Cycloserine

Preview FDA label, Dr. Reddys Laboratories, Inc., oral, effective 2024-07-30. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

Severe renal insufficiency 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. Patients should be monitored by hematologic, renal excretion, blood level, and liver function studies.

Drug interactions

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Label text (1 paragraph)

Drug Interactions: Concurrent administration of ethionamide has been reported to potentiate neurotoxic side effects. Alcohol and cycloserine are incompatible, especially during a regimen calling for large doses of the latter. Alcohol increases the possibility and risk of epileptic episodes. Concurrent administration of isoniazid may result in increased incidence of CNS effects, such as dizziness or drowsiness. Dosage adjustments may be necessary and patients should be monitored closely for signs of CNS toxicity.

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

Pregnancy and lactation

Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies with the use of Cycloserine in pregnant women. A study in 2 generations of rats given doses up to 100 mg/kg/day (approximately equivalent to the maximum recommended human dose on a body surface area basis) demonstrated no teratogenic effect in offspring. Cycloserine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation

Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from cycloserine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Usage in Pediatric Patients: Safety and effectiveness in pediatric patients have not been established.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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