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Sodium rabeprazole. Sodium Rabeprazole
【 Drug alias 】 Polite
Molecular composition: (+) -Na-[4- (3-methoxypropyloxy) -3-methylpyridine - 2-group] methylsulfoyl-1h benzimidazole.
The molecular formula is C16H20N3O3SNa.
【 Preparation specification 】 Tablets, 10mg, 20mg. This product is pure white powder, tasteless. Soluble in water, methanol, and a small amount of pure alcohol and ether. Peptic ulcer, gastroesophageal reflux disease, Zhuo - Ai syndrome, etc. H2 receptor antagonists and proton pump inhibitors are the two most commonly used drugs in the treatment of acid-related peptic diseases. They both increase gastric pH, but proton pump inhibitors act on H+/K+ -ATPase, strongly inhibit gastric acid secretion, and cause a large and lasting increase in gastric pH. Rabeprazole sodium is the latest proton pump inhibitor. Its anti-gastric acid secretion activity was higher than that of the original proton pump inhibitor prilosec. Rabeprazole inhibited H+/K+ -ATPase more strongly than omeprazole, and the
inhibition could be restored. On plasma gastrin water
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Pharmacology and toxicology
Rabeprazole sodium is a novel proton pump inhibitor, which can be used in the treatment of acid-related diseases, such as pine, with less effect. It has selective and strong inhibition of Helicobacter pylori (HP). In a double-blind crossover trial in Switzerland, asymptomatic HP-negative patients were treated with placebo, Rabeprazole sodium 20mg, prilosec (multi-unit tablet system) 20mg, prilosec capsules 20mg, or lansoprazole 30mg. The therapeutic effect of d1 and rabeprazole sodium group was significantly better than that of other groups, with a median pH value of about 3.5. The results showed that rabeprazole showed significant acid inhibition effect after 24h treatment compared with other proton pump inhibitors.
In a Japanese study, patients treated with peptic ulcer with rabeprazole sodium 10mg(n=48), akg 20mg(n=27), another plasma pump inhibitor (n= 31), or an H2 blocker were compared for symptom relief after 1 week. The results showed that rabeprazole sodium had more significant symptom relief after 3 days of treatment than other proton pump inhibitors or H2 receptor blockers.
Clinical trials were conducted in 137 patients with peptic ulcer (102 patients with duodenal bulbar ulcer and 35 patients with gastric ulcer) by randomized open control method. Divided into rabeprazole sodium group 10mg, po, qd and omeprazole group 20mg, po, qd. The treatment duration was 4 weeks for duodenal bulbar ulcer and 6 weeks for gastric ulcer.
The results showed that the pain symptoms of duodenal ball flushing and gastric ulcer patients were significantly improved and the pain duration disappeared after treatment with this product, and there was no statistical difference compared with prilosec group. In the whole trial, 3 patients in the rabeprazole sodium group had adverse reactions, the rate of adverse reactions was 4.29%, and the rate of adverse reactions was 4.48% in the omeprazole group. Adverse reactions to this product were mild and no patients withdrew from the trial due to adverse reactions.
Healthy volunteers po10 ~ 80mg·d-1, qd, for 7 consecutive days. Cmax (peak concentration) and AUC (area under curve) increased with dose, and the plasma half-life was about 1h and was dose-independent. The clearance rate of rabeprazole sodium was 4.37 ~ 8.40mL·min-1·kg-1. The plasma protein binding rate was 96.3%, and about 30% of the drug was excreted in the urine as thiocarboxylic acid and glucosidic acid derivatives. This product is metabolized by the cytochrome P450 enzyme system and its bioavailability is not affected by food or antacids.
It is used to treat acid-related diseases, such as peptic ulcer, gastroesophageal reflux disease, and Zeu-Ehrstein syndrome.
The main adverse reactions were rash, constipation, diarrhea, headache, ALT, AST, ALP, γ-GTP, LDH, total bilirubin and so on. It goes away on its own after withdrawal.
Interact with each other
This product does not affect the removal of Diazepam, phenytoin, warfarin and theophylline; The combination of this product with digoxin or ketoconazole affected the pharmacokinetics of the latter two because their absorption depended on the acidity of the stomach; Rabeprazole did not interact with antacids. Food and time of administration did not affect the bioavailability of rabeprazole sodium.
The dose for adults is 10mg, po, qd, and can be increased to 20mg, po, bid in severe cases.
Matters needing attention
1. Patients with known allergy to this product, benzimiazole derivatives or any component of the dosage form should be conserved.
2. Pregnant and lactating women are prohibited.
3. As this product also has a high curative effect on the symptoms caused by gastric malignant lesions, the possibility of malignant lesions should be excluded before using this product for treatment.
4. Use with caution in patients with severe hepatitis, starting with small dose and monitoring liver function should be used.
5. Not recommended for children younger than 12 years old.
6. Elderly patients do not need to adjust the dosage of this product.