What is the generic version of Focalin (dexmethylphenidate)?

Generic Version of Focalin (Dexmethylphenidate)

The generic version of Focalin (brand name) is dexmethylphenidate hydrochloride, which is available in both immediate-release and extended-release formulations. 1

Formulation Types

Dexmethylphenidate is available in two main formulations:

1. Immediate-release (IR) tablets:

   • Shorter duration of action (approximately 4 hours)
   • Typically requires multiple daily doses
   • Available in 2.5 mg, 5 mg, and 10 mg strengths

2. Extended-release (XR) capsules:

   • Bimodal release profile that mimics two doses of immediate-release given 4 hours apart
   • Allows for once-daily dosing
   • Duration of action up to 12 hours
   • Available in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg strengths 1, 2

Pharmacology

Dexmethylphenidate is the d-threo enantiomer (active isomer) of racemic methylphenidate hydrochloride. Key points about its pharmacology:

• Contains only the active d-isomer of methylphenidate, allowing for half the dose compared to racemic methylphenidate (Ritalin) 3
• Mechanism of action: Blocks reuptake of norepinephrine and dopamine into presynaptic neurons and increases release of these monoamines 1
• Extended-release formulation has a unique design:
  • Half the dose as immediate-release beads
  • Half as enteric-coated, delayed-release beads
  • Creates two distinct peaks approximately 4 hours apart 1, 4

Clinical Considerations

• Efficacy: Dexmethylphenidate XR has shown efficacy in treating ADHD with effects lasting from 0.5 hours after administration up to 11-12 hours post-dose 2
• Dosing convenience: The extended-release formulation eliminates the need for midday dosing at school or work 2
• Administration options: For patients who cannot swallow capsules whole, the contents of dexmethylphenidate XR capsules can be sprinkled on applesauce 2
• Controlled substance: Classified as a Schedule II controlled substance due to potential for abuse 3

Safety Considerations

• Common adverse effects: Decreased appetite, sleep disturbances, increased blood pressure and pulse, headaches, and stomach pain 1
• Cardiovascular monitoring: Regular monitoring of blood pressure and heart rate is recommended, particularly in patients with cardiovascular risk factors 5
• Physical dependence: May produce physical dependence with withdrawal symptoms after abrupt discontinuation including dysphoric mood, depression, fatigue, vivid dreams, insomnia/hypersomnia, increased appetite, and psychomotor changes 1
• Abuse potential: The extended-release formulation appears to have a lower risk of abuse compared to immediate-release formulations 2

Practical Takeaways

• When switching from brand name Focalin to generic dexmethylphenidate, ensure the same formulation (IR or XR) is maintained
• The extended-release formulation offers convenience of once-daily dosing with effects lasting throughout the day
• Dexmethylphenidate requires half the dose of racemic methylphenidate (Ritalin) for equivalent efficacy 3
• Monitor for common side effects, particularly at initiation or dose changes