Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Pharma Dynamics (Pty) Ltd, 1<sup>st</sup> Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa
RISOPET film coated tablets.
| Pharmaceutical Form |
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Film coated tablets. Brown coloured, capsule shaped film coated tablets with a break line on one side and plain on the other side. |
Each film coated tablet contains: 150 mg of rifampicin, 75 mg of isoniazid, 400 mg of pyrazinamide and 275 mg of ethambutol hydrochloride.
Contains ascorbic acid as an anti-oxidant.
RISOPET tablets are sugar free.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Ethambutol is bacteriostatic. It is effective against Mycobacterium tuberculosi and M.bovis with an MIC of 0.5–8µg per ml. The exact mechanism of action is unknown. While it has activity against some atypical mycobacteria including M.Kansasii, activity against other micro-organisms has not yet been reported. |
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Isoniazid is used mainly in the treatment of pulmonary tuberculosis but it appears to be effective also in the treatment of extrapulmonary lesions, including meningitis and genito-urinary disease. |
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Pyrazinamide exhibits tuberculostatic activity. Pyrazinamide is active only at an acid pH, and it is therefore active mainly on the tubercle bacilli located within the cell. |
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Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing extracellular organisms and also has bactericidial activity intracellularly. Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. |
| List of Excipients |
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Tablet cores: Ascorbic acid Film coating: Iron oxide red |
Amber PVC/ACLAR & ALU/ALU blister packs of 28, 56, 84 and 112 tablets, packed into an outer cardboard carton.
Pharma Dynamics (Pty) Ltd, 1st Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa
A42/20.2.3/0890
Date of registration: 20 June 2013
| Drug | Countries | |
|---|---|---|
| RISOPET | South Africa |
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