Generic name: amprenavir
Dosage form: Capsules
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AGENERASE may be taken with or without food; however, a high-fat meal decreases the absorption of amprenavir and should be avoided (see CLINICAL PHARMACOLOGY: Effects of Food on Oral Absorption). Adult and pediatric patients should be advised not to take supplemental vitamin E since the vitamin E content of AGENERASE Capsules exceeds the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU) (see DESCRIPTION).
The recommended oral dose of AGENERASE Capsules for adults is 1,200 mg (twenty-four 50-mg capsules) twice daily in combination with other antiretroviral agents.
For adolescents (13 to 16 years), the recommended oral dose of AGENERASE Capsules is 1,200 mg (twenty-four 50-mg capsules) twice daily in combination with other antiretroviral agents. For patients between 4 and 12 years of age or for patients 13 to 16 years of age with weight of <50 kg, the recommended oral dose of AGENERASE Capsules is 20 mg/kg twice daily or 15 mg/kg 3 times daily (to a maximum daily dose of 2,400 mg) in combination with other antiretroviral agents. The recommended dose of AGENERASE for use in combination with ritonavir has not been established in pediatric patients.
Before using AGENERASE Oral Solution, the complete prescribing information should be consulted.
AGENERASE Capsules and AGENERASE Oral Solution are not interchangeable on a milligram-per-milligram basis (see CLINICAL PHARMACOLOGY).
Patients with Hepatic Impairment
AGENERASE Capsules should be used with caution in patients with moderate or severe hepatic impairment. Patients with a Child-Pugh score ranging from 5 to 8 should receive a reduced dose of AGENERASE Capsules of 450 mg twice daily, and patients with a Child-Pugh score ranging from 9 to 12 should receive a reduced dose of AGENERASE Capsules of 300 mg twice daily (see CLINICAL PHARMACOLOGY: Hepatic Insufficiency).
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