ATAZANAVIR capsule, gelatin coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Greenstone LLC

INN（国際名）:

ATAZANAVIR SULFATE

構図:

ATAZANAVIR 150 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

                                            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].

認証ステータス:

New Drug Application Authorized Generic

製品の特徴

ATAZANAVIR- ATAZANAVIR CAPSULE, GELATIN COATED
GREENSTONE LLC
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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
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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 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