Cycloserine

Indications

INDICATIONS AND USAGE Cycloserine is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis 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. Use of cycloserine in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Cycloserine is effective orally and is currently administered only by this route. The usual dosage is 500 mg to 1 g daily in divided doses monitored by blood levels. 1 The initial adult dosage most frequently given is 250 mg twice daily at 12-hour intervals for the first 2 weeks. A daily dosage of 1 g should not be exceeded.

Contraindications

CONTRAINDICATIONS Administration is contraindicated in patients with any of the following: • Hypersensitivity to cycloserine • Epilepsy • Depression, severe anxiety, or psychosis • Severe renal insufficiency • Excessive concurrent use of alcoho

Warnings and precautions

WARNINGS Administration of cycloserine should be discontinued or the dosage reduced if the patient develops allergic dermatitis or symptoms of CNS toxicity, such as convulsions, psychosis, somnolence, depression, confusion, hyperreflexia, headache, tremor, vertigo paresis, or dysarthria. The toxicity of cycloserine is closely related to excessive blood levels (above 30 mcg/mL), as determined by high dosage or inadequate renal clearance. The ratio of toxic dose to effective dose in tuberculosis is small. The risk of convulsions is increased in chronic alcoholics.

Storage and supply

HOW SUPPLIED Cycloserine is available as a 250 mg capsule with an opaque red cap and opaque gray body imprinted with “PGC” and “F04” in edible black ink on both the cap and the body. Cycloserine Capsules, USP are supplied in cartons of 3 cards. Each card is a ten-capsules blister card as follows: NDC 43598-235-31: carton with 3 cards.

Source: Cycloserine (Cycloserine) — US FDA prescribing information, 2024-07-30, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.