Strattera - Indications & Dosage

DOSAGE AND ADMINISTRATION

Initial Treatment 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 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 (see CLINICAL STUDIES).

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 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 (see CLINICAL STUDIES).

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

Maintenance/ Extended Treatment

There is no evidence available from controlled trials to indicate how long the patient with ADHD should be treated with STRATTERA. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use STRATTERA for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

General Dosing Information

STRATTERA may be taken with or without food. The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated.

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 (see Special Populations under CLINICAL PHARMACOLOGY).