Strattera

[atomoxetine HCl]

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).

Dosing adjustment for use with a strong CYP2D6 inhibitor —

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In children and adolescents up to 70 kg body weight administered strong CYP2D6 inhibitors, e. g., paroxetine, fluoxetine, and quinidine, STRATTERA 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 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.

Atomoxetine can be discontinued without being tapered.

HOW SUPPLIED

STRATTERA capsules are supplied in 10-, 18-, 25-, 40-, and 60-mg strengths.

STRATTERA Capsules 10 mg* 18 mg* 25 mg* 40 mg* 60 mg*
Color Opaque White, Gold, Opaque Opaque Blue, Opaque Blue, Opaque Blue, Opaque White White Opaque White Opaque Blue Gold
Identification LILLY 3227 LILLY 3238 LILLY 3228 LILLY 3229 LILLY 3239 10 mg 18 mg 25 mg 40 mg 60 mg
NDC Codes: Bottles of 30 0002-3227-30 0002-3238-30 0002-3228-30 0002-3229-30 0002-3239-30
*Atomoxetine base equivalent.

Store at 25 C (77 F); excursions permitted to 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature].

Literature revised September 3, 2003
Eli Lilly and Company Indianapolis, IN 46285

www. strattera. com
PV 3753 AMP PRINTED IN USA Copyright 2002, 2003, Eli Lilly and Company. All rights reserved.

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