Active Ingredient: Methylphenidate
Methylphenidate is indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient.
Treatment must be initiated and supervised by a physician specialised in the treatment of ADHD such as an expert paediatrician or a child and adolescent psychiatrist.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In case that patient weight is ≥ 6 kg, oral, between 18 milligrams methylphenidate and 54 milligrams methylphenidate, once daily, over the duration of 1 year.
Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose.
Dose may be adjusted in 18 mg increments. In general, dose adjustment may proceed at approximately weekly intervals.
The maximum daily dose of methylphenidate is 54 mg.
Methylphenidate should not be used in children under the age of 6 years. Safety and efficacy in this age group has not been established.
Methylphenidate may not be indicated in all children with ADHD syndrome. Lower doses of short-acting methylphenidate formulations may be considered sufficient to treat patients new to methylphenidate. Careful dose titration by the physician in charge is required in order to avoid unnecessarily high doses of methylphenidate. The recommended starting dose of methylphenidate for patients who are not currently taking methylphenidate, or for patients who are on stimulants other than methylphenidate, is 18 mg once daily.
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. In children and adolescents, methylphenidate treatment is usually discontinued during or after puberty. The physician who elects to use methylphenidate for extended periods (over 12 months) in patients with ADHD 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 child’s condition (preferably during times of school holidays). Improvement may be sustained when the medicinal product is either temporarily or permanently discontinued.
Treatment must be stopped if the symptoms do not improve after appropriate dose adjustment over a one-month period. If paradoxical aggravation of symptoms or other serious adverse events occur, the dose should be reduced or discontinued.
Once daily in the morning.
It may be administered with or without food.
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