Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Atazanavir capsule is 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 capsules 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 capsules 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 (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see Warnings and Precautions (5.2)]
Atazanavir Capsules, 300 mg are red/blue size ‘00’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘300 mg’ on red cap and ‘T26’ on blue body with white edible ink. NDC: 70518-1365-00 PACKAGING: 30 in 1 BLISTER PACK Keep capsules in a tightly closed container. Store at 20o to 25oC (68o to 77oF) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
ATAZANAVIR SULFATE- ATAZANAVIR CAPSULE REMEDYREPACK 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 capsule 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) 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 capsules 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: 100 mg, 150 mg, 200 mg, and 300 mg. (3, 16) CONTRAINDICATIONS Atazanavir capsules are contraindicated in patients with previously demonstrated hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multifo Baca dokumen lengkapnya