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. 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%. The inhibition of acetylcholinesterase (AChE) in red blood cells by donepezil hydrochloride is correlated with changes in the ADAS-cog scale, measuring selected elements of cognitive ability. The effect of donepezil on the course of the neuropathological process has not yet been studied, therefore the effect of the drug on the progression of the disease 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. Steady state is achieved within 3 weeks. Donepezil binds to plasma proteins in 95%. It is metabolised in the liver via the cytochrome P450 system for 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 any of the excipients.
Precautions:
The drug is not indicated for use in children. Particularly cautiously use in patients with sinus node syndrome, with supraventricular conduction disorders, such as sinoatrial or atrioventricular block; in patients with bronchial asthma or obstructive pulmonary disease; in patients with an increased risk of peptic ulcer disease (patients with a history of ulcer or receiving NSAIDs, these patients should be monitored for peptic ulcer disease). Do not use donepezil concurrently with other acetylcholinesterase inhibitors, agonists or cholinergic antagonists. Donepezil may increase muscle relaxation caused by succinylcholine derivatives during general anesthesia. During treatment, fainting or fits may occur; in these patients, the possibility of blocking the heart or long-term sinus node involvement should be considered. Due to the lactose content, the drug should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
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 often: diarrhea, nausea; Headache. Common: colds; anorexia; hallucinations, agitation, aggressive behavior (receding after dose reduction or discontinuation of treatment); fainting, dizziness, insomnia; vomiting; stomach disorders; rash, pruritus; muscle cramps; urinary incontinence; fatigue, pain, accidents. Uncommon: convulsions; bradycardia; gastrointestinal haemorrhage, peptic ulcer of the stomach and duodenum; slight increase in muscle creatine kinase activity. Rarely: extrapyramidal symptoms; sinoatrial block, atrioventricular block; abnormal liver function, including hepatitis (in the case of unexplained liver dysfunction discontinuation of the drug should be considered).
Dosage:
Orally. Adults and the elderly: the starting dose is 5 mg / day (once); this dose should be used for at least one month. After a clinical evaluation of the monthly treatment with the initial dose, the dose can be increased to 10 mg / day. The maximum recommended daily dose is 10 mg. No dosage adjustment is necessary for patients with renal insufficiency. Due to the increased drug exposure in patients with mild to moderate hepatic impairment, the dose should be increased based on individual patient tolerance; no data on the use of the drug in patients with severe hepatic impairment.The product should be taken in the evening, immediately before bedtime.
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