Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)
Greenstone LLC
ATAZANAVIR SULFATE
ATAZANAVIR 150 mg
ORAL
PRESCRIPTION DRUG
Atazanavir is 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 is contraindicated: Table 6 displays drugs that are contraindicated with atazanavir. Drug Class Drugs within class that are contraindicated with atazanavir Clinical Comment Alpha 1-Adrenoreceptor Antagonist Alfuzosin Potential for increased alfuzosin concentrations, which can result in hypotension. Antimycobacterials Rifampin Rifampin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect and development of resistance. Antineoplastics Irinotecan Atazanavir inhibits UGT1A1 and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities. Antipsychotics Lurasidone Potential for serious and/or life-threatening reactions if atazanavir is coadministered with ritonavir. Pimozide Potential for serious and/or life-threatening reactions such
Atazanavir Capsules Atazanavir capsules are available in the following strengths and configurations of plastic bottles with child-resistant closures. Product Strength* Capsule Shell Color (cap/body) Markings on Capsule (ink color) Capsules per Bottle NDC Number cap body 150 mg blue/powder blue BMS 150 mg (white) 3624 (blue) 60 59762-0408-6 200 mg blue/blue BMS 200 mg (white) 3631 (white) 60 59762-0409-6 300 mg red/blue BMS 300 mg (white) 3622 (white) 30 59762-0410-3 Store atazanavir capsules at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
New Drug Application Authorized Generic
ATAZANAVIR- ATAZANAVIR CAPSULE, GELATIN COATED GREENSTONE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ATAZANAVIR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATAZANAVIR. ATAZANAVIR CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2003 RECENT MAJOR CHANGES Dosage and Administration, Testing Prior to Initiation and During Treatment with Atazanavir (2.2) 10/2017 Dosage of Atazanavir Capsules in Pediatric Patients (2.4) 5/2017 Dosage and Administration of Atazanavir (REYATAZ) Oral Powder in Pediatric Patients (2.5) 5/2017 Contraindications (4) 3/2018 Warnings and Precautions Chronic Kidney Disease (5.5) 10/2017 INDICATIONS AND USAGE Atazanavir is 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) DOSAGE AND ADMINISTRATION • • • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • _Pretreatment testing:_ Renal laboratory testing should be performed in all patients prior to initiation of atazanavir and continued during treatment with atazanavir. Hepatic testing should be performed in patients with underlying liver disease prior to initiation of atazanavir and continued during treatment with atazanavir. (2.2) _Treatment-naive adults:_ atazanavir 300 mg with ritonavir 100 mg once daily with food or atazanavir 400 mg once daily with food. (2.3) _Treatment-experienced adults:_ atazanavir 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) _Atazanavir (REYATAZ) oral powder:_ Must be taken with ritonavir and food and should not be used in pediatric patients who weigh less than 5 kg. (2.5) _Pregnancy:_ atazanavir 300 mg with ritonavir 100 mg once daily with food, with dosing modifications for som Lesen Sie das vollständige Dokument