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Aricept

Aricept
Donepezil (Aricept) is a centrally acting acetylcholinesterase inhibitor used in the treatment of Alzheimer's disease.

Brand: Donepezil

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: October 2023
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Aricept 10 mg
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Aricept 5 mg
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$284.41 $0.79 $134.75 Add to cart
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Product description

Pharmacological action

Buy Aricept tablets in Canada

Selective and reversible inhibitor of acetylcholinesterase, which is the predominant type of cholinesterase in the brain. Donepezil inhibits this enzyme more than 1000 times more strongly than butyrylcholinesterase, which is mainly found outside the CNS.

After a single dose of Aricept at doses of 5 mg or 10 mg, the degree of inhibition of acetylcholinesterase activity, measured in erythrocyte membranes after taking the drug, was 63.6% and 77.3%, respectively.

Inhibition of acetylcholinesterase in erythrocytes by donepezil correlates with changes in the ADAS-cog scale (Alzheimer's Disease Cognitive Assessment Scale).

The possible effect on neuropathological changes has not been studied.

Pharmacokinetics

Absorption of

Aricept Tablet Packaging

Cmax of donepezil in plasma is achieved approximately 3-4 hours after oral administration. Plasma concentrations and AUC increase in proportion to dose. T1 / 2 from plasma is approximately 70 hours, therefore, with systematic use in single doses, Css is achieved, as a rule, within 2-3 weeks after the start of therapy. After reaching equilibrium, plasma donepezil hydrochloride concentration and associated pharmacodynamic effects do not change significantly during the day. Food intake does not affect the absorption of donepezil hydrochloride.

Distribution

Donepezil is approximately 95% bound to plasma proteins. There is no data on the binding of its active metabolite 6-O-desmethyldonepezil to plasma proteins. The distribution of donepezil in various tissues of the body is not well understood. It is assumed that donepezil and / or its metabolites can persist in the body for more than 10 days.

Metabolism and excretion

Donepezil is metabolized in the liver. The main metabolic products of donepezil are compounds M1 and M2 (O-dealkylation and hydroxylation products), M11 and M12 (glucuronidation products M1 and M2, respectively), M4 (hydrolysis product) and M6 (N-oxidation product). There is no data on intrahepatic recirculation of donepezil and / or its metabolic products.

Donepezil is excreted, as well as its metabolites, mainly in the urine: 79% of the dose is found in urine and 21% in feces. Donepezil is predominantly found in urine.

Pharmacokinetics in special clinical situations

Gender, race and smoking have no significant effect on plasma donepezil concentration. The mean plasma levels of donepezil in patients correspond to those in healthy young volunteers.

Mild to moderate liver dysfunction and renal dysfunction do not significantly affect donepezil clearance.

Indications of the drug

Aricept symptomatic treatment of mild to moderate dementia of the Alzheimer's type.

Open the list of ICD-10 codes

regimen For Dosing adults (including elderly patients), the drug is prescribed in an initial dose of 5 mg 1 time / day. The initial dose is continued for at least 4-6 weeks in order to reach equilibrium concentrations of donepezil and to determine the early clinical effect of therapy. After 1 month, the dose of Aricept can be increased to 10 mg / day, which is the maximum recommended daily dose.

Supportive therapy can be continued as long as the therapeutic effect persists, which should be regularly evaluated.

In case of impaired liver and kidney function, dose adjustment is not required.


Contraindications for use

Hypersensitivity to donepezil hydrochloride, other components of the drug, as well as to piperidine derivatives.

The drug should be prescribed with caution to patients with a history of obstructive pulmonary disease (including bronchial asthma), cardiac arrhythmias, during anesthesia, as well as to patients with an increased risk of developing ulcers (for example, patients with a history of peptic ulcer disease or receiving concomitant NSAID therapy).

It is necessary to avoid the simultaneous use of Aricept with other acetylcholinesterase inhibitors, agonists or antagonists of the cholinergic system.

Application during pregnancy and lactation

There have been no controlled studies of the use of Aricept during pregnancy and lactation. There is no information on the elimination of donepezil in breast milk. The drug should be prescribed to pregnant women only if the expected benefit of treatment outweighs the possible risk to the fetus.

Application for violations of liver function

In case of violations of liver function, dose adjustment is not required.

Application for impaired renal function

In case of impaired renal function, dose adjustment is not required.

Use in children

The safety and efficacy of Aricept in children has not been studied, therefore the drug is not recommended to be prescribed to this category of patients.

Special instructions

Treatment should be prescribed and performed by a physician experienced in the management of patients with Alzheimer's disease. The diagnosis must be made according to generally accepted criteria (for example, DSM IV - Diagnostic and Statistical Manual of Mental Disorders, Fourth Revision, ICD 10 - International Classification of Diseases, Tenth Revision).

Maintenance therapy can be continued as long as the therapeutic effect persists. If the drug stops working, it should be canceled. After the termination of treatment, a gradual decrease in the action of Aricept is observed, there is no information about the withdrawal syndrome in case of an abrupt discontinuation of the drug. It is impossible to predict the individual response to Aricept therapy.

