What is the recommended dosing for Aptensio (methylphenidate)?

Aptensio XR (Methylphenidate Extended-Release) Dosing Guidelines

The recommended starting dose for Aptensio XR is 10 mg once daily in the morning, with gradual titration in increments of 5-10 mg weekly as needed, not exceeding the maximum daily dose of 60 mg. 1, 2

Initial Dosing and Titration

• Starting dose:

  • Children (6 years and older): 10 mg once daily in the morning 1, 3
  • Adults: 10 mg once daily in the morning 1

• Dose titration:

  • Increase gradually in increments of 5-10 mg weekly 1
  • Titrate based on symptom control and tolerability 3
  • Administer once daily in the morning, preferably 30-45 minutes before breakfast 1

• Maximum daily dose: 60 mg for both children and adults 2, 1

Administration Considerations

• Aptensio XR provides an early peak followed by approximately 8 hours of action 2
• For adults who experience insomnia, administer the last dose before 6 p.m. 1
• Schedule medication early in the day to minimize sleep disturbances 2

Dosage Adjustments

• If paradoxical aggravation of symptoms or adverse reactions occur, reduce dosage or discontinue if necessary 1
• If no improvement is observed after appropriate dosage adjustment over a one-month period, discontinue medication 1
• Target symptom improvement should be assessed in both home and school settings 2

Monitoring Parameters

• Before treatment initiation:

  • Assess for cardiac disease (history, family history of sudden death/arrhythmia, physical exam) 1
  • Evaluate for history of motor/verbal tics or Tourette's syndrome 1

• During treatment:

  • Monitor blood pressure and heart rate (stimulants cause mean increases of 2-4 mmHg and 3-6 bpm) 1
  • Track growth parameters regularly in children 2
  • Assess for signs of abuse, misuse, or addiction throughout treatment 1
  • Monitor for common side effects: decreased appetite, insomnia, and irritability 2, 3

Clinical Evidence

Aptensio XR has demonstrated efficacy in clinical trials:

• A phase III randomized, double-blind study showed dose-related improvements in ADHD symptoms with 20 mg and 40 mg doses showing statistically significant differences from placebo 3
• Long-term studies have shown maintained symptom control with continued treatment 4

Important Considerations

• Methylphenidate has a high potential for abuse and misuse; assess risk before prescribing 1
• Contraindicated in patients with hypersensitivity to methylphenidate and in those receiving MAOIs or within 14 days of MAOI discontinuation 1
• Avoid use in patients with structural cardiac abnormalities, cardiomyopathy, serious arrhythmia, or coronary artery disease 1

By following these dosing guidelines and monitoring parameters, Aptensio XR can effectively manage ADHD symptoms while minimizing potential adverse effects.