What is the recommended starting dose of Concerta (methylphenidate)?

Concerta Starting Dose

For pediatric patients 6 years and older, start Concerta at 18 mg once daily in the morning, which is equivalent to methylphenidate immediate-release 5 mg three times daily. 1, 2

Pediatric Dosing (Ages 6 and Older)

• Initial dose: 18 mg once daily taken in the morning before breakfast 2, 3
• Titration schedule: Increase by 18 mg weekly increments based on clinical response and tolerability 2, 4
• Maximum recommended dose: 54-72 mg daily, though doses above 60 mg require careful documentation 5, 2
• The 18 mg starting dose provides coverage equivalent to 15 mg total daily dose of immediate-release methylphenidate (5 mg three times daily) 1

Adult Dosing

• Adults typically require higher doses than children due to needing symptom coverage throughout a longer workday 5
• While specific adult starting doses are not explicitly defined in the FDA label, the general approach is to begin with lower doses and titrate upward based on response 2
• Adults may ultimately require doses above 72 mg, but this should be clearly documented with rationale that lower doses were inadequate 5
• Maximum FDA-recommended daily dose is 60 mg, though clinical practice may exceed this with appropriate justification 2

Key Clinical Considerations

Timing and Administration

• Administer in the morning to minimize sleep disturbances 5, 2
• Food does not affect absorption: Unlike some extended-release amphetamine formulations, Concerta provides consistent methylphenidate exposure regardless of whether taken with or without food 6
• Onset of action occurs within 1-2 hours, with effects lasting the full 12-hour period 5, 3

Monitoring Response

• Assess clinical response within 1-2 hours of administration using standardized ADHD rating scales 5
• Approximately 66% of adults achieve clinical response with optimal dosing 5
• If no response after 4 weeks at maximum tolerated dose, consider switching to an alternative stimulant 5
• Plasma methylphenidate levels do not correlate well with clinical response, so dose based on clinical effect rather than weight or plasma concentrations 1

Important Caveats

Formulation Matters

• Not all generic Concerta is therapeutically equivalent: Only OROS (osmotic-release oral system) formulations provide the same clinical efficacy as brand-name Concerta 7
• Non-OROS generic extended-release methylphenidate products have demonstrated significantly reduced effectiveness compared to OROS formulations at equivalent doses 7
• When prescribing, specify "OROS methylphenidate" or "brand Concerta" if therapeutic equivalence is a concern 7

Contraindications and Precautions

• Screen for cardiac disease before initiating: avoid use in patients with structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, or coronary artery disease 2
• Assess for psychiatric risk factors: Screen for history of psychosis or mania before starting treatment 2
• Monitor blood pressure and heart rate throughout treatment 2
• Do not use with MAOIs or within 14 days of MAOI discontinuation 2

Growth Monitoring in Children

• Closely monitor height and weight in pediatric patients, as long-term stimulant use may suppress growth 2
• Consider treatment interruption if growth is not progressing as expected 2

Abuse Potential

• Concerta has lower abuse potential than immediate-release formulations because the medication is in a paste form that cannot be crushed or snorted 1
• However, it remains a Schedule II controlled substance with high potential for abuse and misuse 2
• Assess each patient's risk for abuse, misuse, and addiction before prescribing 2