aricept- donepezil hydrochloride solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

donepezil hydrochloride (UNII: 3O2T2PJ89D) (donepezil - UNII:8SSC91326P)

Saatavilla:

Eisai Inc.

INN (Kansainvälinen yleisnimi):

donepezil hydrochloride

Lääkemuoto:

SOLUTION

Koostumus:

1 mg in 1 mL

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. ARICEPT® is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.

Tuoteyhteenveto:

ARICEPT® Oral Solution is a clear, colorless to light yellow solution containing 1 mg of donepezil hydrochloride in each mL (1 mg/mL). Each teaspoon (5mL) contains 5 mg of donepezil hydrochloride. NDC#62856-851-30          300 mL HDPE Bottles 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 © 2006 Eisai Inc. Printed in U.S.A. Revised October 2006

Valmisteyhteenveto

ARICEPT- DONEPEZIL HYDROCHLORIDE SOLUTION
EISAI INC.
----------
ARICEPT® ORAL SOLUTION
(DONEPEZIL HYDROCHLORIDE)
DESCRIPTION
ARICEPT® (donepezil hydrochloride) is a reversible inhibitor of the
enzyme acetylcholinesterase,
known chemically as
(±)-2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1_H_-
inden-1-one hydrochloride. Donepezil hydrochloride is commonly
referred to in the pharmacological
literature as E2020. It has an empirical formula of C
H NO HCl and a molecular weight of 415.96.
Donepezil hydrochloride is a white crystalline powder and is freely
soluble in chloroform, soluble in
water and in glacial acetic acid, slightly soluble in ethanol and in
acetonitrile and practically insoluble in
ethyl acetate and in n-hexane.
Each 1mL of ARICEPT® Oral Solution contains 1 mg of donepezil
hydrochloride. ARICEPT® Oral
Solution also contains sorbitol solution 70%, povidone K-30, citric
acid anhydrous, sodium citrate
dihydrate, sodium benzoate, methylparaben, propylene glycol, sodium
metabisulfite, purified water and
strawberry flavor.
CLINICAL PHARMACOLOGY
Current theories on the pathogenesis of the cognitive signs and
symptoms of Alzheimer's Disease
attribute some of them to a deficiency of cholinergic
neurotransmission. Donepezil hydrochloride is
postulated to exert its therapeutic effect by enhancing cholinergic
function. This is accomplished by
increasing the concentration of acetylcholine through reversible
inhibition of its hydrolysis by
acetylcholinesterase. There is no evidence that donepezil alters the
course of the underlying dementing
process.
CLINICAL TRIAL DATA
The effectiveness of ARICEPT® as a treatment for Alzheimer's Disease
is demonstrated by the results
of randomized, double-blind, placebo-controlled clinical
investigations in mild, moderate and severe
patients with Alzheimer's Disease.
MILD-MODERATE ALZHEIMER'S DISEASE
The effectiveness of ARICEPT® as a treatment for Alzheimer's Disease
is demonstrated by the results
of two randomized, double-blind, placebo-controlle