Donepezil

eMC §4.2 (Donepezil 10 mg Orodispersible Tablets). ADULTS/ELDERLY: treatment is initiated at 5 mg/day once daily; the 5 mg/day dose should be maintained for at least one month to allow the earliest clinical responses to be assessed and steady-state concentrations to be achieved. Following a one-month clinical assessment at 5 mg/day the dose can be increased to 10 mg/day once daily. Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia, with diagnosis made according to accepted guidelines (e.g. DSM IV, ICD 10). Therapy should only be started if a caregiver is available who will regularly monitor drug intake. Maintenance treatment can be continued for as long as therapeutic benefit exists; the clinical benefit should be reassessed on a regular basis and discontinuation considered when evidence of a therapeutic effect is no longer present. Upon discontinuation a gradual abatement of the beneficial effects is seen. In case of sleep disturbances including abnormal dreams, nightmares or insomnia, intake in the morning may be considered. HEPATIC IMPAIRMENT: due to possible increased exposure in mild to moderate hepatic impairment, dose escalation should be performed according to individual tolerability; there is no data for patients with severe hepatic impairment. PAEDIATRIC: not recommended for use in children and adolescents below 18 years of age — verify any under-18 use against a children's formulary. US LABELLING DIFFERENCE (cross-check only, not the UK maximum): the US prescribing information permits 5 mg to 10 mg once daily for mild to moderate Alzheimer's disease and 10 mg to 23 mg once daily for moderate to severe Alzheimer's disease, with 10 mg not given until the patient has been on 5 mg daily for 4 to 6 weeks and 23 mg not given until the patient has been on 10 mg daily for at least 3 months; the 23 mg tablet must not be split, crushed or chewed. The UK SPC maximum remains 10 mg/day.