Description

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DESCRIPTION
STRATTERA® (atomoxetine) is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NO•HCl, which corresponds to a molecular weight of 291.82. The chemical structure is:
STRATTERA® (atomoxetine) Structural Formula Illustration
Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water.
STRATTERA capsules are intended for oral administration only.
Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. The capsule shells also contain one or more of the following:

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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

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.

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General Dosing Information

STRATTERA capsules are not intended to be opened, they should be taken whole [see PATIENT INFORMATION].

HOW SUPPLIED
Dosage Forms And Strengths
Each capsule contains atomoxetine HCl equivalent to 10 mg (Opaque White, Opaque White), 18 mg (Gold, Opaque White), 25 mg (Opaque Blue, Opaque White), 40 mg (Opaque Blue, Opaque Blue), 60 mg (Opaque Blue, Gold), 80 mg (Opaque Brown, Opaque White), or 100 mg (Opaque Brown, Opaque Brown) of atomoxetine.