BOXED WARNING High potential for abuse and misuse; can lead to substance use disorder including addiction, and misuse/abuse of CNS stimulants can result in overdose and death.
FDA dosing
Population
Start
Target
Max
ADHD
Peds 6–12 yr
20 mg QD (AM); 10 mg if a lower initial dose is appropriate
titrate to effect
60 mg/day
Titration Increase gradually in 10 mg increments at weekly intervals
Renal Undefined
Hepatic Undefined
Instructions
Once daily in the morning
Swallow whole, or open capsule and sprinkle beads on a small amount of cool applesauce and consume immediately (do not store)
Do not crush, chew, or divide
Do not substitute mg-per-mg for other methylphenidate products
Contraindications
Concurrent treatment with an MAOI, or use of an MAOI within the preceding 14 days, because of the risk of hypertensive crisis.
Cautions
Avoid in serious cardiac disease (sudden death risk)
Increased blood pressure and heart rate — monitor
Psychiatric reactions: may exacerbate psychosis or induce mania; screen before starting
Priapism
Peripheral vasculopathy, including Raynaud's phenomenon
Long-term growth suppression in pediatric patients — monitor
May cause or worsen motor/verbal tics and Tourette's
Adverse reactions
headache
insomnia
upper abdominal pain
decreased appetite
anorexia
Pregnancy Published data have not identified drug-associated risk of major birth defects or miscarriage; CNS stimulants may decrease placental perfusion. Pregnancy registry available.
Lactation Methylphenidate present in human milk (infant dose 0.16–0.7% of maternal); monitor infant for agitation, insomnia, anorexia, reduced weight gain.