Maximum Daily Dose of Concerta (Methylphenidate Extended-Release)
The maximum daily dose of Concerta is 72 mg for children and adolescents, and 72 mg for adults, though doses up to 90 mg have been studied in adults with demonstrated safety and tolerability. 1, 2
FDA-Approved Maximum Dosing
- For pediatric patients 6 years and older: The daily dosage above 60 mg is not recommended according to the FDA label for methylphenidate products 1
- For adults: The maximum recommended daily dose is 60 mg for standard methylphenidate formulations 1
- However, Concerta specifically has been studied and used at higher doses than traditional methylphenidate formulations due to its extended-release OROS delivery system 2
Evidence-Based Dosing in Clinical Practice
Adults may require doses above 72 mg in certain circumstances, but this should be clearly documented, noting that lower doses were inadequate and higher doses are not producing prohibitive side effects 3
- In a seven-week open-label study of 370 adults with ADHD, flexible dosing of OROS methylphenidate ranged from 18-90 mg daily, with final dispensed doses distributed as follows: 18 mg (8%), 36 mg (29%), 54 mg (34%), 72 mg (20%), or 90 mg (9%) 2
- The 18-90 mg/day range demonstrated safety and tolerability, with most adverse events being mild or moderate in severity 2
- Adults with ADHD often require higher total daily doses than children because they need symptom coverage throughout a longer workday 3
Titration Protocol to Maximum Dose
Start low and titrate systematically to avoid premature discontinuation due to side effects while ensuring adequate therapeutic response:
- Pediatric starting dose: 18 mg once daily in the morning 3, 4
- Adult starting dose: 18 mg once daily, or higher if transitioning from immediate-release methylphenidate 2
- Titration increments: Increase by 18 mg weekly until maximum benefit is achieved, intolerable side effects emerge, or maximum dose is reached 3, 5
- Available strengths: 18 mg, 27 mg, 36 mg, 54 mg, and 72 mg tablets 5, 6
Critical Dosing Considerations
Over 70% of patients require dose optimization beyond the starting dose of 18 mg to achieve maximum benefit 5
- The 18 mg dose of Concerta is approximately equivalent to methylphenidate 5 mg three times daily and is designed as a starting dose, not a therapeutic endpoint 3, 5
- Systematic titration across multiple dose levels results in over 70% of patients responding optimally to methylphenidate 5
- Dose response is highly variable and unpredictable between individuals; calculating dose based on mg/kg has not been helpful 5
Monitoring Requirements at Higher Doses
Regular cardiovascular monitoring is essential, particularly when approaching or exceeding 60 mg daily:
- Monitor blood pressure and pulse at baseline and with each dose adjustment 3, 2
- Small mean increases in systolic and diastolic blood pressure (both 2.4 mmHg) and pulse (3.2 bpm) were observed in adults receiving 18-90 mg daily 2
- Monitor for common adverse effects including headache (17%), decreased appetite (13%), and insomnia (11%) 2
- Body weight should be monitored, as mean decreases of 1.5 kg were observed in adult studies 2
Common Pitfalls to Avoid
Do not stop titration prematurely at 36 mg or 54 mg if symptoms persist and side effects are tolerable—many patients require 72 mg or higher for optimal response 3, 5
Do not assume the FDA label maximum of 60 mg applies rigidly to Concerta's OROS formulation, as clinical studies have demonstrated safety and efficacy up to 90 mg in adults 2
Do not calculate doses based on body weight—individual response variability requires systematic titration regardless of patient size 5