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The following are adverse reactions in decreasing order of severity within each category associated with CYLERT (pemoline) :

Hepatic: There have been reports of hepatic dysfunction, ranging from asymptomatic reversible increases in liver enzymes to hepatitis, jaundice and life- threatening hepatic failure, in patients taking CYLERT (see PRECAUTIONS and WARNINGS).

Hematopoietic: There have been isolated reports of aplastic anemia.

Central Nervous System: The following CNS effects have been reported with the use of CYLERT (pemoline) : convulsive seizures: literature reports indicate that CYLERT (pemoline) may precipitate attacks of Gilles de la Tourette syndrome; hallucinations; dyskinetic movements of the tongue, lips, face and extremities: abnorrnal oculomotor function including nystagmus and oculogyric crisis; mild depression; dizziness; increased irritability; headache; and drowsiness.

Insomnia is the most frequently reported side effect of CYLERT (pemoline) , it usually occurs early in therapy prior to an optimum therapeutic response. In the majority of cases it is transient in nature or responds to a reduction in dosage.

Gastrointestinal: Anorexia and weight loss may occur during the first weeks of therapy. In the majority of cases it is transient in nature; weight gain usually resumes within three to six months.

Nausea and stomach ache have also been reported.

Genitourinary: A case of elevated acid phosphatase in association with prostatic enlargement has been reported in a 63 year old male who was treated with CYLERT (pemoline) for sleepiness. The acid phosphatase normalized with discontinuation of CYLERT (pemoline) and was again elevated with rechallenge.

Miscellaneous: Suppression of growth has been reported with the long- term use of stimulants in children. (See WARNINGS.) Skin rash has been reported with CYLERT (pemoline) .

Mild adverse reactions appearing early during the course of treatment with CYLERT (pemoline) often remit with continuing therapy. If adverse reactions are of a significant or protracted nature, dosage should be reduced or the drug discontinued.

DRUG ABUSE AND DEPENDENCE

Controlled Substance: CYLERT (pemoline) is subject to control under DEA schedule IV.

Abuse: CYLERT (pemoline) failed to demonstrate a potential for self- administration in primates. However, the pharmacologic similarity of pemoline to other psychostimulants with known dependence liability suggests that psychological and/ or physical dependence might also occur with CYLERT (pemoline) . There have been isolated reports of transient psychotic symptoms occurring in adults following the long- term misuse of excessive oral doses of pemoline. CYLERT (pemoline) should be given with caution to emotionally unstable patients who may increase the dosage on their own initiative.