Active Ingredient: Methylphenidate
Methylphenidate is indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient.
Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in case that patient age in years is ≥ 6
Oral, between 10 milligrams methylphenidate and 30 milligrams methylphenidate, 2 times daily, over the duration of 1 year.
Regimen B, in case that patient age in years is ≥ 6
Tablet, extended release oral, between 20 milligrams methylphenidate and 60 milligrams methylphenidate, once daily, over the duration of 1 year.
Regimen C, in case that patient age in years is ≥ 6
Tablet, extended release oral, between 18 milligrams methylphenidate and 54 milligrams methylphenidate, once daily, over the duration of 1 year.
Tuzulbi prolonged-release chewable tablets consists of an immediate release component (30% of the dose, which ensures rapid onset of action) and a prolonged-release component (70% of the dose, which is designed to maintain therapeutic plasma levels over an extended period). This medicinal product is designed to deliver therapeutic plasma levels for a period of approximately 8 hours following administration.
Careful dose titration is necessary at the start of treatment with methylphenidate. Dose titration should be started at the lowest possible dose.
Other methylphenidate-containing medicinal products with different strengths may be available. Switching from immediate-release methylphenidate-containing medicinal products to prolonged-release chewable tablets, administered as a single dose, provides comparable overall exposure of methylphenidate compared to the same total dose of the immediate release formulation administered twice daily.
The recommended dose of prolonged-release methylphenidate should be equal to the total daily dose of the immediate-release methylphenidate-containing formulation not exceeding a total dose of 60 mg. Examples are provided in the table below.
| Immediate-release methylphenidate dose | Prolonged-release methylphenidate dose |
|---|---|
| 10 mg methylphenidate twice daily | 20 mg once daily |
| 15 mg methylphenidate twice daily | 30 mg once daily |
| 20 mg methylphenidate twice daily | 40 mg once daily |
| 30 mg methylphenidate twice daily | 60 mg once daily |
For patients from 6 years to less than 18 years of age, the recommended starting dose is 20 mg given orally once daily in the morning. The dose may be titrated up or down weekly in increments of 10 mg, 15 mg or 20 mg. The 10 mg and 15 mg doses can each be achieved by breaking in half the functionally scored 20 mg and 30 mg tablets, respectively. The dose should be individualised according to the treatment needs and responses of the patient.
The maximum daily dose of methylphenidate is 60 mg for treatment of children and adolescents (from 6 years to less than 18 years of age) with ADHD.
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 (more than 12 months) in children and adolescents (from 6 years to less than 18 years of age) 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 (preferable during 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 reactions occur, the dosage should be reduced or discontinued.
Tuzulby should be administered orally once daily in the morning with or without food.
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