From the FDA Drug Label
The maximum recommended daily dose is 60 mg. The maximum dose of Concerta (methylphenidate) is 60 mg per day 1.
- This applies to both pediatric patients (6 years of age and older) and adults.
- Daily dosage above 60 mg is not recommended.
From the Research
The maximum recommended daily dose of Concerta (methylphenidate hydrochloride extended-release) is 72 mg for adults and 54 mg for children and adolescents, regardless of weight. Patients should start with lower doses, typically 18 or 36 mg once daily in the morning, with gradual increases as needed and tolerated. Doses should not exceed these maximums due to increased risk of cardiovascular effects (increased heart rate and blood pressure), severe anxiety, psychosis, and other side effects, as highlighted in a study analyzing adverse event reports 2. Concerta works by increasing dopamine and norepinephrine levels in the brain to improve attention and reduce hyperactivity in ADHD. The medication is designed for once-daily dosing with its unique OROS delivery system that provides consistent medication release throughout the day. If the maximum dose is ineffective, healthcare providers may consider alternative medications or combination therapy rather than exceeding these limits, considering the comparative efficacy of methylphenidate and atomoxetine in improving symptoms and quality of life in adults with ADHD 3. Patients should never adjust their dose without medical supervision, given the potential for serious adverse effects associated with methylphenidate, including psychotic disorders and precocious puberty 2. Key considerations in dosing include:
- Starting with lower doses and gradually increasing as needed and tolerated
- Monitoring for cardiovascular and psychiatric side effects
- Considering alternative treatments if the maximum dose is ineffective
- Avoiding dose adjustments without medical supervision, especially in light of findings from a recent head-to-head clinical trial comparing methylphenidate and atomoxetine in children with ADHD 4.