Inactive ingredients in 23 mg tablets include ethylcellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and methacrylic acid copolymer, Type C. The film coating includes ferric oxide, hypromellose , polyethylene glycol , talc, and titanium dioxide.
Inactive ingredients are carrageenan, mannitol, colloidal silicon dioxide, and polyvinyl alcohol. Additionally, the 10 mg tablet contains ferric oxide yellow as a coloring agent. 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. Following multiple dose administration, donepezil accumulates in plasma by fold, and steady state is reached within 15 days. Donepezil is both excreted in the urine intact and extensively metabolized to four major metabolites, two of which are known to be active, and a number of minor metabolites, not all of which have been identified.
When compared to the extensive metabolizers, poor metabolizers had a Population pharmacokinetic analysis suggested that the clearance of donepezil in patients decreases with increasing age.
The effect of age on donepezil clearance may not be clinically significant. Body Weight There was a relationship noted between body weight and clearance.
Formal pharmacokinetic studies evaluated the potential of ARICEPT for interaction with theophylline, cimetidine, warfarin, digoxin, and ketoconazole. Whether there is a clinical effect of quinidine is not known.
This represented an average effect of weak, moderate, and strong CYP2D6 inhibitors. In a 7-day crossover study in 18 healthy volunteers, ketoconazole mg q.
The clinical relevance of this increase in concentration is unknown. Inducers of CYP 3A e. Formal pharmacokinetic studies demonstrated that the metabolism of ARICEPT is not significantly affected by concurrent administration of digoxin or cimetidine.
An in vitro study showed that donepezil was not a substrate of P-glycoprotein. Donepezil was negative in a battery of genotoxicity assays in vitro bacterial reverse mutation, in vitro mouse lymphoma tk, in vitro chromosomal aberration, and in vivo mouse micronucleus.
The no-effect levels of the combination were associated with clinically relevant plasma donepezil and memantine levels.
The relevance of this finding to humans is unknown. 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. Pharmacies near Finding nearby pharmacies Serving Patients We negotiate with the pharmacy industry on behalf of all Americans. Simply pay online and show your proof of payment at local pharmacies serving every community to get everyday low drug prices. We show you the price before you get to the pharmacy.
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