FOSAMPRENAVIR CALCIUM tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

FOSAMPRENAVIR CALCIUM (UNII: ID1GU2627N) (AMPRENAVIR - UNII:5S0W860XNR)

Доступно од:

Mylan Pharmaceuticals Inc.

INN (Међународно име):

FOSAMPRENAVIR CALCIUM

Састав:

FOSAMPRENAVIR 700 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. The following points should be considered when initiating therapy with fosamprenavir plus ritonavir in protease inhibitor-experienced patients: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fosamprenavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Limited data are available for use of fosamprenavir in pregnancy. Fosamprenavir 700 mg twice daily taken with ritonavir 100 mg twice daily should only be considered in pregnant patients who are already on a stable twice-daily regimen of fosamprenavir/ritonavir 700 mg/100 mg prior to pregnancy, and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) (see Clinical Considerations and Data). There are insufficient human data on the use of fosam

Резиме производа:

Fosamprenavir Calcium Tablets, USP are available containing 700 mg of fosamprenavir as fosamprenavir calcium, USP. The 700 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with M on one side of the tablet and FT7 on the other side. They are available as follows: NDC 0378-3520-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep container tightly closed. Dispense in original container.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

FOSAMPRENAVIR CALCIUM- FOSAMPRENAVIR CALCIUM TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOSAMPRENAVIR
CALCIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FOSAMPRENAVIR CALCIUM TABLETS.
FOSAMPRENAVIR CALCIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Fosamprenavir calcium tablets are an HIV protease inhibitor indicated
in combination with other
antiretroviral agents for the treatment of HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
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Dosing Considerations
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Therapy-Naive Adults: Fosamprenavir 1,400 mg twice daily;
fosamprenavir 1,400 mg once daily plus
ritonavir 200 mg once daily; fosamprenavir 1,400 mg once daily plus
ritonavir 100 mg once daily;
fosamprenavir 700 mg twice daily plus ritonavir 100 mg twice daily.
(2.2)
Protease Inhibitor-Experienced Adults: Fosamprenavir 700 mg twice
daily plus ritonavir 100 mg twice
daily. (2.2)
Pregnant Patients: Fosamprenavir 700 mg twice daily plus ritonavir 100
mg twice daily should only be
considered in women who are already on a stable twice-daily regimen of
fosamprenavir/ritonavir 700
mg/100 mg prior to pregnancy and who are virologically suppressed
(HIV-1 RNA less than 50 copies
per mL). (2.2)
Pediatric Patients (aged at least 4 weeks to 18 years): Dosage should
be calculated based on body
weight (kg) and should not exceed adult dose. (2.3)
Hepatic Impairment: Recommended adjustments for patients with mild,
moderate, or severe hepatic
impairment. (2.4)
Fosamprenavir calcium tablets may be taken with or without food. (2.1)
700-mg tablets (3)
Hypersensitivity to fosamprenavir or amprenavir (e.g., Stevens-Johnson
syndrome). (4)
Drugs highly dependent on cytochrome P450 (CYP)3A4 for clearance and
for which elevated plasma
levels may result in serious and/or life-threatenin