Methylphenidate ER (OROS)
CONCERTA
Pronunciation: meth-il-FEN-i-dayt (kon-SER-ta)
“Concert on Math final date”
Concentrate certainly
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
Read the full label on DailyMed ↗
| 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
Available strengths
- ER tab 18, 27, 36, 54 mg
- cap 20, 40, 60, 80, 100 mg
- tab 5, 10, 20 mg
- ER cap 10, 15, 20, 30, 40, 50, 60, 80, 100 mg
- ODT 8.6, 17.3, 25.9 mg
- chew tab 2.5, 5, 10, 20, 30, 40 mg
- ER susp 600 mg/120 mL
- ER susp 750 mg/150 mL
- + 5 other marketed forms not shown
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
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 18 mg | ER tab | 30 qd | $17.28 | not offered |
| 27 mg | ER tab | 30 qd | $20.30 | not offered |
| 36 mg | ER tab | 30 qd | $20.15 | not offered |
| 54 mg | ER tab | 30 qd | $24.15 | not offered |
Other forms: Methylphenidate (RITALIN) · Methylphenidate ER chewable (QUILLICHEW ER) · Methylphenidate ER suspension (QUILLIVANT XR) · Methylphenidate ER (Relexxii) · Methylphenidate LA (RITALIN LA) · Methylphenidate XR-ODT (COTEMPLA XR-ODT) · Methylphenidate patch (DAYTRANA) · Methylphenidate ER evening-dosed (JORNAY PM) · Methylphenidate CD (METADATE CD) · Methylphenidate oral solution (METHYLIN SOLUTION)
⚠ BOXED WARNING
- Abuse, misuse and addiction
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityHypertension, appetite/weight effects, misuse and stimulant-induced psychosis or arrhythmia.
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