Product Overview
[Drug Name]
Trade Name: Dikang/Ansifei
English Name: Rabeprazole Sodium Enteric-coated Tablets
Chinese Pinyin: Leibeilazuona ChangrongPian
[Ingredients]
The main ingredient of this product is rabeprazole sodium. Chemical name: 2-{[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methanesulfinyl}-1H-benzimidazole sodium.
[Properties]
This product is enteric-coated tablets, which appear white or light yellow after removal of the coating.
[Indications]
This product is indicated for the treatment of the following: 1. Active duodenal ulcer; 2. Benign active gastric ulcer; 3. Symptomatic erosive or ulcerative gastroesophageal reflux disease (GORD); 4. In combination with appropriate antibiotics, it can eradicate Helicobacter pylori-positive duodenal ulcers; 5. Maintenance treatment of erosive or ulcerative gastroesophageal reflux disease. The efficacy of this product for treatment exceeding 12 months has not yet been evaluated.
[Dosage and Administration]
This product should not be chewed or crushed; it should be swallowed whole. 1. Usage in Adults/Elderly Patients: A. Active duodenal ulcers and active benign gastric ulcers: 20 mg (2 tablets) once daily in the morning. Most patients with active duodenal ulcers recover after 4 weeks of treatment. However, 2% of patients may require 4 weeks of continued treatment for recovery. Some patients with duodenal ulcers respond to a 10 mg (1 tablet) tablet taken once daily in the morning. Most active benign gastric ulcers recover after 6 weeks of treatment. However, 9% of patients may require 6 weeks of continued treatment for recovery. B. Patients with erosive or ulcerative gastroesophageal reflux disease (GORD): 20 mg (2 tablets) once daily for 4 to 8 weeks. C. Long-term treatment of gastroesophageal reflux disease (GORD): The course of treatment is 12 months, and the maintenance dose is 10 mg (1 tablet) or 20 mg (2 tablets), once a day. Some patients respond to a maintenance dose of 10 mg (1 tablet) per day. D. Radical treatment of Helicobacter pylori: Combined with appropriate antibiotics, it can cure Helicobacter pylori-positive duodenal ulcers. This product should be taken in the morning, before meals. Although the time of administration and food intake have no effect on the efficacy of rabeprazole sodium, this method of administration is more conducive to the treatment. 2. Medication for patients with hepatic and renal insufficiency: Patients with hepatic and renal insufficiency do not need to adjust the dose during medication. However, when using the drug in patients with severe hepatic insufficiency, refer to adverse reactions and precautions.
[Adverse reactions]
According to foreign literature reports: 1 Serious side effects: (1) Shock: There are reports that this product has side effects of allergic reaction and shock. Therefore, if abnormalities are found, the drug should be stopped immediately and properly handled. (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 the drug immediately and seek treatment. (3) Visual impairment: There are reports of visual impairment in foreign countries when taking this drug. 2 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 include anorexia, gastritis, weight gain, depression, pruritus, visual/olfactory dysfunction, stomatitis, diaphoresis, and leukocytosis. Elevated liver enzymes, such as ALT, AST, AIP, gamma-GTP, LDH, and total bilirubin, were reported in 52% of patients. 6. Bullous rash or other skin reactions, including erythema, have been reported. Immediately discontinue the drug if skin lesions occur.
[Contraindications]
1. Patients with hypersensitivity to rabeprazole sodium, benzimidazole substitutes, or any excipients used in the preparation of this formulation should not use this drug. 2. Pregnant and lactating women should not use this drug.
[Precautions]
1. Symptoms treated with rabeprazole sodium do not exclude the possibility of gastric or esophageal cancer. Therefore, the possibility of cancer should be ruled out before initiating treatment with this drug. Although no significant drug-related safety issues have been identified in age- and sex-matched studies comparing patients with mild to moderate hepatic impairment to healthy controls, physicians recommend that patients with severe hepatic impairment exercise particular caution when first using this drug. 2. When taking this drug, regular blood tests and blood biochemistry tests (such as liver enzyme tests) should be performed. If abnormalities are found, discontinue use and seek prompt treatment. 3. Use with caution in patients with impaired liver function.
