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.
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.
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 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.