ATENZA XR

What it is

ATENZA XR is a modified release tablet containing methylphenidate hydrochloride. It is available in strengths of 18 mg, 27 mg, 36 mg and 54 mg.

Approved indications

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

Dosing overview

The dosage of methylphenidate modified release capsules should be individualised according to the patient's clinical needs and responses, with treatment initiated at a low dose and increments at weekly intervals. For children and adolescents new to methylphenidate, the recommended starting dose is 20 mg once daily, although a lower initial dose of 10 mg may be appropriate at clinical discretion. Daily doses above 60 mg are not recommended for the treatment of ADHD in 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 the treatment of ADHD in adults. ATENZA XR should be administered orally once daily in the morning.

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, and stimulant products 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, and adults with serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems should generally not be treated with stimulant drugs. Before initiating treatment, patients should be assessed for pre-existing cardiovascular and psychiatric disorders and a family history of sudden death, ventricular arrhythmia and psychiatric disorders. CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics, and worsening of Tourette's syndrome has also been reported. 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. Moderately reduced weight gain and slight growth retardation have been reported with the long-term use of stimulants 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 needing treatment interruption. Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both paediatric and adult patients, sometimes developing after some time on the drug or during a period of drug withdrawal. Stimulants, including methylphenidate, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon, with signs and symptoms usually intermittent and mild, though very rare sequelae include digital ulceration and soft tissue breakdown.

Contraindications

ATENZA XR 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 of coronary arteries, heart failure, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, cardiac arrhythmia and channelopathies, treatment with monoamine oxidase inhibitors or within 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

ATENZA XR methylphenidate hydrochloride 27 mg modified release tablets are listed on the PBS with authority required restriction at an ex-manufacturer price of A$141.95. ATENZA XR methylphenidate hydrochloride 54 mg modified release tablets are listed on the PBS with authority required restriction at an ex-manufacturer price of A$179.74.

Regulatory history

ATENZA XR methylphenidate hydrochloride modified release tablets in strengths of 18 mg, 27 mg, 36 mg and 54 mg were first registered on the ARTG on 10 April 2026.