Adults/Elderly: The treatment is started with single dose of 5 mg daily. The dose of 5 mg/day should be continued for at least one month in order to receive the earliest clinical responses to the treatment and to reach the steady state concentrations of donepezil hydrochloride. The dose of Donepezil can be increased to the single dose of 10 mg/day after the evaluation of the clinical response obtained with 5 mg dose for one month. The highest recommended dose is 10 mg. The doses above 10 mg/day have not been studied in clinical trials.
Should the treatment be interrupted, a gradual decrease is seen in the beneficial effects of Donepezil. No "rebound" or withdrawing effect has been noticed after the sudden interruption of the treatment.
Or as prescribed by the physician.
Route of administration: Donepezil should be orally taken as daily single dose just before going to bed.
The tablet should be placed onto the tongue, left to dissolve and swollen with a glass of water or without water according to the preference of the patient.
Additional information for special populations: Renal impairment: As the clearance of donepezil hydrochloride is not affected from renal impairment, a similar regime can be applied in these patients.
Hepatic impairment: The dose adjustment should be done according to the personal tolerability due to possible increase in exposure to medicine in case of mild and moderate hepatic impairment.
In a study performed on 10 individuals with stable alcoholic cirrhosis and 10 healthy individuals with the same age and sex the clearance of donepezil hydrochloride decreased 20% in cirrhosis patients in comparison to healthy individuals.
Pediatric population: Donepezil hydrochloride is not recommended to be used in children as its efficacy and safety have not been proven in children.
Geriatric population: No study has been performed to examine the relationship between the pharmacokinetics of donepezil hydrochloride and age. However, the average plasma concentrations monitored in elderly patients with Alzheimer was comparable to that of young healthy volunteers during the treatment.