General Dosing Recommendation: Donepezil hydrochloride is administered once daily with or without food. It should be taken in the evening, just prior to retiring.
Individual response to donepezil cannot be predicted. Treatment should be continued for as long as a therapeutic benefit for the patient exists.
Recommended Oral Donepezil Dose in Adults/Elderly: Initial treatment: 5 mg once a day; The 5 mg once a day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil to be achieved.
Following a one-month clinical evaluation of treatment at 5 mg once a day, the dose of donepezil can be increased to 10 mg once a day.
Maximum recommended dose: 10 mg once a day; Doses greater than 10 mg once a day have not been studied in clinical trials.
Discontinuation of treatment: Discontinuation of therapy should be considered where there is no longer evidence of a therapeutic effect, which should be assessed by periodic evaluations by the physician using input from the patient and caregiver.
Upon discontinuation of treatment, a gradual decrease of the therapeutic effects of donepezil is observed.
There is no evidence of a rebound effect after abrupt discontinuation of therapy.
Titration: Studies in patients with mild to moderate Alzheimer's disease showed that the 10 mg dose, with a one week titration, is likely to be associated with a higher incidence of cholinergic adverse events compared to the 5 mg dose.
Since donepezil steady state is achieved about 15 days after it is started and because the incidence of untoward effects may be influenced by the rate of dose escalation, a dose of 10 mg should not be given until patients have been on a daily dose of 5 mg for 4-6 weeks.
For patients with renal or mild to moderate hepatic impairment: A similar dosing schedule can be followed for patients with renal or mild to moderate hepatic impairment since clearance of donepezil is not significantly affected by these conditions.
Or, as prescribed by a physician.