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
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. |
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 |
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Tablet core: Microcrystalline cellulose Film coat: Polyvinyl Alcohol – Part. hydrolysed |
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.
SONKE PHARMACEUTICALS (PTY) LTD, Ground Floor, Tugela House, Riverside Office Park, 1303 Heuwel Avenue, Centurion
47/20.2.8/0483
05 June 2014
Drug | Countries | |
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ATENEF | South Africa |
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