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STRATTERA (ATOMOXETINE HCL): PRESCRIBING INFORMATION

DESCRIPTION

Atomoxetine (Strattera) 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 C17H21NOxHCl, which corresponds to a molecular weight of 291.82.

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: titanium dioxide, synthetic yellow iron oxide, red iron oxide, FD & C Blue No. 2. The capsules are imprinted with edible black ink.


DOSAGE AND ADMINISTRATION

Strattera dosage and administration


DOSAGE FORMS AND STRENGTHS

Each Strattera capsule contains Atomoxetine Hydrochloride 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)
100 mg (opaque brown, opaque brown) of Atomoxetine.


INDICATIONS AND USAGE

Strattera indications and usage


CONTRAINDICATIONS

Strattera contraindications


CLINICAL PHARMACOLOGY

Strattera clinical pharmacology


NONCLINICAL TOXICOLOGY

Strattera nonclinical toxicology


CLINICAL STUDIES

Strattera clinical studies


WARNINGS

Strattera warnings


PRECAUTIONS

Strattera precautions


ADVERSE REACTIONS

Strattera adverse reactions


DRUG INTERACTIONS

Strattera drug interactions


USE IN SPECIFIC POPULATIONS

Strattera use in specific populations


DRUG ABUSE AND DEPENDENCE

Strattera drug abuse and dependence


OVERDOSAGE

Strattera overdosage


HOW SUPPLIED / STORAGE AND HANDLING

How Supplied

Strattera capsules 10 mg: opaque white, opaque white; identification LILLY 3227
Strattera capsules 18 mg: gold, opaque white; identification LILLY 3238
Strattera capsules 25 mg: opaque blue, opaque white; identification LILLY 3228
Strattera capsules 40 mg: opaque blue, opaque blue; identification LILLY 3229
Strattera capsules 60 mg: opaque blue, gold; identification LILLY 3239
Strattera capsules 80 mg: opaque brown, opaque white; identification LILLY 3250
Strattera capsules 100 mg: opaque brown, opaque brown; identification LILLY 3251

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Manufactured and distributed by Eli Lilly pharmaceutical company and its divisions.

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