the product in the database has an inactive status
indications:
Treatment to reduce gastric acid secretion in patients with a serious condition with contraindications to the use of the drug in oral form, in the following diseases: reflux oesophagitis, duodenal ulcer or mild gastric ulcer, Zollinger-Ellison syndrome.
Composition:
1 vial contains 40 mg of Omeprazole in the form of a sodium salt.
Action:
Proton pump inhibitor (H+/ K+ATP-ases) in the parietal cells of the stomach. Intravenous administration ensures fast and effective suppression of both gastric and stimulated secretion of the stomach (regardless of the type of stimulus). A single intravenous injection of a 40 mg dose has almost the same effect on gastric acid secretion per day as a multiple daily 20 mg oral intake. Omeprazole is approximately 95% bound to plasma proteins. It is completely metabolised, mainly in the liver by the CYP2C19 enzyme. T0,5 is on average 40 minutes. Almost 80% of the dose is excreted in the form of metabolites in the urine, the remaining 20% - with faeces. In the elderly, the bioavailability of omeprazole is slightly increased, while the rate of elimination decreases. In patients with impaired renal function, elimination of the drug decreases simultaneously with the degree of renal dysfunction. In chronic liver failure, the half-life is prolonged to about 3 hours, and the bioavailability may then be greater than 90%. In a small group of patients with genes encoding inactive CYP2C19 enzymes, a reduction in drug elimination was observed, the terminal elimination half-life may be 3-fold longer compared to normal values.
Contraindications:
Hypersensitivity to omeprazole or other components of the drug. Concomitant use with atazanavir.
Precautions:
There is limited experience in the use of the drug in children. The drug is not recommended for use in children below 1 year of age, due to the lack of data on the use of omeprazole in this age group. During treatment there is a small increase in the risk of gastrointestinal infections with bacteriaSalmonella andCampylobacter. In patients with severe hepatic impairment, liver enzymes should be periodically monitored during treatment. Caution should be exercised in patients with impaired renal or hepatic function. It contains less than 1 mmol sodium (23 mg) per dose, which qualifies as 'sodium-free'.
Pregnancy and lactation:
The drug can be used during pregnancy only in exceptional cases. Omeprazole is excreted in breast milk, when deciding to continue breastfeeding or omeprazole treatment, the benefits of breastfeeding for the baby and the benefits of treatment for the woman should be considered.
Side effects:
The drug is well tolerated and its side effects are usually mild and reversible. Common: diarrhea, constipation, abdominal pain, nausea and / or vomiting, bloating with the passing of winds; headache, dizziness, drowsiness, insomnia, vertigo. Uncommon: disturbances in the sense of taste; paresthesia, increase in liver enzymes; rash and / or pruritus, urticaria; bad mood. Rare: dry mouth, oral mucositis, candidiasis, brown-black discoloration of the tongue, pancreatitis; transient confusion, agitation, aggressiveness, depression and hallucinations, especially in severely ill patients; gynecomastia; leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia, encephalopathy in patients with pre-existing severe liver disease, hepatitis with or without jaundice, hepatic failure; weakness in muscle strength, muscle pain, arthralgia; hypersensitivity to light, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia; hypersensitivity reactions such as angioneurotic edema, fever, bronchospasm, interstitial nephritis, anaphylactic shock; excessive sweating, peripheral edema, blurred vision, disturbed taste,hyponatremia. In isolated cases, irreversible visual disturbances have been reported in critically ill patients receiving high doses of the drug. In addition, cases of deafness and blindness have been reported.
Dosage:
Intravenously. Adults.Treatment of patients with contraindications to the use of the drug in oral form (eg patients in severe conditions with reflux oesophagitis, peptic ulcer of the duodenum or stomach): 40 mg once a day for up to 5 days.Zollinger-Ellison syndrome: 60 mg once a day or a higher dose given as two infusions (limited clinical experience). There is no need to modify the dosage in elderly patients and patients with renal impairment. In patients with impaired liver function, a daily dose of 10-20 mg may be sufficient. Children (experience with use is limited), ≥ 1 year (10-20 kg): 10-20 mg once a day; ≥ 2 years (> 20 kg): 20-40 mg once a day. The medicine should only be reconstituted in 100 ml of saline solution or 100 ml of 5% dextrose for infusion - no other solutions for intravenous infusion should be used. The product should be used immediately after reconstitution (ie within 3 hours). Administration of the drug should last 20-30 minutes.
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