EVOTAZ- atazanavir and cobicistat tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S), COBICISTAT (UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG)

Fáanlegur frá:

A-S Medication Solutions

INN (Alþjóðlegt nafn):

ATAZANAVIR SULFATE

Samsetning:

ATAZANAVIR 300 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Product: 50090-1724 NDC: 50090-1724-0 30 TABLET in a BOTTLE

Leyfisstaða:

New Drug Application

Vara einkenni

EVOTAZ- ATAZANAVIR AND COBICISTAT TABLET
A-S MEDICATION SOLUTIONS
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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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
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