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Prescribing Information
ARICEPT® (donepezil hydrochloride) Tablets/ARICEPT® ODT (donepezil hydrochloride) Orally Disintegrating Tablets
Description
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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.

Comp

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.

ARICEPT® ODT tablets are available for oral administration. Each ARICEPT® ODT tablet contains 5 or 10 mg of donepezil hydrochloride. Inactive ingredients are carrageenan, mannitol, colloidal silicon dioxide and polyvinyl alcohol. Additionally, the 10 mg tablet contains ferric oxide (yellow) as a coloring agent.

ARICEPT® (donepezil hydrochloride) Tablets/ARICEPT® ODT (donepezil hydrochloride) Orally Disintegrating Tablets Warnings

ARICEPT Safety Information
 

Important Safety Information

Cholinesterase inhibitors have the potential to increase gastric acid secretion. Patients at risk for developing ulcers, including those receiving concurrent NSAIDs, should be monitored closely for gastrointestinal bleeding.

In clinical trials, syncopal episodes have been reported (2% for ARICEPT versus 1% for placebo).

In clinical trials, the most common adverse events seen with ARICEPT were nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, anorexia, and ecchymosis. In studies, these were usually mild and transient.

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