REYATAZ- atazanavir capsule, gelatin coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Avera McKennan Hospital

INN (Nome Internazionale):

ATAZANAVIR SULFATE

Composizione:

ATAZANAVIR 150 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

REYATAZ® (atazanavir) capsules are available in the following strengths and configurations of plastic bottles with child-resistant closures. 150 mg capsule    NDC 69189-3624-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital 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) 60 150 mg 200 mg blue/blue BMS 200 mg (white) 3631 (white) 60 200 mg 300 mg red/blue BMS 300 mg (white) 3622 (white) 30 300 mg Store REYATAZ capsules at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. REYATAZ oral powder is an orange-vanilla flavored powder, packed in child-resistant packets. Each packet contains 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. REYATAZ oral powder is supplied in cartons (NDC 0003-3638-10) of 30 packets each. [See Dosage and Administration (2.4).] Store REYATAZ oral powder below 30°C (86°F). Once the REYATAZ oral powder is mixed with food or beverage, it may be kept at room temperature 20°C to 30°C (68°F-86°F) for up to 1 hour prior to administration. Store REYATAZ oral powder in the original packet and do not open until ready to use.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

REYATAZ- ATAZANAVIR CAPSULE, GELATIN COATED
AVERA MCKENNAN HOSPITAL
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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
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Indications and Usage (1) 9/2015
Dosage and Administration,
Overview (2.1) 9/2015
Dosage and Administration of REYATAZ
Oral Powder in Pediatric Patients (2.4) 9/2015
Contraindications (4) 9/2016
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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_Treatment-naive adults:_ REYATAZ 300 mg with ritonavir 100 mg once
daily with food or REYATAZ 400 mg once
daily with food. (2.2)
_Treatment-experienced adults:_ REYATAZ 300 mg with ritonavir 100 mg
once daily with food. (2.2)
_Pediatric patients:_ REYATAZ capsule dosage is based on body weight
not to exceed the adult dose and must be
taken with food. (2.3)
_REYATAZ oral powder:_ Must be taken with ritonavir and food and
should not be used in pediatric patients who weigh
less than 5 kg. (2.4)
_Pregnancy:_ REYATAZ 300 mg with ritonavir 100 mg once daily with
food, with dosing modifications for some
concomitant medications. (2.5)
_Dosing modifications:_ may be required for concomitant therapy (2.2,
2.3, 2.4, 2.5), renal impairment (2.6), and hepatic
impairment (2.7).
Capsules: 150 mg, 200 mg, 300 mg. (3, 16)
Oral powder: 50 mg packet. (3, 16)
REYATAZ is contraindicated in patients with previously demonstrated
hypersensitivity (eg, Stevens-Johnson
syndrome, erythema multiforme, or toxic skin eruptions) to any of the
components of this product. (4)
Coadministration with alfuzosin, triazolam, orally ad