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Ingredient:
Each vial contains:
Pharmaceutical ingredient: Omeprazole sodium equivalent to 40 mg omeprazole.
Excipients: Disodium EDTA, sodium hydroxide.
Includes 1 tube of solvent for injection.
Route of administration: Intravenous injection.
Pharmacodynamic:
OCCASION (Omeprazole), a mixture of two optical isomers, reduces gastric acid secretion through a highly targeted mechanism. This is a specific inhibitor of the acid pump of the parietal cell. They act quickly and controlly by inhibiting and reversing the decrease in gastric acid secretion with a once-daily dose.
Omeprazole is a weak base that is concentrated and forms its active form in the strongly acidic environment of intracellular tubules in wall cells, where it inhibits H+, K+-ATPase, acid-pumping enzymes. Effects on the final step of gastric acid formation are dose-dependent and effectively suppress basal and stimulated acid secretion, regardless of the agent.
All observed pharmacodynamic effects can be explained by the effect of Omeprazole on acid excretion.
Intravenous Omeprazole causes dose-dependent inhibition of gastric acid secretion in humans. To achieve immediate gastric acid reduction after repeated 20 mg oral doses, an initial dose of 40 mg intravenously should be used. The result is an immediate reduction in stomach acidity and approximately 90% of the significant reduction persists after 24 hours.
Inhibition of acid secretion is related to the area under the curve (AUC) of Omeprazole and is not related to the actual plasma concentration at the time of administration.
No reduction in efficacy after repeated administration was observed during treatment with Omeprazole.
Helicobacter pylori is associated with digestive acid diseases, including gastric and duodenal ulcer disease, in which approximately 95% and 70% of patients, respectively, are infected with this bacterium. H.Pylori is the main factor in the development of gastritis. H.Pylori along with stomach acid are the agents that cause stomach ulcers. H.Pylori was found to play a role in the development of stomach cancer.
Omeprazole is effective in killing H.Pylori in vitro.
Complete eradication of H.pylori with Omeprazole and antibacterial drugs when combined, with rapid reduction of symptoms, high rate of healing of mucosal lesions, reduction of gastrointestinal ulcers in time long, thereby reducing complications such as gastrointestinal bleeding as well as the need for long-term antisecretory therapy.
During long-term treatment, the occurrence of gastric cysts has been reported to be slightly increased. These changes are the physiological result of marked inhibition of acid secretion, and are benign and reversible tumors.
Reduction in gastric acidity by any mechanism including proton pump inhibition will increase the number of normal bacteria in the gastrointestinal tract. Treatment with acid-reducing drugs may lead to a slightly increased risk of intestinal infections such as Salmonella and Campylobacter.
Pharmacokinetics:
Distribution:
The volume of distribution in healthy subjects is approximately 0.3 L/kg and the same value should be considered for patients with kidney disease. In the elderly, and in people with liver disease, the volume of distribution is slightly reduced. Plasma protein binding of Omeprazole is approximately 95%.
Metabolism and elimination:
The mean terminal phase AUC half-life of Omeprazole is approximately 40 minutes. Total plasma clearance is 0.3-0.6 L/min. There was no change in half-life during treatment.
Omeprazole is completely metabolized by the Cytocrome P450 (CYP) system, primarily in the liver. Much of this metabolism depends on multiple pathways, especially the isoform CYP2C19 (S-mephenytoin hydroxylase), which plays a role in the formation of hydroxyomeprozole, the major metabolite in plasma. Accordingly, as a result of competitive inhibition, there is a potential for drug-drug interactions between Omeprazole and other substrates for CYP2C19.
No metabolites were found to influence gastric acid reduction. Almost 80% of the parenteral dose is excreted as metabolites in the urine, and the remainder is found in the feces, primarily from bile.
Omeprazole elimination is unchanged in patients with impaired renal function. The half-life is increased in patients with impaired liver function, but Omeprazole does not show accumulation with once-daily dosing.
Point
Gastroesophageal reflux.
Peptic ulcer.
Zollinger-Ellison syndrome.
Contraindicated
Hypersensitivity to the drug.
Careful
Before giving Occasion to people with stomach ulcers, the possibility of malignancy must be ruled out (the drug can mask symptoms, thereby delaying diagnosis).
Intravenous injections should be given to seriously ill patients and people with multiple ulcers to prevent ulcer bleeding due to stress. It must be injected slowly intravenously for at least 3 minutes, with a maximum rate of 4 ml/minute. An intravenous dose of 40 mg will immediately reduce the amount of hydrochloride acid (HCl) in the stomach within 24 hours.
Pregnancy period
Although it has not been shown experimentally that omeprazole has the ability to cause deformities and is toxic to the fetus, it should not be used for pregnant women, especially in the first 3 months.
Breastfeeding period
Omeprazole should not be used in breast-feeding women. To date, no research documents have had specific conclusions on this issue.
