Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)
REMEDYREPACK INC.
ATAZANAVIR SULFATE
ATAZANAVIR 200 mg
ORAL
PRESCRIPTION DRUG
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 not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - Use of REYATAZ/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)] . REYATAZ is contraindicated:REYATAZ is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of REYATAZ capsules or REYATAZ oral powder [see Warnings and Precautions (5.2)] . - when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or lif
REYATAZ ® (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 0003-3624-12 200 mg blue/blue BMS 200 mg (white) 3631 (white) 60 0003-3631-12 300 mg red/blue BMS 300 mg (white) 3622 (white) 30 0003-3622-12 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 (2.5) .] 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.
New Drug Application
REYATAZ- ATAZANAVIR CAPSULE, GELATIN COATED REMEDYREPACK INC. ---------- 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) 3/2018 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 _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 medications. (2.6) _Dosing modifications:_ may be required for concomitant therapy (2.3, 2.4, 2.5, 2.6), renal impairment (2.7), and hepatic impa Lesen Sie das vollständige Dokument