FDA Maximum Dosages for Focalin (Dexmethylphenidate)
The FDA-approved maximum daily dose is 30 mg for pediatric patients and 40 mg for adults when using Focalin XR (extended-release), while immediate-release formulations should not exceed 20 mg daily (given as divided doses). 1
Focalin XR (Extended-Release) Maximum Dosages
- Pediatric patients (ages 6-17 years): Maximum of 30 mg once daily 1
- Adults: Maximum of 40 mg once daily 1
- The extended-release formulation provides bimodal release, mimicking two doses of immediate-release dexmethylphenidate given 4 hours apart, allowing for once-daily administration 2, 3
Focalin IR (Immediate-Release) Maximum Dosages
- Maximum daily dose: 20 mg per day, typically divided into two doses 1
- The immediate-release formulation has a relatively short half-life of approximately 2.5 hours in pediatric patients, necessitating multiple daily doses 4
Combined Use of IR and XR Formulations
The FDA labeling does not provide specific guidance on combining immediate-release and extended-release formulations. 1 However, the pharmacokinetic profile must be considered:
- If combining formulations, the total daily dexmethylphenidate dose should not exceed the maximum approved for the patient's age group (30 mg for pediatrics, 40 mg for adults) 1
- The XR formulation already delivers medication in a bimodal pattern designed to cover an entire day (up to 12 hours post-dose) 2, 5
- Adding IR to XR would require careful calculation to avoid exceeding maximum recommended doses
Important Dosing Considerations
- Titration schedule: Increase weekly in increments of 5 mg for pediatric patients and 10 mg for adults 1
- Starting doses: 5 mg once daily for pediatric patients; 10 mg once daily for adults 1
- Conversion from methylphenidate: Dexmethylphenidate XR dosage is half the current total daily dosage of methylphenidate, as dexmethylphenidate contains only the pharmacologically active d-isomer 1, 6
- Duration of effect: XR formulation provides symptom control for 11-12 hours after administration 2