Effects on the ability to drive and operate machinery:
There are no reports.
Adverse reactions (ADR)
Common, ADR > 1/100
Body as a whole: Headache, drowsiness, dizziness.
Gastrointestinal: Nausea, vomiting, abdominal pain, constipation, bloating.
Rare, 1/1000 < ADR < 1/100
Neurological: Insomnia, sensory disorders, dizziness, fatigue.
Skin: Hives, itching, rash.
Liver: Temporary increase in transaminases
Rare, ADR < 1/1000
Body as a whole: Sweating, peripheral edema, hypersensitivity including angioedema, fever, anaphylaxis.
Hematology: Leukopenia, thrombocytopenia, reduction of total and peripheral blood cells, agranulocytosis.
Neurological: Reversible confusion, agitation, depression, hallucinations in elderly patients and especially in seriously ill patients, hearing disorders.
Endocrine: Enlarged breasts in men.
Gastrointestinal: Gastritis, Candida fungal infection, dry mouth.
Liver: Hepatitis with or without jaundice, encephalopathy in people with liver failure.
Respiratory: Bronchospasm.
Musculoskeletal: Joint pain, muscle pain.
Genitourinary: Interstitial nephritis.
Instructions on how to handle ADR
The drug must be stopped when there are signs of severe unwanted effects.
Inform your doctor of any unwanted effects you encounter when using the drug.
Dosage and Administration
Amount:
Duodenal ulcer, gastric ulcer, reflux esophagitis: Patients who cannot take oral medications can be treated via injection at a dose of 40 mg, once a day. Treatment time before switching to oral use is 2-3 days.
In Zollinger-Ellison syndrome, the dose should be adjusted individually. Higher doses and/or multiple times a day may be needed.
After reconstitution, the drug should be injected slowly intravenously over a minimum period of 3 minutes with a maximum rate of 4 ml/minute.
Patients with impaired kidney function:
No dose adjustment is required in patients with impaired renal function.
Patients with impaired liver function:
In patients with impaired liver function, clearance is much reduced, a dose of 10-20 mg is sufficient.
In the elderly: No dose adjustment is required in the elderly.
Children: Treatment experience in children is limited.
How to mix medicine:
Intravenous solution is prepared by dissolving omeprazole powder with solvent (contained in the attached solvent tube). Do not use any other solvents. The reconstituted solution for injection should only be used within 4 hours.
Preparation: Note: Steps 1-5 must be performed consecutively.
1. Use a syringe to withdraw 10 ml of solvent from the solvent tube.
2. Slowly inject about 5 ml of solvent into the vial containing omeprazole powder.
3. Use a syringe to withdraw as much air as possible from the vial to relieve pressure. This will make it easier to inject the remaining solvent into the powder vial.
4. Add the remaining solvent to the powder vial. Make sure to inject all the solvent in the syringe into the vial.
5. Rotate and shake the vial to ensure complete dissolution of omeprazole into the solvent.
6. The reconstituted intravenous solution must be kept below 250C and must be used within 4 hours after reconstitution.
Drug interactions
Omeprazole may increase blood levels of ciclosporin.
Omeprazole increases the effectiveness of antibiotics to eradicate H. pylori.
Omeprazole inhibits the metabolism of drugs metabolized by the hepatic cytochrome P450 enzyme system and may increase blood concentrations of diazepam, phenytoin and warfarin. The reduced metabolism of diazepam makes the drug's effects last longer. At a dose of 40 mg/day omeprazole inhibits phenytoin metabolism and increases phenytoin concentrations in the blood, but a dose of omeprazole 20 mg/day has a much weaker interaction. Omeprazole inhibits warfarin metabolism, but has little effect on bleeding time.
Omeprazole increases the anticoagulant effect of dicoumarol.
Omeprazole reduces nifedipine metabolism by at least 20% and may increase the effects of nifedipine.
Clarithromycin inhibits omeprazole metabolism and causes omeprazole concentrations to double.
No interactions were found between omeprazole and antacids, theophylline, caffeine, quinidine, lidocaine, propanolol, metoprolol or ethanol.
Stability
The intravenous solution must be used within 4 hours after reconstitution. Do not inject if the solution has changed color due to oxidation or if the solution contains precipitate.
Incompatibility
To have a solution for intravenous injection, omeprazole powder must be mixed with the accompanying solvent. Do not use other solvents.
Do not mix or mix omeprazole solution for intravenous injection with other intravenous solutions.
Overdose and treatment
One-time intravenous doses up to 80 mg, daily intravenous doses up to 200 mg and 520 mg intravenous doses over a 3-day period were well tolerated.
In case of overdose, only symptomatic treatment is given, there is no specific treatment.
Quality standards: Manufacturer.
Storage: Avoid light, temperature below 30 0 C.
Expiry date: 24 months from date of manufacture.
Packaging: Box of 1 vial with 1 tube of solvent for injection, with instructions for use.
