ATTORA LA

What it is

ATTORA LA contains methylphenidate hydrochloride in modified release capsule form, available in strengths of 10 mg, 20 mg, 30 mg, 40 mg or 60 mg. ATTORA LA capsules should be administered orally once daily in the morning. ATTORA LA may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of soft food, but the capsules and their contents should not be crushed, chewed or divided. The formulation contains sulfites as an excipient with known effect.

Approved indications

— Treatment of attention-deficit hyperactivity disorder (ADHD) as an integral part of a total treatment program that may include other measures (psychological, educational and social).

Dosing overview

The dosage of ATTORA LA 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 aged 6 years and over, daily doses above 60 mg are not recommended, and the recommended starting dose in patients not currently taking methylphenidate is 20 mg once daily. When a lower initial dose is appropriate, treatment may begin with ATTORA LA 10 mg. Dosage may be adjusted at weekly intervals in 10 mg increments for children. For adults, daily doses above 80 mg are not recommended, and the recommended starting dose in patients not currently taking methylphenidate is 20 mg once daily. Dosage may be adjusted at weekly intervals in 20 mg increments for adults. There are no differences recommended in dosing between male and female adult patients.

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, including methylphenidate, generally should 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, although adults have a greater likelihood than children of having serious structural cardiac abnormalities or other serious cardiac problems. ATTORA LA 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, and frank psychotic episodes can occur, especially with parenteral abuse. CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics, and patients should be regularly monitored for the emergence or worsening of tics during treatment. Moderately reduced weight gain and slight growth retardation have been reported with 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 potentially needing treatment interruption.

Contraindications

ATTORA LA is contraindicated in patients with the following: 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; phaeochromocytoma; 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.

Regulatory history

ATTORA LA methylphenidate hydrochloride in strengths of 10 mg, 20 mg, 30 mg, 40 mg and 60 mg as modified release capsules were first registered on the ARTG on 21 October 2025.