Zyprexa - Indications & Dosage

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TABLET STRENGTH 2.5 mg 5 mg 7.5 mg 10 mg 15 mg 20 mg

Tablet No. 4112 4115 4116 4117 4415 4420 Identification LILLY LILLY LILLY LILLY LILLY LILLY

4112 4115 4116 4117 4415 4420 NDC Codes:

Bottles 60 NDC 0002-NDC 0002-NDC 0002-NDC 0002-NDC 0002-NDC 0002-4112-60 4115-60 4116-60 4117-60 4415-60 4420-60

Blisters -NDC 0002-NDC 0002-NDC 0002-NDC 0002-NDC 0002-NDC 0002-ID* 100 4112-33 4115-33 4116-33 4117-33 4415-33 4420-33

Bottles 1000 NDC 0002-NDC 0002-NDC 0002-NDC 0002-NDC 0002-NDC 0002-4112-04 4115-04 4116-04 4117-04 4415-04 4420-04

* Identi-Dose ® (unit dose medication, Lilly).

ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) are yellow, round, and debossed with the tablet strength. The tablets are available as follows:

ZYPREXA ZYDIS TABLET STRENGTH Tablets* 5 mg 10 mg 15 mg 20 mg

Tablet No. 4453 4454 4455 4456 Debossed 5 10 15 20

NDC Codes: Dose Pack 30 NDC 0002-NDC 0002-NDC 0002-NDC 0002-

(Child-Resistant) 4453-85 4454-85 4455-85 4456-85

ZYPREXA is a registered trademark of Eli Lilly and Company. ZYDIS is a registered trademark of R. P. Scherer Corporation.

*ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is manufactured for Eli Lilly and Company by Scherer DDS Limited, United Kingdom, SN5 8RU.

Store at controlled room temperature, 20° to 25° C (68° to 77° F) [see USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° C (68° to 77° F); that results in a mean kinetic temperature calculated to be not more than 25° C; and that allows for excursions between 15° and 30° C (59° and 86° F) that are experienced in pharmacies, hospitals, and warehouses. Protect from light and moisture.

ANIMAL TOXICOLOGY

In animal studies with olanzapine, the principal hematologic findings were reversible peripheral cytopenias in individual dogs dosed at 10 mg/ kg (17 times the maximum recommended human daily dose on a mg/ m 2 basis), dose-related decreases in lymphocytes and neutrophils in mice, and lymphopenia in rats. A few dogs treated with 10 mg/ kg developed reversible neutropenia and/ or reversible hemolytic anemia between 1 and 10 months of treatment.