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.

AMPRENAVIR/VITAMIN E/PROPYLENE GLYCOL SOLUTION - ORAL

(am-PREN-uh-veer/vitamin E/PRO-puh-leen GLY-koll)

COMMON BRAND NAME(S): Agenerase

WARNING: This medication must be used in combination with other anti-HIV medications. This oral liquid form of amprenavir contains a large amount of propylene glycol. Therefore, it must not be used in infants and children under 4 years old, pregnant women, patients with severe kidney or liver problems, nor in patients who take disulfiram or metronidazole. The oral liquid form of amprenavir should be used only after other treatments have been considered (e.g., amprenavir capsules).

USES: This medication is used in combination with other anti-HIV medicines to treat HIV infection. Because this medication contains propylene glycol (which can cause additional side effects), this liquid form of this drug should be used only after other treatments have been considered (e.g., amprenavir capsules).

HOW TO USE: Take this drug by mouth, generally twice daily; or as directed by your doctor. You may take this with or without food. However, do not take it with a high-fat meal. If you take antacids or didanosine, take them at least one hour before or after taking amprenavir solution. Doing so improves the absorption of amprenavir into your bloodstream. Do not take more or less of this drug than prescribed. Do not stop taking it unless directed to do so by your doctor. Do not take vitamin E supplements unless directed to do so by your doctor; this drug contains vitamin E. Do not switch between the capsule and liquid forms of this medication. They are not equal on a milligram per milligram basis. Consult your doctor or pharmacist.

SIDE EFFECTS: Nausea, vomiting, diarrhea and stomach pain may occur. If these effects persist or worsen, notify your doctor promptly. Report promptly: unusual increases in thirst or urination. Though unlikely to occur, report promptly: seizures, fast heartbeat, muscle aches, rapid breathing, change in amount of urine, dark urine, yellowing eyes/skin, skin rash, mental/mood changes, weight gain. Very unlikely but report promptly: tingling or numbness. 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: Tell your doctor your medical history, including: allergies (especially to sulfa drugs), diabetes, high blood cholesterol or fats (lipids), liver problems, kidney problems, blood disorders (hemophilia), digestive disorders (malabsorption). Caution is advised when this drug is used in the elderly, as this group may be more prone to drug side effects. This liquid solution form of amprenavir must not be used in infants and children less than 4 years of age. It contains propylene glycol, which can cause side effects. This form of amprenavir must not be used during pregnancy. It contains propylene glycol, which can cause side effects. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is not known whether this drug passes into breast milk. Avoid breast-feeding because breast milk can transmit HIV. Consult your doctor or pharmacist for more information.

DRUG INTERACTIONS: This drug should not be used with the following medications because very serious interactions may occur: oral contraceptives. If you are currently using any of these medications, tell your doctor or pharmacist before starting amprenavir/vitamin E/propylene glycol. Tell your doctor of all nonprescription and prescription medication you may use, especially of: astemizole, terfenadine, cisapride, sildenafil, rifamycins (e.g., rifampin, rifabutin), bepridil, ergot drugs (dihydroergotamine, ergotamine), midazolam, triazolam, drugs for irregular heartbeats (antiarrhythmics such as amiodarone, IV lidocaine, quinidine), tricyclic antidepressants (e.g., amitriptyline), methadone, diabetes medicines (e.g., insulin, metformin), "blood thinners" (e.g., warfarin), certain anti-seizure drugs (e.g., phenobarbital, phenytoin, carbamazepine), "statin" drugs for cholesterol (e.g., lovastatin, simvastatin), dapsone, erythromycin, itraconazole, certain benzodiazepines (e.g., diazepam, alprazolam), certain calcium channel blockers (e.g., diltiazem, nifedipine, nicardipine), other anti-HIV drugs (such as delavirdine, efavirenz, nevirapine, didanosine, ritonavir), clozapine, loratadine, pimozide, cimetidine, St John's wort, metronidazole, disulfiram. Do not drink alcoholic beverages while using this drug. The propylene glycol in this medicine can increase the blood levels of alcohol. 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 nausea, weakness, intestinal cramps, headache, flatulence, diarrhea, drowsiness, or loss of consciousness.

NOTES: This medicine is not a cure for HIV infection but has shown positive results. The long-term effects are unknown at this time. Keep all doctor appointments and laboratory tests, which will help monitor your progress. Be aware that this medicine does not reduce the risk of passing the virus to others through sexual contact or blood contamination. This is a potent medicine which should not be shared. Do not allow anyone else to use your medication.

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 (77 degrees F or 25 degrees C) away from light and moisture.

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.