atazanavir 200 mg capsule
1 INDICATIONS AND USAGE Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 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/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 for patients 3 months and older weighing at least 5 kg. ( 1 )
zydus pharmaceuticals (usa) inc.
CAPSULE BLUE 1051
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16 HOW SUPPLIED/STORAGE AND HANDLING
ATAZANAVIR capsules contain
ATAZANAVIR sulfate equivalent to 150 mg of
ATAZANAVIR with off-white to light brown powder filled in size "1" empty hard gelatin capsules with opaque blue cap printed with "1050" in black ink and grey opaque body and are supplied as follows: 70710-1050-6 in bottles of 60's counts 70710-1050-1 in bottles of 100's counts
ATAZANAVIR capsules contain
ATAZANAVIR sulfate equivalent to 200 mg of
ATAZANAVIR with off-white to light brown powder filled in size "0" empty hard gelatin capsules with blue opaque cap printed with "1051" in black ink and blue opaque body and are supplied as follows: 70710-1051-6 in bottles of 60's counts 70710-1051-1 in bottles of 100's counts
ATAZANAVIR capsules contain
ATAZANAVIR sulfate equivalent to 300 mg of
ATAZANAVIR with off-white to light brown powder filled in size "00" empty hard gelatin capsules with orange opaque cap printed with "1052" in black ink and blue opaque body and are supplied as follows: 70710-1052-3 in bottles of 30's counts 70710-1052-1 in bottles of 100's counts Store
ATAZANAVIR capsules at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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