Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)
Golden State Medical Supply Inc.
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
ATAZANAVIR SULFATE- ATAZANAVIR SULFATE CAPSULE GOLDEN STATE MEDICAL SUPPLY INC. ---------- 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), Izlasiet visu dokumentu