What is the dosing schedule for Focalin XR (dexmethylphenidate)?

Dosing Schedule for Focalin XR (Dexmethylphenidate Extended-Release)

Focalin XR is administered once daily in the morning with or without food, with a recommended starting dose of 5 mg for pediatric patients and 10 mg for adults. 1

Initial Dosing

Patients New to Methylphenidate:

• Pediatric patients: Start with 5 mg orally once daily in the morning
• Adult patients: Start with 10 mg orally once daily in the morning

Patients Currently on Methylphenidate:

• For patients currently using methylphenidate: The starting dose should be half (1/2) the total daily dose of racemic methylphenidate
• For patients currently using dexmethylphenidate immediate-release tablets: The same daily dose of Focalin XR may be given

Titration and Maximum Dosing

• Dose may be titrated weekly in increments of:
  • 5 mg in pediatric patients
  • 10 mg in adult patients
• Maximum recommended daily doses:
  • 30 mg for pediatric patients
  • 40 mg for adults
• Daily doses above these maximums have not been studied and are not recommended 1

Administration Options

Focalin XR capsules can be administered in two ways:

1. Swallowed whole
2. Opened and entire contents sprinkled onto applesauce
   • The sprinkled applesauce must be consumed immediately
   • The applesauce with sprinkled beads should be eaten in its entirety without chewing
   • The dose should not be divided; patients should take the entire capsule contents 1

Pharmacokinetic Profile

Focalin XR has a bimodal release profile that mimics two doses of immediate-release dexmethylphenidate given 4 hours apart. This allows for:

• Rapid onset of action (as early as 0.5 hours after administration)
• Sustained effect throughout the day (up to 11-12 hours) 2

Dosage Adjustments

• If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage or discontinue if necessary
• If no improvement is observed after appropriate dosage adjustment over a one-month period, the medication should be discontinued 1

Clinical Considerations

• The once-daily administration avoids the need for a midday dose at school or work 2
• Focalin XR provides effective management of ADHD at half the dose of racemic methylphenidate 3
• All three doses of Focalin XR (10 mg, 20 mg, and 30 mg once daily) have demonstrated significant efficacy compared to placebo in improving ADHD symptoms 4

Important Precautions

• Prior to initiating treatment, assess for:
  • Presence of cardiac disease
  • Family history of sudden death or ventricular arrhythmia
  • Motor or verbal tics or Tourette's syndrome 1
• Focalin XR is contraindicated in patients with:
  • Hypersensitivity to methylphenidate
  • Concomitant treatment with MAOIs or within 14 days following MAOI discontinuation 1

Focalin XR's once-daily dosing schedule with bimodal release provides both immediate and extended symptom control throughout the day, making it a convenient option for ADHD management with demonstrated efficacy and generally good tolerability.