Adult/Elderly: Mild to moderate Alzheimer's Disease: Treatment is initiated at 5mg/day (once-a-day-dosing). Donepezil should be taken orally, in the evening, just prior to retiring. The 5mg/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 hydrochloride to be achieved. Following a 4 to 6 weeks of clinical assessment in patients who tolerated treatment at 5mg/day, the dose of Donepezil can be increased to 10mg/day (once-day-dosing). The maximum recommended daily dose is 10mg.
Severe Alzheimer's Disease: Donepezil is effective at a dose of 10mg administered once daily. However steady state is not achieved for 15 days and because the incidence of untoward effects may be influenced by the rate of dose escalation, a dose of 10mg should not be escalated until patients have been on a daily dose of 5mg for 4 to 6 weeks. Upon discontinuation of treatment, a gradual abatement of the beneficial effects of Donepezil is seen. There is no evidence of a rebound effect after abrupt discontinuation of therapy.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia. Diagnosis should be made according to accepted guidelines (e.g. DSM IV, ICD 10). Therapy with donepezil should only be started if a caregiver is available who will regularly monitor drug intake for the patient. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Therefore, the clinical benefit of donepezil should be reassessed on a regular basis. Discontinuation should be considered when evidence of a therapeutic effect is no longer present. Individual response to donepezil cannot be predicted.
Renal and hepatic impairment: A similar dose schedule can be followed for patients with renal impairment as clearance of donepezil hydrochloride is not affected by this condition.
Children: Donepezil is not recommended for use in children.
Mode of Administration(s): Oral: the orodispersible tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient's preference.