Posology : מינונים

4.2   Posology and method of administration
Treatment must be initiated under the supervision of a specialist in childhood behaviour disorders.
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 (see sections 4.3 and 4.4).
Ongoing monitoring:
Growth, psychiatric and cardiovascular status should be continuously monitored (see also section 4.4).
• Blood pressure and pulse should be recorded on a centile chart at each adjustment of dose and then at least every 6 months;
• Height, 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 Medikinet MR.
Dose titration:
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.
The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.

MEDIKINET MR is taken in the morning with or after breakfast 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.
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 section 5.2). 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 Using Methylphenidate hydrochloride:
Patients established on an immediate-release methylphenidate hydrochloride formulation may be switched to the milligram equivalent daily dose of MEDIKINET MR.
If other formulations of methylphenidate should be substituted, it should be kept in mind that MEDIKINET MR has to be administered with food. Conditions leading to increased gastric pH have to be avoided.
MEDIKINET MR should not be taken too late in the morning as it may cause disturbances in sleep.
However, 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.
For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate containing products are available.
The maximum daily dosage of methylphenidate is 60 mg.
MEDIKINET MR should be given in the morning with or after breakfast.
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 or yoghurt. In this case food should be eaten as well, of course. The capsules and the capsule contents must not be crushed or chewed.
Long-term (more than 12 months) use in children and adolescents
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 is usually discontinued during or after puberty. The physician who elects to use methylphenidate for extended periods (over 12 months) in children and adolescents with ADHD should periodically re-evaluate the long term usefulness of the drug 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 child’s condition (preferable during times of school holidays). Improvement may be sustained when the drug 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.
Adults
Medikinet MR is not licensed for use in adults with ADHD. Safety and efficacy have not been established in this age group.
Elderly
Medikinet MR should not be used in the elderly. Safety and efficacy has not been established in this age group.
Children under 6 years of age
Medikinet MR should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.