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Aricept

"The costs of caring for people with dementia in the United States in 2010 were between $159 billion to $215 billion, and those costs could rise dramatically with the increase in the numbers of older people in coming decades, according to estimate"...

Aricept

Indications
Dosage
How Supplied

INDICATIONS

ARICEPT 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.

DOSAGE AND ADMINISTRATION

ARICEPT should be taken in the evening, just prior to retiring.

ARICEPT can be taken with or without food.

The 23 mg tablet should not be split, crushed or chewed because this may increase its rate of absorption.

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

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.

Moderate to Severe Alzheimer's Disease

ARICEPT has been shown to be effective in controlled clinical trials at doses of 10 mg and 23 mg administered once daily. Results of a controlled clinical trial in moderate to severe Alzheimer's Disease that compared ARICEPT 23 mg once daily to 10 mg once daily suggest that a 23 mg dose of ARICEPT provided additional benefit.

Titration

The recommended starting dose of ARICEPT is 5 mg 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 compared to the 5 mg dose. In open-label trials using a 6 week titration, the type and frequency of these same adverse events were similar between the 5 mg and 10 mg dose groups. Therefore, because ARICEPT steady state is achieved about 15 days after it is started and because the incidence of untoward effects may be influenced by the rate of dose escalation, a dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. A dose of 23 mg once daily can be administered once patients have been on a dose of 10 mg once daily for at least 3 months.

HOW SUPPLIED

Dosage Forms And Strengths

ARICEPT is supplied as film-coated, round tablets containing 5 mg, 10 mg, or 23 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.

The 23 mg tablets are reddish. The strength, in mg (23), is debossed on one side, and ARICEPT is debossed on the other side.

ARICEPT ODT is supplied as round 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 debossed on one side and ARICEPT is debossed on the other side. The 10 mg orally disintegrating tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side.

Storage And Handling

ARICEPT Tablets

Supplied as film-coated, round tablets containing 5 mg, 10 mg, or 23 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.

Bottles of 30 (NDC# 62856-245-30)
Bottles of 90 (NDC# 62856-245-90)
Bottles of 1000 (NDC# 62856-245-11)
Unit Dose Blister Package 100 (10x10) (NDC# 62856-245-41)

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

Bottles of 30 (NDC# 62856-246-30)
Bottles of 90 (NDC# 62856-246-90)
Bottles of 1000 (NDC# 62856-246-11)
Unit Dose Blister Package 100 (10x10) (NDC# 62856-246-41)

The 23 mg tablets are reddish in color. The strength, in mg (23), is debossed on one side and ARICEPT is debossed on the other side.

Bottles of 30 (NDC# 62856-247-30)
Bottles of 90 (NDC# 62856-247-90)

ARICEPT ODT

Supplied as round 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 debossed on one side and ARICEPT is debossed on the other side.

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

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

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).

Distributed by : Eisai Inc., Woodcliff Lake, NJ 07677 Marketed by Pfizer Inc, New York, NY 10017. Revised: Sep 2013

Last reviewed on RxList: 9/19/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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