REYATAZ- atazanavir capsule, gelatin coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)

Tilgængelig fra:

A-S Medication Solutions

INN (International Name):

ATAZANAVIR SULFATE

Sammensætning:

ATAZANAVIR 300 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

REYATAZ® (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: REYATAZ is contraindicated: Table 6 displays drugs that are contraindicated with REYATAZ. Drug Class Drugs within class that are contraindicated with REYATAZ 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 REYATAZ is coadministered with ritonavir. Pimozide Potential for serious and/or life-threatening reactions such

Produkt oversigt:

Product: 50090-1007 NDC: 50090-1007-0 30 CAPSULE, GELATIN COATED in a BOTTLE, PLASTIC Product: 50090-1581 NDC: 50090-1581-0 60 CAPSULE, GELATIN COATED in a BOTTLE, PLASTIC

Autorisation status:

New Drug Application

Produktets egenskaber

REYATAZ- ATAZANAVIR CAPSULE, GELATIN COATED
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REYATAZ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR REYATAZ.
REYATAZ (ATAZANAVIR) CAPSULES, FOR ORAL USE
REYATAZ (ATAZANAVIR) ORAL POWDER
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration,
Testing Prior to Initiation and During Treatment with REYATAZ (2.2)
10/2017
Dosage of REYATAZ Capsules in Pediatric Patients (2.4) 5/2017
Dosage and Administration of REYATAZ Oral Powder in Pediatric Patients
(2.5) 5/2017
Contraindications (4) 10/2017
Warnings and Precautions
Chronic Kidney Disease (5.5) 10/2017
INDICATIONS AND USAGE
REYATAZ 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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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_Pretreatment testing:_ Renal laboratory testing should be performed
in all patients prior to initiation of REYATAZ and
continued during treatment with REYATAZ. Hepatic testing should be
performed in patients with underlying liver
disease prior to initiation of REYATAZ and continued during treatment
with REYATAZ. (2.2)
_Treatment-naive adults:_ REYATAZ 300 mg with ritonavir 100 mg once
daily with food or REYATAZ 400 mg once
daily with food. (2.3)
_Treatment-experienced adults:_ REYATAZ 300 mg with ritonavir 100 mg
once daily with food. (2.3)
_Pediatric patients:_ REYATAZ capsule dosage is based on body weight
not to exceed the adult dose and must be
taken with food. (2.4)
_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:_ REYATAZ 300 mg with ritonavir 100 mg once daily with
food, with dosing modifications for some
concomitant m