Omeprazole Sodium for Injection

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.

Its chemical name is: 5-methoxy-2-{[(4-methoxy-3,5-dimethyl-2-pyridyl)-methyl]-sulfinyl}-1H-benzimidazole sodium salt monohydrate. Molecular formula: C17H18N3NaO3S·H2O Molecular weight: 385.41

This product is white or off-white freeze-dried block or powder.

As an alternative treatment for the following conditions when oral therapy is not appropriate: duodenal ulcer, gastric ulcer, reflux esophagitis and Zollinger-Ellison syndrome.

Intravenous injection. 40 mg at a time, 1 to 2 times a day. Before use, inject 10 ml of special solvent into the vial of freeze-dried powder. Do not use other solvents to dissolve. This product must be used within 2 hours after dissolution, and the push injection time should not be less than 20 minutes.

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 the causal relationship with omeprazole treatment itself has not been determined. Among the following adverse reactions: "common" means an incidence of ≥ 1/100; "uncommon" means an incidence of ≥ 1/1000, but < 1/100; "rare" means an incidence of < 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 peripheral nervous system: reversible mental confusion, agitation, aggressive behavior, depression and hallucinations, more common in severe patients; 2. Endocrine system: gynecomastia in men; 3. Digestive system: dry mouth, stomatitis and stomach Intestinal Candida infection; 4 Blood system: leukopenia, thrombocytopenia, agranulocytosis and various blood cell reductions; 5 Liver: encephalopathy (seen in patients with previous severe liver disease), hepatitis or icteric hepatitis, liver failure; 6 Muscle and bone: joint pain, muscle weakness and myalgia; 7 Skin: photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), alopecia; 8 Others: allergic reactions, such as angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock. Increased sweating, peripheral edema, blurred vision, taste disturbances and hyponatremia. There have been reports in the literature that a case of severe patient with irreversible visual damage after receiving high-dose intravenous omeprazole.

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 animal experiments have not found that this product has adverse effects on pregnancy and lactation or toxic or teratogenic effects on the fetus, it is recommended that pregnant and lactating women should avoid using it 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 continue to use phenytoin are given 20 mg of this product once a day, and the blood concentration of phenytoin is not affected. Similarly, patients who continue to use 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 used in combination with metronidazole or amoxicillin. These antibiotics combined with omeprazole can eradicate H. pylori.

Keep tightly closed in a cool, dark place.

40mg

24 months

Livzon (GROUP) Pharmaceutical FACTORY

• Founded in:

  1989-11-26

• Address:

  No. 38 Chuangye North Road, Jinwan District, Zhuhai City

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