Product Overview
[Drug Name]
Generic Name: Rabeprazole Sodium Enteric-Coated Tablets
Trade Name: XinWeiAn Rabeprazole Sodium Enteric-Coated Tablets 10mg x 14 Tablets
Pinyin Code: XinWeiAn LeiBeiLaZuoNaChangRongPian
[Main Ingredient]
Rabeprazole Sodium
[Indications/Main Functions]
This product is indicated for: 1. Active duodenal ulcers; 2. Benign active gastric ulcers; 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 treatment beyond 12 months has not been evaluated.
[Specifications]
10mg x 14 tablets (XinWeiAn)
[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, taken in the morning. Most patients with active duodenal ulcers resolve after 4 weeks of treatment. However, 2% of patients may require 4 more weeks of treatment to achieve 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 resolve after 6 weeks of treatment. However, 9% of patients may require 6 more weeks of treatment to achieve 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 GORD: Maintenance therapy: 12 months of treatment at 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: In combination with appropriate antibiotics, it can cure 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 is more conducive to 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, leukopenia, leukocytosis, eosinophilia, neutrophilia, lymphocytopenia; ALT, AST, ALP, GTP, LDH, total bilirubin, total cholesterol, and urine protein. 2. Rare adverse reactions (incidence <0.1%) include shock, palpitations, bradycardia, dyspepsia, chest pain, myalgia, visual impairment, insomnia, drowsiness, decreased grip strength, slurred speech, unsteady gait, and hemolytic anemia.
[Contraindications]
Rabeprazole sodium is contraindicated in patients with hypersensitivity to rabeprazole sodium, benzimidazole substitutes, or any excipients used in the preparation of this formulation.
[Drug Interactions]
Rabeprazole is metabolized by the cytochrome P450 (CYP450) enzyme system. Studies in healthy subjects have shown that rabeprazole sodium has no significant clinical interactions with other drugs metabolized by the CYP450 system. Rabeprazole sodium can produce 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, if normal subjects take ketoconazole and 20 mg of rabeprazole sodium daily, the bioavailability of ketoconazole decreases by approximately 30%. Concomitant use of digoxin increases the AUC and Cmax of digoxin by 19% and 29%, respectively. Therefore, patients should be monitored when taking these drugs concurrently with rabeprazole sodium. The mean area under the plasma concentration curve for rabeprazole decreases by 8% and 6%, respectively, when rabeprazole sodium is taken concurrently with antacids and one hour after antacid administration.
[Precautions]
1. The possibility of cancer should be ruled out before initiating treatment with this drug. Although no significant drug-related safety issues have been observed in age- and sex-matched studies comparing patients with mild to moderate hepatic impairment and healthy controls, physicians recommend that patients with severe hepatic impairment exercise particular caution when initially using this drug. 2. While taking this drug, regular blood tests and blood biochemistry tests (such as liver enzyme tests) should be performed. If abnormalities are detected, the drug should be discontinued and prompt treatment should be initiated. 3. Use with caution in patients with impaired liver function.
[Pediatric Use]
Currently, there are no safety and efficacy data for this drug in children.
[Elderly Use]
Clinical studies have shown no difference 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 digestive adverse reactions occur (see "Adverse Reactions"), use with caution and, if necessary, discontinue the drug.
[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 in gastric acid secretion by specifically inhibiting the H+-K+ ATPase system in gastric parietal cells. This effect is dose-dependent and inhibits both basal and stimulated gastric acid secretion. This product has no antagonistic effect on cholinergic and histamine H2 receptors. Toxicological studies revealed that this product tested positive for genotoxicity in the Salmonella typhimurium reverse mutation (Ames) assay, the Chinese hamster ovary gene mutation assay, and the mouse lymphoma cell gene mutation assay; its demethylated metabolite also tested positive in these assays. Results were negative in the in vitro hamster lung cell chromosome aberration assay, the mouse micronucleus assay, and the in vivo and in vitro liver unscheduled DNA synthesis (UDS) assay. Reproductive toxicity: In rats, intravenous administration of rabeprazole at 50 mg/kg/day (plasma AUC approximately 13 times that of the clinically recommended dose) and intravenous administration of this product at 50 mg/kg/day (plasma AUC approximately 8 times that of the clinically recommended dose) showed no significant changes in fertility or reproductive behavior, and no harm was observed in the fetuses. Adequate and well-controlled clinical studies involving pregnant women are lacking. Because animal reproductive toxicity does not always predict the effects of a drug on humans, this product should be used during pregnancy only when clearly needed. Oral administration of rabeprazole (400 mg/day) 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 withhold breastfeeding or discontinue the drug during this period. Carcinogenicity: In an 88/104-week study in CD-1 mice, oral administration of rabeprazole up to 100 mg/kg/day did not increase tumor incidence, at a plasma concentration 1.6 times the recommended patient dose. A 104-week carcinogenicity study in SD rats involved oral administration of 5, 15, 30, and 60 mg/kg/day to males and 5, 15, 30, 60, and 120 mg/kg/day to females. ELC hyperplasia was observed in both males and females at all doses, and benign ELC tumors were observed in females at all doses. Even in the highest dose group (blood concentration equivalent to 0.2 times the clinically recommended dose), no drug-related tumors were observed in male animals.
