| Customization: | Available |
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| Application: | Internal Medicine |
| Usage Mode: | For external use |
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Omeprazole sodium for Injection
Generic name: Omeprazole sodium for injection
Main Ingredient: The main ingredient of this product is omeprazole sodium
Indications 1. Peptic ulcer bleeding, anastomotic ulcer bleeding.
2. Acute gastric mucosa damage complicated by stress and acute gastric mucosa damage caused by non-steroidal anti-inflammatory drugs.
3. Prevention of stress state of severe diseases (such as cerebral hemorrhage, severe trauma, etc.) and upper gastrointestinal bleeding caused by gastric surgery
4. Prevent acid reflux with aspiration pneumonia in patients with general anesthesia or major surgery and weak coma.
5. As an alternative to the following conditions when oral therapy is not available: duodenal ulcer, gastric ulcer, reflux esophagitis and Zollinger-Ellison syndrome.
1. Omeprazole was well tolerated, and most of the adverse reactions were mild and reversible.The following adverse events have been reported in clinical trials or routine use, but in many cases a causal relationship with prilosec treatment itself has not been established.
2. The following adverse reactions are common: incidence ≥1/100;Infrequent means the incidence ≥1/1000, but < 1/100;Rareness was defined as an incidence of < 1 in 1000;
(1) the common
Central and peripheral nervous systems: Headache
Digestive system: diarrhea, constipation, abdominal pain, nausea/vomiting and bloating
(2) is not common
Central and peripheral nervous systems: dizziness, sensory abnormalities, lethargy, insomnia, and dizziness
Liver: Liver enzymes are elevated
Skin: rash and/or itching, urticaria
Others: Discomfort
(3) is rare
Central and peripheral nervous systems: reversible psychosis, agitation, aggressive behavior, depression, and hallucinations
Endocrine system: Male breast feminization
Digestive system: dry mouth, stomatitis, and gastrointestinal candida infection
Blood system: Leukopenia, thrombocytopenia, agranulocytosis and various types of hemocytopenia
Liver: encephalopathy (seen in patients with previously severe liver disease), hepatitis or jaundice hepatitis, liver failure
Muscle and bone: Joint pain, weakened muscle strength, and myalgia
Skin: photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrosis (TEN), hair loss
Others: Allergic reactions, such as angioedema, fever, bronchospasm, interstitial nephritis, and anaphylactic shock.Increased sweating, peripheral edema, blurred vision, taste disorders and hyponatremia
3. There was another case of severe patients who received omeprazole intravenous injection, especially at high dose, and had irreversible visual impairment without causation.
Contraindications People who are allergic to this product are forbidden.
1. This product is for intravenous infusion only.
2. This product has a strong inhibitory effect on gastric acid secretion for a long time, so it is not appropriate to take other antacids or antacids when using this product.In order to prevent excessive acid inhibition, long-term application of large doses is not recommended in general peptic ulcer diseases (except Zollinger-Ellison syndrome).
3. Since this product can significantly increase the pH in the stomach, the absorption of some drugs may be changed.As a result, ketoconazole and etraconazole absorption declines when treated with omeprazole or other acid inhibitors or antacids.
4. Patients with impaired renal function need not adjust the dose;People with impaired liver function need to reduce the amount as appropriate.
5. In the treatment of gastric ulcer, gastric cancer should be excluded before the use of this product, so as not to delay the diagnosis and treatment.
6. In animal experiments, hypergastrinemia, secondary gastric eosinophilic cell enlargement and benign neoplasms were observed after long-term and extensive use of this product, which may also occur after application of other acid inhibitors and subtotal gastrectomy.
Prilosec does not interfere with driving and operating machines.
It is recommended that pregnant and lactating women use this product as far as possible, although no adverse effects or toxicity or teratogenic effects on the fetus have been found in animal experiments.
There is no experience of using this product in children
The elderly don't have to adjust the dose
Drug interactions 1. Because omeprazole is metabolized in the liver by cytoplasmic P4502C19 (CYP2C19), it prolongs the clearance of other enzymatic hydrolyzates such as diazepam, warfarin (R-Warfarin) and phenytoin.
(1) Patients should be monitored while receiving warfarin and phenytoin treatment, and the dose of warfarin or phenytoin should be reduced if necessary.
(2) The serum concentration of phenytoin was not affected in patients who continued to take phenytoin treatment and were given omeprazole 20mg once a day.Similarly, continuous warfarin treatment with 20mg prilosec once a day did not alter the clotting time.
