Methylphenidate ER (OROS)

CONCERTA

Open Methylphenidate ER (OROS) in the interactive console ↗

What it isCONCERTA (2000) is an OROS extended-release dopamine and norepinephrine reuptake inhibitor for ADHD; approved ages: 6-17, adults.

Why this oneIts OROS osmotic CR tablet delivers 22% IR / 78% DR over 10-12 h (Carlat Table 1), with an empty shell often visible in stool.

What limits itSwallow the tablet intact; obstruction risk matters in severe GI narrowing. Appetite loss, insomnia, blood-pressure rise and misuse remain.

FDA-approved for

ADHD (2000)

FDA label

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BOXED WARNING High potential for abuse, misuse, and addiction; misuse/abuse of CNS stimulants can cause overdose and death.

FDA dosing	Population	Start	Target	Max
ADHD	Pediatric 6-12 yr, new to methylphenidate	18 mg QD	18-54 mg QD	54 mg QD
ADHD	Pediatric 13-17 yr, new to methylphenidate	18 mg QD	18-72 mg QD (not to exceed 2 mg/kg/day)	72 mg QD
ADHD	Adults 18-65 yr, new to methylphenidate	18 or 36 mg QD	18-72 mg QD	72 mg QD

Titration Increase in 18 mg increments at weekly intervals

Renal Undefined

Hepatic Undefined

Instructions

Administer once daily in the morning with or without food
Swallow whole with liquids; do not chew, divide, or crush
Do not use in patients with pre-existing severe GI narrowing (nondeformable tablet)
If no improvement after appropriate dose adjustment over 1 month, discontinue

Contraindications

Concomitant MAOIs, or within 14 days of discontinuing an MAOI (risk of hypertensive crisis)

Cautions

Serious cardiac disease — avoid in structural cardiac abnormalities/serious cardiac disease (sudden death)
Increased blood pressure and heart rate — monitor
Psychiatric adverse reactions (new psychotic/manic symptoms); screen for bipolar risk
Priapism
Peripheral vasculopathy, including Raynaud's phenomenon
Long-term growth suppression in pediatric patients
GI obstruction risk with pre-existing GI narrowing
Acute angle closure glaucoma; increased IOP
Motor/verbal tics and worsening of Tourette's

Adverse reactions

Pediatric: upper abdominal pain
Adults: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, tachycardia, hyperhidrosis

Pregnancy Published data inconsistent re: birth defects; CNS stimulants may reduce placental perfusion; pregnancy exposure 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

⚠ BOXED WARNING