Description

The following clinically significant adverse reactions are: Dyskinesia Hallucinations / Psychotic Behavior Impulse Control / Compulsive Behaviors

Dyskinesia: Monitor patients for dyskinesia or exacerbation of existing dyskinesia. Hallucinations/Psychotic Behavior: Consider dosage reduction or stopping Istradefylline if occurs. Impulse Control/Compulsive Behaviors: Consider dosage reduction or stopping Istradefylline if occurs

Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: No adjustment of Istradefylline dosage is recommended on the basis of age. Of the total number of PD patients who received Istradefylline in clinical trials, 53% were ≥65 years and 13% were ≥75 years of age. No overall differences in effectiveness were observed between these patients and younger patients

Antiparkinson drugs

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.