ATAZANAVIR SULFATE- atazanavir capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atazanavir capsule  is 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 capsules are 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 capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)] . Atazanavir capsules are 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)]

Product summary:

Atazanavir Capsules, 300 mg are red/blue size ‘00’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘300 mg’ on red cap and ‘T26’ on blue body with white edible ink. NDC: 70518-1365-00 PACKAGING: 30 in 1 BLISTER PACK Keep capsules in a tightly closed container. Store at 20o to 25oC (68o to 77oF) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATAZANAVIR SULFATE- ATAZANAVIR CAPSULE
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 Reconstituted Syndrome ( 5.10) 09/2020
INDICATIONS AND USAGE
Atazanavir capsule is a 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 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: 100 mg, 150 mg, 200 mg, and 300 mg. (3, 16)
CONTRAINDICATIONS
Atazanavir capsules are contraindicated in patients with previously
demonstrated hypersensitivity (e.g.,
Stevens-Johnson syndrome, erythema multifo