Aricept (Donepezil Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

ARICEPT® is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

DOSAGE AND ADMINISTRATION

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.

Evidence from the controlled trials 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, treatment with a dose of 10 mg should not be contemplated 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.

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