Focalin

(dexmethylphenidate) 

 

 

 

 Full Prescribing Information 

 DailyMed Drug Information 

 

 

 

 

 Forms/Strengths 

 

 Tablets:  2.5 mg, 5 mg, 10 mg 

 

 

 Dosing 

 

 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) 

 

 

 Quick Facts 

 

 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 

 

 

 Indications 

 

   ADHD (ICD-10: F90.0) 

 

 

 Off-Label Uses 

 

  N/A 

 

 

 How to Take 

 

 Take once or twice daily , with doses at least 4 hours apart . 

 Can be taken with or without food ; high-fat meals may delay absorption. 

 Swallow the tablet whole ; do not crush, chew, or split. 

 Avoid taking late in the day to prevent insomnia. 

 

 

 Side Effects 

 

 Decreased appetite, weight loss 

 Abdominal pain 

 Nausea 

 Insomnia 

 Tachycardia, potential elevations in blood pressure 

 Possible new or worsened psychiatric symptoms (psychosis, mania) 

 Priapism (rare, but serious) 

 

 

 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).