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Ceptia

Ceptia Dosage/Direction for Use

donepezil

Manufacturer:

Sriprasit Pharma

Distributor:

SPS Medical

Marketer:

SPS Medical
Full Prescribing Info
Dosage/Direction for Use
Adults/Elderly: Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil hydrochloride should be taken orally, in the evening, just prior to retiring. The tablet should be placed on the tongue and allowed 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 of clinical assessment in patient who tolerated treatment at 5 mg/day, the dose can be increased to 10 mg/day (once-a-day dosing). The maximum recommended daily dose is 10 mg for vascular dementia and DLB. Doses greater than 10 mg/day have not been studied in clinical trials for vascular dementia and DLB.
For patient with DLB, the dose may be decreased to 5 mg depending on the symptoms of the patient.
Upon discontinuation of treatment, a gradual abatement of the beneficial effects of donepezil hydrochloride is seen. There is no evidence of a rebound effect after abrupt discontinuation of therapy.
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 (see Pharmacology: Pharmacokinetics under Actions), dose escalation should be performed according to individual tolerability. There are no data for patients with severe hepatic impairment.
Children: Donepezil hydrochloride is not recommended for use in children.
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