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Posology: Treatment must be initiated and supervised by a doctor specialised in the treatment of ADHD such as an expert paediatrician, a child and adolescent psychiatrist or a psychiatrist.
Pre-treatment screening: Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death and accurate recording of pre-treatment height and weight on a growth chart. In case of adults, only weight should be recorded (see Contraindications and Precautions).
Ongoing monitoring: Growth (children), weight, psychiatric and cardiovascular status should be continuously monitored (see also Precautions).
Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;
Height (children), weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart;
Development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then least every 6 months and at every visit.
Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
Dose titration: General aspects: The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.
Children should not take Medikinet MR too late in the morning as it may cause disturbances in sleep.
For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate containing products are available.
Children: Careful dose titration is necessary at the start of treatment with methylphenidate. This is normally achieved using an immediate-release formulation taken in divided doses. The recommended starting daily dose is 5 mg once daily or twice daily (e.g. at breakfast and lunch), increasing if necessary by weekly increments of 5-10 mg in the daily dose according to tolerability and degree of efficacy observed. MEDIKINET MR 10 mg once daily may be used in place of immediate-release methylphenidate hydrochloride 5 mg twice daily from the beginning of treatment where the treating physician considers that twice daily dosing is appropriate from the outset and twice daily treatment administration is impracticable.
MEDIKINET MR consists of an immediate-release component (50% of the dose) and a modified-release component (50% of the dose). Hence, MEDIKINET MR 10 mg yields an immediate-release dose of 5 mg and an extended-release dose of 5 mg methylphenidate hydrochloride. The extended-release portion of each dose is designed to maintain a treatment response through the afternoon without the need for a midday dose. It is designed to deliver therapeutic plasma levels for a period of approximately 8 hours, which is consistent with the school day rather than the whole day (see Pharmacology: Pharmacokinetics under Actions). For example, 20 mg of MEDIKINET MR is intended to take the place of 10 mg at breakfast and 10 mg at lunchtime of immediate-release methylphenidate hydrochloride.
Patients currently established on an immediate-release methylphenidate hydrochloride formulation may be switched to the milligram equivalent daily dose of MEDIKINET MR.
If the effect of the medicinal product wears off too early in the evening, disturbed behaviour may recur.
A small dose of an immediate-release methylphenidate hydrochloride tablet late in the day may help to solve this problem. In that case, it could be considered that adequate symptom control might be achieved with a twice daily immediate-release methylphenidate regimen.
The pros and cons of a small evening dose of immediate-release methylphenidate versus disturbances in falling asleep should be considered.
Treatment should not continue with MEDIKINET MR if an additional late dose of immediate-release methylphenidate is required, unless it is known that the same extra dose was also required for a conventional immediate-release regimen at equivalent breakfast/lunchtime dose.
The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.
The maximum daily dose of methylphenidate hydrochloride in children is 60 mg.
Adults: Continuation of methylphenidate therapy: Adult patients who have shown clear benefit from treatment with MEDIKINET MR in childhood and/or adolescence may continue treatment with MEDIKINET MR into adulthood, initially at the same daily dose (mg/day). Whether or not a dose adjustment depending on efficacy and tolerability is necessary or possible must be reviewed regularly.
Adults new to MEDIKINET MR: Any treatment with methylphenidate requires individual dose titration against efficacy and tolerability because individual response may vary substantially. Initiation of treatment in adults who are new to MEDIKINET MR therefore requires careful dose titration. Dose titration should be started at the lowest possible dose.
The recommended starting dose is 10 mg daily, which may be increased if necessary by weekly increments of 10 mg in the daily dose according to tolerability and degree of efficacy observed. The total dose (daily dose) should be given in two divided doses in the morning and at midday.
The aim of individual titration should be to find the lowest daily dose that achieves satisfactory symptom control.
Compared to children and adolescents, adult patients may require a higher daily dose, based on the patient's body weight.
The maximum daily dose is based on the patient's body weight and must not exceed 1 mg/kg body weight. Regardless of body weight, a maximum daily dose of 80 mg methylphenidate hydrochloride should not be exceeded because limited experience with daily doses greater than 80 mg is available from clinical studies.
Long-term use (more than 12 months): The safety and efficacy of long term use of methylphenidate has not been systematically evaluated in controlled trials. Methylphenidate treatment should not and need not, be indefinite. Methylphenidate treatment can usually be discontinued during or after puberty, when used in children with ADHD.
The physician who elects to use methylphenidate for extended periods (over 12 months) should periodically re-evaluate the long term usefulness of the medicinal product for the individual patient with trial periods off medication to assess the patient's functioning without pharmacotherapy. It is recommended that methylphenidate is de-challenged at least once yearly to assess the patient's condition (for children preferably during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.
Dose reduction and discontinuation: Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dosage should be reduced or discontinued.
Elderly: Methylphenidate should not be used in the elderly. Safety and efficacy has not been established in patients older than 60 years of age.
Children under 6 years of age: Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
Method of administration: Oral use.
MEDIKINET MR has to be taken with or after a meal in order to obtain sufficiently prolonged action and to avoid high plasma peaks. Methylphenidate hydrochloride is absorbed much faster from MEDIKINET MR when the medicinal product is taken on an empty stomach. In this case, release may not be adequately sustained. Therefore MEDIKINET MR should not be administered without food.
Children: MEDIKINET MR should be given in the morning with or after breakfast.
Adults: MEDIKINET MR should be given in the morning and at lunchtime with or after the meals.
The capsules may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce or yoghurt and given immediately, and not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed.
