CONCERTA EXTENDED-RELEASE TABLET 18 mg

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**Dosage and Administration** **Dosage** **_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 to 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 Table 1.  Clinical judgment should be used when selecting the starting 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, 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended. A 27mg dosage strength is available for physicians who wish to prescribe between 18 and 36mg dosage. **_Maintenance/extended treatment_** 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. **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 once daily in the morning. CONCERTA® must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed (see _Precautions – Information for Patients_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). CONCERTA® may be administered with or without food (see _Pharmacokinetic Properties – Food effects_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **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. Long-term effects of methylphenidate in children are not yet available. Although a causal relationship has not been established, suppression of growth (ie weight gain and/or height) has been reported with the long-term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored. Patients who are not growing or gaining weight as expected should have their treatment interrupted. **_Elderly (over 65 years of age)_** Use of CONCERTA® in elderly patients over 65 years of age has not been studied in controlled trials. **_Renal insufficiency_** There is no experience with the use of CONCERTA® in patients with renal insufficiency (see _Pharmacokinetic Properties – Special populations, Renal insufficiency_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Hepatic insufficiency_** There is no experience with the use of CONCERTA® in patients with hepatic insufficiency.