The drug is indicated as an alternative to oral therapy. Treatment and prevention of duodenal ulcer recurrence. Treatment and prevention of recurrent stomach ulcer. In combination with appropriate antibiotics, eradication therapyHelicobacter pylori in peptic ulcer disease. Treatment of gastric and duodenal ulcers associated with the use of NSAIDs and prevention of their formation in patients at risk of their occurrence. Treatment of reflux oesophagitis. Long-term supportive care for patients after healing of reflux oesophagitis. Treatment of symptomatic gastroesophageal reflux disease. Treatment of Zollinger-Ellison syndrome.
Composition:
One vial contains 42.6 mg of Omeprazole sodium, equivalent to 40 mg of omeprazole.
Action:
A specific inhibitor of the so-called proton pump (H+/ K+ ATP-ases) in the parietal cells of the stomach. It effectively inhibits both the basic and stimulated secretion of hydrochloric acid in the stomach, regardless of the type of stimulant. It is 97% bound to plasma proteins, T0,5 is usually less than 1 hour. Metabolism occurs in the liver, mainly involving the CYP2C19 isoenzyme. 80% of inactive metabolites are excreted through the kidneys, the remainder in the bile.
Contraindications:
Hypersensitivity to Omeprazole, substituted benzimidazoles or other components of the preparation. It should not be given at the same time as nelfinavir.
Precautions:
There is limited experience with the intravenous formulation in children. Omeprazole may reduce the absorption of vitamin B12what to take into account in patients with vitamin B deficiency12 in the body and in case of risk factors that reduce the absorption of vitamin B12 during long-term treatment.
Pregnancy and lactation:
The preparation can be used during pregnancy. Omeprazole passes into breast milk, although there is little chance of affecting the breastfed infant when taken at the recommended doses.
Side effects:
Common: headache; diarrhea, constipation, abdominal pain, nausea and vomiting, bloating. Uncommon: skin inflammation, rash and / or pruritus, urticaria; dizziness and central nervousness, paresthesia, drowsiness; insomnia; increased liver enzymes; malaise, peripheral edema. Rare: leukopenia, thrombocytopenia; hypersensitivity reactions, e.g. fever, angioneurotic edema and anaphylactic reaction / shock; hyponatremia; agitation, confusion, depression; taste disorders; blurred vision; bronchial spasm; dry mouth, oral mucositis and gastrointestinal candidiasis; hepatitis with jaundice and without jaundice; baldness, hypersensitivity to light; pain in the joints and muscles; interstitial nephritis; increased sweating. Very rare: agranulocytosis, pancytopenia; hypomagnesemia; aggression, hallucinations; hepatic failure, encephalopathy in patients with pre-existing liver disease; erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, weakness in muscle strength; gynecomastia. Treatment with proton pump inhibitors may slightly increase the risk of gastrointestinal infections with bacteria such asSalmonella andCampylobacter. In critically ill patients receiving omeprazole as an intravenous infusion, especially at high doses, irreversible visual impairment has been reported but no causal relationship has been established between these disorders and the use of the drug.
Dosage:
Intravenously. Adults:Treatment of patients in whom oral therapy is inappropriate / not recommended: 40 mg once a day.Zollinger-Ellison syndrome: the recommended starting dose is 60 mg. It may be necessary to administer higher doses of the drug and in such cases the dose should be adjusted individually. If the daily dose is greater than 60 mg, the total dose should be divided and the medicine should be given twice daily. There is no need to adjust the dose in elderly patients, patients with impaired renal function.Patients with hepatic impairment should be adjusted due to the fact that the plasma half-life is prolonged, a sufficient daily dose of 10-20 mg. The drug should be administered as an intravenous infusion over 20-30 minutes. Method of administration: dilute in 100 ml of 5% Glucose solution or 0.9% NaCl solution.
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