FOSAMPRENAVIR CALCIUM tablet, coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Sun Pharmaceutical Industries, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 calcium tabletsplus ritonavir in protease inhibitor-experienced patients: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fosamprenavir calcium during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Limited data are available for use of fosamprenavir calcium in pregnancy. fosamprenavir calcium 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 calcium/ritonavir 700 mg/100 mg prior to pregnancy, and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) (see

Produkto santrauka:

Fosamprenavir calcium tablets, 700 mg, are pink colored, coated, oval-shaped tablets with “RJ47” imprinted on one side with black ink and plain on the other side. They are supplied as follows- Store at 20° C to 25° C (68° F to 77° F) [See USP Controlled Room Temperature]. Keep bottle tightly closed. Protect from moisture.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

FOSAMPRENAVIR CALCIUM- FOSAMPRENAVIR CALCIUM TABLET, COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Fosamprenavir calcium tablet are HIV protease inhibitor indicated in
combination with other antiretroviral agents for the
treatment of HIV-1 infection. (1) (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
Dosing Considerations (2)
•
•
DOSAGE FORMS AND STRENGTHS
700 mg tablets (3) (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
Dosage and Administration, Adults (2.2) 03/2019
Contraindications (4) 03/2019
Therapy-Naive Adults: Fosamprenavir calcium tablets 1,400 mg twice
daily; fosamprenavir calcium tablets 1,400 mg
once daily plus ritonavir 200 mg once daily; fosamprenavir calcium
tablets 1,400 mg once daily plus ritonavir 100 mg
once daily; fosamprenavir calcium tablets 700 mg twice daily plus
ritonavir 100 mg twice daily. (2.2)
Protease Inhibitor-Experienced Adults: Fosamprenavir calcium tablets
700 mg twice daily plus ritonavir 100 mg twice
daily. (2.2)
Pregnant Patients: Fosamprenavir calcium tablets 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 calcium /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)
Fosamprenavir Calcium Or