ARICEPT® is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild to moderate Alzheimer's Disease, as well as in patients with severe Alzheimer's Disease.

Mild to Moderate Alzheimer's Disease

The dosages of ARICEPT® 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 ARICEPT® 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.

Severe Alzheimer's Disease

ARICEPT® has been shown to be effective in controlled clinical trials at a dose of 10 mg administered once daily.

Evidence from the controlled trials in mild to moderate Alzheimer's Disease indicates that the 10 mg dose, with a one week titration, is likely to be associated with a higher incidence of cholinergic adverse events than the 5 mg dose. In open label trials using a 6 week titration, the frequency of these same adverse events was similar between the 5 mg and 10 mg dose groups. Therefore, because steady state is not achieved for 15 days and because the incidence of untoward effects may be influenced by the rate of dose escalation, a dose of 10 mg should not be achieved until patients have been on a daily dose of 5 mg for 4 to 6 weeks.

ARICEPT® should be taken in the evening, just prior to retiring. ARICEPT® can be taken with or without food.

Allow ARICEPT® ODT tablet to dissolve on the tongue and follow with water.

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)

ARICEPT® ODT is supplied as tablets containing either 5 mg or 10 mg of donepezil hydrochloride.

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

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

5 mg (White) Unit Dose Blister Package 30 (10x3) (NDC# 62856-831-30)
10 mg (Yellow) Unit Dose Blister Package 30 (10x3) (NDC# 62856-832-30)

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

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. FDA revision date: 10/13/2006

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