Metadate CD (Methylphenidate Hydrochloride) - Indications and Dosage

INDICATION AND USAGE

Attention Deficit Hyperactivity Disorder (ADHD)

METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of METADATE CD in the treatment of ADHD was established in one controlled trial of children aged 6 to 15 who 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, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., 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 Types 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 not only of medical but of 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 child and not solely on the presence of the required number of DSM-IV characteristics.

Need For Comprehensive Treatment Program

METADATE CD 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 children with this syndrome. Stimulants are not intended for use in the child who exhibits 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 child’s symptoms.

Long-Term Use

The effectiveness of METADATE CD for long-term use, i.e., for more than 3 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use METADATE CD 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

METADATE CD is administered once daily in the morning, before breakfast.

METADATE CD may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, and not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed (see PRECAUTIONS: Information for Patients).

Dosage should be individualized according to the needs and responses of the patient.

Initial Treatment

The recommended starting dose of METADATE CD is 20 mg once daily. Dosage may be adjusted in weekly 10-20 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending upon tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended.

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 METADATE CD. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use METADATE CD 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

METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules are available in six strengths:

10 mg, green/white capsules, imprinted with “UCB 579” in white letters on the green cap, and “10 mg” in black letters on the white body of the capsule.

      NDC 53014-579-07      Bottle of 100 Capsules

20 mg, blue/white capsules, imprinted with ”UCB 580” in white letters on the blue cap, and “20 mg” in black letters on the white body of the capsule.

      NDC 53014-580-07      Bottle of 100 Capsules

30 mg, reddish-brown/white capsules, imprinted with “UCB 581” in white letters on the reddish-brown cap, and “30 mg” in black letters on the white body of the capsule.

      NDC 53014-581-07      Bottle of 100 Capsules

40 mg, yellow ivory/white capsules, imprinted with “UCB 582” in black letters on the yellow ivory cap, and “40 mg” in black letters on the white body of the capsule.

      NDC 53014-582-07      Bottle of 100 Capsules

50 mg, purple/white capsules, imprinted with “UCB 583” in white letters on the purple cap, and “50 mg” in black letters on the white body of the capsule.

      NDC 53014-583-07      Bottle of 100 Capsules

60 mg, white/white capsules, imprinted with “UCB 584” in black letters on the white cap, and “60 mg” in black letters on the white body of the capsule.

      NDC 53014-584-07      Bottle of 100 Capsules

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

Keep out of the reach of children.