Active Ingredient: Donepezil
Donepezil hydrochloride is indicated for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia.
For this indication, competent medicine agencies globally authorize below treatments:
Oral, 5 milligrams donepezil, once daily at the end of the day, over the duration of 1 month. Afterwards, oral, between 5 milligrams donepezil and 10 milligrams donepezil, once daily at the end of the day. The maximum allowed total dose is 10 milligrams donepezil daily.
Treatment is initiated at 5 mg/day (once-a-day dosing). 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 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 is seen.
Donepezil should be taken orally, in the evening, just prior to retiring.
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