Index of drugs

Adults: treatment of duodenal ulcer; prevention of recurrence of duodenal ulcer; treatment of stomach ulcers; prevention of recurrent stomach ulcers; in combination with appropriate antibiotics, eradication therapyHelicobacter pylori in peptic ulcer disease; treatment of gastric and duodenal ulcer associated with NSAIDs; prevention of gastric and duodenal ulceration associated with the use of NSAIDs in patients at risk of their occurrence; 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 over 1 year old and about > 10 kg: treatment of reflux oesophagitis; symptomatic treatment of heartburn and acid reflux in gastroesophageal reflux disease. Dties older than 4 years and young people: in combination with antibiotics for the treatment of duodenal ulcer caused byH. pylori.

1 enteral capsules contain 20 mg or 40 mg omeprazole. The product contains sucrose.

Proton pump inhibitor. Omeprazole is a racemic mixture of two enantiomers, reduces the secretion of hydrochloric acid in the stomach. It achieves a high concentration in the highly acidic environment of the secretory cells of the lining cells of the gastric mucosa, where it is converted into its active form and causes inhibition of the activity of the proton pump - H⁺/ K⁺- ATP-azy. The effect on the final stage of the formation of hydrochloric acid in the stomach is dose-dependent and provides highly effective inhibition of the secretion of hydrochloric acid in the stomach, both basal and stimulated, regardless of the stimulant of this secretion. Oral administration of omeprazole once a day provides fast and effective inhibition of gastric acid secretion in the stomach 24 hours a day, with maximum effect achieved after 4 days of drug administration. Absorption of omeprazole is rapid and C_max occurs about 1-2 hours after administration. Bioavailability after a single administration is about 40%, and after repeated about 60%. It binds to plasma proteins in approximately 97%. It is metabolized mainly by the CYP2C19 isoenzyme, which causes the formation of the main metabolite - hydroxy Omeprazole, as well as by CYP3A4, responsible for the formation of omeprazole sulphone. T_0,5 is <1 h. Almost 80% of the orally administered dose is excreted in the form of metabolites in the urine, the remainder in the faeces, mainly bile.

Hypersensitivity to omeprazole, substituted benzimidazoles or other components of the preparation. It should not be given at the same time as nelfinavir.

In case of any disturbing symptoms (eg significant unintentional weight loss, recurrent vomiting, difficulty swallowing, bloody vomiting or tarry stool), as well as in the case of suspicion or presence of gastric ulcer, the presence of neoplastic lesions should be excluded, because treatment with the preparation may relieve symptoms and delay the diagnosis. During long-term use, especially for more than one year, patients should be monitored regularly. Treatment with the preparation may slightly increase the risk of gastrointestinal infections, e.g. bacteriaSalmonella andCampylobacter. Omeprazole may reduce the absorption of vitamin B₁₂ - this should be taken into account in the case of patients with limited supply in the body or risk factors for reduced absorption of vitamin B₁₂ in long-term treatment. The use of atazanavir is not recommended - if such combination therapy is necessary, close clinical monitoring (eg viral load) is recommended with an increase of atazanavir to 400 mg with 100 mg ritonavir; do not exceed the 20 mg dose of omeprazole per day. Co-administration of omeprazole and Clopidogrel should be avoided. Some children with chronic conditions may need long-term treatment, but it is not recommended.Proton pump inhibitors, especially when used in high doses and in long-term therapy (over 1 year), may slightly increase the risk of hip fractures, carpal and spinal bones, especially in the elderly or in patients with other known risk factors, and general risk fractures at 10-40%. Patients at risk for osteoporosis should receive care in accordance with current clinical guidelines and should take the appropriate dose of vitamin D and calcium. In patients treated with PPI, such as omeprazole, for at least three months and in the majority of patients taking PPI for one year, cases of heavy hypomagnesaemia (tetany, delirium, dizziness and ventricular arrhythmias that may start unnoticed and remain unnoticed) have been reported. If necessary, supplement Magnesium deficiency and discontinue PPI. For patients who are presumed to be long-term or taking IPP including Digoxin or other agents that may cause hypomagnesaemia (eg diuretics), consideration should be given to measuring magnesium in the blood prior to treatment with IPP and periodic measurements during treatment. Due to the sucrose content, the drug should not be used in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. Kaps. 20 mg contain sunset yellow which may cause allergic reactions. 1 capsule 20 mg contains 0.653 mg sodium, which should be taken into account in patients on a low-fat diet.

