RITALIN

What it is

RITALIN is a modified-release tablet containing methylphenidate hydrochloride, available in strengths of 18, 27, 36 or 54 mg. It is designed to have a 12-hour duration of effect. RITALIN is administered orally once daily and should be taken in the morning.

Approved indications

— Treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Dosing overview

Treatment should be started on the lowest possible dose. Children greater than 6 years old and adolescents may have dosage adjusted in 9 mg increments between 18 mg and 36 mg and consecutively in an 18 mg increment to a maximum of 54 mg per day taken once daily in the morning. Adults can have dosage adjusted from an initial dose of 18 or 36 mg per day in 18 mg increments to a maximum of 72 mg per day taken once daily in the morning. Patients respond at different dose levels and RITALIN must be titrated to effect on an individual patient needs and response basis.

Key safety warnings

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. 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. RITALIN 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. Treatment emergent psychotic or manic symptoms, such as 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. If the seizure frequency increases following the initiation of methylphenidate, consideration should be given to discontinuation of the drug. Consistently medicated children 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

RITALIN 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 (MAO) inhibitors or selective MAO-A inhibitors or within a minimum of 14 days following discontinuation of these agents; 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, since RITALIN might worsen these conditions.

PBS listing

RITALIN is listed on the PBS in modified-release capsule formulations containing methylphenidate hydrochloride 10 mg, 20 mg, 30 mg, 40 mg and 60 mg. All listings are restricted to authority required. Ex-manufacturer prices range from A$45.23 to A$496.58.

Regulatory history

RITALIN 10 mg tablets were first listed on the ARTG on 2 August 1991. RITALIN LA modified-release capsules in strengths of 20 mg, 30 mg and 40 mg were first listed on 21 August 2002. A 10 mg modified-release capsule strength was added on 18 December 2009. The 60 mg modified-release capsule was first listed on 11 March 2016. In March 2020, the PBAC recommended listing of the 60 mg capsule under the same conditions as the currently listed RITALIN LA strengths for the treatment of Attention Deficit Hyperactivity Disorder.