Rabeprazole Sodium Enteric-coated Tablets

1. Pharmacological action: Rabeprazole sodium is a secretion-inhibiting drug and a substitute for benzimidazole. It has no anticholinergic and anti-H2 histamine properties, but it can attach to the surface of gastric parietal cells to inhibit the secretion of gastric acid by inhibiting H/K-ATPase. This enzyme system is regarded as an acid proton pump, so rabeprazole sodium, as a proton pump inhibitor in the stomach, blocks the production of gastric acid, and this effect is dose-related. Animal experiments have confirmed that rabeprazole sodium can be excreted from plasma and gastric mucosa shortly after administration. Gastric acid secretion inhibition properties: The drug effect is exerted within one hour after oral administration of 20 mg of rabeprazole sodium, and the blood drug concentration reaches a peak within 2 to 4 hours. After the first use of rabeprazole sodium for 23 hours, the basal gastric acid amount and the gastric acid amount stimulated by food can be inhibited, with inhibition rates of 69% and 82%, respectively, and the duration can be as long as 48 hours. This action time is significantly longer than the half-life in pharmacokinetics (about 1 hour). The mechanism of action is to inhibit H/K-ATPase. The inhibitory effect of rabeprazole sodium on gastric acid secretion can be slightly enhanced with increasing doses, but it can reach a stable level after three days. Even after discontinuation of the drug, this stable level can be maintained for 2 to 3 days. 2. Toxicological studies: 1) A 2-year oral toxicity test was conducted on rats at a dose of 5 mg/kg, and carcinoid tumors were found in the stomach of female rats. 2) Animal experiments (oral administration of more than 25 mg/kg in rats) found that the thyroid weight and blood thyroxine increased, so pay attention to thyroid function when taking it. Effect on serum gastrin: In clinical trials, patients received rabeprazole sodium 10 mg or 20 mg, once a day, for a course of 24 months. Serum gastrin levels increased within 2 to 8 weeks of medication. Usually, serum gastrin values can return to pre-treatment levels within one to two weeks after discontinuation of the drug.

The main ingredient of this product is rabeprazole sodium. Chemical name: 2-{[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methanesulfinyl}-1H-benzimidazole sodium. Molecular formula: C18H20N3O3SNa. Molecular weight: 381.43.

This product is a light yellow enteric-coated tablet, which appears white after removing the coating.

Gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis, Zollinger-Ellison syndrome. It is used as an auxiliary to eradicate Helicobacter pylori in patients with gastric ulcer or duodenal ulcer.

This product cannot be chewed or crushed before taking, it should be swallowed whole. 1. Use in adults/elderly patients. 1) Patients with active duodenal ulcer and active benign gastric ulcer: 20 mg (2 tablets), once a day, in the morning. Most patients with active duodenal ulcers recover after 4 weeks of medication. However, 2% of patients need to continue taking the medication for 4 weeks to achieve recovery. Some patients with duodenal ulcer respond to a therapeutic dose of 10 mg (1 tablet) tablet taken in the morning, once a day. Most active benign gastric ulcers need to be cured after six weeks of medication. However, 9% of patients need to continue taking the medication for another six weeks to achieve recovery. 2) Patients with erosive or ulcerative gastroesophageal reflux disease (GORD): 20 mg (2 tablets), once a day, the course of treatment is 4 to 8 weeks. 3) Long-term treatment of gastroesophageal reflux disease

According to foreign literature reports: 1. Serious side effects: (1) Shock: There are reports that this product has side effects such as allergic reaction and shock. Therefore, if any abnormality is found, stop taking it immediately and handle it properly. (2) Blood: This product rarely causes various blood cell reductions, thrombocytopenia, granulocytopenia, hemolytic anemia, etc. However, it may occasionally cause granulocytopenia, anemia, etc. If any abnormality is found, stop taking it immediately and treat it. (3) Visual impairment: There are reports of visual impairment when taking this drug abroad. The most common adverse reactions are headache, diarrhea and nausea. Other adverse reactions include rhinitis, abdominal pain, weakness, gastrointestinal flatulence, pharyngitis, vomiting, nonspecific pain or back pain, dizziness, flu symptoms, infectious cough, constipation and insomnia. 3. Adverse reactions include itching, rash, palpitations, myalgia, chest pain, dry mouth, indigestion, nervous hypersensitivity, drowsiness, bronchitis, sinusitis, chills, belching, leg cramps, urinary tract infection, arthritis and fever, limb weakness, numbness, decreased grip strength, unsteady gait, and fatigue. 4. Rare adverse reactions should include: anorexia, gastritis, weight gain, depression, pruritus, visual and olfactory dysfunction, stomatitis, sweating and leukocytosis. 5.2% of patients experienced elevated liver enzymes, such as ALT, AST, AI;P,;GTP, LDH, and total bilirubin. 6. Bullous rash or other skin reactions including erythema have been reported. When skin lesions occur, the drug should be discontinued immediately.

1. Patients who are allergic to rabeprazole sodium, benzimidazole substitutes, or any excipients used in the preparation of this preparation are contraindicated. 2. Pregnant and lactating women are contraindicated.

Precautions for children: The safety for children has not been determined (no experience). Precautions for pregnancy and lactation: Pregnant and lactating women are prohibited. Precautions for the elderly: This drug is mainly metabolized by the liver. Generally, the function of the elderly is low, which will cause side effects. If serious side effects occur, the drug should be discontinued.

Rabeprazole sodium is a member of the proton pump inhibitor (PPI) class of compounds that is metabolized by the cytochrome P450 (CYP450) hepatic drug metabolism system. Studies in healthy subjects have shown that there is no clinically significant interaction between rabeprazole sodium and other drugs metabolized by the CYP450 system, such as warfarin, phenytoin, theophylline or diazepam. Rabeprazole sodium can inhibit gastric acid secretion for a long time. This product interacts with compounds that are absorbed depending on pH, so potential interactions should be investigated. The simultaneous administration of rabeprazole sodium to normal subjects resulted in a 33% decrease in ketoconazole levels and a 22% increase in digoxin levels. Therefore, individual patient testing is required to determine whether dose adjustment is required when these drugs are taken with this product.

Keep tightly closed and away from light.

20mg

24 months

Double-Crane Pharmaceutical(Hainan) Co., Ltd.

• Founded in:

  2004-04-07

• Address:

  No. 2, Yaogu Sanheng Road, Yaogu Industrial Park, Haikou National High-tech Zone

• Tax NO.:

  91460100754396590D

• Registered Funds:

  150 million yuan

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