Adults: Patients New to Methylphenidate: The recommended starting dosage 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 dosage of CONCERTA for patients who are currently taking methylphenidate twice daily or three times daily, at dosages of 10 to 60 mg/day is provided in the following table: (See Table 2.)
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Clinical judgment should be used when selecting the dose for patients currently taking methylphenidate in other regimens.
Dose Titration: The 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 and 72 mg in adolescents and in adults 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, the drug should be discontinued.
Special Populations: Pediatrics (under 6 years of age): Use of CONCERTA in patients under six years of age has not been studied in controlled trials. CONCERTA should not be used in patients under six years old.
Elderly (over 65 years of age): Use of CONCERTA in patients over 65 years of age has not been studied in controlled trials.
Administration: CONCERTA is administered orally once daily. As the effect has been shown to be present 12 hours after dosing, the product should be taken in the morning.
CONCERTA must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed (see Dose administration under Precautions).
CONCERTA may be administered with or without food (see Pharmacology: Pharmacokinetics: Food effects under Actions).