Index of drugs

Adults. Treatment of duodenal ulcer. Prevention of duodenal ulcer recurrence. Treatment of stomach ulcers. Prevention of recurrent stomach ulcers. In combination with appropriate antibiotics, eradication therapyHelicobacter pyloriin peptic ulcer disease. Treatment of gastric and duodenal ulcers associated with NSAIDs. Prevention of gastric and duodenal ulcers associated with NSAIDs in patients at risk of developing them. Treatment of reflux oesophagitis. Long-term supportive care for patients after healing of reflux oesophagitis. Treatment of symptomatic gastroesophageal reflux disease. Treatment of Zollinger-Ellison syndrome.Children. Children aged> 1 year and children ≥ 10 kg: treatment of reflux oesophagitis; symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease. Children and adolescents aged> 4 years: in combination with antibiotics for the treatment of duodenal ulcer caused byH. pylori.

1 hard gastro-resistant capsule contains 20 mg or 40 mg Omeprazole (and 2 mg or 4 mg lactose, respectively).

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 to plasma proteins in approximately 97%. It is completely metabolised by the cytochrome P450 system, mainly CYP2C19 (to hydroxyomeprazole) and partly by CYP3A4 (to the omeprazole sulfone). 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. In slow metabolisers (who do not have active CYP2C19 isoenzyme), the mean AUC is 5-10 times higher than in fast metabolisers (those with active CYP2C19 isozymes), mean C values_max they are also 3-5 times larger; however, these data do not give any consequences regarding the dosage of omeprazole.

Hypersensitivity to the active substance, substituted benzimidazoles or any of the excipients. Do not use with nelfinavir.

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. Patients who have been on treatment for a long time (especially if the treatment lasts for more than a year) should remain under regular medical supervision. Some children with chronic conditions may need long-term treatment, but it is not recommended. There are no long-term data on the effect of omeprazole treatment on the maturation and growth of the body. 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) due to hypo or achlorhydria; this should be taken into account during long-term treatment of patients with reduced vitamin B stores₁₂ or risk factors that favor its absorption. 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. 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 omperazole with atazanavir is not recommended (reduction of atazanavir exposure). Due to the lactose content, the drug should not be used in patients with galactose intolerance, Lapp lactose deficiency or malabsorption of glucose-galactose.

The preparation can be used during pregnancy. Omeprazole passes into breast milk, but there is no risk of adverse effects on the child when using the drug at therapeutic doses.

Common: headache, diarrhea, constipation, abdominal pain, nausea, vomiting, bloating. Uncommon: insomnia, dizziness, paresthesia, drowsiness, dermatitis, increased liver enzymes, dermatitis, pruritus, rash, urticaria, malaise, peripheral edema, hip fracture, wrist or spine. Rare: leukopenia, thrombocytopenia, hypersensitivity reactions (eg fever, angioneurotic edema and anaphylactic reaction / shock), hyponatremia, agitation, confusion, depression, dysgeusia, blurred vision, bronchospasm, dryness or inflammation of the oral mucosa, gastrointestinal candidiasis , microscopic colitis, hepatitis with jaundice or without jaundice, alopecia, photosensitivity, joint pain, muscle pain, interstitial nephritis, hyperhidrosis. Very rare: agranulocytosis, pancytopenia, aggression, hallucinations, hepatic failure, encephalopathy in patients with pre-existing liver disease, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscle weakness, gynecomastia. Frequency unknown: hypomagnesemia. The profile of adverse reactions in children was the same as in adults, both during short-term and long-term treatment.

