Focalin XR

(dexmethylphenidate XR)

Forms/Strengths

• Capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg

Dosing

• Age: ≥ 6 y/o
• Onset: ~ 30 min
• Duration: 8-12 hours
• Release Profile: 50% IR, 50% ER
• Considerations: Capsules may be swallowed whole or opened, and the entire contents can be sprinkled on applesauce.
• Initial Dose:
  • New to methylphenidate:
    • 6-17 y/o: 5 mg
    • Adults: 10 mg
  • Currently on methylphenidate: Focalin XR dosage is half (1/2) the current total daily dosage of methylphenidate
  • Currently on Focalin IR: Give the same daily dose of Focalin XR
• Titration:
  • 6-17 y/o: 5 mg weekly
  • Adults: 10 mg weekly
• Max Dose:
  • 6-17 y/o: 30 mg/day
  • Adults: 40 mg/day

Quick Facts

• Inhibits dopamine/norepinephrine reuptake; enhances focus, attention, and impulse control
• Extended-release formulation provides sustained symptom control
• Uses SODAS technology for a bi-modal release profile (initial and extended release)
• Contains isolated active dextroisomer (dexmethylphenidate), potentially allowing for lower dosing
• Common side effects: decreased appetite, insomnia, headache, stomach upset

Indications

•  ADHD (ICD-10: F90.0)

Off-Label Uses

• N/A 

How to Take

• Take once daily in the morning to minimize the risk of insomnia.
• Can be taken with or without food; high-fat meals may delay absorption.
• Swallow the capsule whole; do not crush or chew.
• If needed, the capsule can be opened, and contents sprinkled on applesauce—consume immediately without chewing.
  

Side Effects

• Common: Dry mouth, dyspepsia, headache, anxiety, decreased appetite
• Serious: Cardiac issues, psychiatric symptoms, priapism, peripheral vasculopathy, growth suppression in children

Monitoring / Labs

• Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
• Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
• Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
• Abuse Potential: Monitor for misuse or diversion.

Education

• When to Call the Doctor:

  • Severe mood changes, aggression, or suicidal thoughts.
  • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
  • Uncontrolled movements, tics, or worsening anxiety.
  • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
  • Unexplained weight loss or delayed growth in pediatric patients.

• Safety Tips:

  • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
  • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
  • Avoid caffeine and other stimulants, which may amplify side effects.
  • Ensure adequate hydration and nutrition, as appetite suppression is common.
  • Tapering may be required if discontinuing after long-term use.

• Parent Tips for Pediatric Patients:

  • Encourage a nutrient-dense diet to counteract appetite suppression.
  • Administer in the morning before school for optimal effect.
  • Monitor school performance and behavioral changes.
  • Observe for sleep disturbances; adjust timing if necessary.
  • Communicate regularly with teachers and caregivers about medication effects.

Additional Information

• Contraindications:

  • Hypersensitivity to dexmethylphenidate or formulation components.
  • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
  • History of substance use disorder, unless benefits outweigh risks.

• Pregnancy:

  • Category C; use only if benefits outweigh risks.
  • May cause neonatal withdrawal symptoms or low birth weight.

• Lactation:

  • Excreted in breast milk; not recommended due to potential infant exposure.

• Drug Interactions:

  • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
  • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
  • Alkalinizing agents (e.g., sodium bicarbonate) may increase dexmethylphenidate levels.
  • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).