LEXIVA fosamprenavir calcium tablet film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

REMEDYREPACK INC.

INN (International Name):

FOSAMPRENAVIR CALCIUM

Sammensetning:

FOSAMPRENAVIR 700 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application

Preparatomtale

LEXIVA- FOSAMPRENAVIR CALCIUM TABLET, FILM COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEXIVA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LEXIVA.
LEXIVA (FOSAMPRENAVIR CALCIUM) TABLETS, FOR ORAL USE
LEXIVA (FOSAMPRENAVIR CALCIUM) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.7)
12/2017
INDICATIONS AND USAGE
LEXIVA is an HIV protease inhibitor indicated in combination with
other antiretroviral agents for the treatment of HIV-1
infection. ( 1)
DOSAGE AND ADMINISTRATION
Therapy-Naive Adults: LEXIVA 1,400 mg twice daily; LEXIVA 1,400 mg
once daily plus ritonavir 200 mg once daily;
LEXIVA 1,400 mg once daily plus ritonavir 100 mg once daily; LEXIVA
700 mg twice daily plus ritonavir 100 mg twice
daily. ( 2.2)
Protease Inhibitor-Experienced Adults: LEXIVA 700 mg twice daily plus
ritonavir 100 mg twice daily. ( 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)
Dosing Considerations
LEXIVA tablets may be taken with or without food. ( 2.1)
LEXIVA suspension: Adults should take without food; pediatric patients
should take with food. ( 2.1)
DOSAGE FORMS AND STRENGTHS
700-mg tablets ( 3)
50-mg-per-mL oral suspension ( 3)
CONTRAINDICATIONS
Hypersensitivity to LEXIVA or amprenavir (e.g., Stevens-Johnson
syndrome). ( 4)
Drugs highly dependent on CYP3A4 for clearance and for which elevated
plasma levels may result in serious and/or
life-threatening events. ( 4)
Review ritonavir contraindications when used in combination. ( 4)
WARNINGS AND PRECAUTIONS
The concomitant use of LEXIVA with ritonavir and certain other drugs
may result in known or potentially significant
drug interactions. Consult the full prescribing information prior to
and during treatment fo