METHYLPHENIDATE-TEVA XR

What it is

METHYLPHENIDATE-TEVA XR contains methylphenidate hydrochloride in modified release formulations available in 10 mg, 20 mg, 30 mg, 40 mg or 60 mg strengths.

Approved indications

— Attention-Deficit Hyperactivity Disorder (ADHD).

Dosing overview

The dosage of METHYLPHENIDATE-TEVA XR should be individualised according to the patient's clinical needs and responses, with treatment initiated at a low dose and increments at weekly intervals. METHYLPHENIDATE-TEVA XR modified release capsules should be administered orally once daily in the morning. For children and adolescents aged 6 years and over, the recommended starting dose for patients new to methylphenidate is 20 mg once daily, although a lower initial dose of 10 mg may be appropriate in the clinician's judgement, with a maximum daily dose above 60 mg not recommended. For adults, only the modified release formulation should be used, with a recommended starting dose of 20 mg once daily and a maximum daily dose above 80 mg not recommended.

Key safety warnings

It is essential that patients with pre-existing structural cardiac abnormalities or other serious heart problems being considered for treatment are 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, 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. METHYLPHENIDATE-TEVA XR increases heart rate and systolic and diastolic blood pressure, so caution is indicated in patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, and blood pressure should be monitored at appropriate intervals in all patients taking methylphenidate, especially those with hypertension. In psychotic patients, administration of methylphenidate may exacerbate symptoms of behaviour disturbance and thought disorder, and co-morbidity of psychiatric disorders in ADHD is common and should be taken into account when prescribing stimulant products. Patients and caregivers should be alerted about the need to monitor for clinical worsening, suicidal behaviour or thoughts or unusual changes in behaviour and to seek medical advice immediately if these symptoms appear. 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, so family history should be assessed and clinical evaluation for tics or Tourette's syndrome should precede use, and METHYLPHENIDATE-TEVA XR is contraindicated in case of diagnosis or family history of Tourette's syndrome. Serotonin syndrome has been reported following co-administration of methylphenidate with serotonergic drugs such as selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors, and concomitant use 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, and growth should be monitored as clinically necessary during treatment, with patients not growing or gaining height or weight as expected potentially needing 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, developing after some time on the drug or sometimes during a period of drug withdrawal, and patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Contraindications

METHYLPHENIDATE-TEVA 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 coronary arteries, heart failure, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, cardiac arrhythmia and channelopathies, treatment with monoamine oxidase inhibitors or 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.

Regulatory history

METHYLPHENIDATE-TEVA XR was first listed on the ARTG on 13 October 2021 in four strengths: 18 mg, 27 mg, 36 mg and 54 mg modified release tablets.