Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA
REYDIN (Film-coated tablets).
| Pharmaceutical Form |
|---|
|
Blue coloured, capsule shaped biconvex film coated tablet, debossed with ‘C’ on one side and plain on other side. |
Each REYDIN film-coated tablet contains:
Lamivudine 300 mg.
Tenofovir disoproxil 300 mg (equivalent to tenofovir disoproxil fumarate).
Dolutegravir 50 mg (as dolutegravir sodium).
Excipients: croscarmellose sodium, hydroxypropyl methyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, opadry blue (containing polyvinyl alcohol, talc, titanium dioxide, indigo carmine, glycerol esters of fatty acids, sodium lauryl sulfate, brilliant blue aluminum lake), povidone, sodium starch glycolate.
Contains sugar: Mannitol 145 mg.
For full list of excipients, see section 6.1.
| 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 |
|---|
|
Croscarmellose sodium |
Containers of 28’s: REYDIN is packed in a 85 cc white HDPE bottle with 38 mm Non Child Resistant Cap containing 28 tablets and two silica gel bags of 2 g each, packed in a cardboard carton.
Containers of 30’s: REYDIN is packed in a 85 cc white HDPE bottle with 38 mm Non Child Resistant Cap containing 30 tablets and two silica gel bags of 2 g each, packed in a cardboard carton.
CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530, RSA
REYDIN: 52/20.2.8/0451.450
31 August 2018
| Drug | Countries | |
|---|---|---|
| REYDIN | South Africa |
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