Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: Innovata Pharmaceuticals (Pty) LTD, 100 Northern Parkway Rd, Crownwood Office, Block D, Ground Floor, Ormonde, 2091
DUROBAC (TABLETS).
DUROBAC DOUBLE STRENGTH (TABLETS).
| Pharmaceutical Form |
|---|
|
DUROBAC: Flat, white bisected tablets with bevelled edges. DUROBAC DOUBLE STRENGTH: White, oblong, biconvex, bisected tablets. |
Each DUROBAC tablet contains: 80 mg Trimethoprim and 400 mg Sulphamethoxazole.
Each DUROBAC DOUBLE STRENGTH tablet contains: 160 mg Trimethoprim and 800 mg Sulphamethoxazole.
Sugar free.
Contains preservative: Nipastat 0.15 mg.
| Active Ingredient | Description | |
|---|---|---|
| Sulfamethoxazole |
Sulfamethoxazole competitively inhibits the utilisation of para-aminobenzoic acid in the synthesis of dihydrofolate by the bacterial cell resulting in bacteriostasis. |
|
| Trimethoprim |
Trimethoprim is a dihydrofolate reductase inhibitor, inhibiting the conversion of bacterial dihydrofolic acid to tetrahydrofolic acid, required for the synthesis of some amino acids. Its effects are considerably greater on the cells of micro-organisms than on the mammalian cells. |
| List of Excipients |
|---|
|
Hydrogenated vegetable oil |
DUROBAC: 28 or 56 tablets packed in a L.D.P.E “ziploc” plastic patient ready packs and 100, 500 or 1000 tablets packed in HDPE containers.
DUROBAC DOUBLE STRENGTH: 30 or 100 tablets packed in white securitainers and 1000 tablets packed in HDPE containers.
Innovata Pharmaceuticals (Pty) LTD, 100 Northern Parkway Rd, Crownwood Office, Block D, Ground Floor, Ormonde, 2091
DUROBAC: J/20.2/279
DUROBAC DOUBLE STRENGTH: P/20.2/55
Date of first authorization: November 1993
| Drug | Countries | |
|---|---|---|
| DUROBAC | South Africa |
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