Expiration date: 04/2025
Composition and form of release:
1 capsule contains omeprazole 10 or 20 mg in a contour cell-free package or contour cell package of 10 PCs., in a cardboard pack of 3 packages.
Characteristics:
Solid opaque gelatin capsules with a light cream body and a light cream lid.
Pharmacological action:
Inhibits the enzyme H+K+ATPase (proton pump) in the parietal cells of the stomach and thus blocks the final stage of hydrochloric acid synthesis.
Pharmacokinetics:
It is quickly absorbed from the gastrointestinal tract, Cmax is reached in 0, 5-1 hours. Bioavailability — 30-40%. Binding to plasma proteins — 90%. It is almost completely metabolized in the liver. It is mainly excreted by the kidneys as metabolites.
Description of pharmacological action:
After a single oral administration, the effect occurs within the first hour, reaches a maximum after 2 hours and continues for 24 hours. After discontinuation of the drug, secretory activity is fully restored in 3-5 days.
Indications:
Peptic ulcer of the stomach and duodenum, reflux esophagitis, erosive and ulcerative lesions of the stomach and duodenum caused by taking NSAIDs or associated with Helicobacter pylori (as part of complex therapy), Zollinger-Ellison syndrome.
Contraindications:
Hypersensitivity.
Use during pregnancy and lactation:
Contraindicated. Breast-feeding should be stopped during treatment.
Side effect:
Nervous system and sensory organs: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations, visual and taste disorders.
From the cardiovascular system and blood (hematopoiesis, hemostasis): leukopenia, thrombocytopenia.
From the digestive tract: nausea, diarrhea/constipation, abdominal pain, dry mouth, stomatitis, transient increase in the level of liver enzymes in plasma.
From the musculoskeletal system: muscle weakness, myalgia, arthralgia.
Skin: urticaria, itching.
Other: peripheral edema, increased sweating, fever, gynecomastia.
Drug interaction:
Increases the concentration of clarithromycin in the blood plasma. It slows down the elimination of certain drugs that are metabolized in the liver by microsomal oxidation (diazepam, phenytoin, indirect anticoagulants). Inhibits the absorption of ketoconazole, ampicillin, iron preparations.
Dosage and administration:
Inside, without chewing and drinking a small amount of liquid.
Duodenal ulcer in the acute phase — 20 mg/day for 2-4 weeks (in resistant cases — up to 40 mg/day). Gastric ulcer in the acute phase and erosive-ulcerative esophagitis — 20-40 mg/day for 4-8 weeks. Eradication of Helicobacter pylori — 20 mg 2 times a day for 7 days in combination with antibacterial agents. Anti — relapse treatment of gastric and duodenal ulcer-10-20 mg/day. Anti-relapse treatment of reflux esophagitis — 20 mg/day for a long time (up to 6 months). Erosive and ulcerative lesions of the gastrointestinal tract caused by taking NSAIDs — 20 mg/day for 4-8 weeks. Zollinger-Ellison syndrome — the dose is selected individually depending on the initial level of gastric secretion, usually-60 mg/day, if necessary — up to 80-120 mg/day in 2 doses.
In patients with severe hepatic insufficiency, the daily dose should not exceed 20 mg.
Overdose:
Symptoms: visual impairment, drowsiness, agitation, headache, increased sweating, dry mouth, nausea, tachycardia.
Treatment: symptomatic therapy, no specific antidote.
Precautionary measures:
Before starting treatment, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract (due to possible masking of symptoms and difficulties in diagnosis).
