Omeprazole Sodium for Injection (Intravenous Infusion)

Omeprazole is a racemic mixture of a pair of active optical enantiomers. It reduces gastric acid secretion through a highly targeted mechanism of action and is a special inhibitor of the acid pump in gastric parietal cells. This product acts rapidly, and a once-daily dose can reversibly inhibit gastric acid secretion. Omeprazole is a weakly alkaline substance that is concentrated and converted into active substances in the highly acidic environment of the tubules in gastric parietal cells, inhibiting H, K-ATPase (proton pump). This inhibitory effect on the final step of gastric acid formation is dose-related, and highly inhibits basal gastric acid secretion and irritant gastric acid secretion, but has nothing to do with irritants. Intravenous administration of omeprazole in humans inhibits gastric acid secretion in a dose-related manner. In order to quickly achieve the same effect of reducing gastric acidity as multiple oral administrations of 20 mg, it is recommended to give 40 mg of omeprazole intravenously for the first time. Intravenous injection of 40 mg of omeprazole rapidly reduces gastric acidity, with an average decrease of 90% within 24 hours. The inhibitory effect of omeprazole on gastric acid secretion is related to the area under the drug-time curve (AUC), but has nothing to do with the blood drug concentration at the time of administration. Helicobacter pylori is associated with acid peptic diseases, including duodenal ulcers and gastric ulcers, with 95% and 70% of duodenal ulcers and gastric ulcers, respectively, being associated with Helicobacter pylori infection. Helicobacter pylori is the main cause of gastritis. Helicobacter pylori and gastric acid together are the main causes of peptic ulcers. Omeprazole combined with antibiotics can eradicate Helicobacter pylori, which is associated with rapid relief of symptoms, high rates of gastric mucosal repair, and long-term relief of peptic ulcer disease, thereby reducing complications such as gastrointestinal bleeding, and also reducing the need for long-term treatment with anti-acid drugs. Any method, including the reduction of gastric acid caused by proton pump inhibitors, increases the number of normal flora in the gastrointestinal tract, and the risk of gastrointestinal infection with Salmonella and Campylobacter may be slightly increased with acid-suppressing drug treatment. In a study of rats given long-term omeprazole, enlargement of gastric ECL cells and benign tumors were observed, which is the result of persistent hypergastrinemia due to gastric acid suppression. Similar findings were also seen after treatment with H2 receptor antagonists, proton pump inhibitors, and partial fundus resection. Apparently, these changes were not a direct effect of the above drugs.

The main ingredient of this product is: Omeprazole sodium.

This product is white loose mass or powder, and the special solvent is colorless transparent liquid.

Mainly used for: 1. Peptic ulcer bleeding, anastomotic ulcer bleeding. 2. Acute gastric mucosal damage during stress and acute gastric mucosal damage caused by nonsteroidal anti-inflammatory drugs. 3. Also commonly used to prevent severe diseases (such as cerebral hemorrhage, severe trauma, etc.) and prevent rebleeding after gastric surgery. 4. Prevent gastric acid reflux combined with aspiration pneumonia after general anesthesia or major surgery and in weak and comatose patients.

Intravenous drip: Dissolve the contents of the bottle in 100 ml of 0.9% sodium chloride injection or 100 ml of 5% glucose injection before use. After the product is dissolved, the intravenous drip time should be 20-30 minutes or longer. It is forbidden to dissolve and dilute with other solvents or other drugs. When oral therapy is not suitable for patients with duodenal ulcers, gastric ulcers and reflux gastroenteritis, the recommended dose of intravenous drip of this product is 40 mg, once a day. Patients with Zollinger-Ellison syndrome are recommended to receive intravenous drip of omeprazole 60 mg as a starting dose, once a day. Patients with Zollinger-Ellison syndrome may require a higher daily dose, and the dose should be individualized. When the daily dose exceeds 60 mg, it should be administered in two doses.

Omeprazole is well tolerated, and most adverse reactions are mild and reversible. The following adverse reactions were reported in clinical trials or routine use, but in many cases a causal relationship with omeprazole treatment itself has not been established. Among the following adverse reactions: common refers to an incidence ≥ 1/100; uncommon refers to an incidence ≥ 1/1000, but < 1/100; rare refers to an incidence < 1/1000. 1 Common 1 Central and peripheral nervous system: headache; 2 Digestive system: diarrhea, constipation, abdominal pain, nausea/vomiting and flatulence; 2 Uncommon 1 Central and peripheral nervous system: dizziness, paresthesia, drowsiness, insomnia and vertigo; 2 Liver: elevated liver enzymes; 3 Skin: rash and/or itching, urticaria; 4 Others: discomfort; 3 Rare 1 Central and

It is contraindicated for those who are allergic to this product.

Precautions for children: There is no experience of using this product for children. Precautions for pregnancy and lactation: Although the results of foreign epidemiological studies have shown that omeprazole has no adverse effects on the health of pregnant women or fetuses/newborns; omeprazole can be secreted into breast milk, and the effect on infants is still unknown. It is recommended that pregnant and lactating women avoid using this product as much as possible. Precautions for the elderly: No dosage adjustment is required for elderly patients.

Because this product can reduce gastric acidity, the absorption of some drugs may be altered. Therefore, the absorption of ketoconazole and itraconazole will be reduced when treated with omeprazole or other acid inhibitors or antacids. Because omeprazole is metabolized in the liver by cytochrome F4502C19 (CYP2C19), it will prolong the clearance of other enzymatic products such as diazepam, warfarin (R-warfarin) and phenytoin. This product should be monitored when used with warfarin and phenytoin, and the dose of warfarin or phenytoin should be reduced if necessary. Patients who are continuously treated with phenytoin are given 20 mg of this product once a day, and the blood concentration of phenytoin is not affected. Similarly, patients who are continuously treated with warfarin are given 20 mg of this product once a day, and the clotting time is not changed. When omeprazole is used in combination with clarithromycin, their blood concentrations will increase. However, there is no interaction when it is used in combination with metronidazole or amoxicillin. These antibiotics combined with omeprazole can eradicate H. pylori.

Store at room temperature, valid for 3 years.

40mg

24 months

AstraZeneca Pharmaceutical Co., Ltd.

• Founded in:

  1993-10-26

• Address:

  No. 2 Huangshan Road, New District, Wuxi

• Tax NO.:

  91320214607915071G

• Registered Funds:

  $191.2 million

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