ATAZANAVIR SULFATE- atazanavir capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Major Pharmaceuticals

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Atazanavir capsule  is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir capsules are contraindicated: Table 6 displays drugs that are contraindicated with atazanavir capsules.   Drug Class Drugs within class that are contraindicated with atazanavir capsules 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 capsules are coadministered with ritonavir.   Pimozide Potenti

Product samenvatting:

Atazanavir Capsules, 300 mg are red/blue size ‘00’ hard gelatin capsule filled with off-white to pale yellow granular powder and imprinted with ‘300 mg’ on red cap and ‘T26’ on blue body with white edible ink. Carton of 30 capsules (10 capsules per blister pack x 3), NDC 0904-6875-04 Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ATAZANAVIR SULFATE- ATAZANAVIR CAPSULE
MAJOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATAZANAVIR CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ATAZANAVIR CAPSULES.
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 Capsules (2.2) 10/2017
Dosage of Atazanavir Capsules in Pediatric Patients (2.4) 5/2017
Contraindications (4) 3/2018
Warnings and Precautions
Chronic Kidney Disease (5.5) 10/2017
INDICATIONS AND USAGE
Atazanavir capsule is a protease inhibitor indicated for use in
combination with other antiretroviral agents
for the treatment of HIV-1 infection for patients 6 years and older
weighing at least 15 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 capsules and continued during treatment with atazanavir
capsules. Hepatic testing should
be performed in patients with underlying liver disease prior to
initiation of atazanavir capsules and
continued during treatment with atazanavir capsules. (2.2) _ _
_Treatment-naive adults:_ Atazanavir capsules 300 mg with ritonavir
100 mg once daily with food or
atazanavir capsules 400 mg once daily with food. (2.3)
_Treatment-experienced adults:_ Atazanavir capsules 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)
_Pregnancy:_ Atazanavir capsules 300 mg with ritonavir 100 mg once
daily with food, with dosing
modifications for some concomitant medications. (2.6)
_Dosing modifications: _may be required for concomitant therapy (2.3,
2.4, 2.6), renal impairment