ATRIPLA- efavirenz, emtricitabine, and tenofovir disoproxil fumarate tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

EFAVIRENZ (UNII: JE6H2O27P8) (EFAVIRENZ - UNII:JE6H2O27P8), EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S), TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

Disponible depuis:

A-S Medication Solutions

DCI (Dénomination commune internationale):

EFAVIRENZ

Composition:

EFAVIRENZ 600 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

ATRIPLA® is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. ATRIPLA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to efavirenz, a component of ATRIPLA. Coadminstration of ATRIPLA with voriconazole is contraindicated. Efavirenz, a component of ATRIPLA, significantly decreases voriconazole plasma concentrations, and coadministration may decrease the therapeutic effectiveness of voriconazole. Also, voriconazole significantly increases efavirenz plasma concentrations, which may increase the risk of efavirenz-associated side effects. Because ATRIPLA is a fixed-dose combination product, the dose of efavirenz cannot be altered [See Clinical Pharmacology (12.3) Tables 4 and 5]. Pregnancy Category D [See Warnings and Precautions (5.9)] Antiret

Descriptif du produit:

Product: 50090-0980 NDC: 50090-0980-0 30 TABLET, FILM COATED in a BOTTLE, PLASTIC

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

ATRIPLA- EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATRIPLA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ATRIPLA.
ATRIPLA (EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE)
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
WARNING: POSTTREATMENT EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ATRIPLA IS NOT APPROVED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS
(HBV) INFECTION. SEVERE ACUTE
EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS COINFECTED
WITH HBV AND HIV-1 WHO HAVE
DISCONTINUED EMTRIVA OR VIREAD, TWO OF THE COMPONENTS OF ATRIPLA.
HEPATIC FUNCTION SHOULD BE
MONITORED CLOSELY IN THESE PATIENTS. IF APPROPRIATE, INITIATION OF
ANTI-HEPATITIS B THERAPY MAY BE
WARRANTED. (5.1)
RECENT MAJOR CHANGES
Boxed Warning, Lactic Acidosis/Severe Hepatomegaly with Steatosis
Warnings and Precautions, Lactic Acidosis/Severe Hepatomegaly with
Steatosis (5.3)
Warnings and Precautions, Coadministration with Related Products (5.4)
Warnings and Precautions, QTc Prolongation (5.5)
Warnings and Precautions, Psychiatric Symptoms (5.6)
Warnings and Precautions, Fat Redistribution (5.15)
INDICATIONS AND USAGE
ATRIPLA, a combination of 2 nucleoside analog HIV-1 reverse
transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse
transcriptase inhibitor, is indicated for use alone as a complete
regimen or in combination with other antiretroviral agents
for the treatment of HIV-1 infection in adults and pediatric patients
12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
Recommended dose in adults and pediatric patients (12 years of age and
older and weighing at least 40 kg): One tablet
once daily taken orally on an empty stomach, preferably at bedtime.
(2)
Dose in renal impairment: Should not be administered in patients with
estimated creatinine clearance below 50 mL/min.
(2)
Wit