Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Customer care: 0860 ADCOCK/232625
TRIVENZ, 600 mg/200 mg/300 mg, film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablets. TRIVENZ is a pink coloured, capsule shaped, film-coated tablet debossed with "H" on one side and "128" on the other side. |
Each film-coated tablet of TRIVENZ contains:
Efavirenz 600 mg
Emtricitabine 200 mg
Tenofovir disoproxil fumarate 300 mg
Sugar free.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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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). |
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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. |
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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: Croscarmellose sodium Film coating: Opadry II Pink: Macrogol/polyethylene glycol (E1521) |
TRIVENZ is packed as 28's, 30's, 60's, 84's, 90's, 120's, 180's and 500's in white opaque, heavy weight high density polyethylene (HDPE) bottles with child-resistant closures and a silica gel desiccant sachet.
Not all packs sizes may be marketed.
Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Customer care: 0860 ADCOCK/232625
47/20.2.8/0328
19 April 2013
| Drug | Countries | |
|---|---|---|
| TRIVENZ | South Africa |
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