The results of epidemiological studies indicate the lack of adverse effects of omeprazole on pregnancy or fetal / newborn health. The drug 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 and vomiting, bloating. Uncommon: skin inflammation, rash, pruritus, urticaria; fracture of the bone (ilium, wrist or spine); dizziness, paresthesia, drowsiness; insomnia; increased liver enzymes; malaise, peripheral edema. Rare: leukopenia, thrombocytopenia; hypersensitivity reactions, e.g. fever, angioneurotic edema and anaphylactic reaction / shock; hyponatremia; agitation, confusion, depression; taste disorders; blurred vision; bronchial spasm; dry mouth, oral mucositis and gastrointestinal candidiasis; hepatitis with jaundice and without jaundice; baldness, hypersensitivity to light; pain in the joints and muscles; interstitial nephritis; increased sweating. Very rare: agranulocytosis, pancytopenia; aggression, hallucinations; hepatic failure, encephalopathy in patients with pre-existing liver disease; erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, weakness in muscle strength; gynecomastia. Frequency unknown: hypomagnesemia.

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; some patients may need a daily dose of 10-40 mg.Treatment of stomach ulcers20 mg once a day for 4-8 weeks; in patients with refractory gastritis, a dose of 40 mg once daily for 8 weeks is used.Prevention of recurrent stomach ulcers20-40 mg once a day.Erpication of H.pylori in 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 omeprazole, 250 mg Clarithromycin (interchangeably 500 mg), 400 mg Metronidazole (interchangeably 500 mg or 500 mg tinidazole), administered twice daily for 1 week; or omeprazole 40 mg once a day, 500 mg Amoxicillin and 400 mg metronidazole (interchangeably 500 mg or 500 mg tinidazole) 3 times a day 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 ulceration associated with the use of NSAIDs20 mg once a day.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 disease10-20 mg once daily for 4 weeks; if the symptom control has not been achieved after 4 weeks, further diagnostic tests are recommended.Treatment of Zollinger-Ellison syndrome: select individually, the recommended starting dose is 60 mg once a day, and a maintenance dose of 20-120 mg per day; doses higher than 80 mg should be administered in 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 yr, 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 treatment of symptomatic heartburn and acid reflux in reflux disease of the esophagus lasts 2-4 weeks.Children> 4 years and young people. Treatment of duodenal ulcers caused by infectionsH. pylori: mc. 15-30 kg - combination therapy 10 mg omeprazole, 25 mg / kg Amoxicillin, 7.5 mg / kg clarithromycin, twice a day for 1 week; mc. 31-40 kg - combination therapy with 20 mg omeprazole, 750 mg amoxicillin, 7.5 mg / kg clarithromycin, twice a day for 1 week; mc. > 40 kg - combination therapy with 20 mg of omeprazole, 1000 mg of amoxicillin, 500 mg of clarithromycin, twice a day for 1 week; duration of treatment is 1-2 weeks. No dosage adjustment is necessary in elderly patients and patients with renal insufficiency. In patients with impaired liver function, a daily dose of 10-20 mg may be sufficient. The drug is recommended to take in the morning, preferably on an empty stomach. In patients with swallowing disorders or in children, the drug can be used by opening the capsule and swallowing it, drinking half a glass of water or mixing the contents of the capsule with a slightly acidic liquid, e.g. fruit juice, apple sauce, or after mixing with water. Alternatively, patients can suck the capsule and swallow the microgranules with half a glass of water. The microgranules must not be chewed. The capsules must not be chewed or crushed.