DRUG INTERACTIONS
Carcinogenesis
Long-term studies have been conducted in rats with doses as high as 150 mg/kg/day for eighteen months. There was no significant difference in the incidence of any neoplasm between treated and control animals.
Mutagenesis
Data are not available concerning long-term effects on mutagenicity in animals or humans.
Impairment of Fertility
The results of studies in which rats were given 18.75 and 37.5 mg/kg/day indicated that pemoline did not affect fertility in males or females at those doses.
Pregnancy
Teratogenic Effects
Pregnancy Category B
Reproduction studies have been performed in rats and rabbits at doses of 18.75 and 37.5 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
|
OVERDOSAGE
Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, hypertension and mydriasis. Consult with a Certified Poison Control Center regarding treatment for up to date guidance and advice. Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Chlorpromazine has been reported in the literature to be useful in decreasing CNS stimulation and sympathomimetic effects.
Efficacy of peritoneal dialysis or extracorporeal hemodialysis for CYLERT overdosage has not beenestablished.
|
