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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

EFAVIRENZ

Composition:

EFAVIRENZ 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ATRIPLA ® is indicated as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. - 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 [see Warnings and Precautions (5.2)] . - ATRIPLA is contraindicated to be coadministered with voriconazole or elbasvir/grazoprevir [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)]. Antiretroviral Pregnancy Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in adults and adolescents exposed to ATRIPLA during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at (8

Product summary:

ATRIPLA tablets are pink, capsule shaped, film coated, debossed with "123" on one side and plain faced on the other side. NDC: 70518-0341-00 PACKAGING: 30 in 1 BLISTER PACK Store at 25 °C (77 °F); excursions permitted to 15–30 °C (59–86 °F) [See USP Controlled Room Temperature]. Keep container tightly closed. Dispense only in original container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

New Drug Application

Summary of Product characteristics

ATRIPLA- EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
TABLET,
FILM COATED
REMEDYREPACK INC.
----------
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, AND TENOFOVIR DISOPROXIL FUMARATE)
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B VIRUS (HBV) HAVE BEEN
REPORTED IN PATIENTS
COINFECTED WITH HBV AND HIV-1 WHO HAVE DISCONTINUED PRODUCTS
CONTAINING
EMTRICITABINE (FTC) AND/OR TENOFOVIR DISOPROXIL FUMARATE (TDF), AND
MAY OCCUR WITH
DISCONTINUATION OF ATRIPLA. CLOSELY MONITOR HEPATIC FUNCTION WITH BOTH
CLINICAL AND
LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO ARE
COINFECTED WITH
HIV-1 AND HBV AND DISCONTINUE ATRIPLA. IF APPROPRIATE, INITIATION OF
ANTI-HEPATITIS B
THERAPY MAY BE WARRANTED. ( 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions
Nervous System Symptoms ( 5.6)
10/2019
Immune Reconstitution Syndrome ( 5.12)
10/2019
INDICATIONS AND USAGE
ATRIPLA is a three-drug combination of efavirenz (EFV), a
non-nucleoside reverse transcriptase inhibitor,
and emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both
HIV-1 nucleoside analog reverse
transcriptase inhibitors, and is indicated as a complete regimen or in
combination with other antiretroviral
agents for the treatment of HIV-1 infection in adults and pediatric
patients weighing at least 40 kg. ( 1)
DOSAGE AND ADMINISTRATION
Testing: Consult Full Prescribing Information for important testing
recommendations prior to initiation
and during treatment with ATRIPLA. ( 2.1)
Recommended dosage in adults and pediatric patients weighing at least
40 kg: One tablet once daily
taken orally on an empty stomach, preferably at bedtime. ( 2.2)
Renal impairment: Not recommended in patients with estimated
creati