Structural cardiac abnormalities: Although a causal relationship has not been established, sudden death has been reported in patients with structural cardiac abnormalities treated with ADHD drugs with stimulant effects. These treatments should be used with caution in patients with structural cardiac abnormalities.
Patients under six years old: CONCERTA should not be used in patients under six years old. Sufficient data on the safety of long-term use of methylphenidate is not yet available.
Motor and verbal tics, and worsening of Tourette's syndrome: Central nervous system (CNS) stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette's syndrome has also been reported. It is recommended that the family history be assessed, and that the patient is clinically evaluated for tics or Tourette's syndrome before initiating methylphenidate. Regular monitoring for the emergence or worsening of tics or Tourette's syndrome during treatment with methylphenidate is recommended at every dose adjustment and every visit, and treatment discontinued if clinically appropriate.
Long-term use: Although a causal relationship has not been established, suppression of growth (i.e., 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.
Dose administration: CONCERTA must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Because the CONCERTA tablet is non-deformable and does not appreciably change in shape in the GI tract, CONCERTA should ordinarily not be administered to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic) or in patients with dysphagia or significant difficulty in swallowing tablets. There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of drugs in non-deformable controlled-release formulations. Due to the controlled release design of the tablet, CONCERTA should only be used in patients who are able to swallow the tablet whole.
Psychotic or manic symptoms: Clinical experience suggests that in psychotic patients, administration of methylphenidate may exacerbate symptoms of behavior disturbance and thought disorder.
Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients.
Treatment emergent psychotic or manic symptoms, eg. Hallucinations, delusional thinking or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptpms occur, consideration should be given to a possible causal role of the stimulant and discontinuation of treatment may be appropriate.
Aggressive behavior: Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.
Priapism: Prolonged and painful erections requiring immediate medical attention (sometimes including surgical intervention), have been reported with methylphenidate products, including CONCERTA in both pediatric and adult patients (see Adverse Reactions). Priapism can develop after some time on methylphenidate, often subsequent to an increase in dose. Priapism has also appeared during a period of methyphenidate withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained erections or frequent and painful erections should seek immediate medical attention.
Conditions requiring caution: CONCERTA should be given with caution in the following conditions: Psychotic patients: Clinical experience suggests that in psychotic patients, administration of methylphenidate may exacerbate symptoms of behavior disturbance and thought disorder.
Underlying medical conditions that might be compromised by increases in blood pressure or heart rate: Use cautiously in patients with hypertension. Cardiovascular status and blood pressure should be monitored at appropriate intervals in patients taking CONCERTA, especially patients with hypertension. In the laboratory classroom clinical trials in children, both CONCERTA and methylphenidate tid increased resting pulse by an average of 2 to 6 bpm and produced average increases of systolic and diastolic blood pressure of roughly 1 to 4 mm Hg during the day, relative to placebo. In placebo-controlled studies in adults, mean increases in resting pulse rate of apporoximately 4 to 6 bpm were observed with CONCERTA at endpoint vs. a mean change of roughly -2 to 3 bpm with placebo. Mean changes in blood pressure at endpoint ranged from about -1 to 1 mm Hg (systolic) and 0 to 1 mm Hg (diastolic) for CONCERTA and from -1 to 1 mm Hg (Systolic) and 2 to 0 mm Hg (diastolic) for placebo. Therefore, caution is indicated in treating patients whose underlying medical conditions might be compromised by increase in blood pressure or heart rate, eg. those with preexisting hypertension, heart failure, recent myocardial infarction, or hyperthyroidism.
Children, adolescents or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
History of drug dependence or alcoholism: CONCERTA should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
History of seizure or prior EEG abnormalities: There is some clinical evidence that methylphenidate may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in absence of history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
Visual disturbances: Symptoms of visual disturbances have been encountered in rare cases. Difficulties with accommodation and blurring of vision have been reported.
Hematologic monitoring: Periodic hematologic monitoring (Complete Blood Count, differential, and platelet counts) is advised during prolonged therapy.
Drug Abuse and Dependence: Controlled Substance Class: CONCERTA, like other methylphenidate products, is classified as a Schedule II controlled substance.
Abuse, Dependence, and Tolerance: See Warnings for boxed warning containing drug abuse and dependence information.
Effects on Ability to Drive and Use Machines: Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Patients should be cautioned accordingly until they are reasonably certain that CONCERTA does not adversely affect their ability to engage in such activities.