DOSAGE AND ADMINISTRATION
CONCERTA® should be administered orally once daily in the morning with or without food.
CONCERTA® must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed (see PRECAUTIONS: Information for Patients).
Based on an assessment of clinical benefit and tolerability, doses may be increased at weekly intervals for patients who have not achieved an optimal response at a lower dose.
Patients New to Methylphenidate
The recommended starting dose of CONCERTA® for patients who are not currently taking methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg once daily.
| Patient Age || Recommended Starting Dose || Maximum Dosage |
|Children 6-12 years of age ||18 mg/day ||54 mg/day |
|Adolescents 13-17 years of age ||18 mg/day ||72 mg/day |
not to exceed 2 mg/kg/day
Patients Currently Using Methylphenidate
The recommended dose of CONCERTA® for patients who are currently taking methylphenidate bid or tid, at doses of 10 to 45 mg/day is provided in Table 4. Dosing recommendations are based on current dose regimen and clinical judgment. Initial conversion dosage should not exceed 54 mg daily. After conversion, dosages may be adjusted to a maximum of 72 mg/day taken once daily in the morning. In general, dosage adjustment may proceed at approximately weekly intervals.
TABLE 4 Recommended Dose Conversion from Methylphenidate Regimens to CONCERTA®
| Previous Methylphenidate Daily Dose || Recommended CONCERTA ®|
|5 mg Methylphenidate bid or tid||18 mg q am |
|10 mg Methylphenidate bid or tid||36 mg q am |
|15 mg Methylphenidate bid or tid||54 mg q am |
Other methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.
A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 mg and 36 mg dosages.
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with CONCERTA®. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.
Nevertheless, 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. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
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.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.