Dosage and Administration :
Adults/Elderly
Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil hydrochloride (Servonex®) tablets should be taken orally, in the evening, just prior to retiring. 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 one-month clinical assessment of treatment at 5 mg/day, the dose of Donepezil hydrochloride (Servonex®) tablets can be increased to 10 mg/day (once a-day dosing). The maximum recommended daily dose is 10 mg. Doses greater than 10 mg/day have not been studied in clinical trials.
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.
Upon discontinuation of treatment, a gradual abatement of the beneficial effects of Donepezil hydrochloride (Servonex®) tablet is seen.
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.
Due to possible increased exposure in mild to moderate hepatic impairment, dose escalation should be performed according to individual tolerability. There are no data for patients with severe hepatic impairment.
Children
Donepezil hydrochloride (Servonex®) tablet is not recommended for use in children and adolescents below 18 years of age.
Route of Administration
Donepezil hydrochloride (Servonex®) tablet should be taken orally, in the evening, just prior to retiring.