Concerta (Methylphenidate Hydrochloride) - Indications and Dosage

INDICATION AND USAGE

Attention Deficit Hyperactivity Disorder (ADHD)

CONCERTA^® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of CONCERTA^® in the treatment of ADHD was established in three controlled trials of children aged 6-12 and in one controlled trial in adolescents aged 13-17. All patients met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY).

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, eg, in social, academic, or occupational functioning, and be present in two or more settings, eg, school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities;“on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.

Need for Comprehensive Treatment Program

CONCERTA^® is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.

Long-Term Use

The effectiveness of CONCERTA^® for long-term use, ie, for more than 4 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use CONCERTA^® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

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 ® Starting Dose
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.

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.

HOW SUPPLIED

CONCERTA^® (methylphenidate HCl) Extended-release Tablets are available in 18 mg, 27 mg, 36 mg, and 54 mg dosage strengths. The 18 mg tablets are yellow and imprinted with “alza 18”. The 27 mg tablets are gray and imprinted with “alza 27”. The 36 mg tablets are white and imprinted with “alza 36”. The 54 mg tablets are brownish-red and imprinted with “alza 54”. All four dosage strengths are supplied in bottles containing 100 tablets.

18 mg 100 count bottle         NDC 17314-5850-2
27 mg 100 count bottle         NDC 17314-5853-2
36 mg 100 count bottle         NDC 17314-5851-2
54 mg 100 count bottle         NDC 17314-5852-2

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from humidity.