ARTIGE

What it is

ARTIGE contains methylphenidate hydrochloride and is available as a modified release capsule in strengths of 10 mg, 20 mg, 30 mg, 40 mg or 60 mg. The capsules are administered orally once daily in the morning. ARTIGE may be swallowed as whole modified release capsules or alternatively administered by sprinkling the capsule contents on soft food, but the capsules and their contents should not be crushed, chewed or divided.

Approved indications —

Attention-Deficit Hyperactivity Disorder (ADHD), as an integral part of a total treatment program that may include psychological, educational and social measures.

Dosing overview

Dosage should be individualised according to the patient's clinical needs and responses, with treatment initiated at a low dose and increments made at weekly intervals. For children and adolescents aged 6 years and over who are new to methylphenidate, the recommended starting dose is 20 mg once daily, or 10 mg if a lower initial dose is appropriate. Daily doses above 60 mg are not recommended for children and adolescents. For adults new to methylphenidate, the recommended starting dose is 20 mg once daily. Daily doses above 80 mg are not recommended for adults. Dosage may be adjusted at weekly intervals in 10 mg increments for children and 20 mg increments for adults.

Key safety warnings

Patients with pre-existing structural cardiac abnormalities or other serious heart problems being considered for treatment should be assessed by a cardiologist before initiating treatment, with on-going cardiological supervision maintained throughout treatment. 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, and stimulant products should generally not be used in patients with known serious structural cardiac abnormalities or other serious cardiac problems that may increase the risk of sudden death. Sudden death, stroke and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD, and adults with serious structural cardiac abnormalities or other serious cardiac problems should generally not be treated with stimulant drugs. ARTIGE increases heart rate and systolic and diastolic blood pressure, and caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, such as those with pre-existing hypertension. Blood pressure should be monitored at appropriate intervals in all patients taking methylphenidate, especially in those with hypertension. In psychotic patients, administration of methylphenidate may exacerbate symptoms of behaviour disturbance and thought disorder. Psychotic symptoms, including visual and tactile hallucinations or mania have been reported in patients administered usual prescribed doses of stimulant products, and physicians should consider treatment discontinuation if psychotic symptoms occur. CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics, and worsening of Tourette's syndrome has been reported. Patients should be regularly monitored for the emergence or worsening of tics during treatment with methylphenidate. Moderately reduced weight gain and slight growth retardation have been reported with the long-term use of stimulants including methylphenidate in children, and growth should be monitored as clinically necessary during treatment, with patients who are not growing or gaining height or weight as expected possibly requiring treatment interruption. Carefully medicated children treated consistently throughout the year have a temporary slowing in growth rate, on average about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years. ARTIGE should be given cautiously to patients with a history of drug dependence or alcoholism, as chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour.

Contraindications

ARTIGE is contraindicated in patients with anxiety and tension states, agitation, family history or diagnosis of Tourette's syndrome, glaucoma, hyperthyroidism, pre-existing cardiovascular disorders including uncontrolled hypertension, angina pectoris, arterial occlusive disease especially coronary arteries, heart failure, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, cardiac arrhythmia and channelopathies, treatment with monoamine oxidase (MAO) inhibitors or within a minimum of 14 days following discontinuation of a MAO inhibitor, pheochromocytoma, known drug dependence or alcohol abuse, severe depression, anorexia nervosa, psychotic symptoms or suicidal tendency, or known hypersensitivity to methylphenidate or to any component of the formulation.

PBS listing

ARTIGE methylphenidate hydrochloride 10 mg tablet is listed on the PBS with one item, authority required restriction, at an ex-manufacturer price of A$16.17.

Regulatory history

ARTIGE methylphenidate hydrochloride 10 mg tablets were first listed on the ARTG on 2 June 2005.