BOXED WARNING High potential for abuse, misuse, and addiction; misuse/abuse of CNS stimulants can result in overdose and death. Assess abuse risk before prescribing and monitor during treatment.
FDA dosing
Population
Start
Target
Max
Attention deficit hyperactivity disorder (ADHD)
patients ≥6 years
20 mg QD in the morning
titrate weekly by 10, 15, or 20 mg/day
60 mg/day
Titration Titrate weekly in increments of 10, 15, or 20 mg/day.
Renal Undefined
Hepatic Undefined
Not recommended in pediatric patients younger than 6 years.
Instructions
Administer orally once daily in the morning, with or without food.
Do not substitute for other methylphenidate products on a mg-per-mg basis.
Screen for cardiac disease and for tics/Tourette's before initiating.
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 in serious cardiac disease
Increased blood pressure and heart rate
Psychiatric adverse reactions (new psychotic/manic symptoms)
Priapism
Peripheral vasculopathy including Raynaud's phenomenon
Long-term growth suppression in pediatric patients
Risks in phenylketonurics (contains phenylalanine)
Acute angle-closure glaucoma
Increased intraocular pressure
Adverse reactions
Decreased appetite
Insomnia
Nausea
Vomiting
Dyspepsia
Abdominal pain
Weight decreased
Anxiety
Dizziness
Irritability
Affect lability
Tachycardia
Increased blood pressure
Pregnancy Limited data insufficient to inform drug-associated risk; no teratogenicity in animal studies at multiples of human dose.
Lactation Methylphenidate present in human milk (infant dose 0.16–0.7% of maternal weight-adjusted dose); monitor infant.