ATAZANAVIR SULFATE- atazanavir capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

American Health Packaging

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for 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. - Use of atazanavir capsules/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)]. - 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 associated with serious and/or life-threatening

Resumen del producto:

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. Unit dose packaged of 30 (5 x 6) NDC 60687-399-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ATAZANAVIR SULFATE- ATAZANAVIR CAPSULE
AMERICAN HEALTH PACKAGING
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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
Dosage and Administration, Testing Prior to Initiation and During
Treatment with Atazanavir Capsules
( 2.2)
10/2017
Dosage of Atazanavir Capsules in Pediatric Patients ( 2.4)
5/2017
Contraindications ( 4)
3/2018
Warnings and Precautions Chronic Kidney Disease ( 5.5)
10/2017
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 for 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)
CONTRAINDICA