ALZER 10 DONEPEZIL HYDROCHLORIDE TABLETS USP 10 MG [SIN16006P]

Product Info

ALZER 10 DONEPEZIL HYDROCHLORIDE TABLETS USP 10 MG

[SIN16006P]

THERAPEUTIC INDICATIONS

Donepezil Hydrochloride tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia.

POSOLOGY AND METHOD OF ADMINISTRATION

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, and can be taken with or without food. 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 4–6 weeks clinical assessment of treatment at 5 mg/day, the dose of Donepezil Hydrochloride 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 (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 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, 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.

CONTRAINDICATIONS

Donepezil Hydrochloride is contraindicated in pregnancy. Donepezil Hydrochloride is contraindicated in patients with a known hypersensitivity to donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.