The efficacy of Aricept in patients with severe dementia of the Alzheimer's type, other types of dementia, or other types of memory impairment (eg, age-related cognitive decline) has not been studied.

Aricept, being a cholinesterase inhibitor, can enhance muscle relaxation of the succinylcholine type during anesthesia.

Cholinesterase inhibitors (including Aricept) can have a vagotonic effect on heart rate (in particular, cause bradycardia). The potential for this action may be important in patients with CVS or other supraventricular conduction disorders such as sinoatrial or AV block.

With an increased risk of ulceration, for example, in patients with a history of peptic ulcer disease or in patients receiving concomitant NSAID therapy, increased caution should be exercised during treatment with Aricept, because cholinomimetics can increase the secretion of acid in the stomach. However, in placebo-controlled studies of Aricept, there was no increase in the incidence of peptic ulcers or gastrointestinal bleeding.

It is believed that cholinomimetics are capable of causing generalized seizures. However, the onset of seizures while taking Aricept may also be a manifestation of Alzheimer's disease.


Considering the cholinomimetic effect of cholinesterase inhibitors, Aricept should be prescribed with caution to patients with asthma or a history of obstructive pulmonary disease.

Use in pediatrics

The safety and efficacy of Aricept in children has not been studied, therefore the drug is not recommended to be prescribed to this category of patients.

Influence on the ability to drive vehicles and work with mechanisms

Alzheimer's type dementia itself may be accompanied by impaired ability to drive and use complex equipment. In addition, Aricept, mainly at the beginning of treatment or when the dose is increased, can cause fatigue, dizziness and muscle cramps. The question of the ability of a patient with Alzheimer's type dementia to drive a car or use complex equipment while taking Aricept should be decided by the doctor after assessing the patient's individual response to treatment.

Overdose

Symptoms: cholinergic crisis (severe nausea, vomiting, profuse salivation, sweating, bradycardia, decreased blood pressure, respiratory depression, collapse and convulsions). An increase in muscle weakness is possible, which, if the respiratory muscles are damaged, can even lead to death.

Treatment: symptomatic therapy. As an antidote for an overdose of Aricept, tertiary anticholinergics can be used, in particular atropine at an initial dose of 1-2 mg IV, then the dose is selected depending on the effect. It is not known whether donepezil and / or its metabolites are removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).

Drug interactions

Clinical experience with the use of Aricept is limited, therefore, when prescribing the drug, the risk of interactions with other drugs unknown to date should be taken into account.

Donepezil hydrochloride and / or its metabolic products do not inhibit the metabolism of theophylline, warfarin, cimetidine, digoxin, thioridazine, risperidone and sertraline.

Simultaneous intake of digoxin, cimetidine, thioridazine, risperidone and sertraline does not affect the metabolism of donepezil hydrochloride.

The use of Aricept simultaneously with levodopa / carbidopa for 21 days did not affect the concentration of these drugs in the blood. At the same time, no effect on motor activity was revealed.

CYP3A4 and, to a lesser extent, CYP2D6 are involved in the metabolism of donepezil. Ketoconazole and quinidine, which are inhibitors of CYP3A4 and 2D6, respectively, inhibit donepezil metabolism. Therefore, these and other CYP3A4 inhibitors such as itraconazole and erythromycin, and CYP2D6 inhibitors such as fluoxetine, may inhibit donepezil metabolism. In healthy volunteers, ketoconazole increased mean donepezil concentrations by about 30%. However, this effect was incomparable with the effect of ketoconazole on other substances metabolized with the participation of CYP3A4, therefore, it is unlikely to have clinical significance.

The simultaneous use of Aricept does not affect the pharmacokinetics of ketoconazole.

Enzyme inducers such as rifampicin, phenytoin, carbamazepine, and ethanol can cause decreased levels of donepezil. However, the extent of such an inhibitory or inducing effect is not known, so caution should be exercised when using such agents in combination with Aricept.

Aricept can influence the action of drugs with anticholinergic activity. In addition, when used concomitantly, donepezil may potentiate the action of succinylcholine, other muscle relaxants or cholinergic receptor agonists and beta-blockers that affect cardiac conduction, although in vitro studies have shown that donepezil hydrochloride has a minimal effect on succinylcholine hydrolysis.

With the simultaneous use of other cholinomimetics and quaternary anticholinergic drugs, such as glycopyrrolate, with Aricept, cases of atypical changes in blood pressure and heart rate have been described.


Side effect

From the digestive system: often (> 5%) - diarrhea, nausea, vomiting.

From the side of the central nervous system and peripheral nervous system: often (> 5%) - fatigue, insomnia, muscle cramps.

From the side of the cardiovascular system: rarely - fainting, bradycardia, sinoatrial and AV blockade.

Others: rarely - a slight increase in the concentration of muscle CPK in serum.

In controlled clinical trials, patients were also observed:

From the side of the central nervous system: headache, dizziness, hallucinations, anxiety, aggressive behavior, epileptic seizures.

From the digestive system: dyspepsia, hepatitis, stomach and duodenal ulcers and bleeding from the gastrointestinal tract.

Others: pain of various localization, accidents, colds.

Side effects observed in controlled clinical trials in at least 2% of patients taking Aricept, with a frequency exceeding that in the placebo group.