Treatment of symptoms of gastro-oesophageal reflux (eg heartburn and acid reflux) in adult patients.
Composition:
One capsule contains 20 mg of omeprazole. The drug contains sucrose.
Action:
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 rapid inhibition of gastric acid secretion in the stomach 24 hours a day, with maximum effect being achieved after 4 days of drug administration. Absorption of omeprazole is rapid and Cmax 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. T0,5 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.
Contraindications:
Hypersensitivity to omeprazole, substituted benzoimidazoles or to any of the excipients. Do not use with nelfinavir.
Precautions:
If any disturbing symptoms occur (eg significant unintentional weight loss, recurrent vomiting, swallowing difficulties, bloody vomiting or tarry stools), and if gastric ulceration is suspected or present, the presence of neoplastic lesions should be ruled out because the use of omeprazole may alleviate the symptoms and delay the diagnosis. The use of proton pump inhibitors may lead to a small increase in the risk of gastrointestinal infections such asSalmonella andCampylobacter. Regular monitoring and caution should be used in patients with long-term recurrent symptoms of indigestion or heartburn, particularly in patients over 55 years of age. Caution should be exercised in patients with a history of gastric ulcer or gastrointestinal surgery, and patients with jaundice or severe liver disease. Do not use omeprazole preventively. The medicine contains 0.653 mg sodium per dose - its use should be considered in patients on a controlled diet. In addition, the drug contains sucrose - it should not be used in patients with rare fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
Pregnancy and lactation:
Omeprazole can be used during pregnancy. The drug passes into breast milk, but there is no risk of adverse effects on the child when using the drug in therapeutic doses.
Orally. Adults: 20 mg once a day for 14 days. It may be necessary to take capsules for 2-3 consecutive days to get relief. In the majority of patients, heartburn disappears completely within 7 days. After having completely relieved the symptoms, the treatment should be terminated. It is recommended to take the medicine in the morning, with half a glass of water. Kaps. you can not chew or crush. A patient with dysphagia may open the capsule and swallow the contents directly with half a glass of water or after mixing with a weakly acidic liquid, e.g. fruit juice or apple sauce, or after mixing with still water. Alternatively, patients can suck the capsule and swallow the pellets with half a glass of water. Pellets must not be chewed.
(C)
