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

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: convulsive seizures: literature reports indicate that CYLERT 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, 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 for sleepiness. The acid phosphatase normalized with discontinuation of CYLERT 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.

Mild adverse reactions appearing early during the course of treatment with CYLERT 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 is subject to control under DEA schedule IV.

Abuse: CYLERT 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. There have been isolated reports of transient psychotic symptoms occurring in adults following the long- term misuse of excessive oral doses of pemoline. CYLERT should be given with caution to emotionally unstable patients who may increase the dosage on their own initiative.

The interaction of CYLERT (pemoline) with other drugs has not been studied in humans. Patients who are receiving CYLERT concurrently with other drugs, especially drugs with CNS activity, should be monitored carefully.

Decreased seizure threshold has been reported in patients receiving CYLERT concomitantly with antiepileptic medications.

Bookmark this page: