Treatment must be initiated under the supervision of a specialist in childhood and/or adolescent behavioural disorders.
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).
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 at least every 6 months and at every visit.
Patients should be monitored for the risk of diversion, misuse and abuse of methylphenidate.
Careful dose titration is necessary at the start of treatment with Concerta XL. Dose titration should be started at the lowest possible dose. A 27 mg dosage strength is available for those who wish to prescribe between the 18 mg and 36 mg dosages.
Other strengths of this medicinal product and other methylphenidate-containing products may be available.
The dosage may be adjusted in 18 mg increments In general, dosage adjustment may proceed at approximately weekly intervals.
The maximum daily dosage of Concerta XL is 27 mg.
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