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 5 mg contains 128.2 mg of lactose, 1 tablet 10 mg contains 256.4 mg of lactose.
Action:
Selective, reversible acetylcholinesterase inhibitor responsible for the decomposition of acetylcholine in nerve endings at o.u.n. In clinical trials, it was confirmed that the drug in a statistically significant and dose-dependent manner increases the percentage of patients who improved cognitive skills, functioning in social and family life and the ability to function independently (therapy at least 6 months). After oral administration, donepezil is well absorbed from the gastrointestinal tract and reaches its maximum concentration in the blood within 3-4 hours. Steady state is achieved within 3 weeks of starting treatment. The food does not affect the absorption of the drug. Donepezil is approximately 95% bound to plasma proteins. It is metabolised by cytochrome P450 to many metabolites. It is excreted mainly in the urine in the form of metabolites and in unchanged form. T0,5 in plasma is about 70 h.
Contraindications:
Hypersensitivity to donepezil hydrochloride, piperidine derivatives or any of the excipients.
Precautions:
The use of donepezil in patients with severe dementia in Alzheimer's disease, other types of dementia or other types of memory disorders (eg age-related cognitive impairment) has not been studied. Cholinesterase inhibitors can exert a vagotonic effect on heart rate - particularly cautiously use in patients with sick sinus syndrome or supraventricular conduction disorders, such as sinoatrial or atrioventricular block (risk of syncope, convulsions, heart block and sinus arrest). Use with caution in patients with a history of ulcer or receiving NSAIDs. Caution should be exercised in patients with asthma or obstructive pulmonary disease. Due to the lactose content, patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose should not take this product. The product is not recommended for use in children and adolescents.
Pregnancy and lactation:
There are no data on the use of donepezil in pregnant women; should not be used during pregnancy unless clearly necessary. Women receiving donepezil hydrochloride should not breast-feed.
Side effects:
Very common: diarrhea, nausea, headache. Common: cold, anorexia, hallucinations, agitation, aggressive behavior (regress after dose reduction or discontinuation of treatment), fainting, dizziness, insomnia, vomiting, stomach disorders, rash, pruritus, muscle cramps, urinary incontinence, fatigue, pain. Uncommon: convulsions, bradycardia, gastrointestinal haemorrhage, peptic ulcer of the stomach and duodenum, slight increase in the concentration of muscle creatine kinase in the blood. Rare: extrapyramidal symptoms, sinoatrial block, atrioventricular block, liver dysfunction (including hepatitis).
Dosage:
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's disease. Oral: the starting dose is 5 mg once a day; this dose should be used for at least one month. After a clinical evaluation of the efficacy of the initial dose, the dose can be increased to 10 mg once a day. The maximum recommended daily dose is 10 mg. Maintenance treatment should be continued as long as the therapeutic effect of the product persists for the patient. 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 tablet should be taken in the evening before bedtime.
(C)