2. When omeprazole is combined with clarithromycin, their blood concentrations rise.However, when combined with metronidazole or amoxicillin, there was no interaction.These antibiotics, when combined with omeprazole, eradicate Helicobacter pylori.
3. Omeprazole interact with other medications studies show that oral omeprazole 20 to 40 mg daily does not affect other relevant CYP isoenzyme, interact with the following no metabolic enzyme substrates, such as this CYP1A2, phenacetin, caffeine, theophylline), CYP2C9 (S - warfarin, piroxicam, diclofenac and naproxen), CYP2D6 (metoprolol, propranolol), CYP2E1 (ethanol) and CYP3A (ring spore fungus element, lidocaine, quinidine, estradiol, erythromycin, budesonide).
In the clinical trial of drug overdose, the cumulative dose of intravenous administration of this product reached 270mg for one day and 650mg for three days, with dose-related adverse reactions at the end
Drug toxicology 1. Omeprazole is a racemic mixture of a pair of active optically active enantiomers. It is a specific inhibitor of the acid pump in gastric wall cells due to its highly targeted mechanism of action to reduce gastric acid secretion.The product works quickly, and a daily dose can reversibly inhibit gastric acid production.
2. Omeprazole is a weakly alkaline substance that is concentrated and converted into an active substance in the highly acidic environment of the gastric wall cell tubules, inhibiting H+,K+ -ATPase (proton pump).This inhibition of the final step of gastric acid formation is dose-dependent and highly inhibits basal and irritant gastric acid secretion, but is independent of the irritant.
(1) Omeprazole is administered intravenously in humans to inhibit gastric acid secretion in a dose-related manner. In order to achieve the same effect of reducing gastric acidity as repeated oral administration of 20 mg, 40 mg omeprazole is recommended for the first time.Intravenous administration of 40 mg omeprazole rapidly reduced gastric acidity by an average of 90% within 24 hours.
(2) The inhibitory effect of omeprazole on gastric acid secretion was related to the area under the drug-time curve (AUC), but not to the blood concentration at the time of administration.
3. Helicobacter pylori is associated with acid peptic diseases, including duodenal and gastric ulcers, which are associated with H. pylori infection in 95% and 70% of cases, respectively.Helicobacter pylori is the main cause of gastritis.Together with stomach acid, Helicobacter pylori is a major cause of peptic ulcer disease.Combined with antibiotics, omeprazole eradicates Helicobacter pylori, which is associated with rapid relief of symptoms, high rates of gastric mucosal repair, and long-term remission of peptic ulcer disease, thereby reducing complications such as gastrointestinal bleeding, as well as the need for long-term treatment with anti-prozac.
4. Any method, including the reduction of gastric acid caused by proton pump inhibitors, increases the number of normal bacteria in the GASTROINTESTINAL tract, and treatment with acid-inhibiting drugs may slightly increase the risk of infection by Salmonella and Campylobacter.
5. In the long-term administration of omeprazole in rats, gastric ECL cell enlargement and benign tumor were observed, which were the result of persistent hypergastrinemia due to gastric acid inhibition.Similar findings were found after treatment with H2 receptor antagonists, proton pump inhibitors, and partial bottomectomy.Obviously these changes are not a direct result of the above drugs.
Pharmacokinetics 1. Distribution The distribution volume of healthy people is about 0.3L/kg, and patients with renal insufficiency also have a similar distribution volume.The distribution volume was slightly lower in the elderly or in patients with liver insufficiency, and the plasma protein binding rate was about 95%.
2. Omeprazole was administered intravenally in metabolism and excretion. The mean terminal phase half-life of the drug-time curve was about 40 minutes, and the total plasma clearance rate was 0.3 ~ 0.6L/min.The half-life did not change during treatment.Omeprazole is completely metabolized in the liver by cytochrome P450 (CYP) enzyme system.It mainly relies on the specific isotype CYP2C19 (S-Mephentoin hydroxylase), whose genetic expression has polymorphism. Omeprazole is catalyzed by CYP2C19 to produce hydroxyl omeprazole, which is the main metabolite in plasma.In view of this, there may be metabolic drug-drug interactions between omeprazole and other SUBstrates of CYP2C19 due to competitive inhibition.
3. Omeprazole metabolites have no effect on the secretion of gastric acid.About 80% of the intravenous dose is excreted in the form of metabolites in the urine, while the rest is secreted mainly by bile and excreted in the faeces.
4. There was no change in the clearance of omeprazole in patients with renal failure and an increase in the clearance half-life in patients with liver impairment, but no accumulation of omeprazole in the once-daily oral dose.
Store in shade and airtight
Implementation standard YBH18732006
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