Lansoprazole for injection

Pharmacological action: Lansoprazole is a proton pump inhibitor. After being distributed in the acidic environment of gastric mucosal parietal cells, the drug is converted into an active metabolite. This metabolite combines with the sulfhydryl group of H, K-ATPase present in the acid-generating site, inhibiting acid secretion by inhibiting the activity of H, K-ATPase. Lansoprazole inhibits gastric acid secretion in a dose-dependent manner, and has an inhibitory effect on both basal and stimulated gastric acid secretion within 24 hours after administration. Healthy adults take 30 mg once, twice a day, and sustained inhibition of gastric acid secretion can be seen. It has been reported that blood coagulation and platelet aggregation are greatly impaired under acidic conditions. Fibrin formed by blood coagulation can be dissolved by pepsin under acidic conditions. This drug improves blood coagulation and platelet aggregation by increasing the pH value in the stomach, and inhibits the activity of pepsin to inhibit bleeding. In addition, under acidic conditions, the repair of damaged gastric mucosa is inhibited. This drug increases the pH value in the stomach by inhibiting acid secretion, promoting the repair of damaged mucosa. Toxicological studies: Genetic toxicity: The results of the Ames test, the rat liver cell unscheduled DNA synthesis test, the mouse micronucleus test, and the rat bone marrow cell chromosome aberration test were all negative. The results of the in vitro human lymphocyte chromosome aberration test were positive. Reproductive toxicity: Rats and rabbits were given lansoprazole intravenously at a dose of 30 mg/kg/day (8 times and 16 times the clinically recommended dose for humans calculated by body surface area), and no adverse effects on fertility and embryos were found. Carcinogenicity studies: SD rats were orally administered lansoprazole at a dose of 5-150 mg/kg/day for 24 consecutive months (1 to 40 times the clinically recommended dose of 30 mg/d for patients weighing 50 kg calculated by body surface area). The results showed that lansoprazole induced gastrointestinal chromaffin-like (ECL) cell proliferation and benign ECL cell tumors in a dose-dependent manner; the incidence of intestinal epithelialization in the gastric epithelium of the test animals increased. The incidence of testicular Leydig cell adenomas in male rats increased in a dose-related manner. The incidence of these adenomas in rats given a dose of 15 to 150 mg/kg/day (4 to 40 times the recommended human clinical dose calculated by body surface area) exceeded the natural incidence of rats of this strain (1.4 to 10%). In a one-year toxicity study, one of the 30 rats given a dose of 50 mg/kg/day (13 times the recommended human clinical dose calculated by body surface area) developed a testicular Leydig cell adenoma. CD-1 mice were given lansoprazole at a dose of 15 to 600 mg/kg/day (2 to 80 times the recommended human clinical dose calculated by body surface area) for 24 consecutive months. As a result, lansoprazole induced ECL cell proliferation in a dose-dependent manner, and the incidence of liver tumors in mice given the drug increased. The incidence of tumors in male mice in the 300 and 600 mg/kg/day groups and female mice in the 150 to 600 mg/kg/day group exceeded the historical incidence of tumors in mice of this strain. Administration of lansoprazole 75-600 mg/kg/day resulted in testicular adenomas in mice.

The main ingredient of this product is lansoprazole. Chemical name: 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1H-benzimidazole. Chemical structure: Molecular formula: C16H14F3N3O2S Molecular weight: 369.37 Excipients: mannitol, polyethylene glycol 400, sodium hydroxide.

This product is white or off-white loose mass or powder.

Used for the treatment of various types of corrosive esophagitis, reflux esophagitis, gastric ulcer, duodenal ulcer.

Intravenous drip: Usually 30 mg once a day for adults, twice a day, and the course of treatment should not exceed 7 days. Once the patient can take the drug orally, the oral solution of lansoprazole should be used. Before use, dissolve the contents of the bottle with 5 ml of sterile water for injection, and then dilute with 100 ml of 0.9% sodium chloride injection for intravenous drip. The recommended time is not less than 30 minutes. Note when using: (1) When using this product for intravenous drip, it should be equipped with a filter with a pore size of 1.2μm to remove precipitates that may be produced during the infusion process. These precipitates may cause embolism of small blood vessels and have serious consequences. (2) In the case of high risk such as spurting or gushing bleeding, blood vessel exposure, etc., endoscopic hemostasis measures should be used first. (3) This product is only for intravenous drip. It should be used as soon as possible after dissolution and should not be stored. Avoid mixing with liquids other than 0.9% sodium chloride injection and other drugs for intravenous drip. (4) If the hemostasis effect is achieved within the first 3 days of treatment with this product, oral medication should be used instead, and unlimited intravenous administration is not allowed.

The side effects of this product are mild, mainly manifested as dry mouth, dizziness and nausea.

Pregnant or lactating women should not use it.

Precautions for children: The safety of this product for children has not been determined and there is no experience of its use. Precautions for pregnancy and lactation: Pregnant and lactating women should not use this product. Precautions for the elderly: Generally, the physiological functions of the elderly decline, so the drug should be used with caution.

Lansoprazole is metabolized by the liver cytochrome P450 enzyme system, especially CYP3A4 and CYP2C19 enzymes. Lansoprazole can significantly and long-term inhibit gastric acid secretion, so it can theoretically promote or inhibit the absorption of some co-administered drugs. 1. Contraindications to Combination Drug Name Clinical Manifestations Mechanism of Action, Risk Factors Atazanavir Sulfate may weaken the efficacy of atazanavir sulfate. The gastric acid secretion inhibition of this product can reduce the solubility of atazanavir and reduce the blood concentration. 2. Notes on Combination Drug Name Clinical Manifestations Mechanism of Action, Risk Factors Theophylline Theophylline blood concentration decreases. This product induces liver drug metabolizing enzymes and can promote the metabolism of theophylline. Tacrolimus The blood concentration of tacrolimus increases. This product can competitively block the metabolism of tacrolimus by liver drug metabolizing enzymes. Digoxin and methyldigoxin may enhance the effect of drugs. Due to the gastric acid secretion inhibition of this product, digoxin hydrolysis is inhibited, which may increase its blood concentration. Itraconazole and gefitinib may weaken the effect of drugs. Due to the inhibitory effect of this product on gastric acid secretion, there is a possibility that the blood concentration of the drug will decrease. Phenytoin and diazepam have been reported to have a similar drug, omeprazole, which can delay the metabolism and excretion of the drug.

Keep away from light and store in a cool place (not exceeding 20℃).

30mg

18 months

Changzhou Siyao Pharmaceuticals Co., Ltd.

• Founded in:

  1996-03-25

• Address:

  Meilongba, southern suburb of Changzhou, Jiangsu Province

• Tax NO.:

  91320400608126461P

• Registered Funds:

  $7.08 million

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