Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: King Pharmaceuticals Ltd, Donegal Street, Ballybofey, County Donegal, Ireland
Cycloserine inhibits cell wall synthesis in susceptible strains of Gram-positive and Gram-negative bacteria and in Mycobacterium tuberculosis.
Cycloserine is indicated in the treatment of active pulmonary and extra-pulmonary tuberculosis (including renal disease) when the organisms are susceptible to this drug and after failure of adequate treatment with the primary medications (streptomycin, isoniazid, rifampicin and ethambutol). Like all anti-tuberculous drugs, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent.
Cycloserine may be effective in the treatment of acute urinary tract infections caused by susceptible strains of Gram-positive and Gram-negative bacteria, especially Klebsiella/Enterobacter species and Escherichia coli. It is generally no more and may be less effective than other antimicrobial agents in the treatment of urinary tract infections caused by bacteria other than mycobacteria. Use of cycloserine in these infections should be considered only when the more conventional therapy has failed and when the organism has been demonstrated to be sensitive to the drug.
The usual dosage is 500 mg to 1 g daily in divided doses, monitored by blood level determinations. The initial adult dosage most frequently given is 250 mg twice daily at 12-hour intervals for the first two weeks. A daily dosage of 1g should not be exceeded.
As for adults but reduce dosage if renal function is impaired.
The usual starting dose is 10 mg/kg/day, then adjusted according to blood levels obtained and therapeutic response.
For oral administration.
Acute toxicity can occur if more than 1 g is ingested by an adult. Chronic toxicity is dose related and can occur if more than 500 mg is administered daily. For patients with renal impairment see ‘Contra-indications’ and ‘Warnings’. Toxicity commonly affects the central nervous system. Effects may include headache, vertigo, confusion, drowsiness, hyper-irritability, paraesthesias, dysarthria and psychosis. Following larger ingestions, paresis, convulsions and coma often occur. Ethanol may increase the risk of seizures.
Symptomatic and supportive therapy is recommended. Activated charcoal may be more effective in reducing absorption than emesis or lavage. In adults, many neurotoxic effects can be both treated and prevented with 200 300 mg of pyridoxine daily. Haemodialysis removes cycloserine from the bloodstream but should be reserved for life-threatening toxicity.
Shelf life: 2 years.
Store below 25°C. Keep the bottle tightly closed in order to protect from moisture.
Cycloserine capsules are red and grey.
HDPE bottles of 100 capsules fitted with a child resistant, HDPE/polypropylene cap with an induction heat sealed liner. 1 desiccant disc (HDPE canister containing 3g silica gel) is included in each bottle.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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