ATAZANAVIR capsule, gelatin coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

REMEDYREPACK INC.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: - Atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. [see Use in Specific Populations ( 8.4)] . - Use of atazanavir with 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 (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see Warnings and Precautions (

Resumen del producto:

Atazanavir Capsules Atazanavir capsules are available in the following strengths and configurations of plastic bottles with child-resistant closures. 300 mg atazanavir equivalent to 341.69 mg atazanavir sulfate. 300 mg, Red/blue, printed with Cipla no marking on body, NDC: 70518-2832-00 PACKAGING: 30 in 1 BLISTER PACK Keep capsules in a tightly closed container. Atazanavir capsules should be stored at 25° C (77° F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ATAZANAVIR- ATAZANAVIR CAPSULE, GELATIN COATED
REMEDYREPACK 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
RECENT MAJOR CHANGES
Contraindications (4) 09/2020
Warnings and Precautions
Immune Reconsituted Syndorm (5.10) 09/2020
INDICATIONS AND USAGE
Atazanavir capsules are protease inhibitor indicated for use in
combination with other antiretroviral agents
for the treatment of HIV-1 infection in adults and in pediatric
patients 6 years and older weighing at least
15 kg. ( 1)
DOSAGE AND ADMINISTRATION
_Pretreatment testing_ : Renal laboratory testing should be performed
in all patients prior to initiation of
atazanavir capsule and continued during treatment with atazanavir
capsule. Hepatic testing should be
performed in patients with underlying liver disease prior to
initiation of atazanavir capsule and
continued during treatment with atazanavir capsule. ( 2.2)
_Treatment-naive adults:_ Atazanavir capsule 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 capsule 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 capsule 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,
2.3, 2.6), renal impairment ( 2.7),
and hepatic impairment ( 2.8).
DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg, 150 mg, 200 mg, 300 mg. ( 3, 16)
CONTRAINDICATIONS
Atazanavir capsule is contraindicated in patients with previously
demonstrated hypersensitivity (eg,
Stevens-Johnson syndrome, erythema multiforme, or toxic