Galantamine Hydrobromide Dispersible Tablets

Pharmacological action Galantamine is a selective, competitive and reversible acetylcholinesterase inhibitor. In addition, galantamine can enhance the intrinsic effect of acetylcholine by binding to the allosteric site of nicotinic receptors. Through the above mechanism of action, the activity of the cholinergic system is enhanced, and the cognitive function of patients with Alzheimer's disease is improved. Toxicological studies The results of the genotoxicity test of galantamine in the Ames test, mouse lymphoma test, CHO cell chromosome aberration test, and mouse micronucleus test were all negative. Reproductive toxicity Female rats were given 14 days before mating and male rats 60 days before mating at a dose of 16 mg/kg/day (calculated in mg/m2, equivalent to 7 times the maximum recommended dose [MRHD] for humans), and no effect on fertility was observed. Pregnant rats and rabbits were given doses of 16 and 40 mg/kg, respectively (25 times and 63 times the human therapeutic dose, respectively), and no teratogenic effects were observed. In rats, a non-significant increase in the incidence of skeletal abnormalities was observed at a dose of 16 mg/kg/day. Carcinogenicity In a 2-year rat carcinogenicity study, a slight increase in the incidence of endometrial adenocarcinoma was observed at doses of 10 mg/kg/day (4 times the MRHD based on mg/m2; 6 times the human based on AUC) and 30 mg/kg/day (12 times the MRHD based on mg/m2; 19 times the human based on AUC). No increase in tumor incidence was observed in female rats at doses of 2.5 mg/kg/day (2 times the MRHD based on mg/m2; 2 times the human based on AUC) and in male rats at doses of 30 mg/kg/day (12 times the MRHD based on mg/m2; 12 times the human based on AUC). In a 6-month carcinogenicity study in transgenic mice (P53-deficient), the dose reached 20 mg/kg/day, and in a 2-year carcinogenicity study in mice, the dose reached 10 mg/kg/day (calculated in mg/m2, equivalent to 2 times the MRHD; calculated in AUC, equivalent to humans), and no increase in tumor incidence was observed.

The main ingredient of this product is galanthamine hydrobromide. Chemical name: 11-methyl-3-methoxy-4a,5,9,10,11,12-hexahydro-6H-benzofuran[3a,3,2ef][2]benzazepine-6-ol hydrobromide. Chemical structure: Molecular formula: C17H21NO3·HBr Molecular weight: 368.27

This product is white or off-white tablets.

This product is used to treat mild to moderate Alzheimer's dementia symptoms

Oral administration, it is recommended to take it with breakfast and dinner. Starting dose: The recommended dose is 4 mg once, twice a day, for 4 weeks. Ensure adequate fluid intake during treatment. Maintenance dose: The initial maintenance dose is 8 mg once, twice a day. At this dose, the patient maintains it for at least 4 weeks. After a comprehensive evaluation of the patient's clinical efficacy and tolerability, the physician can increase the dose to the highest clinically recommended dose, 12 mg once, twice a day. Please refer to the above recommended regimen or follow the doctor's advice when taking this product. Please refer to the relevant section of the instructions for precautions for use in special populations. This product has no withdrawal reaction.

1. Nervous system: Fatigue, dizziness, headache, tremor, insomnia, and dreaminess are common. Hypertonia, paresthesia, aphasia, and hyperkinesia are rare. 2. Gastrointestinal system: Abdominal distension, nausea, vomiting, abdominal pain, diarrhea, anorexia, weight loss, and indigestion are common. There are also reports of dysphagia and gastrointestinal bleeding. 3. Cardiovascular system: Bradycardia and arrhythmia are seen. Hypotension is rare. 4. Blood system: Anemia is seen, and thrombocytopenia is occasionally seen. 5. Endocrine and metabolic system: Hyperglycemia is occasionally seen, and hypokalemia has been reported.

1. It is contraindicated for patients who are allergic to any of the ingredients in this product. 2. Galantamine is a cholinesterase inhibitor and is contraindicated under anesthesia. 3. It is contraindicated for patients with angina pectoris and bradycardia. 4. It is contraindicated for patients with severe asthma or pulmonary dysfunction. 5. It is contraindicated for patients with severe liver damage. 6. It is contraindicated for patients with severe kidney damage. 7. It is contraindicated for patients with mechanical intestinal obstruction, urinary tract obstruction or bladder surgery recovery period.

Precautions for children: There is no research information and data on the use of galantamine in children, and it is recommended that children do not use this product. Precautions for pregnancy and lactation: 1. There is no data on pregnant women taking this product, so pregnant women should weigh the pros and cons when taking it. 2. It is not clear whether this product is excreted from breast milk, and there is no research data on breastfeeding women, so breastfeeding women are not recommended to use this product. Precautions for the elderly: It is not clear yet, please refer to the content under other items.

1. This product has the potential to weaken the therapeutic effect of anticholinergic drugs. 2. It has a synergistic effect when used in combination with cholinergic agents and other cholinesterase inhibitors. 3. This product can be used in combination with imipenem and ketoconazole to increase its bioavailability. 4. It can be used in combination with erythromycin to reduce the efficacy of this product. 5. There are reports of atrioventricular conduction block when this product is used in combination with digoxin.

Keep sealed.

4mg (calculated as galantamine)

24 months

Hainan HEALTH CARE Laboratories Limited

• Founded in:

  1996-11-25

• Address:

  Guilinyang Industrial Zone, Meilan District, Haikou City, Hainan Province

• Tax NO.:

  91460100620025532X

• Registered Funds:

  $5.32 million

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