ATAZANAVIR SULFATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Atazanavir sulfate capsules are 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 is 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 sulfate 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 sulfate capsules [see Warnings and Precautions ( 5.2)] . - wh

Product summary:

Atazanavir sulfate capsules are available as: 150 mg – capsules with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted “5526” on the body and “TEVA” on the cap, in bottles of 60 (NDC 51407-171-60). (DISCONTINUED) 200 mg – capsules with light-turquoise body and light-turquoise cap, imprinted “93” over “5527” on both the cap and the body, in bottles of 60 (NDC 51407-172-60). 300 mg – capsules with light-blue-opaque body and red-opaque cap, imprinted “93” over “5528” on both the cap and the body, in bottles of 30 (NDC 51407-173-30). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ATAZANAVIR SULFATE- ATAZANAVIR SULFATE CAPSULE
GOLDEN STATE MEDICAL SUPPLY INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ATAZANAVIR SULFATE CAPSULES
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATAZANAVIR SULFATE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ATAZANAVIR SULFATE
CAPSULES.
ATAZANAVIR SULFATE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration,
Testing Prior to Initiation and During Treatment with Atazanavir
Sulfate Capsules ( 2.2)
10/2017
Dosage of Atazanavir Sulfate 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 sulfate capsules are 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 sulfate capsules and continued during treatment with
atazanavir sulfate capsules. Hepatic
testing should be performed in patients with underlying liver disease
prior to initiation of atazanavir
sulfate capsules and continued during treatment with atazanavir
sulfate capsules. ( 2.2)
_Treatment-naive adults:_ Atazanavir sulfate 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 sulfate capsules 300 mg
with ritonavir 100 mg once daily
with food. ( 2.3)
_Pediatric patients:_ Atazanavir sulfate capsule dosage is based on
body weight not to exceed the adult
dose and must be taken with food. ( 2.4)
_Pregnancy:_ Atazanavir sulfate 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),