the product in the database has an inactive status
indications:
Symptomatic treatment of mild to moderately severe dementia in Alzheimer's disease.
Composition:
1 tabl powl. contains 5 mg or 10 mg donepezil hydrochloride. 1 tabl orodispersible hydrochloride contains 5 or 10 mg of donepezil hydrochloride. The preparation contains lactose.
Action:
Selective and reversible acetylcholinesterase inhibitor - the main enzyme that breaks down acetylcholine in the brain. In patients with Alzheimer's disease, the drug administered in therapeutic doses inhibits the enzyme activity in about 64-77%. Inhibition of acetylcholinesterase by the drug correlates with changes in the cognitive performance scale of patients with Alzheimer's disease (ADAS-cog). The effect of donepezil on the course of the neuropathological process has not yet been examined, therefore the impact of the drug on the further development of the disease process can not be assessed. The maximum concentration of the drug in the blood occurs 3-4 hours after oral administration. The food does not affect absorption. A stationary state is achieved within 3 weeks. Donepezil binds to plasma proteins in 95%. It is metabolised in the liver with the participation of CYP2D6 and CYP3A4 isoenzymes to many metabolites (one of the metabolites - 6-O-demethyldonepezil is pharmacologically active). The drug is excreted in urine (approximately 57%) and faeces (approximately 14.5%). T0,5 is about 70 hours.
Contraindications:
Hypersensitivity to donepezil hydrochloride, piperidine derivatives or other ingredients of the preparation.
Precautions:
No studies on the use of donepezil have been performed in patients with severe dementia in Alzheimer's disease, other types of dementia or other types of memory impairment (eg age-related cognitive impairment). Use with caution in patients with a sinus node syndrome or supraventricular dysfunction disorders (eg, sinoatrial or AV block), with an increased risk of peptic ulcer disease (eg patients with a history of peptic ulcer disease or patients taking NSAIDs) and in patients with asthma or obstructive pulmonary disease. There are no data on the use of the preparation in patients with severe hepatic impairment. The product is not recommended for use in children and adolescents. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or poor glucose-galactose absorption.
Pregnancy and lactation:
Due to the lack of data, donepezil should not be used during pregnancy unless clearly necessary. It is not known whether Donepezil is excreted in human milk, therefore the drug should not be used during breast-feeding.
Side effects:
Very common: diarrhea, nausea, headaches. Common: fainting, dizziness, insomnia, vomiting, stomach disorders, urinary incontinence, rash, pruritus, muscle spasms, anorexia, cold, accidents, fatigue, pain and hallucinations, agitation, aggressive behavior (regress after a dose reduction or discontinuation of the drug). Uncommon: slight increase in muscle creatine kinase, bradycardia, gastrointestinal haemorrhage, gastric and duodenal ulcers, convulsions. Rare: sinoatrial block, atrioventricular block, extrapyramidal symptoms, liver dysfunction, including hepatitis (discontinuation of the drug should be considered if unexplained liver dysfunction occurs). If you experience fainting or convulsions, you should consider the possibility of a heart block or sinus arrest. Although this was not observed in clinical trials of donepezil hydrochloride, cholinomimetics may cause obstruction of the bladder outlet.
Dosage:
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's disease. Orally. Adults: The starting dose is 5 mg once a day. This dose should be used over a period of at least one month to assess the effectiveness of the preparation and to obtain a stationary concentration of the drug in the blood. After assessing the effectiveness of treatment with a dose of 5 mg a day for one month, you can increase the dose to 10 mg once a day.The maximum recommended daily dose is 10 mg. No dosage adjustment is necessary for patients with renal insufficiency. In patients with mild or moderate hepatic impairment, the dose should be increased according to individual patient tolerability. The tablets should be taken in the evening, at bedtime. The tablet to be broken down in the mouth should be put on the tongue before swallowing and let it dissolve.
(C)