Orally.Adults. Treatment of duodenal ulcer20 mg once daily for 2-4 weeks; in patients with refractory ulcer disease, a dose of 40 mg once daily for 4 weeks is used.Prevention of duodenal ulcer recurrence (uninfected patientsH. pylori or when eradicationH. pylori not possible): usually 20 mg once a day; in some patients a dose of 10 mg may be sufficient; if the therapy fails, the dose may be increased to 40 mg once a day.Treatment of stomach ulcers20 mg once a day for 4-8 weeks; in patients with peptic ulcer disease refractory to treatment, a dose of 40 mg once daily for 8 weeks is used.Prevention of recurrent stomach ulcers20 times daily, if necessary, the dose may be increased to 40 mg once a day.eradicationH. pylori in patients with peptic ulcer disease: recommended diagrams - 20 mg of omeprazole, 500 mg of Clarithromycin, 1000 mg of Amoxicillin, administered twice daily for 1 week; or 20 mg of omeprazole, 250 mg of Clarithromycin (alternatively 500 mg), 400 mg of Metronidazole (alternatively 500 mg or 500 mg of tididazole), administered twice daily for 1 week; or 40 mg omeprazole once daily, 500 mg Amoxicillin and 400 mg metronidazole (or 500 mg or 500 mg tinidazole) 3 times daily for 1 week; if infection persistsH. pylori the treatment regimen can be repeated.Treatment of gastric and duodenal ulcers associated with the use of NSAIDs20 mg once a day for 4-8 weeksPrevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients with an increased risk of their occurrence: in patients at risk (age> 60 years, history of gastric and duodenal ulceration, upper gastrointestinal bleeding) 20 mg once daily.Treatment of reflux oesophagitis20 mg once a day for 4-8 weeks; in patients with severe reflux oesophagitis, 40 mg once daily for 8 weeks are used.Long-term maintenance treatment in patients with healing reflux oesophagitis: 10 mg once a day, if necessary 20-40 mg once a day.Treatment of symptomatic gastroesophageal reflux disease20 mg once a day, in some patients 10 mg daily; if the symptoms do not improve after 4 weeks of treatment with 20 mg daily, further diagnostic tests are recommended.Treatment of Zollinger-Ellison syndrome: individual dosing, treatment should continue until there are clinical indications, the recommended starting dose is 60 mg per day and the maintenance dose 20-120 mg per day; doses higher than 80 mg should be administered in 2 divided doses.Children> 1 year and about ≥10 kg. Treatment of reflux oesophagitis and symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease: ≥1 yo, mc. 10-20 kg - 10 mg once a day, if necessary 20 mg per day; ≥2 years, mc. > 20 kg - 20 mg once a day, if necessary 40 mg daily; the duration of treatment in reflux oesophagitis is 4-8 weeks, and the symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease lasts 2-4 weeks, if symptom control is not achieved after 2-4 weeks, the patient should be further examined. diagnostic tests.Children> 4 years and young people. Treatment of duodenal ulcers caused by infectionH. pylori: mc. 15-30 kg - 10 mg omeprazole, 25 mg / kg Amoxicillin, 7.5 mg / kg clarithromycin, administered twice daily for 1 week; mc. 31-40 kg - 20 mg omeprazole, 750 mg amoxicillin, 7.5 mg / kg clarithromycin, administered twice daily for 1 week; mc. > 40 kg - 20 mg of omeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, administered twice daily for 1 week; duration of treatment is 1-2 weeks; treatment should be supervised by a specialist doctor.Special groups of patients.No dosage adjustment is necessary for elderly patients or patients with renal impairment. In patients with hepatic impairment, a dose of 10-20 mg may be sufficient.Way of giving. The drug should be taken in the morning, preferably not with a meal. The capsules should be swallowed whole with a glass of water. The capsules should not be chewed or crushed. For patients with swallowing disorders and children who are able to drink or swallow the food, the semi-solid capsule can be opened and the contents swallowed directly with half a glass of water or mixed with a slightly acidic liquid, e.g. fruit juice or apple sauce or after mixing with still water. The prepared suspension should be drunk immediately (or within 30 minutes) and always stir immediately before drinking and drink half a glass of water. Alternatively, patients can suck the capsule and swallow pellets with half a glass of water. Pellets must not be chewed.