What is the maximum recommended dose of Focalin (dexmethylphenidate) for Attention Deficit Hyperactivity Disorder (ADHD)?

Maximum Recommended Dose of Focalin (Dexmethylphenidate) for ADHD

The maximum recommended daily dose of Focalin (dexmethylphenidate) is 30 mg for pediatric patients and 40 mg for adults, as doses above these levels have not been studied and are not recommended by the FDA. 1

Dosing Guidelines by Age Group

Children and Adolescents

• Starting dose: 5 mg once daily in the morning (with or without food) 1
• Titration: May increase weekly in 5 mg increments based on response and tolerability 1
• Maximum daily dose: 30 mg 1

Adults

• Starting dose: 10 mg once daily in the morning (with or without food) 1
• Titration: May increase weekly in 10 mg increments based on response and tolerability 1
• Maximum daily dose: 40 mg 1

Administration Options

• May be taken as whole capsules
• Alternatively, capsules may be opened and entire contents sprinkled onto applesauce (should be consumed immediately without chewing) 1
• The dose of a single capsule should not be divided 1

Dosing Considerations for Patients Currently on Methylphenidate

For patients already taking methylphenidate products:

• The recommended starting dose of Focalin XR is half (1/2) the total daily dose of racemic methylphenidate 1
• Patients currently using immediate-release dexmethylphenidate may be given the same daily dose of Focalin XR 1

Efficacy and Duration of Action

• Focalin XR has a bimodal release profile that mimics two doses of immediate-release dexmethylphenidate given 4 hours apart 2
• This allows for once-daily administration with effects lasting up to 11-12 hours after administration 2
• Studies show significant improvements in ADHD symptoms from as early as 0.5 hours after administration 2

Important Safety Considerations

• Assess for cardiac disease before initiating treatment 1
• Evaluate for history of tics or Tourette's syndrome prior to starting medication 1
• Monitor for signs of abuse, misuse, and addiction throughout treatment 1
• Regular monitoring of blood pressure, heart rate, and growth in pediatric patients is recommended 3

Common Side Effects

• In pediatric patients: dyspepsia, decreased appetite, headache, and anxiety 1
• In adults: dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety 1

When to Consider Dose Reduction or Discontinuation

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

Focalin is a Schedule II controlled substance with potential for abuse and misuse. Always assess each patient's risk for abuse before prescribing and monitor throughout treatment 1.