What is the recommended dosage and treatment approach for a patient with Attention Deficit Hyperactivity Disorder (ADHD) taking Focalin (dexmethylphenidate)?

Focalin (Dexmethylphenidate) Dosing and Treatment Approach for ADHD

For adults newly diagnosed with ADHD, start Focalin extended-release at 10 mg once daily in the morning, titrate weekly by 10 mg increments based on response, with a maximum dose of 40 mg daily. 1

Initial Dosing by Patient Population

Adults (Treatment-Naive or New to Methylphenidate)

• Start with 10 mg once daily in the morning with or without food 1
• This represents the FDA-approved starting dose for adult patients not currently on methylphenidate 1

Pediatric Patients (Ages 6-17 Years)

• Start with 5 mg once daily in the morning with or without food 1
• Lower starting dose reflects increased sensitivity in younger patients 1

Patients Currently on Racemic Methylphenidate

• Use half (1/2) the total daily dose of racemic methylphenidate as your starting dose of dexmethylphenidate 1
• This 2:1 conversion ratio reflects the fact that dexmethylphenidate contains only the active d-isomer 2

Patients Currently on Immediate-Release Dexmethylphenidate

• Give the same total daily dose when switching to extended-release formulation 1

Titration Protocol

Increase weekly in 5 mg increments for pediatric patients and 10 mg increments for adults until optimal symptom control is achieved 1. The FDA label is explicit about this titration schedule, which balances efficacy against tolerability 1.

Maximum Recommended Doses

• Pediatric patients: 30 mg daily 1
• Adult patients: 40 mg daily 1
• Doses above these limits have not been studied and are not recommended 1

Pre-Treatment Screening Requirements

Before prescribing Focalin, you must assess for specific contraindications and risk factors:

Cardiovascular Assessment

• Obtain careful personal and family history of sudden death or ventricular arrhythmia 1
• Perform physical examination focusing on cardiac findings 1
• Measure baseline blood pressure and pulse 3
• Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other serious cardiac disease 1

Substance Abuse Screening

• Screen for current or past substance abuse history, as this represents a relative contraindication requiring close supervision 3
• Dexmethylphenidate is a Schedule II controlled substance with high potential for abuse and misuse 1
• Consider non-stimulant alternatives in patients with active substance use disorders 3

Psychiatric Screening

• Screen for risk factors for developing manic episodes before initiating treatment 1
• Assess family history and clinically evaluate for motor or verbal tics or Tourette's syndrome 1

Ophthalmologic Considerations

• Evaluate patients at risk for acute angle closure glaucoma (e.g., those with significant hyperopia) by an ophthalmologist 1
• Use cautiously in patients with open-angle glaucoma or abnormally increased intraocular pressure only if benefits outweigh risks 1

Administration Options

Capsules may be swallowed whole OR opened and the entire contents sprinkled on applesauce 1. This flexibility is particularly useful for patients who have difficulty swallowing capsules 4.

• If using the sprinkle method, consume the applesauce immediately without chewing the beads 1
• Do not store sprinkled medication 1
• Never divide a single capsule dose—take the entire contents 1

Monitoring During Treatment

Follow-Up Schedule

Schedule monthly visits until symptoms stabilize, assessing both therapeutic response and adverse effects at each dose adjustment 3, 5

Vital Sign Monitoring

• Monitor blood pressure and pulse at each visit 3, 6
• Stimulants can increase blood pressure and heart rate 1

Growth Monitoring in Pediatric Patients

• Closely monitor height and weight in children and adolescents 1
• Pediatric patients not growing or gaining weight as expected may need treatment interruption 1

Symptom Assessment

• Use standardized ADHD rating scales to objectively measure improvement 3, 5
• Research demonstrates significant improvements on teacher and parent rating scales with dexmethylphenidate treatment 2, 7

Duration of Action and Timing Considerations

Dexmethylphenidate extended-release provides symptom control for approximately 12 hours after once-daily morning dosing 4. The bimodal release profile mimics two doses of immediate-release dexmethylphenidate given 4 hours apart 4.

• Efficacy begins as early as 0.5 hours post-dose and extends to 11-12 hours 4
• Research confirms significant effects at 6 hours post-dose on both symptom ratings and objective measures 8
• Avoid afternoon dosing to minimize insomnia risk 9

Common Adverse Effects and Management

The most common adverse reactions (≥5% and twice the rate of placebo) include:

In Pediatric Patients

• Dyspepsia, decreased appetite, headache, and anxiety 1

In Adults

• Dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety 1

Management Strategies

• For agitation and insomnia: reduce dose and ensure medication is taken early in the day 9
• Most side effects are mild to moderate in severity and similar to other stimulants 7
• Rare but serious effects include hypertension, palpitations, arrhythmias, confusion, and psychosis 9

When to Switch or Discontinue

Switching to Alternative Stimulant

If the first stimulant trial fails, switch to an alternative stimulant formulation before moving to non-stimulants 3, 6. Stimulants remain first-line treatment due to superior efficacy and rapid onset 3, 6.

Discontinuation Criteria

• If paradoxical aggravation of symptoms or intolerable adverse reactions occur, reduce dosage or discontinue 1
• If no improvement after appropriate dosage adjustment over one month, discontinue the drug 1
• Research demonstrates that 61.5% of patients relapse when switched to placebo versus only 17.1% who continue dexmethylphenidate 8

Critical Contraindications

Absolute contraindications include:

• Known hypersensitivity to methylphenidate or other components 1
• Concurrent treatment with MAOI or use of MAOI within preceding 14 days 1

Special Warnings

Priapism Risk

If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention 1

Peripheral Vasculopathy

Careful observation for digital changes is necessary during treatment 1. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy, including Raynaud's phenomenon 1.

Tics and Tourette's Syndrome

Regularly monitor patients for emergence or worsening of tics or Tourette's syndrome 1. Discontinue treatment if clinically appropriate 1.

Efficacy Evidence

Research demonstrates robust efficacy for dexmethylphenidate:

• 82% of patients achieved "much" or "very much improved" ratings during open-label titration 8
• All three fixed doses (10,20,30 mg) showed significant superiority over placebo on teacher, parent, and clinician ratings 7
• Average titrated dose of 18.25 mg/day dexmethylphenidate is as efficacious as 32.14 mg/day racemic methylphenidate, confirming the 2:1 potency ratio 2