Focalin XR

(dexmethylphenidate XR)
Full Prescribing Information
DailyMed Drug Information
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).