the product in the database has an inactive status
indications:
Treatment to suppress the secretion of hydrochloric acid in the stomach of seriously ill patients in whom oral therapy is not recommended, with diseases such as: reflux oesophagitis, duodenal ulceration or benign 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 provides fast and effective inhibition of both hydrochloric acid excretion, both basal and stimulated (regardless of the type of stimulus). A single intravenous injection of a 40 mg dose has almost the same effect on the secretion of hydrochloric acid per day as a multiple daily oral dose of 20 mg. 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 should not be used in children up to 1 year of age, due to lack of data. In patients with peptic ulcer, if necessary, determine whether there is an infectionHelicobacter pyloriIn patients with a positive test result, eradication therapy should be eliminated as far as possible. If stomach ulceration is suspected, malignant neoplasm should be ruled out before treatment, treatment may reduce symptoms and delay diagnosis. Diagnosis of reflux oesophagitis should be confirmed by endoscopic examination. 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. Non -injectionable forms of omeprazole have reported the occurrence of blindness and deafness - it is recommended to control the eye and hearing. It contains less than 1 mmol sodium (23 mg) per dose, which qualifies as 'sodium-free'.
Pregnancy and lactation:
The drug should be ordered during pregnancy only if clearly indicated. Past experience does not indicate an increased risk of birth defects or other adverse effects of omeprazole in pregnancy or in the unborn child. 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:
Common: diarrhea, constipation, abdominal pain, nausea / vomiting, bloating; headache, dizziness, drowsiness, insomnia, dizziness. Uncommon: paresthesia, increase in liver enzymes; exacerbation and / or pruritus, urticaria; bad mood. Rare: dry mouth, candidiasis of the mouth and gastrointestinal tract, brown-black discoloration of the tongue, pancreatitis; reversible 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 hepatic impairment, hepatitis with or without jaundice, hepatic failure; muscle weakness, 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; increased sweating, peripheral edema, blurred vision, disturbed taste, hyponatremia. In isolated cases, irreversible visual disturbances have been reported in very severe patients receiving high doses of the drug. In addition, cases of deafness and blindness have been reported.
Dosage:
Intravenously. Adults.Treatment of patients in whom oral therapy is not indicated (eg patients with severe conditions with reflux oesophagitis, duodenal ulcers or stomach ulcers): 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 Glucose solution for infusion - no other solutions for intravenous infusion should be used. The product should be used immediately after reconstitution (ie within 6 hours). Administration of the drug should last 20-30 minutes.
(C)
