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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.
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 non-absorbable 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.
Use in other indications: CONCERTA should not be used to treat severe depression and/or for the prevention or treatment of normal fatigue states.
Psychotic or manic symptoms: Psychotic (e.g., hallucinations) or manic symptoms have been reported in patients without a prior history of psychotic illness or mania during treatment with CONCERTA at usual doses. If such symptoms occur, consideration should be given to a possible causal role of CONCERTA and discontinuation of treatment may be appropriate (see Adverse Reactions).
Aggression, anxiety and agitation: Aggressive behavior, marked anxiety, or agitation are often observed in patients with ADHD, and have been reported in patients treated with CONCERTA (see Adverse Reactions). Anxiety led to discontinuation of CONCERTA in some patients. It is recommended to monitor patients beginning treatment with CONCERTA for the appearance of, or worsening of, aggressive behavior, marked anxiety, or agitation.
Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained erections or frequent and painful erections should seek immediate medical attention.
Cerebrovascular disorders: Cerebrovascular disorders (including cerebral vasculitis and cerebral hemorrhage) have been reported with the use of CONCERTA (see Adverse Reactions). Consider cerebrovascular disorders as a possible diagnosis in any patient who develops new neurological symptoms that are consistent with cerebral ischemia during CONCERTA therapy. These symptoms could include severe headache, unilateral weakness or paralysis, and impairment of coordination, vision, speech, language, or memory. If a cerebrovascular disorder is suspected during treatment, discontinue CONCERTA immediately. Early diagnosis may guide subsequent treatment.
In patients with pre-existing cerebrovascular disorders (e.g., aneurysm, vascular malformations/anomalies), treatment with CONCERTA is not recommended.
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: In the laboratory classroom clinical trials in children, both CONCERTA and methylphenidate three times daily 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 approximately 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 increases in blood pressure or heart rate. Blood pressure (especially for patients with hypertension) and heart rate should be monitored at appropriate intervals in patients taking CONCERTA.
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.
Hematologic monitoring: Periodic hematologic monitoring (Complete Blood Count, differential, and platelet counts) is advised during prolonged therapy.
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.
Use in Children: 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.
