atazanavir sulfate

FDA Drug Profile

Drug Details

Generic Name
atazanavir sulfate
Brand Names
N/A
Application Number
Sponsor
Patheon Inc.
NDC Codes
3
Dosage Forms
CAPSULE, GELATIN COATED, POWDER
Routes
N/A
Active Ingredients
ATAZANAVIR SULFATE

Indications and Usage

1 INDICATIONS AND USAGE 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 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 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 )