Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530 Phone: +27 21 943 4200 Customer Care: 080 222 6662 E-mail: info@cipla.co.za
DALIDUO 50/25 film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Pink coloured, capsule shaped biconvex film-coated tablet debossed with “Cipla” on one side and plain on other side. |
DALIDUO (film-coated tablet): Each tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine and dolutegravir sodium equivalent to 50 mg dolutegravir.
Each tablet contains sugar and sweeteners 145 mg mannitol and 52 mg lactose monohydrate.
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. |
|
| Rilpivirine |
Rilpivirine is a diarylpyrimidine NNRTI of HIV-1. Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ. |
| List of Excipients |
|---|
|
Tablet core List of components of Opadry II pink: Polyvinyl alcohol-part hydrolyzed |
DALIDUO is packed in a 50 cc white round HDPE Bottle consisting of a Silica Gel Bag 2 gm Stripax (Multisorb) R/F and closed with a 33 mm Blue Child Resistant Cap. The HDPE bottle is packed into an outer cardboard carton. Pack sizes are 28 and 30 tablets.
CIPLA MEDPRO (PTY) LTD, Building 9, Parc du Cap, Mispel Street, Bellville, 7530
Phone: +27 21 943 4200
Customer Care: 080 222 6662
E-mail: info@cipla.co.za
Date of first authorisation: 09 November 2021
| Drug | Countries | |
|---|---|---|
| DALIDUO | South Africa |
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