Product Overview
[Drug Name]
Trade Name: Dingnuo
English Name: Rabeprazole Sodium Enteric-coated Tablets
Chinese Pinyin: Leibeilazuona Changrong Pian
[Ingredients]
2-[[[4-(3-methoxypropoxy)-3-methyl-α-pyridyl]methyl]sulfinyl]-1H-benzimidazole sodium. Chemical Structure: Molecular Formula: C18
[Properties]
This product is enteric-coated tablets, which appear light yellow after removal of the enteric coating.
[Indications]
This product is indicated for: 1. Active duodenal ulcers; 2. Benign active gastric ulcers; 3. Erosive and ulcerative gastroesophageal reflux disease (GERD) 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 product for treatment exceeding 12 months has not yet been evaluated.
[Dosage and Administration]
This tablet should not be chewed or crushed; it should be swallowed whole.
1. Dosage for 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 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 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]
Reported in foreign literature: 1. Serious side effects: (1) Shock: There are reports of allergic reactions and shock. If any abnormality is found, stop taking the drug immediately and treat it properly. (2) Blood: This drug rarely causes various blood cell reductions, thrombocytopenia, granulocytopenia, hemolytic anemia, etc. However, it can occasionally cause granulocytopenia, anemia, etc. If any abnormality is found, stop taking the drug immediately and treat it. (3) Visual impairment: There are reports of visual impairment in foreign patients taking this drug. 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, dyspepsia, nervousness, drowsiness, bronchitis, sinusitis, chills, belching, leg cramps, urinary tract infection, arthritis, 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, sweating, and leukocytosis. Elevated liver enzymes, such as ALT, AST, AIP, gamma-GTP, LDH, and total bilirubin, occurred in 5.2% of patients. 6. Bullous rash or other skin reactions, including erythema, have been reported. Discontinue the drug immediately if skin lesions occur.
[Contraindications]
1. This product is contraindicated in patients with allergies to rabeprazole sodium, benzimidazole substitutes, or any excipients used in the preparation of this product. 2. This product is contraindicated in pregnant and lactating women.
[Precautions]
1. The possibility of cancer should be ruled out before initiating treatment with this drug. Although no significant drug-related safety issues were 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. If abnormalities are found, the drug should be discontinued and prompt treatment should be initiated. 3. This drug should not be used in patients with impaired liver function.
[Use in Special Populations]
Precautions for Children:
Safety for children is unknown (no clinical experience).
Precautions for Pregnancy and Lactation:
This drug is contraindicated in pregnant and lactating women.
Precautions for the Elderly:
This drug is primarily metabolized by the liver, which generally decreases in the elderly, leading to side effects. If severe side effects occur, discontinue use.
Drug Interactions: Rabeprazole sodium, 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 inhibition 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 with this product. In clinical trials, no interactions with liquid antacids were 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 have demonstrated that rabeprazole sodium is metabolized by CYP450 isoforms (CYP2C19 and CYP3A4). This study suggests 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 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 does not antagonize cholinergic and histamine H2 receptors.
[Storage]
Store tightly closed in a cool, dry place (not exceeding 20°C).
[Strength]
20 mg
[Packaging]
Aluminum-plastic packaging, 7 tablets per box
[Expiry Date]
24 months
[Approval Number]
National Medical Products Approval No. H20080125
[Manufacturer]
Jincheng Haisi Pharmaceutical Co., Ltd.
