CYLERT (pemoline) is indicated in Attention Deficit Hyperactivity Disorder (ADHD). Because of its association with life threatening hepatic failure, CYLERT should not ordinarily be considered as first line therapy for ADHD (see WARNINGS).

CYLERT (pemoline) therapy should be proof of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

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 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.

CYLERT (pemoline) is supplied as monogrammed, grooved tablets in three dosage strengths:

18.75 mg tablets (white) in bottles of 100 (NDC 0074-6025-13);

37.5 mg tablets (orange-colored) in bottles of 100 (NDC 0074-6057-13);

75 mg tablets (tan-colored) in bottles of 100 (NDC 0074-6073-13).

CYLERT (pemoline) Chewable is supplied as 37.5 mg monogrammed, grooved tablets (orange- colored) in bottles of 100 (NDC 0074-6088-13).

Recommended Storage: Store below 86° F (30° C).

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