Use with caution in patients with psychosis, bipolar disorder, history of seizures/EEG abnormalities, and hypertension. OROS(R) methylphenidate should not be used in patients with pre-existing severe gastrointestinal narrowing, known structural cardiac abnormalities or other serious heart problems. Stimulants may cause new psychotic or manic symptoms; discontinuation of treatment may be appropriate. Aggressive behavior or hostility should be monitored in patients beginning treatment.
Methylphenidate may produce difficulties with accommodation and blurring of vision. Hematologic monitoring is advised during prolonged therapy.
The most common adverse events reported in children aged six to 12 years receiving up to 54 mg were headache (14%), upper respiratory tract infection (8%), and abdominal pain (7%). The most common adverse events reported in adolescents receiving up to 72 mg were headache (9%), accidental injury (6%), and insomnia (5%).
About McNeil Pediatrics
McNeil Pediatrics Division of McNeil-PPC, Inc. is committed to meeting the needs of pediatric medicine through the development of therapies specifically formulated for children. Its leading pediatric product, OROS(R) methylphenidate, is a once-a-day treatment for Attention Deficit Hyperactivity Disorder (ADHD) that uniquely combines methylphenidate with an exclusive OROS(R) delivery system. OROS(R) methylphenidate is the number one ADHD prescribed medication in the U.S. for children and adolescents. McNeil Pediatrics also markets a medication for treatment of pediatric patients with autism.
OROS(R) is a registered trade mark of ALZA Corporation.
(1) The number of prescriptions for OROS MPH(R) and other MPH
treatments was similar (=28 vs 25 million), yet OROS MPH(R)
accounted for 23% of DAWN reports while other MPH formulations
accounted for 77%. Th