What is the recommended dosing and administration for starting Concerta (methylphenidate) in an adult?

Starting Concerta in Adults with ADHD

Recommended Initial Dosing

For adults starting Concerta (OROS methylphenidate), begin with 18-36 mg once daily in the morning, titrate by 18 mg increments weekly as tolerated, with a maximum dose of 72 mg/day (though FDA labeling for immediate-release methylphenidate specifies 60 mg/day maximum). 1

Specific Dosing Protocol

Starting Dose

• Initial dose: 18 mg once daily in the morning 2, 1
• The FDA label for methylphenidate indicates adults should receive divided doses 2-3 times daily for immediate-release formulations, but Concerta's extended-release design allows once-daily dosing 1
• Average therapeutic dosage range is 20-30 mg daily of methylphenidate equivalents 1

Titration Schedule

• Increase by 18 mg increments weekly based on response and tolerability 2, 3
• The maximum FDA-approved daily dose is 60 mg for methylphenidate products, though some sources reference up to 72 mg for Concerta specifically 1
• Titration should continue until optimal symptom control is achieved or dose-limiting side effects occur 3

Administration Timing

• Administer once daily in the morning 1
• For adults with insomnia concerns, ensure the last (or only) dose is taken before 6 PM 1
• Concerta can be taken with or without food, as the osmotic delivery system provides consistent methylphenidate exposure independent of meals 4, 5

Critical Pre-Treatment Screening

Before prescribing Concerta, you must assess for: 1

• Cardiac disease risk factors: Obtain careful personal and family history of sudden death, ventricular arrhythmia, structural cardiac abnormalities, cardiomyopathy, or serious arrhythmias 1
• Contraindications: Known hypersensitivity to methylphenidate, current MAOI use or use within 14 days 1
• Substance abuse risk: Assess each patient's risk for abuse, misuse, and addiction given methylphenidate's high abuse potential 1
• Psychiatric history: Screen for risk factors for mania, psychosis, or bipolar disorder 1
• Tics or Tourette's syndrome: Evaluate family history and clinically assess for motor or verbal tics 1

Pharmacokinetic Advantages of Concerta

• Duration of action: 10-12 hours with once-daily dosing, eliminating need for mid-day doses 5, 6
• Ascending delivery profile: The OROS technology provides an initial bolus followed by increasing plasma concentrations that peak 7-9 hours post-dose, designed to overcome acute tolerance (tachyphylaxis) 5
• Rapid onset: Therapeutic effects begin within 1-2 hours of administration 5, 6
• Food-independent absorption: Unlike amphetamine-based extended-release products, Concerta provides consistent early drug exposure regardless of high-fat breakfast consumption 4

Monitoring and Dose Adjustment

Initial Month

• Assess response after appropriate dosage adjustment over one month 1
• If no improvement is observed after one month of adequate dosing, discontinue Concerta 1
• Monitor for paradoxical aggravation of symptoms, which may require dose reduction or discontinuation 1

Ongoing Monitoring

• Blood pressure and heart rate: CNS stimulants increase BP by 2-4 mmHg and heart rate by 3-6 bpm on average 1
• Signs of abuse or misuse: Reassess risk throughout treatment and monitor for diversion 1
• Psychiatric symptoms: Watch for emergence of psychotic or manic symptoms 1
• Cardiovascular symptoms: Monitor for chest pain, palpitations, or syncope 1

Common Pitfalls to Avoid

• Do not use in patients with structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, or coronary artery disease due to risk of sudden death 1
• Avoid concurrent MAOI use due to risk of hypertensive crisis 1
• Do not crush or allow patients to crush tablets: Concerta is designed as an intact osmotic pump system; crushing defeats the extended-release mechanism and increases abuse potential 2, 6
• Do not assume weight-based dosing: Behavioral responses to methylphenidate are highly variable, so titrate based on clinical response rather than body weight 3
• Educate patients about abuse potential: Methylphenidate has high potential for diversion, misuse, and development of substance use disorder 1

Special Considerations for Adults

• Adults may require higher total daily doses (up to 60 mg) compared to the starting dose, with the average therapeutic dose being 20-30 mg daily 1
• Comorbid substance abuse is a major concern: Exercise extreme caution when prescribing to adults with current or past substance use disorders 2
• Response rates in adults: Studies show 78% improvement with methylphenidate at 1 mg/kg total daily dose versus 4% with placebo, though response rates vary from 23-75% across studies 2
• Common adult side effects: Loss of appetite, insomnia, and anxiety are most frequently reported 2