Administer orally once daily. As the effect has been shown to be present 12 hrs after dosing, Concerta should be taken once daily in the morning.
Concerta should be swallowed whole with the aid of liquids and must not be chewed, divided, or crushed (see Precautions). It may be administered with or without food (see Pharmacokinetics under Actions).
Patients New to Methylphenidate: The recommended starting dose of Concerta for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults.
Patients Currently Using Methylphenidate: The recommended dose of Concerta for patients who are currently taking methylphenidate twice daily or 3 times daily, at doses of 10-60 mg/day, is provided as follows: Recommended Dose Conversion from Methylphenidate Regimens to Concerta: Methylphenidate 5 mg twice daily or 3 times daily: Concerta 18 mg every morning; methylphenidate 10 mg twice daily or 3 times daily: Concerta 36 mg; methylphenidate 15 mg twice daily or 3 times daily: Concerta 54 mg every morning; methylphenidate 20 mg twice daily or 3 times daily: Concerta 72 mg every morning.
Clinical judgement should be used when selecting the dose for patients currently taking methylphenidate in other regimens.
Dose Titration: Dosage should be individualized according to the needs and responses of the patient. Doses may be increased in 18-mg increments at weekly intervals. Daily dosages above 54 mg in children, 72 mg in adolescents and 108 mg in adults have not been studied and are not recommended.
Maintenance/Extended Treatment: The long-term use of methylphenidate has not been systematically evaluated in controlled trials. The physician who elects to use Concerta for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy.
Dose Reduction and Discontinuation: If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or if necessary, Concerta should be discontinued.
Children <6 years: Use of Concerta in patients <6 years has not been studied in controlled trials. Concerta should not be used in patients <6 years.
Elderly: Use of Concerta in elderly patients >65 years has not been studied in controlled trials.