OMEE Omeprazole Sodium 40mg Lyophilized Powder for IV Injection 10mL
RXDRUG-DRP-5882-04
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
It is used in conditions where inhibition of gastric acid secretion may be beneficial, including aspiration syndromes, dyspepsia, gastro esophageal reflux disease, peptic ulcer disease and the Zollinger Ellison Syndrome.
Dosage/Direction for Use
In patients who are unsuited to receive oral therapy. Omeprazole sodium may be given on a short-term basis by intravenous infusion, in a usual dose equivalent to 40 mg of the base over a period of 20 to 30 minutes. It may also be given by slow intravenous injection. Or as prescribed by the physician.
Contraindications
Contraindicated in patients with known hypersensitivity to any component of the formulation.
Special Precautions
Before giving Omeprazole or other proton pump inhibitors to patients with gastric ulcers the possibility of malignancy should be excluded since these drugs may mask symptoms and delay diagnosis. Omeprazole and other proton pump inhibitors should be used with caution in hepatic impairment and dose adjustment may be required.
Adverse Reactions
The most common adverse effects are headache, diarrhea, and skin rash. They have sometimes been severe enough to require stopping treatment.
Drug Interactions
Omeprazole and other proton pump inhibitors are metabolised by the cytochrome P450 system, primarily by isoenzyme CYP2C19, and to a smaller extent by CYP3A4. Inhibitors or inducers of these isoenzymes may affect exposure to omeprazole and other proton pump inhibitors. In turn, proton pump inhibitors may alter the metabolism of some drugs metabolised by these enzymes. Omeprazole may prolong the elimination of diazepam, phenytoin, and warfarin. Omeprazole and other proton pump inhibitors can reduce the absorption of drugs such as dasatinib, ketoconazole and itraconazole, whose absorption is dependent on an acid gastric pH. With voriconazole, the plasma concentration of both drugs may be increased. Omeprazole and other proton pump inhibitors should not be used with atazanavir, as they substantially reduce exposure to atazanavir.
Caution For Usage
Direction for Reconstitution: Sterile freeze-dried powder should be reconstituted with 10ml of Sterile Water for Injection. Reconstituted injection is to be used within 24 hours if stored at temperatures not exceeding 30°C. If refrigerated, consume within 24 hours. In case of discoloration of content, please do not use and discard the vial.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacokinetics: Omeprazole is rapidly but variably absorbed after oral doses. Absorption is not significantly affected by food. Omeprazole is acid labile and the pharmacokinetics of the various formulations developed to improve oral bioavailability may vary. The absorption of omeprazole also appears to be dose-dependent; increasing the dosage above 40 mg has been reported to increase the plasma concentrations in a non-linear fashion because of saturable first-pass hepatic metabolism. In addition, bioavailability is higher after long-term use.
Bioavailability of Omeprazole may be increased in elderly patients, in some ethnic groups such as Chinese, and in patients with hepatic impairment, but is not markedly affected in patients with renal impairment.
On absorption, Omeprazole is almost completely metabolized in the liver, primarily by the cytochrome P450 isoenzyme CYP2C19 to form hydroxy-omeprazole, and to a small extent by CYP3A4 to form omeprazole sulfone. The metabolites are inactive, and are excreted mostly in the urine and to a lesser extent in bile. The elimination half life from plasma is reported to be about 0.5 to 3 hours. Omeprazole is about 95% bound to plasma proteins.
Bioavailability of Omeprazole may be increased in elderly patients, in some ethnic groups such as Chinese, and in patients with hepatic impairment, but is not markedly affected in patients with renal impairment.
On absorption, Omeprazole is almost completely metabolized in the liver, primarily by the cytochrome P450 isoenzyme CYP2C19 to form hydroxy-omeprazole, and to a small extent by CYP3A4 to form omeprazole sulfone. The metabolites are inactive, and are excreted mostly in the urine and to a lesser extent in bile. The elimination half life from plasma is reported to be about 0.5 to 3 hours. Omeprazole is about 95% bound to plasma proteins.
MedsGo Class
Antacids, Antireflux Agents & Antiulcerants
Features
Brand
Omee
Full Details
Dosage Strength
40mg
Drug Ingredients
- Omeprazole
Drug Packaging
Lyophilized Powder for Injection (I.V.) 10ml
Generic Name
Omeprazole Sodium
Dosage Form
Lyophilized Powder For Injection (I.V.)
Registration Number
DRP-5882-04
Drug Classification
Prescription Drug (RX)
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