Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)
Physicians Total Care, Inc.
ATAZANAVIR SULFATE
ATAZANAVIR 150 mg
ORAL
PRESCRIPTION DRUG
REYATAZ® (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from controlled studies of 96 weeks duration in antiretroviral-naive and 48 weeks duration in antiretroviral-treatment-experienced adult and pediatric patients at least 6 years of age. The following points should be considered when initiating therapy with REYATAZ: - In Study AI424-045, REYATAZ/ritonavir and lopinavir/ritonavir were similar for the primary efficacy outcome measure of time-averaged difference in change from baseline in HIV RNA level. This study was not large enough to reach a definitive conclusion that REYATAZ/ritonavir and lopinavir/ritonavir are equivalent on the secondary efficacy outcome measure of proportions below the HIV RNA lower limit of detection [see Clinical Studies (14.2) ]. - The number of baseline primary protease inhibitor mutations affects the virologic response to
REYATAZ® (atazanavir sulfate) Capsules are available in the following strengths and configurations of plastic bottles with child-resistant closures. * atazanavir equivalent as atazanavir sulfate. REYATAZ (atazanavir sulfate) Capsules should be stored at 25° C (77° F); excursions permitted to 15–30° C (59–86° F) [see USP Controlled Room Temperature].
New Drug Application
REYATAZ - ATAZANAVIR SULFATE CAPSULE, GELATIN COATED PHYSICIANS TOTAL CARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE REYATAZ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REYATAZ. REYATAZ (ATAZANAVIR SULFATE) CAPSULES INITIAL U.S. APPROVAL: 2003 RECENT MAJOR CHANGES Dosage and Administration (2.2) 10/2011 Dosage and Administration (2.3) 02/2011 INDICATIONS AND USAGE REYATAZ is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV- 1 infection. (1) DOSAGE AND ADMINISTRATION _Treatment-naive patients: _REYATAZ 300 mg with ritonavir 100 mg once daily with food or REYATAZ 400 mg once daily with food. When coadministered with tenofovir, the recommended dose is REYATAZ 300 mg with ritonavir 100 mg. (2.1) _Treatment-experienced patients:_ REYATAZ 300 mg with ritonavir 100 mg once daily with food. (2.1) _Pediatric patients (6 to less than 18 years of age):_ Dosage is based on body weight not to exceed the adult dose. (2.2) _Pregnancy:_ REYATAZ 300 mg with ritonavir 100 mg once daily with food, with dosing modifications for some concomitant medications. (2.3) _Concomitant therapy:_ Dosing modifications may be required. (2.1, 7) _Renal impairment:_ Dosing modifications may be required. (2.4) _Hepatic impairment:_ Dosing modifications may be required. (2.5) DOSAGE FORMS AND STRENGTHS Capsules: 100 mg, 150 mg, 200 mg, 300 mg. (3, 16) CONTRAINDICATIONS REYATAZ is contraindicated in patients with previously demonstrated hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. (4) Coadministration with alfuzosin, triazolam, orally administered midazolam, ergot derivatives, rifampin, irinotecan, lovastatin, simvastatin, indinavir, cisapride, pimozide, St. John’s wort, and sildenafil when dosed as REVATIO . (4) WARNINGS AND PRECAUTIONS _Cardiac conduction abnormalities:_ PR interval prolongation may o Lees het volledige document