Pemoline (withdrawn from US market 2005)

Hepatotoxicity

  • Life threatening hepatotoxicity limits use as first line agent in ADHD. May have long latency period
  • Written informed consent from patient prior to initiation

Monitoring data

  • Unresponsive patients should be removed from therapy at 3 wks.
  • Initiate therapy only in patients with normal baseline LFTs and without liver disease.
  • Serum ALT (SGPT) at baseline & every 2 weeks thereafter. If therapy interrupted, repeat baseline ALT and continue every 2 weeks, thereafter.
  • Informed Consent recommended
  • Discontinue if serum ALT increases are clinically significant or any increase > 2 times upper limit of normal

Patient counseling

Communications

Index to FDA Drug Safety Information

Package inserts

Pemoline

Additional information

Keywords: Cylert
Updated: January 2018