IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ABACAVIR - ORAL

(uh-BACK-uh-veer)

COMMON BRAND NAME(S): Ziagen

WARNING: Infrequently, this drug can cause severe (sometimes fatal) allergic reactions, liver problems, and blood acid-base balance (lactic acidosis) problems. If you develop symptoms such as rash, fever, fatigue, difficult or rapid breathing, cough, throat inflammation, dark urine, yellowing of the skin or eyes, drowsiness, muscle aches, stomach/abdominal pain, nausea, vomiting, or diarrhea immediately stop using this medication and notify your doctor. Do not restart this medication if an allergic reaction to this drug has occurred because more severe, life-threatening problems could occur (including low blood pressure and death). Also, if an allergic reaction is only suspected, this medication should never be restarted. (See precautions regarding stopping and starting this medication.) It is not known how long this drug will benefit those with HIV infection.

USES: This medication is used to treat HIV infection in combination with other anti-HIV medications. This medication contains abacavir. The use of lamivudine, abacavir, and tenofovir in combination may not be effective in treating HIV infection. If you are currently taking all three of these drugs, your doctor or pharmacist should carefully review your treatment plan. Consult your doctor or pharmacist for more details.

HOW TO USE: Take this medication by mouth as directed, generally twice daily with or without food. Dosage is based on your condition and response to therapy. Read the Medication Guide provided by your pharmacist. Carry the "Warning Card" with you at all times. It is very important to continue taking this medication and other anti-HIV medications exactly as prescribed by your doctor. Do not skip any doses.

SIDE EFFECTS: Headache and trouble sleeping may occur. If these effects persist or worsen, notify your doctor. Very unlikely but report promptly: dark urine, yellowing of the eyes or skin, rapid breathing, change in amount of urine. Changes in body fat may occur while you are taking this medication (e.g., increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction to this drug include: fever, nausea, vomiting, diarrhea, skin rash, extreme tiredness, achiness, stomach pain, swelling, trouble breathing, cough, sore throat. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, including: allergies (especially drug allergies), liver disease, alcohol dependence, diabetes. Limit alcohol intake, as it may intensify side effects of this drug. If you must stop using this drug due to an allergic reaction, never use the drug again or death could result. Consult MD and read the "Warning Card" for more details. If you stop using abacavir (e.g., forget to order a refill) even for a short time and then restart the drug, you have an increased chance of developing the very serious (possibly fatal) allergic reaction. Do not stop treatment unless specifically instructed to do so. Know the symptoms of this allergic reaction (see side effects section). Consult your doctor or pharmacist before restarting abacavir, and be sure you have easy access to medical care if you are restarting treatment. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug is excreted into breast milk. Avoid breast-feeding because breast milk can transmit HIV. Consult your doctor or pharmacist before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you may use, especially of: drugs that cause liver problems (e.g., isoniazid)., lamivudine and tenofovir. 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.

NOTES: This medication is not a cure for HIV infection but has shown positive results. You may continue to have illnesses related to HIV infection. Keep all doctor appointments and scheduled laboratory tests (e.g., liver function) as your therapy will be monitored. Be aware that this medication does not reduce the risk of passing the virus to others through sexual contact or blood contamination. This is a potent medication which should not be shared.

MISSED DOSE: If you miss a dose, contact your doctor or pharmacist immediately (see Precautions section for more details).

STORAGE: Store capsules at room temperature between 68 and 77 degrees F (20-25 degrees C) away from light and moisture. The oral liquid may be stored at room temperature or may be refrigerated. Do not freeze.

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).

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Copyright 2004 by First DataBank, Inc.