[Use in Special Populations]
Precautions for Children:
Currently, there are no safety and efficacy data for this drug in children.
Precautions for Pregnancy and Lactation:
Pregnant and lactating women are contraindicated.
Precautions for Elderly:
This drug is primarily metabolized by the liver. Elderly individuals generally have reduced liver function and may experience side effects. If severe side effects occur, discontinue use.
[Drug Interactions]
Rabeprazole sodium, as a member of the proton pump inhibitor (PPI) class of compounds, is metabolized by the cytochrome P450 (CYP450) hepatic drug metabolism system. Studies in healthy subjects have shown no clinically significant interactions between rabeprazole sodium and other drugs metabolized by the CYP450 system, such as warfarin, phenytoin, theophylline, or diazepam. Rabeprazole sodium provides long-term, sustained suppression of gastric acid secretion. This product has been shown to interact with compounds whose absorption is pH-dependent, and potential interactions should be investigated. Concomitant administration of rabeprazole sodium in healthy subjects resulted in a 33% decrease in ketoconazole levels and a 22% increase in digoxin levels. Therefore, individual patient testing is necessary to determine whether dose adjustments are necessary when these drugs are taken concomitantly with this product. In clinical trials, no interaction with liquid antacids was observed when antacids were coadministered with this product, including a specific study to determine this interaction. This product has no clinically relevant interactions with food. In vitro studies in human liver microsomes indicate that rabeprazole sodium is metabolized by CYP450 isoforms (CYP2C19 and CYP3A4). These studies suggest a low potential for interaction; however, the effects on cyclosporine metabolism are similar to those previously observed with other proton pump inhibitors.
[Pharmacological Action]
Rabeprazole sodium is an antisecretory drug and an alternative to benzimidazoles. It lacks anticholinergic and anti-H2 histamine properties, but it binds to the surface of gastric parietal cells and inhibits gastric acid secretion by inhibiting H+-K+-ATPase. This enzyme system is considered an acid proton pump, so rabeprazole sodium acts as a proton pump inhibitor in the stomach, inhibiting gastric acid production. This effect is dose-related. Animal studies have demonstrated that rabeprazole sodium is excreted from the plasma and gastric mucosa shortly after administration. Its gastric acid secretion inhibitory properties: Rabeprazole sodium exerts its effect within one hour after oral administration of 20 mg, reaching peak plasma concentrations within 2-4 hours. Within 23 hours of the first dose, rabeprazole sodium suppresses basal gastric acid production and food-stimulated gastric acid production by 69% and 82%, respectively. This duration of action persists for up to 48 hours, significantly longer than the pharmacokinetic half-life (approximately one hour). Its mechanism of action is inhibition of H+-K+-ATPase. The inhibitory effect of rabeprazole sodium on gastric acid secretion increases slightly with increasing dose, but reaches a stable level after three days. This stable level is maintained for 2-3 days even after discontinuation of the drug. Toxicological studies: (1) Oral toxicity tests were conducted on rats at a dose of 5 mg/kg for 2 years, and carcinoid tumors were found in the stomach of female rats. (2) Animal experiments (oral administration of 25 mg/kg or more in rats) showed an increase in thyroid weight and blood thyroxine. Therefore, attention should be paid to thyroid function when taking the drug. Effect on serum gastrin: In clinical trials, patients received rabeprazole sodium 10 mg or 20 mg once a day for 24 months. Serum gastrin levels increased within 2 to 8 weeks of treatment. Usually, serum gastrin values can return to pre-treatment levels within one to two weeks after discontinuation of the drug.
[Storage]
Store in a cool, dark place
[Specifications]
20 mg*7 tablets
[Packaging specifications]
Box
[Expiration date]
24 months.
[Approval number]
National Medicine Standard No. H20040715
[Manufacturer]
Company name: Chengdu Dikang Pharmaceutical Co., Ltd.
