RINIDATE

What it is

Rinidate contains methylphenidate hydrochloride in modified release capsules available in strengths of 10 mg, 20 mg, 30 mg, 40 mg or 60 mg. Rinidate modified release capsules should be administered orally once daily in the morning.

Approved indications

— Attention-Deficit Hyperactivity Disorder (ADHD).

Dosing overview

The dosage of Rinidate should be individualised according to the patient's clinical needs and responses, and should be initiated at a low dose with increments at weekly intervals. For children and adolescents aged 6 years and over, the recommended starting dose for patients not currently taking methylphenidate is 20 mg once daily, though treatment may begin with 10 mg when a lower initial dose is judged appropriate. Daily doses above 60 mg are not recommended for the treatment of ADHD in children and adolescents. For adults, the recommended starting dose for patients not currently taking methylphenidate is 20 mg once daily. Daily doses above 80 mg are not recommended for the treatment of ADHD in adults.

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. Rinidate increases heart rate and systolic and diastolic blood pressure, and blood pressure should be monitored at appropriate intervals in all patients taking methylphenidate, especially in those with hypertension. Psychotic symptoms, including visual and tactile hallucinations or mania have been reported in patients administered usual prescribed doses of stimulant products including Rinidate, and physicians should consider treatment discontinuation if psychotic symptoms occur. Methylphenidate has been causally associated with aggression, and emergent aggressive behaviour or an exacerbation of baseline aggressive behaviour has been reported during stimulant therapy. 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 potentially requiring treatment interruption. 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. Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both paediatric and adult patients, often developing after some time on the drug or subsequent to an increase in dose.

Contraindications

Rinidate 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 (MAO) inhibitors and 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; and known hypersensitivity to methylphenidate or to any component of the formulation.

PBS listing

No information regarding PBS listing is available in the provided sources.

Regulatory history

Rinidate methylphenidate hydrochloride 10 mg tablet blister pack was first listed on the ARTG on 6 March 2025 under licence category RE.