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STRATTERA (ATOMOXETINE HCL): DOSAGE AND ADMINISTRATION

Acute Treatment

Dosing of children and adolescents up to 70 kg body weight

Strattera (Atomoxetine Hydrochloride) should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day.

The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less.

Dosing of children and adolescents over 70 kg body weight and adults

Strattera (Atomoxetine Hydrochloride) capsules should be initiated at a total daily dose of 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response. There are no data that support increased effectiveness at higher doses.

The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.

Maintenance / Extended Treatment

It is generally agreed that pharmacological treatment of ADHD may be needed for extended periods. The benefit of 60 maintaining pediatric patients (ages 6-15 years) with ADHD on Atomoxetine (Strattera) after achieving a response in a dose range of 1.2 to 1.8 mg/kg/day was demonstrated in a controlled trial. Patients assigned to Atomoxetine (Strattera) capsules in the maintenance phase were generally continued on the same dose used to achieve a response in the open label phase. The physician who elects to use Atomoxetine HCl (Strattera) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

General Dosing Information

Atomoxetine HCl (Strattera) capsules may be taken with or without food.

Atomoxetine Hydrochloride (Strattera) can be discontinued without being tapered.

Atomoxetine Hydrochloride (Strattera) capsules are not intended to be opened, they should be taken whole.

The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated.

Dosing in Specific Populations

Dosing adjustment for hepatically impaired patients

For those ADHD patients who have hepatic insufficiency (HI), dosage adjustment is recommended as follows: For patients with moderate HI (Child-Pugh Class B), initial and target doses should be reduced to 50% of the normal dose (for patients without HI). For patients with severe HI (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of normal.

Dosing adjustment for use with a strong CYP2D6 inhibitor or in patients who are known to be CYP2D6 PMs

In children and adolescents up to 70 kg body weight administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, or in patients who are known to be CYP2D6 PMs, Strattera (Atomoxetine) should be initiated at 0.5 mg/kg/day and only increased to the usual target dose of 1.2 mg/kg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.

In children and adolescents over 70 kg body weight and adults administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, Strattera (Atomoxetine) capsules should be initiated at 40 mg/day and only increased to the usual target dose of 80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.

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