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.