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Since CYLERT (pemoline) 's marketing in 1975, 13 cases of acute hepatic failure have been reported to the FDA. While the absolute number of reported cases is not large. the rate of reporting ranges from 4 to 17 times the rate expected in the general population. This estimate may be conservative because of under reporting and because the long latency between initiation of CYLERT (pemoline) treatment and the occurrence of hepatic failure may limit recognition of the association. If only a por-tion of actual cases were recognized and reported, the risk could be substantially higher.
Of the 13 cases reported as of May 1996, 11 resulted in death or liver transplantation, usually within four weeks of the onset of signs and symptoms of liver failure. The ear-liest onset of hepatic abnormalities occurred six months after initiation of CYLERT (pemoline) . Although some reports described dark urine and nonspecific prodromal symptoms (e.g., anorexia, malaise, and gastrointestinal symp-toms), in other reports it was not clear if any prodromal symptoms preceded the onset of jaundice. It is also not clear if the recom-mended baseline and periodic liver function testing are predictive of these instances of acute liver failure. CYLERT (pemoline) should be dis-continued if clinically significant hepatic dysfunction is observed during its use (see PRECAUTIONS).
Decrements in the predicted growth (i.e., weight gain and/or height) rate have been reported with the long- term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored.
Clinical experience suggests that in psychotic children administration of CYLERT (pemoline) may exacerbate symptoms of behavior disturbance and thought disorder.
CYLERT (pemoline) should be administered with caution to patients with significantly impaired renal function.
Since CYLERT (pemoline) 's market introduction. there have been reports of elevated liver enzymes associated with its use. Many of these patients had this increase detected several months after starting CYLERT (pemoline) . Most patients were asymptomatic, with the increase in liver enzymes returning to normal after CYLERT (pemoline) was discontinued. Liver function tests should be performed prior to and periodically during therapy with CYLERT (pemoline) . Treatment with CYLERT (pemoline) should be initiated only in individual without liver disease and with normal baseline liver function tests.
The relationship, if any, between reversible elevations in liver function tests and the occurrence of life threatening hepatic failure in patients on long-term therapy with CYLERT (pemoline) is not known. Liver function testing may not predict the onset of acute liver failure. Nonetheless, CYLERT (pemoline) should be discontinued if clinically significant liver function test abnormalities are revealed at any time during therapy with this drug (see WARNINGS).
Drug Interactions: The interaction of CYLERT (pemoline) with other drugs has not been studied in humans. Patients who are receiving CYLERT (pemoline) concurrently with other drugs, especially drugs with CNS activity, should be monitored carefully.
Decreased seizure threshold has been reported in patients receiving CYLERT (pemoline) concomitantly with antiepileptic medications.
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 treated and control animals. neoplasm between
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.
Studies in rats have shown an increased incidence of stillbirths and cannibalization when pemoline was administered at a dose of 37.5 mg/kg/day. Postnatal survival of offspring was reduced at doses of 18.75 and 37.5 mg/kg/day.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CYLERT (pemoline) is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children below the age of 6 years have not been established.
Long-term effects of CYLERT (pemoline) in children have not been established (see WARNINGS
CNS stimulants, including pemoline, have been reported to precipitate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in children and their families should precede use of stimulant medications.
Drug treatment is not indicated in all cases of ADHD and should be considered only in light of complete history and evaluation of the child. The decision to prescribe CYLERT (pemoline) should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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