Index of drugs

Adults. Treatment of duodenal ulcer. Prevention of duodenal ulcer recurrence. Treatment of peptic ulcer. Prevention of peptic ulcer recurrence. In combination therapy with appropriate antibiotics - eradicationHelicobacter pylori in peptic ulcer disease. Treatment of gastric and duodenal ulcer associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs). Prevention of peptic ulcer of the stomach and duodenum associated with the use of NSAIDs. Treatment of reflux oesophagitis. Maintenance treatment of reflux oesophagitis to prevent relapse. Symptomatic treatment of gastroesophageal reflux disease. Treatment of Zollinger-Ellison syndrome.Children> 1 year and weighing ≥ 10 kg. Treatment of reflux oesophagitis. Symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease.Children> 4 years and young people. In combination therapy with antibiotics for the treatment of duodenal ulcer caused byH. pylori.

1 hard gastro-resistant capsule contains 20 mg or 40 mg omeprazole. The product contains sucrose and dyes.

Proton pump inhibitor (H⁺/ K⁺ATP-ases) in the parietal cells of the stomach. It inhibits the secretion of hydrochloric acid, both basic and stimulated (regardless of the stimulating factor of this secretion). Increases the pH of gastric juice. After oral administration of Omeprazole in the form of hard capsules, the drug is absorbed in the small intestine, reaching C_max after 1-2 h. Food does not affect the bioavailability of the drug, which after a single dose is about 40%; after multiple doses once a day - around 60%. About 97% is bound to plasma proteins. The drug is completely metabolised, mainly in the liver by the CYP2C19 enzyme. Almost 80% of the dose is excreted in the form of metabolites in the urine, the remaining 20% ​​in the faeces. T_0,5 it is shorter than 1 hour.

Hypersensitivity to Omeprazole, substituted benzoimidazoles or any of the excipients. Do not use with nelfinavir.

Treatment with the preparation may slightly increase the risk of gastrointestinal infections, e.g. bacteriaSalmonella andCampylobacter. Omeprazole, due to the induction of hypo or achlorhydria, may reduce the absorption of vitamin B₁₂ - this should be taken into account during long-term treatment of patients with a limited supply of this vitamin in the body or risk factors for reduced absorption of vitamin B₁₂. Omeprazole, as a CYP2C19 inhibitor, may interact with drugs metabolised by this isoenzyme - be careful. Co-administration of omeprazole and Clopidogrel should be avoided. The use of the preparation with atazanavir is not recommended. Some children suffering from chronic diseases may require long-term treatment, which, however, is not recommended. There are no long-term data on the effect of omeprazole treatment on the maturation and development of the child. Due to the sucrose content, the preparation should not be used in patients with fructose intolerance, malabsorption of glucose-galactose and sucrase-isomaltase deficiency.

Omeprazole can be used during pregnancy. Omeprazole passes into breast milk, but it does not affect the child when using therapeutic doses.

Common: headache, abdominal pain, diarrhea, constipation, bloating, nausea, vomiting, dry mouth, inflammation of the mouth, gastrointestinal candidiasis. Uncommon: insomnia, dizziness, paresthesia, drowsiness, increased activity of liver enzymes, dermatitis, pruritus, urticaria, rash, malaise, peripheral edema. Rare: leukopenia, thrombocytopenia, hypersensitivity reactions (eg fever, angioneurotic edema, anaphylactic reaction and / or shock), hyponatremia, agitation, confusion, depression, dysgeusia, blurred vision, bronchospasm, hepatitis with or without jaundice, alopecia , hypersensitivity to light, joint pain, muscle pain, interstitial nephritis, increased sweating.Very rare: pancytopenia, agranulocytosis, hypomagnesaemia, aggression, hallucinations, hepatic failure, encephalopathy in patients with coexisting liver disease, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscle weakness, gynecomastia.

