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pemoline (Cylert): Drug Facts, Side Effects and Dosing

What is Cylert (pemoline), and how does it work?

Cylert (pemoline) is a central nervous system stimulant used to treat attention deficit hyperactivity disorder (ADHD). The brand name Cylert is no longer available in the U.S. Generic versions may be available.

Cylert (pemoline) is a central nervous system stimulant. Pemoline is structurally dissimilar to the amphetamines and methylphenidate.

It is an oxazolidine compound and is chemically identified as 2-amino-S-phenyl-2-oxazolin4-one.

What are the side effects of Cylert (pemoline)?

Common side effects of Cylert (pemoline) include:

Because of its association with life threatening hepatic failure, CYLERT (pemoline) should not ordinarily be considered as first line drug therapy for ADHD.

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.

What is the dosage for Cylert (pemoline)?

Cylert (pemoline) is administered as a single oral dose each morning. The recommended starting dose is 37.5 mg/day. This daily dose should be gradually increased by 18.75 mg at one week intervals until the desired clinical response is obtained. The effective daily dose for most patients will range from 56.25 to 75 mg. The maximum recommended daily dose of pemoline is 112.5 mg.

Clinical improvement with Cylert (pemoline) is gradual. Using the recommended schedule of dosage titration, significant benefit may not be evident until the third or fourth week of drug administration.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

What drugs interact with Cylert (pemoline)?

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.

Is Cylert (pemoline) safe to take while pregnant or breastfeeding?

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.

Nonteratogenic effects

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.


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