BOXED WARNING High potential for abuse and misuse → substance use disorder incl. addiction; CNS-stimulant misuse/abuse can cause overdose and death. Assess abuse risk before prescribing; monitor throughout treatment.
FDA dosing
Population
Start
Target
Max
ADHD — patients new to methylphenidate (or on other stimulants)
Peds ≥6 yr (label dosing text addresses pediatric patients)
2.5 mg BID (5 mg/day), with or without food
Individualized; titrate weekly 2.5–5 mg
20 mg/day (10 mg BID)
ADHD — patients currently on racemic methylphenidate
Peds (per label dosing text)
Half the current total daily methylphenidate dose
Individualized
20 mg/day (10 mg BID)
Titration Weekly (2.5–5 mg increments)
Renal Undefined
Hepatic Undefined
Instructions
BID, doses at least 4 hours apart, with or without food
Reduce dose or discontinue if paradoxical aggravation of symptoms or adverse reactions
Discontinue if no improvement after appropriate dose adjustment over 1 month
Pretreatment: cardiac history/exam and screen for tics/Tourette's and family history
Contraindications
Concomitant MAOI treatment, or within 14 days of stopping an MAOI (hypertensive crisis risk)
Cautions
Avoid in serious cardiac disease; increases BP and heart rate — monitor
Long-term growth suppression in peds — monitor growth; interrupt if not growing/gaining as expected
Acute angle-closure glaucoma / increased IOP
Emergence/worsening of tics and Tourette's
Adverse reactions
Peds (≥5% and 2× placebo): abdominal pain, fever, nausea, anorexia
Pregnancy d-enantiomer of methylphenidate; published methylphenidate data have not identified drug-associated risk of major birth defects/miscarriage; possible CNS-stimulant fetal risks; registry available
Lactation Methylphenidate present in milk (infant dose 0.16–0.7% of maternal weight-adjusted dose); no adverse infant reports; monitor breastfed infant