Alzime Dosage/Direction for Use

Mild to moderate Alzheimer disease: 5 or 10 mg once daily.
The higher dose of 10 mg did not provide a statistically significant clinical benefit greater than that of the 5 mg dose. There is a suggestion, however, based upon order of group mean scores and dose trend analyses of data from these clinical trial, that a daily dose of donepezil 10 mg 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.
Severe Alzheimer's disease: 10 mg administered once daily.
Dose titration-Evidence from the controlled trials in mild to moderate Alzheimer's disease indicated that the 10 mg dose, with a 1-week titration, is likely to be associated with a higher incidence of cholinergic adverse reactions than the 5 mg dose. In open-label trials using a 6-week titration, the frequency of these same adverse reactions was similar between the 5 and 10 mg dose groups. Therefore, because steady state is not achieved for 15 days and the incidence of untoward effects may be influenced by the rate of dose escalation, a dose of 10 mg should not be achieved until patients have been on a daily dose of 5 mg for 4 to 6 weeks.
Vascular dementia: 5 or 10 mg administered once daily. Doses greater than 10 mg/day have not been studied in clinical trials in vascular dementia.
Dosage in renal impairment: Limited data in a few patients with moderate to severe renal impairment (creatinine clearance less than 22 mL/minute per 1.73 m²) indicate no difference in the clearance of donepezil compared with that in healthy individuals matched for age and gender and the manufacture makes no specific recommendation for dosage adjustment in patients with renal impairment.
Dosage in hepatic impairment: Clearance of donepezil in a limited number of patients with stable alcoholic cirrhosis was reduced by 20% compared with that in healthy age and gender matched individuals; however, the manufacturer makes no specific recommendation for dosage adjustment in patient with hepatic disease.
Children: There are no adequate and well-controlled trials to document the safety and efficacy of donepezil in any illness occurring in children.
Mode of Administration: Donepezil hydrochloride is administered orally. The drug is administered once daily in the evening at bedtime. Because food does not affect the rate or extent of absorption of donepezil when administered as conventional film-coated tablets, the drug can be administered with or without food.