CONCERTA

What it is

CONCERTA is a modified-release tablet for once-a-day oral administration containing 18, 27, 36 or 54 mg methylphenidate hydrochloride. It is designed to have a 12-hour duration of effect.

Approved indications

— Treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Dosing overview

CONCERTA is administered orally once daily and should be taken in the morning. CONCERTA must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. Treatment should be started on the lowest possible dose. Patients respond at different dose levels and CONCERTA must be titrated to effect on an individual patient needs and response basis. Patients should be reviewed at least annually to assess if there is an ongoing requirement for treatment with CONCERTA.

Key safety warnings

Sudden death has been reported in association with central nervous system stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs. It is essential that children, adolescents, or adults with pre-existing structural cardiac abnormalities or other serious heart problems being considered for treatment are assessed by a cardiologist before initiating treatment. Ongoing cardiologist supervision should be maintained throughout treatment in these patients. CONCERTA should be given cautiously to patients with a history of drug or alcohol dependence. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. 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. Treatment emergent psychotic or manic symptoms, for example, hallucinations, delusional thinking or mania in patients without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. There is some clinical evidence that methylphenidate may lower the convulsive threshold in a small minority of patients. Patients treated with methylphenidate should be monitored for the new appearance of seizures or a reduction in seizure-control. Carefully medicated children treated for 7 days per week throughout the year have a temporary slowing in growth rate, on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years. Growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Contraindications

CONCERTA is contraindicated in patients with known hypersensitivity to methylphenidate or any inactive ingredient; in patients with poorly-controlled open-angle or angle-closure glaucoma; in combination with non-selective, irreversible monoamine oxidase inhibitors or selective monoamine oxidase-A inhibitors or within a minimum of 14 days following discontinuation of such inhibitors; in patients with hyperthyroidism; in patients with severe angina pectoris; in patients with cardiac arrhythmia; in patients with phaeochromocytoma; in patients with known drug dependence or alcohol abuse; in patients with uncontrolled hypertension; in patients with cardiomyopathies; in patients with ischaemic heart disease; in patients with myocardial infarctions; and in patients who currently exhibit severe depression, anorexia nervosa, psychotic symptoms or suicidal tendency.

PBS listing

CONCERTA is listed on the Pharmaceutical Benefits Scheme at four strengths: 18 mg, 27 mg, 36 mg and 54 mg tablets containing methylphenidate hydrochloride (extended release). All are listed as a single item per strength with authority required restriction. Ex-manufacturer prices range from A$148.22 to A$301.49 depending on strength.

Regulatory history

CONCERTA was first registered on the Australian Register of Therapeutic Goods on 3 September 2003, with the 18 mg, 36 mg and 54 mg strengths (ARTG 93862, 93863, 93864). The 27 mg strength was added on 7 August 2006 (ARTG 124502).