Focalin XR

Full Prescribing Information

DailyMed Drug Information

Forms/Strengths

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

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

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.

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

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.

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.

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).