Donepezil
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Donepezil hydrochloride tablet USP is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
History
There is currently no drug history available for this drug.
Other Information
Donepezil hydrochloride USP 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 USP 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 USP is a white to off white crystalline powder and is soluble in water, methanol and chloroform and sparingly soluble in acetic acid.
Donepezil hydrochloride USP is available for oral administration in film-coated tablets containing 5 and 10 mg of donepezil hydrochloride USP.
Inactive ingredients in 5 mg and 10 mg tablets are corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating contains hypromellose, polyethylene glycol, talc and titanium dioxide. Additionally, the 10 mg tablet contains yellow iron oxide as a coloring agent.
Meets Organic Impurities Test Procedure 2
Sources
Donepezil Manufacturers
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Camber Pharmaceuticals, Inc.
![Donepezil (Donepezil Hydrochloride) Tablet [Camber Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Donepezil | Camber Pharmaceuticals, Inc.
Donepezil hydrochloride tablet should be taken in the evening, just prior to retiring.
Donepezil hydrochloride tablet can be taken with or without food.
2.1 Mild to Moderate Alzheimer’s DiseaseThe dosages of donepezil hydrochloride tablet shown to be effective in controlled clinical trials are 5 mg and 10 mg administered once per day.
The higher dose of 10 mg did not provide a statistically significantly greater clinical benefit than 5 mg. There is a suggestion, however, based upon order of group mean scores and dose trend analyses of data from these clinical trials, that a daily dose of 10 mg of donepezil hydrochloride tablet might provide additional benefit for some patients. Accordingly, whether or not to employ a dose of 10 mg is a matter of prescriber and patient preference.
2.2 Severe Alzheimer’s DiseaseDonepezil hydrochloride tablet has been shown to be effective in controlled clinical trials at doses of 10 mg administered once daily.
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