ATAZANAVIR capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Zydus Pharmaceuticals USA Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg. Limitations of Use: -   Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. -   Use of atazanavir/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)] . Atazanavir is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see Warnings and Precautions (5.2)] . - when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs are asso

Resumo do produto:

Atazanavir Capsules contain atazanavir sulfate equivalent to 150 mg of atazanavir with off-white to light brown powder filled in size "1" empty hard gelatin capsules with opaque blue cap printed with "1050" in black ink and grey opaque body and are supplied as follows: 70710-1050-6 in bottles of 60's counts 70710-1050-1 in bottles of 100's counts Atazanavir Capsules contain atazanavir sulfate equivalent to 200 mg of atazanavir with off-white to light brown powder filled in size "0" empty hard gelatin capsules with blue opaque cap printed with "1051" in black ink and blue opaque body and are supplied as follows: 70710-1051-6 in bottles of 60's counts 70710-1051-1 in bottles of 100's counts Atazanavir Capsules contain atazanavir sulfate equivalent to 300 mg of atazanavir with off-white to light brown powder filled in size "00" empty hard gelatin capsules with orange opaque cap printed with "1052" in black ink and blue opaque body and are supplied as follows: 70710-1052-3 in bottles of 30's counts 70710-1052-1 in bottles of 100's counts Store atazanavir capsules at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ATAZANAVIR- ATAZANAVIR CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATAZANAVIR CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ATAZANAVIR CAPSULES.
ATAZANAVIR CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Atazanavir capsules are a protease inhibitor indicated for use in
combination with other antiretroviral
agents for the treatment of HIV-1 infection for patients 3 months and
older weighing at least 5 kg. (1)
DOSAGE AND ADMINISTRATION
_Pretreatment testing: _Renal laboratory testing should be performed
in all patients prior to initiation of
atazanavir capsules and continued during treatment with atazanavir
capsules. Hepatic testing should
be performed in patients with underlying liver disease prior to
initiation of atazanavir capsules and
continued during treatment with atazanavir capsules. (2.2)
_Treatment-naive adults: _Atazanavir capsules 300 mg with ritonavir
100 mg once daily with food or
atazanavir capsules 400 mg once daily with food. (2.3)
_Treatment-experienced adults: _Atazanavir capsules 300 mg with
ritonavir 100 mg once daily with food.
(2.3)
_Pediatric patients: _Atazanavir capsule dosage is based on body
weight not to exceed the adult dose
and must be taken with food. (2.4)
_Pregnancy: _Atazanavir capsules 300 mg with ritonavir 100 mg once
daily with food, with dosing
modifications for some concomitant medications. (2.6)
_Dosing modifications: _may be required for concomitant therapy (2.3,
2.4, 2.6), renal impairment (2.7),
and hepatic impairment (2.8).
DOSAGE FORMS AND STRENGTHS
Capsules: 150 mg, 200 mg, 300 mg. (3, 16)
CONTRAINDICATIONS
Atazanavir capsules are contraindicated in patients with previously
demonstrated hypersensitivity (e.g.,
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 derivat