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SEROMYCIN (CYCLOSERINE): WARNINGS
CNS effects of Seromycin (Cycloserine) capsules are the most frequent adverse effects. Drowsiness, dizziness, somnolence, headache, depression, lethargy, tremor, hyperreflexia, dysarthria, paresthesia, anxiety, nervousness, vertigo, confusion and disorientation (with loss of memory), major and minor clonic seizures, paresis, seizures, and coma have been reported. Psychosis (possibly with suicidal tendencies), personality changes, hyperirritability, and aggression have also occurred.
Increased risk of seizures in chronic alcoholics.
Adverse CNS effects of Seromycin (Cycloserine) capsules 250 mg appear to be dose related and occur within the first 2 weeks of therapy in about 30% of those receiving 500 mg daily. Determine plasma concentrations at least once weekly in patients receiving > 500 mg daily, in patients with reduced renal function, and in those with signs or symptoms of toxicity. Adverse nervous system effects are minimized when plasma cycloserine concentrations are < 30 mcg/mL.
Some experts recommend that neuropsychiatric status be assessed at least once monthly and more frequently if symptoms develop. Patients with renal impairment should be closely monitored for evidence of neurotoxicity.
If symptoms of CNS toxicity (e.g., psychosis, seizures, somnolence, confusion, depression, hyperreflexia, tremor, headache, vertigo, dysarthria, paresis) occur, reduce dosage or discontinue cycloserine. Symptoms generally disappear when the drug is discontinued.
Sedatives may be effective in controlling anxiety or tremor; anticonvulsants may control seizures.
Value of pyridoxine in preventing cycloserine-associated CNS toxicity has not been proven. Neurotoxic effects may be relieved or prevented by concomitant administration of pyridoxine hydrochloride (100–300 mg daily).
Rash and allergic reactions reported for Cycloserine (Seromycin). Photosensitivity has occurred.
If allergic dermatitis occurs, reduce dosage or discontinue cycloserine.
Carcinogenesis, Mutagenicity, and Impairment of Fertility
Studies have not been performed to determine potential for carcinogenicity. The Ames test and unscheduled DNA repair test were negative. A study in 2 generations of rats showed no impairment of fertility relative to controls for the first mating but somewhat lower fertility in the second mating.
Seromycin (Cycloserine) related pharmaceutical drugs and medications
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