ATAZANAVIR- atazanavir capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Camber Pharmaceuticals, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 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 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 (eg, Stevens- Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [ see Warnings and Precautions (

Produktbesonderheiten:

Atazanavir Capsules 150 mg are off white to pale yellow colored granular powder filled in size "1" hard gelatin capsules with green opaque cap imprinted with "H" in black color and light green opaque body imprinted with "A6" in black color. Bottles of 60 with child-resistant closure          NDC 31722-653-60 Bottles of 1000 with child-resistant closure      NDC 31722-653-10 Carton of 100 (10×10) unit-dose capsules       NDC 31722-653-31 150 mg atazanavir equivalent to 170.854 mg atazanavir sulfate. Atazanavir Capsules 200 mg are off white to pale yellow colored granular powder filled in size "0" hard gelatin capsules with green opaque cap imprinted with "H" in black color and light green opaque body imprinted with "A7'' in black color. Bottles of 60 with child-resistant closure          NDC 31722-654-60 Bottles of 1000 with CT closure                       NDC 31722-654-10 Carton of 100 (10×10) unit-dose capsules       NDC 31722-654-31 200 mg atazanavir equivalent to 227.805 mg atazanavir sulfate. Atazanavir Capsules 300 mg are off white to pale yellow colored granular powder filled in size "00" hard gelatin capsules with orange opaque cap imprinted with "H" in black color and green opaque body imprinted with "A8" in black color. Bottles of 30 with child-resistant closure            NDC 31722-655-30 Bottles of 500 with child-resistant closure          NDC 31722-655-05 Carton of 100 (10×10) unit-dose capsules         NDC 31722-655-31 300 mg atazanavir equivalent to 341.708 mg atazanavir sulfate. Store atazanavir capsules at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ATAZANAVIR - ATAZANAVIR CAPSULE
CAMBER PHARMACEUTICALS, INC.
----------
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 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)
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 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: 150 mg, 200 mg, 300 mg. ( 3,16)
CONTRAINDICATIONS
• Atazanavir capsules are contraindicated in patients with
previously demonstrated hypersensitivity (eg,
Stevens-Johnson syndrome, eryth