Product Overview
[Drug Name]
Generic Name: Rabeprazole Sodium Enteric-Coated Tablets
Trade Name: DiKang Rabeprazole Sodium Enteric-Coated Tablets, 20mg*5 Tablets
Pinyin Full Code: DiKang LeiBeiLaZuoNaChangRongPian, 20mg*5 Tablets
[Main Ingredient]
Rabeprazole sodium.
[Properties]
This product is an enteric-coated tablet, appearing white or light yellow after removal of the coating.
[Indications/Main Functions]
1. Active duodenal ulcer; 2. Benign active gastric ulcer; 3. Erosive or ulcerative gastroesophageal reflux disease (GORD) associated with clinical symptoms; 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 drug for treatment exceeding 12 months has not yet been evaluated.
[Specifications]
20mg*5 tablets (Dikang)
[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, once daily, in the morning. Most patients with active duodenal ulcers resolve after 4 weeks of treatment. However, 2% of patients may require further treatment for another 4 weeks to achieve recovery. Some patients with duodenal ulcers respond to a 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 further treatment for another 6 weeks to achieve recovery. B. Patients with erosive or ulcerative gastroesophageal reflux disease (GORD): 20mg (2 tablets), once daily, for 4 to 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 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 facilitates treatment. 2. Use in patients with hepatic and renal insufficiency: No dosage 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% to 5%): photosensitivity reaction, headache, nausea, vomiting, constipation, abdominal distension, diarrhea, rash, urticaria; erythropenia, leukocytopenia, leukocytosis, eosinophilia, neutrophilia, lymphocytopenia; elevated ALT, AST, ALP, γ-GTP, LDH, total bilirubin, total cholesterol, and BUN; proteinuria.
2. Rare (incidence <0.1%): shock, palpitations, bradycardia, lower abdominal pain, dyspepsia, chest pain, myalgia, visual impairment, dizziness, insomnia, drowsiness, fatigue, decreased grip strength; limb weakness, dysesthesia, slurred speech, unsteady gait, hemolytic anemia.
[Contraindications]
This product is contraindicated in patients with allergies to rabeprazole sodium, benzimidazole substitutes, or any excipients used in the preparation of this product.
Drug Interactions: Rabeprazole sodium is metabolized by the cytochrome P450 (CYP450) enzyme system. Studies in healthy subjects have shown no clinically significant interactions between rabeprazole sodium and other drugs metabolized by the CYP450 system. Rabeprazole sodium produces a sustained inhibitory effect on gastric acid secretion. Because rabeprazole sodium decreases gastric acidity, it may interact with drugs whose absorption is dependent on gastric pH. For example, daily coadministration of ketoconazole and 20 mg of rabeprazole sodium in healthy subjects reduced ketoconazole bioavailability by approximately 30%. Concomitant administration of digoxin increased the AUC and Cmax of digoxin by 19% and 29%, respectively. Therefore, patients should be monitored when taking these drugs concomitantly with rabeprazole sodium. The mean area under the plasma concentration curve for rabeprazole sodium decreased by 8% and 6%, respectively, when rabeprazole sodium was taken concomitantly with antacids and one hour after antacid administration. Coadministration of omeprazole, a similar drug to this drug, with phenytoin has been reported to result in delayed phenytoin metabolism or excretion.
[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 liver impairment with healthy controls, physicians recommend that patients with severe liver impairment exercise particular caution when initially using this drug. 2. While taking this drug, regular blood tests and blood biochemistry (such as liver enzyme tests) should be performed. Abnormalities should be detected, and treatment should be discontinued and prompt. 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 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 digestive reactions 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.
