TRIVENZ Film-coated tablet Ref.[115318] Active ingredients: Efavirenz Emtricitabine Tenofovir disoproxil

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

Product name and form

TRIVENZ, 600 mg/200 mg/300 mg, film-coated tablets.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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

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 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 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
Hydroxypropyl cellulose
Magnesium stearate
Microcrystalline cellulose
Sodium lauryl sulphate

Film coating:

Opadry II Pink:

Macrogol/polyethylene glycol (E1521)
Iron oxide black (E172)
Iron oxide red (E172)
Polyvinyl alcohol-part hydrolysed (E1203)
Talc (E553b)
Titanium dioxide (E171)

Pack sizes and marketing

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.

Marketing authorization holder

Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Customer care: 0860 ADCOCK/232625

Marketing authorization dates and numbers

47/20.2.8/0328

19 April 2013

Drugs

Drug Countries
TRIVENZ South Africa

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