Dosage & Administration

Adults/Elderly:

Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil hydrochloride (ARICEPT EVESS®) should be taken orally, in the evening, just prior to retiring or as prescribed by physician. The tablet should be placed on the tongue and allow to disintegrate before swallowing with or without water, according to patient preference. The 5 mg/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 4-6 weeks clinical assessment in patients who tolerated treatment at 5 mg/day, the dose of Donepezil hydrochloride (ARICEPT EVESS®) can be increased to 10 mg/day (once-a-day dosing).

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. 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.

Upon discontinuation of treatment, a gradual abatement of the beneficial effects of Donepezil hydrochloride is seen. There is no evidence of a rebound or withdrawal effect after abrupt discontinuation of therapy.

For patient with DLB, the dose may be decreased to 5 mg depending on the symptoms of the patient. Efficacy should be evaluated by cognitive function tests and interviews with patients and their family members/caregivers about subjective and objective symptoms up to 12 weeks after the start of administration. The administration should be discontinued if the benefits do not outweigh the risks based on a comprehensive evaluation of cognitive function, psychiatric symptoms, behavioral disturbances, activities of daily living, etc. Periodic efficacy evaluations should be conducted to determine whether dosing should be continued although the decision to continue dosing is based on the results of efficacy evaluation up to 12 weeks after the start of dosing.

Renal and Hepatic impairment:

A similar dose schedule can be followed for patients with renal or mild to moderate hepatic impairment because clearance of donepezil hydrochloride is not significantly affected by these conditions.

Children:

There are no adequate and well controlled trials to document the safety and efficacy of donepezil hydrochloride in any illness occurring in children.