Maximum Dose of Focalin XR (Dexmethylphenidate)
The maximum recommended daily dose of Focalin XR (dexmethylphenidate extended-release) is 30 mg for pediatric patients and 40 mg for adults. 1
Dosing Guidelines
Pediatric Patients (≥6 years)
- Starting dose: 5 mg once daily in the morning
- Titration: Weekly increments of 5 mg
- Maximum daily dose: 30 mg
Adult Patients
- Starting dose: 10 mg once daily in the morning
- Titration: Weekly increments of 10 mg
- Maximum daily dose: 40 mg
Conversion from Other Methylphenidate Formulations
- For patients currently on methylphenidate: The Focalin XR dosage should be half (1/2) the current total daily dosage of methylphenidate
- For patients currently on immediate-release dexmethylphenidate: Give the same daily dose of Focalin XR
Administration Considerations
- Focalin XR can be taken with or without food in the morning
- Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce 1
- The bimodal release profile mimics two doses of immediate-release dexmethylphenidate given 4 hours apart, allowing for once-daily administration 2
Efficacy and Duration of Action
- Focalin XR provides symptom control throughout the day, with effects starting as early as 30 minutes after administration and lasting up to 11-12 hours 2
- Clinical trials have demonstrated efficacy across multiple doses (10 mg, 20 mg, and 30 mg once daily) in pediatric patients with ADHD 3
Important Clinical Considerations
- Dexmethylphenidate contains only the d-threo-enantiomer of methylphenidate, which is the pharmacologically active component 4
- Due to this, dexmethylphenidate is approximately twice as potent as racemic methylphenidate, requiring half the dose for equivalent efficacy 4
- Focalin XR is a Schedule II controlled substance, reflecting its potential for abuse, though the extended-release formulation appears to have a lower risk of abuse compared to immediate-release formulations 2
Monitoring
- Regular monitoring for adverse effects is essential, particularly:
- Appetite suppression
- Sleep disturbances
- Cardiovascular effects (heart rate, blood pressure)
- Growth (in pediatric patients)
While some patients may respond adequately to lower doses, exceeding the maximum recommended doses does not typically provide additional benefit and may increase the risk of adverse effects.