Donepezil Hydrochloride Tablets

Pharmacological action: It is currently believed that the pathogenesis of cognitive impairment in Alzheimer's disease is partly related to the low function of cholinergic neurotransmission. Donepezil hydrochloride may exert its therapeutic effect by enhancing the function of cholinergic nerves. It reversibly inhibits the hydrolysis of acetylcholine by acetylcholinesterase, thereby increasing the concentration of acetylcholine. If it is speculated according to the above mechanism of action, as the disease progresses, the number of functional cholinergic neurons gradually decreases, and the effect of donepezil may weaken. There is currently no evidence that donepezil can change the basic course of dementia. Toxicological studies Reproductive toxicity: Rats were given donepezil 10 mg/kg/day (about 8 times the recommended maximum human dose based on body surface area), and fertility was not affected. Pregnant rats and rabbits were given donepezil up to 16 and 10 mg/kg/day (about 13 and 16 times the recommended maximum human dose based on body surface area), respectively, and no obvious teratogenic effect was observed. In another study, rats were given donepezil 10 mg/kg/day (about 8 times the recommended maximum human dose based on body surface area) from day 17 of pregnancy to day 20 after delivery. The number of stillbirths increased slightly, and the survival rate of offspring within 4 days after delivery decreased slightly. Genotoxicity: Donepezil was not found to be mutagenic in the Ames bacterial reverse mutation test. Donepezil was found to produce a clastogenic effect in the Chinese hamster lung cell chromosome aberration test. Donepezil did not produce a clastogenic effect in the mouse micronucleus test. Carcinogenicity: There is currently no research data on the carcinogenicity of donepezil.

Donepezil hydrochloride. Chemical name: () 2,3-dihydro-5,6-dimethoxy-2-{[(1-phenylmethyl)-4-piperidinyl]methyl}-1H-inden-1-one hydrochloride.

Film-coated tablets appear white after removing the film coating.

For the treatment of mild or moderate Alzheimer's dementia symptoms.

Oral. The initial dose is 5 mg (1 tablet) once a day, taken before bedtime; and the initial dose should be maintained for at least 1 month before the dose can be increased to 10 mg (2 tablets) once a day based on the therapeutic effect. The maximum recommended dose is 10 mg per day. No clinical studies have been conducted on doses greater than 10 mg per day. After stopping treatment, the efficacy of donepezil hydrochloride gradually decreases, and there is no rebound phenomenon when treatment is discontinued. For patients with renal insufficiency and mild to moderate hepatic insufficiency, the elimination of donepezil hydrochloride is not affected, so these patients can use a similar dosage regimen. Or follow the doctor's advice.

Common adverse reactions include: nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, tiredness and loss of appetite. Symptoms are usually mild and short-lived, and there is no need to adjust the dose. Continuous medication can relieve symptoms. Less common adverse reactions include headache, dizziness, mental disorders (hallucinations, irritability, aggressive behavior), weight loss, vision loss, chest pain, joint pain, depression, dreaminess, drowsiness, new neurological symptoms, rash, stomach pain, gastrointestinal dysfunction, frequent or irregular urination. Rare adverse reactions reported are syncope, bradycardia or arrhythmia, sinoatrial block, atrioventricular block, heart murmur, epilepsy or black stools.

Patients with allergic reactions to donepezil hydrochloride, piperidine derivatives or excipients in the preparation are contraindicated.

Precautions for children: This product is not recommended for children. Precautions for pregnancy and lactation: 1. Pregnancy: The results of teratogenicity experiments conducted at about 80 times the human dose in pregnant rats and 50 times the human dose in rabbits did not find teratogenicity. However, in experiments conducted at 50 times the human dose in pregnant rats, the administration from 17 days of pregnancy to 20 days after delivery slightly increased stillbirths, and the survival rate of pups 4 days after delivery decreased slightly. However, no abnormal effects were found at the next lower dose of about 15 times the human dose. Donepezil should not be used during pregnancy. 2. Lactation: It is not clear whether donepezil hydrochloride is secreted through women's breast milk, and no tests have been conducted in lactating women. Therefore, women taking donepezil cannot breastfeed. Precautions for the elderly: Refer to item 1 of "Usage and Dosage".

Phenytoin sodium, carbamazepine, dexamethasone, rifampicin, and phenobarbital, inducers of CYP3A4 and CYP2D6 isoenzymes, can increase the clearance rate of this product. Ketoconazole and quinidine, inhibitors of CYP3A4 and CYP2D6 isoenzymes, inhibit the metabolism of this product. This product has not been found to interfere with the metabolism of theophylline, cimetidine, warfarin, and digoxin. 4. This product may affect drugs with anticholinergic activity.

Sealed and stored in a cool and dry place. The validity period is tentatively 24 months

5mg

24 months

Shaanxi ARK Pharmaceutical Co., Ltd.

• Founded in:

  1998-03-13

• Address:

  Pengcun Industrial Zone, Yijun County, Tongchuan City, Shaanxi Province

• Tax NO.:

  91610200221270442P

• Registered Funds:

  7.7849 million yuan

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