METHYLPHENIDATE XR ARX

What it is

Methylphenidate XR ARX contains methylphenidate hydrochloride in modified release tablet formulations of 18 mg, 27 mg, 36 mg and 54 mg strengths.

Approved indications

— Treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

Dosing overview

The dosage of methylphenidate XR ARX should be individualised according to the patient's clinical needs and responses. Treatment should be initiated at a low dose, with increments 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, although treatment may begin with 10 mg when a lower initial dose is appropriate. Daily doses above 60 mg are not recommended for the treatment of ADHD in children and adolescents. For adults, only the modified release formulation should be used for ADHD treatment, with a recommended starting dose of 20 mg once daily for patients new to methylphenidate. Daily doses above 80 mg are not recommended for the treatment of ADHD in adults. Methylphenidate XR ARX modified release tablets should be administered orally once daily in the morning.

Key safety warnings

Patients with pre-existing structural cardiac abnormalities or other serious heart problems being considered for treatment must be assessed by a cardiologist before initiating treatment, with ongoing 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. Methylphenidate should generally not be used in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm 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. 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. Methylphenidate XR ARX increases heart rate and systolic and diastolic blood pressure. 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. In psychotic patients, administration of methylphenidate may exacerbate symptoms of behaviour disturbance and thought disorder. Treatment of ADHD with stimulant products including methylphenidate should not be initiated in patients with acute psychosis, acute mania, or acute suicidality. These acute conditions should be treated and controlled before ADHD treatment is considered. 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. Serotonin syndrome has been reported following co-administration of methylphenidate with serotonergic drugs such as selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors. The concomitant use of methylphenidate and serotonergic drugs is not recommended as this may lead to the development of serotonin syndrome. Moderately reduced weight gain and slight growth retardation have been reported with the long-term use of stimulants, including methylphenidate, in children. Growth should be monitored as clinically necessary during treatment, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both paediatric 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. Stimulants, including methylphenidate, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown.

Contraindications

Methylphenidate XR ARX is contraindicated in patients with anxiety and tension states, agitation, a 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 inhibitors and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor, pheochromocytoma, known drug dependence or alcohol abuse, severe depression, anorexia nervosa, psychotic symptoms or suicidal tendency, and known hypersensitivity to methylphenidate or to any component of the formulation.

PBS listing

Methylphenidate XR ARX is listed on the PBS in four strengths: 18 mg, 27 mg, 36 mg and 54 mg extended release tablets. All four items require authority required restriction, with ex-manufacturer prices ranging from A$31.08 to A$45.45.

Regulatory history

Methylphenidate XR ARX was first registered on the ARTG on 24 June 2021, with four approved variants containing 18 mg, 27 mg, 36 mg and 54 mg of methylphenidate hydrochloride as modified release tablets.