Focalin

Full Prescribing Information

DailyMed Drug Information

Forms/Strengths

Age: ≥ 6 y/o
Onset: ~ 30 minutes
Duration: 5-6 hours
Considerations: Give approximately 1/2 the methylphenidate dose. Administer orally twice daily, at least 4 hours apart, with or without food.
Initial Dose:
- New to methylphenidate: 2.5 mg twice daily
- Currently taking methylphenidate: Start with half the current total daily dose of methylphenidate (up to 10 mg twice daily)
Titration: Increase by 2.5-5 mg daily every 3 to 7 days
Max Dose: 20 mg/day (10 mg twice daily)

Increases synaptic dopamine and norepinephrine by enhancing presynaptic release
Improves focus, attention, and impulse control
Immediate-release formulation for rapid onset
Unique formulation contains the isolated active dextroisomer (dexmethylphenidate), potentially allowing for lower dosing
Common side effects: decreased appetite, insomnia, increased blood pressure, headache

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).