Product Overview
[Drug Name]
Generic Name: Rabeprazole Sodium Enteric-Coated Tablets
Trade Name: XinWeiAn Rabeprazole Sodium Enteric-Coated Tablets 10mg*7 Tablets
Pinyin Code: XinWeiAn LeiBeiLaZuoNaChangRongPian 10mg*7 Tablets
[Main Ingredient]
Rabeprazole sodium.
[Properties]
This product is an enteric-coated tablet that appears white or off-white after the enteric coating is removed.
[Indications/Main Functions]
This product is indicated for: 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 cure 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.
[Specifications]
10mg*7 tablets (Xinwei'an)
[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: 20mg (2 tablets) once daily in the morning. Most patients with active duodenal ulcers resolve after 4 weeks of treatment. However, 2% of patients may require 4 weeks of continued treatment for complete recovery. Some patients with duodenal ulcers respond to a single 10mg tablet taken once daily in the morning. Most active benign gastric ulcers resolve after 6 weeks of treatment. However, 9% of patients may require 6 weeks of continued treatment for complete recovery. B. Patients with erosive or ulcerative gastroesophageal reflux disease (GORD): 20mg (2 tablets) once daily for 4-8 weeks. C. Long-term treatment regimen for gastroesophageal reflux disease (GORD): Maintenance therapy: The course of treatment is 12 months, with a maintenance dose of 10 mg (1 tablet) or 20 mg (2 tablets) once daily. Some patients respond to a maintenance dose of 10 mg (1 tablet) per day. D. Curative treatment of Helicobacter pylori: Combined with appropriate antibiotics, it can eradicate Helicobacter pylori-positive duodenal ulcers. This product should be taken in the morning, before meals. Although the timing of administration and food intake do not affect the efficacy of rabeprazole sodium, this route of administration facilitates treatment. 2. Use in patients with hepatic and renal insufficiency: No dose adjustment is required for patients with hepatic and renal insufficiency. However, when using this product in patients with severe hepatic insufficiency, please refer to the "Adverse Reactions and Precautions" section.
Adverse Reactions
1. Occasional (incidence 0.1-5%): photosensitivity reaction, headache, nausea, vomiting, constipation, diarrhea, rash; erythropenia, leukocytopenia, leukocytosis, eosinophilia, neutrophilia, lymphocytopenia; ALT, AST, ALP, GTP, LDH, total bilirubin, total cholesterol, urine protein, etc. 2. Rare (incidence <0.1%): shock, palpitations, bradycardia, dyspepsia, chest pain, myalgia, visual impairment, insomnia, drowsiness, decreased grip strength, slurred speech, staggering gait, hemolytic anemia, etc.
Contraindications
1. Patients allergic to rabeprazole sodium, benzimidazole substitutes, or any excipients used in the preparation of this formulation are contraindicated.
Drug Interactions
Rabeprazole is metabolized by the cytochrome P450 (CYP450) enzyme system. Studies in healthy subjects have shown that rabeprazole sodium has no clinically significant interactions with other drugs metabolized by the CYP450 system. Rabeprazole sodium produces a sustained inhibitory effect on gastric acid secretion. Because rabeprazole sodium decreases acidity, it may interact with drugs whose absorption is dependent on gastric pH. For example, daily administration of ketoconazole and 20 mg of rabeprazole sodium in healthy subjects reduced ketoconazole bioavailability by approximately 30%. Concomitant administration of digoxin increased digoxin's AUC and Cmax by 19% and 29%, respectively. Therefore, patients should be monitored when taking these drugs concomitantly with rabeprazole sodium. The mean plasma concentration area under the curve decreased by 8% and 6%, respectively, when rabeprazole sodium was taken concomitantly with antacids and one hour after antacid administration.
[Precautions]
1. The possibility of cancer should be ruled out before initiating treatment with this product. Although no significant drug-related safety issues were observed in age- and sex-matched studies comparing patients with mild to moderate liver impairment to healthy controls, physicians recommend special caution when initially using this drug in patients with severe liver impairment. 2. While taking this drug, regular blood tests and blood chemistry tests (such as liver enzyme tests) should be performed. If abnormalities are detected, discontinue use and seek prompt treatment. 3. Use with caution in patients with liver impairment.
[Pediatric Use]
Currently, there are no safety and efficacy data for this drug in children.
[Elderly Use]
Clinical studies have shown no differences in efficacy or safety between patients aged 65 and over and younger patients, but greater sensitivity in some elderly patients cannot be ruled out. Because this drug is primarily metabolized in the liver, and elderly patients often have impaired liver function, adverse reactions may occur. Therefore, if adverse reactions to the digestive system occur (see "Adverse Reactions"), use with caution and discontinue the medication if necessary.
[Overdose]
There is no known specific antidote. In the event of an overdose, appropriate supportive care should be implemented based on the patient's clinical symptoms and signs.
[Pharmacology and Toxicology]
Pharmacological Action: Rabeprazole is a benzimidazole compound and a second-generation proton pump inhibitor. It blocks the final step of gastric acid secretion by specifically inhibiting the H+-K+ ATPase system in gastric parietal cells. This effect is dose-dependent and can inhibit both basal and stimulated gastric acid secretion. This product has no antagonistic effect on cholinergic and histamine H2 receptors. Toxicological Studies: Genetic Toxicology. Toxicity: The results of the Salmonella typhimurium reverse mutation (Ames) test, the Chinese hamster ovary gene mutation test, and the mouse lymphoma cell gene mutation test were all positive; its demethylated metabolite was also positive in the test; the results of the in vitro hamster lung cell chromosome aberration test, the mouse micronucleus test, and the in vivo and in vitro liver unscheduled DNA synthesis (UDS) test were all negative. Reproductive toxicity: Rats were given rabeprazole 50 mg/kg/day intravenously (plasma AUC was approximately 13 times that of the clinically recommended dose for patients) and 50 mg/kg/day intravenously (plasma AUC was approximately 8 times that of the clinically recommended dose for patients) without intravenous administration of this product. No significant changes were observed in fertility and reproductive behavior. Normally, no harm has been observed in animal fetuses. There are no adequate and well-controlled clinical studies of drug administration in pregnant women. Because animal reproductive toxicity does not always predict the effects of a drug on humans, this drug should be used during pregnancy only when clearly needed. Rabeprazole 400 mg/kg/day administered orally during late pregnancy and lactation in rats resulted in slower weight gain. Because many drugs are excreted in breast milk and may have toxic side effects in nursing infants, the importance of the drug to the mother should be considered when deciding whether to discontinue breastfeeding or the drug during this period. Carcinogenicity: In studies conducted in CD-1 mice for 88/104 weeks, oral administration of rabeprazole at doses up to 100 mg/kg/day resulted in decreased weight gain in rats. No increase in tumor incidence was observed after 104 days of treatment, at which time the blood concentration was 1.6 times the recommended dose for patients. A 104-week carcinogenicity study was conducted in SD rats, with male rats receiving oral doses of 5, 15, 30, and 60 mg/kg/day, and female rats receiving oral doses of 5, 15, 30, 60, and 120 mg/kg/day. Both male and female rats developed gastrointestinal chromaffin cell (ELO) proliferation at all doses, and female rats developed benign gastrointestinal chromaffin cell (ELO) tumors at all doses. No drug-related tumors were observed in males, even at the highest dose (blood concentration equivalent to 0.2 times the recommended clinical dose).
