ATRIPLA Film-coated tablet Ref.[27854] Active ingredients: Efavirenz Emtricitabine Tenofovir disoproxil

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Product name and form

Atripla 600 mg/200 mg/245 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Pink, capsule-shaped, film-coated tablet, of dimensions 20 mm x 10.4 mm, debossed with “123” on one side, plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as fumarate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Efavirenz

Efavirenz is a NNRTI of HIV-1. Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).

Emtricitabine

Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2 and HBV. Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination. Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.

Tenofovir disoproxil

Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.

List of Excipients

Tablet core:

Croscarmellose sodium
Hyprolose
Magnesium stearate (E572)
Microcrystalline cellulose (E460)
Sodium laurilsulfate

Film-coating:

Iron oxide black
Iron oxide red
Macrogol 3350
Poly(vinyl alcohol)
Talc
Titanium dioxide (E171)

Pack sizes and marketing

High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and silica gel desiccant.

The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Marketing authorization dates and numbers

EU/1/07/430/001
EU/1/07/430/002

Date of first authorisation: 13 December 2007
Date of latest renewal: 17 September 2012

Drugs

Drug Countries
ATRIPLA Austria, Canada, Cyprus, Germany, Estonia, Spain, France, Hong Kong, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.