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.

RITONAVIR SOLUTION - ORAL

(rye-TAWN-uh-veer)

COMMON BRAND NAME(S): Norvir

WARNING: Use of ritonavir with certain nonsedating antihistamines (e.g., astemizole, terfenadine); sedatives and tranquilizers (e.g., midazolam, triazolam); heart medications (antiarrhythmics such as bepridil, flecainide, propafenone, quinidine); or ergot- containing drugs may cause severe, even fatal, side effects. Tell your doctor if you use any of these types of medications before using ritonavir.

USES: This medication belongs to a class of drugs called protease inhibitors and is used, either alone or in combination with other drugs, to treat human immunodeficiency virus (HIV) infection.

HOW TO USE: Shake well before each dosing. Take twice daily by mouth with meals if possible. A common side effect of nausea may be decreased by increasing the dose of ritonavir gradually over 5 days. In patients beginning combination therapy with other HIV medications, nausea can be decreased by starting the second medication between 5 and 14 days after therapy with ritonavir has begun. The taste of the solution can be improved by mixing it with chocolate milk, Ensure or Advera. Be sure to take the mixture within 1 hour after mixing. Do not increase or decrease your dose Do not increase your dose unless told to do so by your doctor.

SIDE EFFECTS: The most common side effects are weakness, loss of appetite, nausea, vomiting, diarrhea, altered taste, stomach pain; or numbness or tingling of mouth, hands, or feet. Less common side effects include blurred vision, dizziness, headache, loss of coordination; muscle or joint pain; or drowsiness. Inform your doctor if these should persist or worsen. Tell your doctor immediately if any of these serious side effects occur: chills, rash, rapid heart rate, increased urination, unusual thirst, unusual bleeding or bruising (blood in the urine or stool), severe stomach pain, shortness of breath. 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. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before taking this drug tell your doctor of previous illnesses, especially: liver disease, kidney disease, diabetes, blood disorders. Tobacco smoking may decrease the effects of this drug. Ritonavir solution contains alcohol. This medication should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor. It is not known if this medication appears in breast milk. Because breast milk can transmit HIV, do not breast-feed.

DRUG INTERACTIONS: Before you take this drug, tell your doctor of all the drugs you take including prescription and nonprescription medications especially: amiodarone, astemizole, bepridil, bupropion, cisapride, clozapine, disulfiram, encainide, flecainide, meperidine, metronidazole, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, terfenadine, zolpidem, benzodiazepines (e.g., diazepam, chlordiazepoxide), clarithromycin, rifampin, drugs that can harm the kidneys (e.g., gentamicin, amphotericin), St John's wort, other protease inhibitors (e.g., saquinavir). Inform your doctor if you are taking any of the following drugs: birth control pills, cyclosporine, dexamethasone, dronabinol, lansoprazole, losartan, omeprazole, ondansetron, prednisone, quinine, tacrolimus, theophylline, warfarin, anti- cancer drugs, cholesterol-reducing drugs, antidepressants, oral drugs used for diabetes, anti-seizure drugs, heart medication, high blood pressure drugs (e.g., calcium channel blockers, beta- blockers), drugs used to treat schizophrenia, pain medication (narcotic analgesics and NSAIDS). This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. 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 change in amount of urine; or numbness or tingling in the arms, hands, legs, or feet.

NOTES: This medication does not cure HIV. Patients treated with ritonavir may continue to acquire "opportunistic" infections associated with HIV. This medication also does not prevent transmission of HIV to others through sexual contact or blood.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is within 2 hours of the next dose, skip the missed dose and resume your usual dosing schedule. It is important not to miss doses of this drug.

STORAGE: Store at room temperature between 68 and 77 degrees F (20-25 degrees C). Do not refrigerate because crystals may form and the drug will not be properly absorbed. Store solution in the original container and keep the cap tightly closed. Do not expose the medication to heat or sunlight. Do not store in the bathroom.

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.