CONCERTA EXTENDED-RELEASE TABLET 36 MG [SIN12098P]

Product Info

CONCERTA EXTENDED-RELEASE TABLET 36 MG

[SIN12098P]

Indications
CONCERTA® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of CONCERTA® in the treatment of ADHD was established in controlled trials of children and adolescents aged 6 to 17 and adults aged 18 to 65 who met DSM-IV criteria for ADHD.

CONCERTA® should be used as a part of a comprehensive treatment program where remedial measures alone prove insufficient. A comprehensive treatment program for the treatment of ADHD may include other measures (psychological, educational, social) for patients with this disorder. Diagnosis must be made according to the current DSM criteria or ICD guidelines.

CONCERTA® treatment is not indicated in all patients with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity of the patient’s symptoms. Stimulants are not intended for use in the patient 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.

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.

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
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.

Dosage reduction and discontinuation
If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage, or, if necessary, discontinue CONCERTA®.

If improvement is not observed after appropriate dosage adjustment over a one- month period, discontinue CONCERTA®.

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.

Contraindications
CONCERTA® is contraindicated:

• in patients known to be hypersensitive to methylphenidate or other components of the product;

• in patients with glaucoma;

• during treatment with monoamine oxidase (MAO) inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase (MAO) inhibitor (hypertensive crisis may result) (see Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• in patients with hyperthyroidism;

• in patients with severe angina pectoris;

• in patients with cardiac arrhythmia;

• in patients with phaeochromocytoma.