Index of drugs

Peptic ulcer of the stomach or duodenum, also co-existing with the infectionHelicobacter pylori. Reflux oesophagitis. Symptomatic treatment of gastroesophageal reflux disease (burning in the esophagus - heartburn). Zollinger's team - Ellison. Prophylaxis of aspiration pneumonia prior to general anesthesia in patients at risk of aspiration of acid gastric contents. Symptoms of indigestion related to acid. Treatment and prophylaxis of benign gastric ulcer and duodenal ulcer and erosion caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs) in patients with a history of gastrointestinal mucosal damage who require NSAID treatment.

1 hard capsules contain 20 mg of Omeprazole (and 96 mg of sucrose).

Omeprazole, which is a racemic mixture of two enantiomers, is a specific inhibitor of the proton pump (H⁺/ K⁺ ATPase) in the parietal cells of the gastric mucosa. It reduces the secretion of hydrochloric acid in the stomach, both basal and stimulated. Omeprazole is not stable in an acidic environment and is therefore administered orally in the form of capsules filled with coated pellets. Absorption of omeprazole is rapid and C_max occurs about 1-2 hours after administration. The bioavailability of omeprazole after a single oral administration is approximately 40%. Multiple administration once a day increases the bioavailability to about 60%. Omeprazole binds approximately 95% of plasma proteins. It is completely metabolised by the cytochrome P450 system, mainly CYP2C19 (to hydroxyomeprazole). Almost 80% of an orally administered dose is excreted as metabolites in the urine; the remaining part with faeces. T_0,5 is <1 h. In patients with hepatic impairment the metabolic rate is reduced.

Hypersensitivity to the active substance or any of the excipients. Do not use with atazanavir.

In patients with suspected or diagnosed peptic ulcer disease, as well as any disturbing symptoms (eg, significant unintentional weight loss, recurrent vomiting, swallowing difficulties, bloody vomiting or tarry stools), the cancerous background of the disease should be excluded, as omeprazole treatment may alleviate the symptoms of cancer and delay its diagnosis. Treatment with omeprazole may cause a slight increase in the risk of gastrointestinal infections with such bacteria asSalmonella spp. And Campylobacter spp.Omeprazole may reduce the absorption of vitamin B₁₂ (Cyanocobalamin); in the treatment of seriously ill children who require long-term omeprazole therapy and have a vitamin B concentration₁₂ is borderline or very small, it is recommended to control the concentration of vitamin B₁₂ in blood. Patients treated with omeprazole for at least 3 months (in most cases for one year) have experienced severe hypomagnesaemia; in patients who are envisaged for long-term treatment or who are taking proton pump inhibitors concomitantly with Digoxin or hypomagnesaemic agents (eg diuretics), Magnesium determination should be considered before starting omeprazole treatment and then periodically during treatment. Proton pump inhibitors can increase the overall risk of fractures by 10-40%; Patients at risk of osteoporosis should receive care in accordance with current clinical guidelines, and provide adequate amounts of vitamin D and calcium. Do not use this medicine in children under 3 years. Due to the sucrose content, the drug should not be used in patients with rare hereditary disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

During pregnancy and breastfeeding (omeprazole is excreted in breast milk) to be used only in cases where the benefit for the mother outweighs the potential risk to the fetus or infant breastfeeding. Omeprazole (doses up to 80 mg / day) given to women during labor did not cause any adverse effects on the fetus.Animal studies have not confirmed the adverse effects of omeprazole used during pregnancy and lactation; no evidence of embryotoxicity or teratogenicity was found.

Common: headache, diarrhea, constipation, bloating (including gas), epigastric pain, nausea, vomiting. Uncommon: dizziness, paresthesia, photosensitivity, malaise, drowsiness, insomnia, increased liver enzymes, rash, dermatitis and / or pruritus, urticaria, hip fracture, wrist or spine, feeling unwell. Rare: recurrent confusion, agitation, aggression, depression and hallucinations (mainly in severely ill patients), gynecomastia, dryness or oral mucositis, gastrointestinal candidiasis, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, encephalopathy in patients with pre-existing severe hepatic disease, hepatitis with or without coexisting jaundice, hepatic failure, joint pain, muscle pain, muscle weakness, impotence, rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia, hypersensitivity reactions , angioneurotic edema, fever, bronchospasm, interstitial nephritis, anaphylactic shock, increased sweating, peripheral edema, blurred vision, dysgeusia, hyponatremia. Frequency unknown: hypomagnesemia.

Orally.Adults. Duodenal ulcer: active duodenal ulcer - 20 mg once a day for 2-4 weeks; duodenal ulcer resistant to treatment - 40 mg once daily for approximately 4 weeks; prevention of duodenal ulcer recurrence - 10 mg once a day, if necessary, the dose can be increased to 20-40 mg once a day.Peptic ulcer disease: 20 mg once a day for 4-8 weeks; peptic ulcer disease refractory to treatment - 40 mg once a day for about 8 weeks; prevention of recurrent stomach ulcer - 20 mg once a day, if necessary, the dose can be increased to 40 mg once a day.Treatment of infectionsH. pylori: Three-component regimen: A. - 20 mg omeprazole twice a day for 7 days in combination with antibiotic therapy (1 g Amoxicillin twice daily and 500 mg of Clarithromycin twice a day); or B. - 20 mg omeprazole twice daily for 7 days in combination with antibiotic therapy (250 mg of clarithromycin twice daily and 400 mg of Metronidazole / or 500 mg of thymidazole twice daily); or C. - 40 mg omeprazole once daily for 7 days in combination with antibiotic therapy (500 mg amoxicillin 3 times daily and 400 mg metronidazole 3 times daily). Two-component scheme: A. - omeprazole 40 mg / day and amoxicillin 1.5 g / day in divided doses for 2 weeks; or B. - 40 mg of omeprazole once daily and 500 mg of clarithromycin 3 times daily for 2 weeks. If after the end of treatment, according to any of the above therapeutic regimens, the patient continues to have an infectionHelicobacter pylorithe treatment can be repeated.Reflux oesophagitis: 20 mg once a day for 4-12 weeks; severe reflux esophagitis - 40 mg once a day; maintenance treatment - 10 mg once a day, if necessary, the dose can be increased to 20-40 mg once a day.Symptomatic treatment of gastroesophageal reflux disease: 10-20 mg once daily, if the symptoms persist after 4 weeks of treatment with 20 mg daily, further diagnostic tests are recommended.Zollinger-Ellison syndrome: initially 60 mg once a day, most patients require maintenance doses of 20-120 mg per day. The dose and duration of treatment are determined individually for each patient. Daily doses> 80 mg should be given in 2 divided doses.Prophylaxis of aspiration pneumonia: 40 mg in the evening before surgery and 40 mg in the morning on the day of surgery.Symptoms of indigestion related to acid: 10-20 mg once daily, if the symptoms persist after 4 weeks of treatment with 20 mg daily, further diagnostic tests are recommended.Treatment of gastric and duodenal ulcers and eradication caused by the use of NSAIDs and prophylaxis20 mg once daily with NSAIDs.Children> 3 years.Reflux oesophagitis: mc. 10-20 kg - 10 mg once a day; mc. > 20 kg - 20 mg once a day.Special groups of patients.In patients with hepatic insufficiency, the drug is administered at a dose of 10-20 mg per day.There is no need to change the dosage in patients with renal insufficiency or in the elderly.Way of giving.The capsules should be swallowed whole, they should not be chewed or crushed. In case of swallowing difficulties, the 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, for example fruit juice, yogurt or still water and drink within 30 minutes of preparation, washed down with half a glass of water.