Active Ingredient: Atomoxetine
Atomoxetine is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older and in adolescents as part of a comprehensive treatment programme. Treatment must be initiated by a specialist in the treatment of ADHD, such as a paediatrician or child/adolescent psychiatrist. Diagnosis should be made according to current DSM criteria or the guidelines in ICD.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
40 - 100 mg
From 40 To 100 mg once every day
40 mg
80 mg
Atomoxetine should be initiated at a total daily dose of 40 mg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is 80mg. No additional benefit has been demonstrated for doses higher than 80 mg. The maximum recommended total daily dose is 100 mg. The safety of single doses over 120mg and total daily doses above 150mg have not been systematically evaluated.
Prior to prescribing it is necessary to take an appropriate medical history and conduct a baseline evaluation of a patient’s cardiovascular status, including blood pressure and heart rate.
Cardiovascular status should be regularly monitored with blood pressure and pulse recorded after each adjustment of dose and then at least every 6 months. For paediatric patients the use of a centile chart is recommended.
In the study programme no distinct withdrawal symptoms have been described. In cases of significant adverse effects, atomoxetine may be stopped abruptly; otherwise the drug may be tapered off over a suitable time period.
Treatment with atomoxetine need not be indefinite. Re-evaluation of the need for continued therapy beyond 1 year should be performed, particularly when the patient has reached a stable and satisfactory response.
Atomoxetine can be administered with or without food.
Atomoxetine can be administered as a single daily dose in the morning.
Patients who do not achieve a satisfactory clinical response (tolerability [e.g. nausea or somnolence] or efficacy) when taking atomoxetine as a single daily dose might benefit from taking it as twice daily evenly divided doses in the morning and late afternoon or early evening.
Oral
0.5 - 1.2 mg per kg of body weight
From 0.5 To 1.2 mg per kg of body weight once every day
1.2 mg per kg of body weight
Atomoxetine should be initiated at a total daily dose of approximately 0.5mg/kg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is approximately 1.2mg/kg/day (depending on the patient’s weight and available dosage strengths of atomoxetine). No additional benefit has been demonstrated for doses higher than 1.2mg/kg/day. The safety of single doses over 1.8mg/kg/day and total daily doses above 1.8 mg/kg have not been systematically evaluated. In some cases it might be appropriate to continue treatment into adulthood.
Prior to prescribing it is necessary to take an appropriate medical history and conduct a baseline evaluation of a patient’s cardiovascular status, including blood pressure and heart rate.
Cardiovascular status should be regularly monitored with blood pressure and pulse recorded after each adjustment of dose and then at least every 6 months. For paediatric patients the use of a centile chart is recommended.
In the study programme no distinct withdrawal symptoms have been described. In cases of significant adverse effects, atomoxetine may be stopped abruptly; otherwise the drug may be tapered off over a suitable time period.
Treatment with atomoxetine need not be indefinite. Re-evaluation of the need for continued therapy beyond 1 year should be performed, particularly when the patient has reached a stable and satisfactory response.
Atomoxetine can be administered with or without food.
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