Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S), COBICISTAT (UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG)
A-S Medication Solutions
ATAZANAVIR SULFATE
ATAZANAVIR 300 mg
ORAL
PRESCRIPTION DRUG
EVOTAZ® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults. Limitations of Use: EVOTAZ is contraindicated: Table 1 displays drugs that are contraindicated with EVOTAZ. Alpha 1-Adrenoreceptor Antagonist Alfuzosin Potential for increased alfuzosin concentrations, which can result in hypotension. Antianginal Ranolazine Potential for serious and/or life-threatening reactions. Antiarrhythmics Dronedarone Potential for increased dronedarone concentrations. Anticonvulsants Carbamazepine, phenobarbital, phenytoin Potential for decreased atazanavir plasma concentrations, which may result in loss of therapeutic effect and development of resistance. Antigout Colchicine Contraindicated in patients with renal and/or hepatic impairment due to the potential for serious and/or life-threatening reactions. Antimycobacterials Rifampin Rifampin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeut
Product: 50090-1724 NDC: 50090-1724-0 30 TABLET in a BOTTLE
New Drug Application
EVOTAZ- ATAZANAVIR AND COBICISTAT TABLET A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EVOTAZ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVOTAZ. EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET, FOR ORAL USE INITIAL U.S. APPROVAL: 2015 RECENT MAJOR CHANGES Dosage and Administration Laboratory Testing Prior to Initiation and During Treatment with EVOTAZ (2.1) 1/2017 Dosage in Patients with Renal Impairment (2.3) 1/2017 Not Recommended in Patients with Any Degree of Hepatic Impairment (2.4) 1/2017 Contraindications (4) 1/2017 Warnings and Precautions New Onset or Worsening Renal Impairment When Used with Tenofovir DF (5.4) 1/2017 INDICATIONS AND USAGE EVOTAZ is a two-drug combination of atazanavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1) _Limitations of Use_ Use of EVOTAZ in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions. (1) DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • ® Recommended dosage in adults: One tablet once daily, taken orally with food. (2.1) _Renal impairment:_ EVOTAZ is not recommended for use in treatment-experienced patients with end-stage renal disease managed with hemodialysis. (2.3,8.6) _Hepatic impairment:_ EVOTAZ is not recommended in patients with any degree of hepatic impairment. (2.4,8.7) Tablets: 300 mg of atazanavir and 150 mg of cobicistat. (3) EVOTAZ is contraindicated in patients with previously demonstrated hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. (4) Coadministration with certain drugs for which altered plasma concentrations are associated with serio Прочетете целия документ