Aricept

[donepezil hydrochloride]

Drug Description
DESCRIPTION

ARICEPT® (donepezil hydrochloride) is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (?±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. Donepezil hydrochloride is commonly referred to in the pharmacological literature as E2020.

It has an empirical formula of C24H29NO3HCl and a molecular weight of 415.96. Donepezil hydrochloride is a white crystalline powder and is freely soluble in chloroform, soluble in water and in glacial acetic acid, slightly soluble in ethanol and in acetonitrile and practically insoluble in ethyl acetate and in n-hexane.

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ARICEPT® is available for oral administration in film-coated tablets containing 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, and magnesium stearate. The film coating contains talc, polyethylene glycol, hypromellose and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide (synthetic) as a coloring agent.

HOW SUPPLIED

ARICEPT® is supplied as film-coated, round tablets containing either 5 mg or 10 mg of donepezil hydrochloride.

The 5 mg tablets are white. The strength, in mg (5), is debossed on one side and ARICEPT is debossed on the other side.

The 10 mg tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side.

5 mg (White) Bottles of 30 (NDC# 62856-245-30)
Bottles of 90 (NDC# 62856-245-90)
Unit Dose Blister Package 100 (10x10)
(NDC# 62856-245-41)
10 mg (Yellow) Bottles of 30 (NDC# 62856-246-30)
Bottles of 90 (NDC# 62856-246-90)
Unit Dose Blister Package 100 (10x10)
(NDC# 62856-246-41)

Storage: Store at controlled room temperature, 15°C to 30°C (59°F to 86°F).

RX only

ARICEPT® is a registered trademark of
Eisai Co., Ltd.
Manufactured and Marketed by Eisai Inc., Teaneck, NJ 07666
Marketed by
Pfizer Inc., New York, NY 10017

© 2004 Eisai Inc.

Printed in U.S.A.

200336 Revised April 2004