ATENEF Film-coated tablet Ref.[50537] Active ingredients: Efavirenz Emtricitabine Tenofovir disoproxil

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: SONKE PHARMACEUTICALS (PTY) LTD, Ground Floor, Tugela House, Riverside Office Park, 1303 Heuwel Avenue, Centurion

Product name and form

ATENEF.

(efavirenz 600 mg / emtricitabine 200 mg / tenofovir disoproxil fumarate 300 mg).

Film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

White to off-white, capsule shaped, film-coated tablets debossed with ‘RF21’ on one side and plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains:

Efavirenz 600 mg.

Emtricitabine 200 mg.

Tenofovir disoproxil fumarate 300 mg equivalent to Tenofovir disoproxil 245 mg.

Sugar free.

For 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:

Microcrystalline cellulose
Croscarmellose sodium
Iron oxide red
Magnesium stearate
Hydroxypropyl cellulose
Sodium lauryl sulfate

Film coat:

Polyvinyl Alcohol – Part. hydrolysed
Titanium Dioxide
Macrogol/PEG 3350
Talc

Pack sizes and marketing

28, 30, 84 or 90 Tablets packed in a white opaque HDPE bottle. The HDPE bottle is packed with or without an outer cardboard carton.

HDPE bottle pack for 28 and 30: The HDPE bottle is a white, opaque 100 ml HDPE bottle with a white polypropylene, round cylindrical 38 mm cap with a heat seal liner.

HDPE bottle pack for 84 and 90: The HDPE bottle is a white, opaque 250 ml HDPE bottle with a white polypropylene, round cylindrical 38 mm cap with a heat seal liner.

The cap is a white polypropylene, round cylindrical cap with a heat seal liner and printed with “SEALED for YOUR PROTECTION” in black. The bottle also contains a desiccant.

Marketing authorization holder

SONKE PHARMACEUTICALS (PTY) LTD, Ground Floor, Tugela House, Riverside Office Park, 1303 Heuwel Avenue, Centurion

Marketing authorization dates and numbers

47/20.2.8/0483

05 June 2014

Drugs

Drug Countries
ATENEF South Africa

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