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 the medication code number (E
245) is debossed on the other side.
The 10 mg tablets are yellow and have the strength debossed
on one side (10) and the medication code (E 246) on the
other side.
5 mg (White)
Bottles
of 30
NDC#
62856-245-30
Unit
Dose Blister Package l00 (l0xl0)
NDC# 62856-245-41
10 mg (Yellow)
Bottles
of 30
NDC#
62856-246-30
Unit
Dose Blister Package 100 (l0xl0)
NDC# 62856-246-41
Storage: Store at controlled room temperature,
75° C to 30° C (59° F to 86° F).
Caution-Federal law prohibits dispensing without prescription.
