REYATAZ- atazanavir sulfate capsule, gelatin coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)

Dostopno od:

Physicians Total Care, Inc.

INN (mednarodno ime):

ATAZANAVIR SULFATE

Sestava:

ATAZANAVIR 150 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

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].

Status dovoljenje:

New Drug Application

Lastnosti izdelka

REYATAZ - ATAZANAVIR SULFATE CAPSULE, GELATIN COATED
PHYSICIANS TOTAL CARE, INC.
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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