Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Viatris Healthcare (Pty) Ltd, 4 Brewery Street, Isando, Kempton Park, 1600, Republic of South Africa
ACRIPTEGA (film-coated tablets).
| Pharmaceutical Form |
|---|
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White to off white, film-coated, capsule-shaped, biconvex bevelled edge tablet debossed with “M” on one side and “LTD” on the other side of the tablet. |
Each ACRIPTEGA film-coated tablet contains:
Tenofovir disoproxil fumarate 300 mg
Lamivudine 300 mg
Dolutegravir sodium equivalent to dolutegravir 50 mg
Excipients with known effect:
Contains sugar: Lactose monohydrate 136 mg.
ACRIPTEGA contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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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 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. |
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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 |
|---|
|
Croscarmellose sodium {film-coating colourant: Opadry II White: Macrogol/PEG 4000; polyvinyl alcohol – part. hydrolysed; talc; titanium dioxide: Aqua-ll White (A22D10542): polyvinyl alcohol; titanium dioxide, polyethylene glycol, talc}. |
ACRIPTEGA will be packed in a round, blue, opaque High-Density Polyethylene (HDPE) bottle, round wide mouth, blue with blue opaque polypropylene (PP) screw closure and with wad containing aluminium induction sealing liner. Packed in an outer carton.
Pack sizes of 30’s, 84’s, 90’s and 180’s.*
* Not all pack sizes may be marketed
Viatris Healthcare (Pty) Ltd, 4 Brewery Street, Isando, Kempton Park, 1600, Republic of South Africa
52/20.2.8/0199
Date of first authorisation: 31 August 2018
Date of Renewal of authorisation: 25 September 2024
| Drug | Countries | |
|---|---|---|
| ACRIPTEGA | Nigeria, South Africa |
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