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.
Central nervous system stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Therefore, clinical evaluation for tics in patients should precede use of stimulant medication. Family history should be assessed.
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.
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 Concerta tablet is non-deformable and does not appreciably change in shape in the gastrointestinal 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.
Concerta should not be used to treat severe depression and/or for the prevention or treatment of normal fatigue states.
Psychotic (eg, 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).
Patients beginning treatment with Concerta should be monitored for the appearance or worsening of aggressive behavior. Aggression is frequently associated with ADHD; however, emergence or worsening of aggression has been reported during treatment with Concerta (see Adverse Reactions).
Concerta should be given with caution in the following conditions: Clinical experience suggests that in psychotic patients, administration of methylphenidate may exacerbate symptoms of behavior disturbance and thought disorder.
In the laboratory classroom clinical trials in children, both Concerta and methylphenidate administered 3 times daily increased resting pulse rate by an average of 2-6 beats per minute (bpm) and produced average increases of systolic and diastolic blood pressure of roughly 1-4 mmHg during the day, relative to placebo. In placebo-controlled studies in adults, mean increases in resting pulse rate of approximately 4-6 bpm were observed with Concerta at endpoint versus a mean change of roughly -2 to 3 bpm with placebo. Mean changes in blood pressure at endpoint ranged from about -1 to 1 mmHg (systolic) and 0-1 mmHg (diastolic) for Concerta and from -1 to 1 mmHg (systolic) and -2 to 0 mmHg (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.
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.
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, Concerta should be discontinued.
Symptoms of visual disturbances have been encountered in rare cases. Difficulties with accommodation and blurring of vision have been reported.
Periodic hematologic monitoring (complete blood count, differential and platelet counts) is advised during prolonged therapy.
Effects on the Ability to Drive or Operate Machinery: 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 pregnancy: The safety of methylphenidate for use during human pregnancy has not been established. No studies are available on the use of Concerta in pregnant women. Concerta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Methylphenidate hydrochloride has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times the maximum recommended human dose on a mg/kg basis.
Teratogenic effects were not seen in rats at methylphenidate hydrochloride doses up to 30 mg/kg/day, resulting in an approximate systemic exposure to methylphenidate of 9-12 times that seen in trials in volunteers and patients with the maximum recommended dose of Concerta, based on pharmacokinetic data.
Methylphenidate did not impair fertility in mice that received up to 160 mg/kg/day methylphenidate hydrochloride in an 18-week continuous breeding study.
Use in lactation: It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Concerta is administered to a nursing woman.
Use in children: Concerta should not be used in patients <6 years. Sufficient data on the safety of long-term use of methylphenidate is not yet available.
Use in the elderly: Use of Concerta in elderly patients >65 years has not been studied in controlled trials.