BOXED WARNING Abuse, misuse, and addiction — high potential; can lead to substance use disorder; misuse/abuse can result in overdose and death. Assess risk before prescribing and monitor throughout treatment
FDA dosing
Population
Start
Target
Max
Attention deficit hyperactivity disorder (ADHD)
Patients 6 years and older
20 mg QD in the evening
Individualized
100 mg/day
Titration May titrate weekly in increments of 20 mg
Renal No experience in renal insufficiency; renal impairment expected to have little effect on pharmacokinetics
Hepatic Undefined
Evening dosing only (delayed- plus extended-release design)
Instructions
Take once daily in the evening only; initiate at 8:00 p.m. and adjust between 6:30 p.m. and 9:30 p.m. to optimize next-morning tolerability/efficacy
Do not take in the morning
Take consistently with or without food
Swallow whole or open and sprinkle entire contents on applesauce (consume immediately, do not chew; do not divide dose)
Do not substitute for other methylphenidate products on a mg-per-mg basis
Contraindications
Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days, because of the risk of hypertensive crisis
Cautions
Risks to patients with serious cardiac disease (avoid in structural cardiac abnormalities/serious cardiac disease)
Peripheral vasculopathy including Raynaud's phenomenon
Long-term suppression of growth in pediatric patients
Acute angle closure glaucoma
Increased intraocular pressure and glaucoma
Motor/verbal tics and worsening of Tourette's syndrome
Adverse reactions
Decreased appetite
Insomnia
Nausea
Vomiting
Dyspepsia
Abdominal pain
Weight decreased
Anxiety
Dizziness
Irritability
Affect lability
Tachycardia
Blood pressure increased
Headache (pediatric)
Pregnancy Insufficient data to inform drug-associated risk; CNS stimulants may cause vasoconstriction and decrease placental perfusion
Lactation Methylphenidate present in human milk (infant dose 0.16-0.7% of maternal weight-adjusted dose); monitor infant for agitation, insomnia, anorexia, reduced weight gain