Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Genus Pharmaceuticals Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK
‘Zinamide’ is indicated in patients with active tuberculosis caused by Mycobacterium tuberculosis.
‘Zinamide’ is not active against the atypical mycobacteria. ‘Zinamide’ should only be given in combination with other antituberculous agents.
Adults:
Under 50kg bodyweight: maximum of 3 tablets or 1.5g daily.
50kg and over bodyweight: maximum of 4 tablets or 2g daily.
35mg/kg daily.
Adults:
Under 50kg bodyweight: maximum of 4 tablets or 2g 3 times a week.
50kg and over bodyweight: maximum of 5 tablets or 2.5g 3 times a week.
Children: 50mg/kg 3 times a week.
Zinamide' should be administered with at least one other effective antituberculous drug. The use of ‘Zinamide’ in combination therapy does not modify the accepted dosages of other antituberculous agents.
The general considerations outlined above should also apply to elderly patients.
Multi-resistant M. tuberculosis may be present in immunocompromised patients. The organism should always be cultured to confirm its type and drug sensitivity. Confirmed M. tuberculosis infection sensitive to first-line drugs should be treated with a standard 6 month regimen; after completing treatment, patients should be closely monitored. The regimen may need to be modified if infection is caused by resistant organisms and specialist advice is needed.
In meningeal or pericardial tuberculosis, a corticosteroid should be started at the same time as antituberculosis therapy.
Liver toxicity and hyperuricaemia may occur with overdosage.
The stomach should be emptied by gastric lavage if necessary.
There is no specific antidote. General supportive measures should be employed. Liver function should be monitored closely, and a high-carbohydrate, low-fat diet employed. Care should be taken to avoid exposure of the patient to other potential hepatotoxic agents, including alcohol. Benzodiazepines may be given if there is evidence of central nervous system stimulation.
Probenecid may be given for hyperuricaemia.
The plasma half-life of pyrazinamide is about nine to ten hours.
60 months for bottles.
36 months for blisters.
Store at temperatures below 25°C.
Amber glass bottles or HDPE bottles containing 100 tablets and PVC/Al blister packs containing 30 or 60 tablets.
Not all pack sizes may be marketed.
None.
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