Orally.Adults: Treatment of duodenal ulcer20 mg once daily for 2-4 weeks; duodenal ulcers resistant to treatment: 40 mg once daily for approximately 4 weeksPrevention of duodenal ulcer recurrencein patients with a negative test for presenceH. pylorior when eradicationH. pyloriis impossible, the recommended dose is 20 mg once a day. For some patients, a dose of 10 mg daily may be sufficient. If necessary, the dose can be increased to 40 mg.Treatment of peptic ulcer: 20 mg once a day for 4-8 weeks; peptic ulcer resistant to treatment: 40 mg for 8 weeksPrevention of peptic ulcer recurrence20 mg once a day; if necessary, the dose can be increased to 40 mg once a day.eradicationH. pylori in peptic ulcer disease: the choice of antibiotics should take into account the patient's tolerance to the medicine; compliance with national, regional and local patterns of resistance and treatment guidelines should be observed. One of the following treatments is recommended: A - omeprazole 20 mg + Clarithromycin 500 mg + Amoxicillin 1000 mg all given twice a day for one week; B - omeprazole 20 mg + clarithromycin 250 mg (alternatively 500 mg) + Metronidazole 400 mg (or 500 mg or tididazole 500 mg) all administered twice daily for one week; C - omeprazole 40 mg once a day with amoxicillin 500 mg and metronidazole 400 mg (or 500 mg or tididazole 500 mg) administered 3 times a day for one week. In each treatment regimen, treatment can be repeated if the result for presenceH. pylori it is still positive.Treatment of gastric and duodenal ulcer associated with the use of NSAIDs20 mg once daily for 4-8 weeksPrevention of peptic ulcer of the stomach and duodenum associated with the use of NSAIDs in patients at risk(age> 60 years, history of gastric and duodenal ulceration, upper gastrointestinal bleeding): 20 mg once a day. Treatment of reflux oesophagitis: 20 mg once daily for 4-8 weeks; heavy reflux oesophagitis: 40 mg once daily for 8 weeksLong-term treatment of patients after resolution of reflux oesophagitis: 10 mg once a day; if necessary, the dose can be increased to 20-40 mg once a day.Symptomatic treatment of gastroesophageal reflux disease20 mg daily; a patient may respond well to 10 mg daily, therefore individual dose adjustments should be considered; if the symptoms do not improve after 4 weeks of treatment with 20 mg daily, the patient should undergo further tests.Zollinger-Ellison syndrome: the dose should be adjusted individually and treatment should be continued as long as there are clinical indications, the recommended starting dose is 60 mg per day, most patients require maintenance doses of 20-120 mg per day. Daily doses above 80 mg should be given in 2 divided doses.Children aged> 1 year and weighing 10 kg. Treatment of reflux oesophagitis and symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease: children ≥1 yrs. 10-20 kg: 10 mg once a day, if necessary, the dose may be increased to 20 mg once a day; children ≥ 2 years old. > 20 kg: 20 mg once a day; if necessary, the dose can be increased to 40 mg once a day. In reflux oesophagitis, the treatment time is 4-8 weeks; in symptomatic treatment of heartburn and acid reflux in gastro-esophageal reflux disease - 2-4 weeks, if no symptom control has been obtained after this period, the patient should undergo further tests.Children> 4 years and young people. Treatment of duodenal ulcer caused byH. pylori: national, regional and local guidelines on bacterial resistance, duration of treatment (usually 7 days, sometimes up to 14 days) and appropriate use of antibacterial agents should be considered when selecting the right combination therapy. Therapy should be supervised by a specialist doctor. Weight 15-30 kg: omeprazole 10 mg, amoxicillin 25 mg / kg and clarithromycin 7.5 mg / kg all administered twice daily for 1 week; mc.31-40 kg: omeprazole 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg / kg all administered twice daily for 1 week; mc. > 40 kg: omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg all given twice daily for 1 week.Special groups of patients: No dosage adjustment is necessary for patients with impaired renal function and in the elderly. Patients with hepatic impairment may be given a dose of 10-20 mg per day.
The preparation should be administered in the morning. Swallow the capsules whole with half a glass of water. The capsules should not be chewed or crushed. For patients who have difficulties swallowing and for children who can drink or swallow food, the semi-solid capsule can be opened and swallowed with half a glass of water. You can also mix the contents of the capsule with a slightly acidic liquid, e.g. fruit juice, apple sauce or water. The suspension should be drunk immediately or not later than 30 minutes after preparation. Then refill the glass with half water and drink. The suspension should always be mixed before drinking. You can also suck the capsule and swallow the pellets with half a glass of water. Pellets coated with a salt-resistant coating must not be chewed.