Source: Health Products Regulatory Authority (ZA) Revision Year: 2018 Publisher: Aurobindo Pharma (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
VOLUTRIP (tablet).
| Pharmaceutical Form |
|---|
|
Pink coloured, oval, biconvex, film-coated tablet debossed with ‘N33’ on one side and plain on the other side. |
Each VOLUTRIP tablet contains dolutegravir sodium equivalent to 50 mg of dolutegravir, lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg which is equivalent to 245 mg of tenofovir disoproxil.
Contains sugar: 145,37 mg mannitol.
| Active Ingredient | Description | |
|---|---|---|
| Dolutegravir |
Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. |
|
| Lamivudine |
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription. |
|
| 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 |
|---|
|
The other ingredients of VOLUTRIP are colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose, opadry II pink 85F94172, povidone, sodium starch glycolate and sodium stearyl fumarate. In addition opadry II pink 85F94172 contains iron oxide red (C.I. No: 77491), oxide black (C.I. No: 77499), polyethylene glycol, talc and titanium dioxide (C.I. No: 77891). |
Tablets are packed in white opaque round 100 mL HDPE container with 38 mm neck finish closed with white opaque polypropylene 38 mm – 400 child resistant closure with wad having induction sealing liner. The HDPE container also contains 3 g of silica gel sachet.
Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
Aurobindo Pharma (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
52/20.2.8/0212.210
| Drug | Countries | |
|---|---|---|
| VOLUTRIP | South Africa |
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