctor's instructions carefully. Taking more than the recommended dose of bupropion will increase your risk of having a seizure. Do not stop taking this medication without notifying your doctor. Since this drug may cause sleeplessness at first, it is best not to take this near bedtime. It may take 4 weeks or more before the full effects of this medication are noticed.

SIDE EFFECTS
This medication is generally well tolerated. Dry mouth, headache, increased sweating, nausea/vomiting, constipation, anxiety, fatigue and blurred vision may occur. If these effects persist or worsen, notify your doctor. Report promptly: unusual weight loss or gain, palpitations, agitation, trouble sleeping. Unlikely but report promptly: tremor, dizziness, fainting, mood changes, slowed movements, difficulty urinating, decreased sex drive, drowsiness. Very unlikely but report promptly: seizures, mental problems, fever, muscle aches, yellowing of the eyes or skin. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms may include trouble breathing, rash, itching, swelling, or severe dizziness. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS

Before taking bupropion, tell your doctor if you have: history of seizures or head injury or brain tumor, heart disease, liver or kidney disease, eating disorder, diabetes, alcohol dependence, any allergies, the intent to quit smoking. Because of the possibility this drug will make you dizzy and affect coordination, do not drive or operate machinery until you get used to the drug's effects. Limit or avoid consumption of alcoholic beverages; alcohol can increase your risk of seizures. Chronic alcohol users who suddenly stop the intake of alcohol while taking bupropion may increase the risk of having seizures. Suddenly stopping certain tranquilizers (e.g., diazepam, chlordiazepoxide) is not recommended because doing so may increase the risk of having seizures. Elderly patients may be more sensitive to the effects of this drug. Tell your doctor if you are pregnant or plan to become pregnant before taking this drug. This drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS Before taking bupropion tell your doctor of all nonprescription and prescription medications you may use especially: MAO inhibitors (e.g., isocarboxazid, phenelzine, tranylcypromine, pargyline, selegiline, linezolid, furazolidone), levodopa, ritonavir, corticosteroids (e.g. prednisone), sedatives, adrenaline-like stimulants (e.g., ephedrine), products containing nicotine (e.g., patches or gum). Also report use of drugs which might increase seizure risk (decrease seizure threshold) such as: phenothiazines (e.g., chlorpromazine), tricyclic antidepressants (e.g., amitriptyline), isoniazid (INH), theophylline. Excess caffeine intake can increase the chance of seizures with this drug. Check all nonprescription/prescription drug labels for caffeine. Consult your doctor or pharmacist. A certain product used to help quit smoking contains bupropion. Do not take that product while using this one. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include seizures, hallucinations, rapid heart rate, and loss of consciousness.

NOTES
Do not allow anyone else to take this medication.

MISSED DOSE
Take any missed dose as soon as possible but not if it is within 4 hours of the next dose. If it is time for the next dose, skip the missed dose and resume your regular schedule. Do not "double-up" the dose.

STORAGE
Store at room temperature and keep away from moisture and sunlight. Do not store in the bathroom.

IMPAX Launches Generic Version of Wellbutrin SR 200mg Tablets Wednesday December 22, 8:35 am ET HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 22, 2004--IMPAX Laboratories, Inc. (Nasdaq:IPXL - News) today announced that the Company has begun commercial distribution of its Bupropion Hydrochloride 200mg Extended Release Tablets. The product is being sold under the Global label and marketed by IMPAX's Global Pharmaceuticals division. As previously announced, the U.S. Food and Drug Administration (FDA) granted final approval to the Company's Abbreviated New Drug Application for a generic version of Wellbutrin SR® (Bupropion Hydrochloride) 200mg Tablets on December 3, 2004. The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product. GlaxoSmithKline markets Wellbutrin SR for the treatment of depression. U.S. sales of Wellbutrin SR 200mg Tablets were approximately $212 million in the 12 months ended October 31, 2004, according to NDCHealth. IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company, applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division, and intends to market its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, Calif., and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
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