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Alzepil® [Donepezil]

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Clinical Pharmacology

Alzepil is a specific and reversible acetylcholinesterase inhibitor that is the predominant type of cholinesterase in the brain. The drug inhibits this enzyme more than 1000 times stronger than butyrylcholinesterase, which is contained mainly outside the central nervous system. After a single dose of the drug in doses of 5 mg or 10 mg, the degree of inhibition of acetylcholinesterase activity, measured in erythrocyte membranes, was 63.6% and 77.3%, respectively. Inhibition of acetylcholinesterase in erythrocytes under the action of donepezil correlates with changes in the ADAS-cog scale (cognitive function assessment scale in Alzheimer's disease). The ability of Alzepil to alter the course of concomitant neurological diseases has not been studied. Thus, the drug cannot be considered to affect the progression of such diseases.


Suction. Cmax Donepezil in plasma after oral administration is reached in about 3-4 hours. Concentration in plasma and AUC increase in proportion to the dose. T1/2 is approximately 70 hours and the systematic use of single doses leads to the achievement of an equilibrium state, which is achieved within 2-3 weeks after the start of therapy. In equilibrium, the concentration of donepezil in plasma and the corresponding pharmacodynamic activity vary slightly during the day. Eating does not affect the absorption of donepezil.

Distribution. Plasma protein binding - 95%. The binding of plasma proteins of the active metabolite, 6-O-desmethyldoneepesil, is unknown. Distribution has not been studied. Donepezil and / or its metabolites may persist in the body for more than 10 days.

Metabolism and excretion. Donepezil is metabolized in the liver by the cytochrome P450 system and is excreted mainly by the kidneys: approximately 57% of the administered dose is found in the urine (17% in unchanged form) and 14.5% in the faecal masses.

After a single dose of 5 mg, the concentration of unchanged donepezil in plasma is 30% of the dose taken, 6-O-desmethyldonepestyl - 11% (the only metabolite with similar activity with donepezil hydrochloride), donepezil-cis-N-oxide - 9%, 5-O-desmethyldonepesyl - 7% and the glucuronic conjugate 5-O-desmethyldoneepesyl - 3%.

Gender, race and smoking do not have a significant effect on plasma plasma level of donepezil.

Increased C may be observed in patients with mild or moderate hepatic donepezil in blood plasma.


Symptomatic treatment of mild or moderate Alzheimer's disease


1 tablet contains:
active substance: donepezil hydrochloride monohydrate (corresponds to donepezil hydrochloride - 5 mg)
Excipients: MCC; low substitution hydroxypropylcellulose (L-HPC B1); magnesium stearate; Opadry Y-1-7000 white (hypromellose; titanium dioxide; macrogol 400)

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Alzepil® [Donepezil]

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