Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
FOSAMPRENAVIR CALCIUM (UNII: ID1GU2627N) (AMPRENAVIR - UNII:5S0W860XNR)
REMEDYREPACK INC.
FOSAMPRENAVIR CALCIUM
FOSAMPRENAVIR 700 mg
PRESCRIPTION DRUG
New Drug Application
LEXIVA- FOSAMPRENAVIR CALCIUM TABLET, FILM COATED REMEDYREPACK INC. ---------- 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 Prečítajte si celý dokument