Strattera

Strattera Dosage/Direction for Use

atomoxetine

Manufacturer:

Eli Lilly

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
For oral use. STRATTERA can be administered as a single daily dose in the morning. Patients who experience unwanted effects when taking STRATTERA as a single daily dose may benefit from taking it as twice daily evenly divided doses in the morning and late afternoon or early evening.
Dosing of Children and Adolescents Up To 70 kg Body Weight: STRATTERA should be initiated at a total daily dose of approximately 0.5 mg/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 1.2 mg/kg/day (depending on the patient's weight and available dosage strengths of atomoxetine). No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day.
In children and adolescents under 70 kg body weight, the safety of single doses over 1.8 mg/kg/day and total daily doses above 1.8 mg/kg have not been systematically evaluated.
Treatment must be initiated by or under the supervision of a physician with appropriate knowledge and experience of childhood and/or adolescence behavioural disorders (for example, paediatrician or child/adolescent psychiatrist).
Dosing of Chidren and Adolescents Over 70 kg Body Weight and Adults: STRATTERA 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 80 mg. No additional benefit has been demonstrated for doses higher than 80 mg (see Pharmacology: Pharmacodynamics under Actions). The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg. In children and adolescents over 70 kg body weight and adults, the safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated. Treatment must be initiated by or under the supervision of a psychiatrist with appropriate knowledge and experience of adult ADHD.
STRATTERA may be taken with or without food and it can be discontinued without tapering the dose.
Special Populations: Hepatic Insufficiency: For patients with moderate hepatic insufficiency (Child-Pugh Class B), initial and target doses should be reduced to 50% of the usual dose. For patients with severe hepatic insufficiency (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of usual dose.
Renal Insufficiency: Subjects with end stage renal disease had higher systemic exposure to atomoxetine than healthy subjects (about a 65% increase), but there was no difference when exposure was corrected for mg/kg dose. STRATTERA can therefore be administered to ADHD patients with end stage renal disease or lesser degrees of renal insufficiency using the usual dosing regimen. Atomoxetine may exacerbate hypertension in patients with end stage renal disease.
Elderly Use: The safety and efficacy of atomoxetine in elderly patients have not been established.
Pediatric Use:
The safety and efficacy of atomoxetine in pediatric patients less than 6 years of age have not been established. The efficacy of atomoxetine beyond 18 months of treatment and safety of atomoxetine beyond 2 years of treatment have not been systemically evaluated.
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