atazanavir capsule
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 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 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 )
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CAPSULE RED Amneal 300mg 1138
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atazanavir capsule
amneal pharmaceuticals ny llc
atazanavir capsule
amneal pharmaceuticals ny llc
atazanavir capsule
amneal pharmaceuticals ny llc
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16 HOW SUPPLIED/STORAGE AND HANDLING
ATAZANAVIR capsules, 100 mg are supplied as size ‘2’ hard gelatin capsules having imprinted ‘Amneal 100 mg’ on blue opaque cap with white ink and ‘1135’ on white opaque body with blue ink, filled with off-white to yellow granular powder. They are available as follows: Bottles of 60: NDC 69238-1135-6
ATAZANAVIR capsules, 150 mg are supplied as size ‘1’ hard gelatin capsules having imprinted ‘Amneal 150 mg’ on blue opaque cap with white ink and ‘1136’ on powder blue opaque body with blue ink, filled with off-white to yellow granular powder. They are available as follows: Bottles of 60: NDC 69238-1136-6
ATAZANAVIR capsules, 200 mg are supplied as size ‘0’ hard gelatin capsules having imprinted ‘Amneal 200 mg’ on blue opaque cap and ‘1137’on blue opaque body with white ink, filled with off-white to yellow granular powder. They are available as follows: Bottles of 60: NDC 69238-1137-6
ATAZANAVIR capsules, 300 mg are supplied as size ‘00’ hard gelatin capsules having imprinted ‘Amneal 300 mg’ on red opaque cap and ‘1138’ on blue opaque body with white ink, filled with off-white to yellow granular powder. They are available as follows: Bottles of 30: NDC 69238-1138-3 Keep capsules in a tightly closed container. Store
ATAZANAVIR capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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