Product Overview
[Drug Name]
Generic Name: Rabeprazole Sodium Enteric-Coated Tablets
Trade Name: RuiBoTe Rabeprazole Sodium Enteric-Coated Tablets 10mg*14 Tablets
Pinyin Full Code: RuiBoTe LeiBeiLaZuoNaChangRongPian 10mg*14 Tablets
[Main Ingredient]
The main ingredient of this product is rabeprazole sodium.
[Properties]
This product is an enteric-coated tablet that appears white or off-white after removal of the coating.
[Indications/Main Functions]
This product is indicated for the following treatments: 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.
[Specifications]
10mg*14 tablets
[Dosage and Administration]
This product should not be chewed or crushed; swallow the tablet 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 in the morning, once daily. 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 to 8 weeks. C. Long-term Treatment of 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) daily. D. Curative Treatment of Helicobacter pylori: Combined with appropriate antibiotics, it can eradicate H. pylori-positive duodenal ulcers. This medication 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 medication in patients with severe hepatic insufficiency, please refer to "Adverse Reactions and Precautions."
[Adverse Reactions]
According to international literature: 1. Serious Side Effects: 1) Shock: There have been reports of allergic reactions and shock. If any abnormalities are observed, discontinue use immediately and seek appropriate treatment. 2) Blood: This product rarely causes various blood cell reductions, thrombocytopenia, granulocytopenia, hemolytic anemia, etc. However, it may occasionally cause granulocytopenia and anemia. If any abnormality is found, stop taking the drug immediately and seek treatment. 3) Visual impairment: There have been reports of visual impairment in patients taking this drug abroad. 2. The most common adverse reactions are headache, diarrhea, and nausea. Other adverse reactions include rhinitis, abdominal pain, weakness, 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, nervousness, 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. 5. Elevated liver enzymes, such as ALT, AST, AI-P, γ-GTP, LDH, and total bilirubin, have been reported in 2% of patients. 6. Bullous rash or other skin reactions, including erythema, have been reported. Immediately discontinue the drug if skin lesions occur.
[Contraindications]
1. Rabeprazole sodium is contraindicated in patients with hypersensitivity to rabeprazole sodium, benzimidazole substitutes, or any excipients used in the preparation of this formulation. 2. Rabeprazole is contraindicated in pregnant and lactating women.
[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-lasting suppression of gastric acid secretion. This product has been linked to interactions 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 interactions with liquid antacids were observed with this product in 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.
[Precautions]
1. Symptomatic responses to treatment with rabeprazole sodium do not exclude the presence of gastric or esophageal cancer. Therefore, 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 hepatic impairment to healthy controls, physicians recommend that patients with severe hepatic impairment exercise particular caution when using this drug for the first time. 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 the drug and seek prompt treatment. 3. Use with caution in patients with impaired liver function.
[Pediatric Use]
Safety in children has not been established (no experience with this drug).
[Elderly Use]
This drug is primarily metabolized by the liver. Elderly individuals generally have impaired liver function and may experience side effects. If severe side effects occur, discontinue use.
[Overdose]
There is no known specific antidote. Rabeprazole sodium is extensively protein-bound and, therefore, is not readily dialyzable. Treatment should be symptomatic.
[Pharmacology and Toxicology]
Pharmacological Action: Rabeprazole sodium is an antisecretory drug and an alternative to benzimidazole. It lacks anticholinergic and anti-H2 histamine properties, but it can bind to the surface of gastric parietal cells and inhibit H+/K+-ATPase, thereby inhibiting gastric acid secretion. This enzyme system is considered an acid proton pump, so rabeprazole sodium acts as a proton pump inhibitor in the stomach, blocking gastric acid production. This effect is dose-dependent. Animal studies have demonstrated that rabeprazole sodium is excreted from the plasma and gastric mucosa shortly after administration. Gastric Acid Secretion Inhibition: 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-induced gastric acid production by 69% and 82%, respectively. This inhibition persists for up to 48 hours, significantly longer than the pharmacokinetic half-life (approximately 1 hour). The mechanism of action is inhibition of H+/K+-ATPase. The inhibitory effect of rabeprazole sodium on gastric acid secretion may increase slightly with increasing dose, 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. Toxicological studies: (1) A 2-year oral toxicity study 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 25 mg/kg or more in rats) found that the thyroid weight and blood thyroxine increased, so attention should be paid 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 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.
