Index of drugs

Treatment of symptoms of gastro-oesophageal reflux (eg heartburn, acid reflux) in adults.

1 enteral capsules contain 10 mg of 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. 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. 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. Due to the content of yellow-orange pigment drug may cause allergic reactions. 1 capsule contains 0.32665 mg of sodium, which should be taken into account in patients on a low-sodium diet.

The results of epidemiological studies indicate the lack of adverse effects of omeprazole on pregnancy or fetal / newborn health. 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: insomnia, dizziness, dizziness, paresthesia, drowsiness, increased activity of liver enzymes, dermatitis, rash, pruritus, urticaria, bone fractures (ilium, wrist or spine), malaise, peripheral edema. Rare: leukopenia, thrombocytopenia, hypersensitivity reactions (eg fever, angioneurotic edema and anaphylactic reaction / shock), hyponatremia, agitation, confusion, depression, dysgeusia, blurred vision, bronchospasm, dry mouth, oral mucositis, gastrointestinal candidiasis, hepatitis with and without jaundice, alopecia, hypersensitivity to light, joint and muscular pain, interstitial nephritis, increased sweating. Very rare: agranulocytosis, pancytopenia, hypomagnesaemia, aggression, hallucinations, hepatic failure, encephalopathy in patients with pre-existing liver disease, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscle weakness, gynecomastia.

Orally. Adults: 10 mg once a day for 14 days. For improvement, it may be necessary to take capsules for 2-3 consecutive days. In the majority of patients, heartburn disappears completely within 7 days. No dosage adjustment is necessary in elderly patients and patients with renal insufficiency. In patients with hepatic impairment, due to the possibility of increased bioavailability and prolonged half-life, the daily dose should be reduced.
The drug should be taken in the morning, preferably with a meal, by swallowing them whole with a glass of water. In patients with swallowing disorders, the drug can be used by opening the capsule and swallowing its content, drinking half a glass of water or mixing the contents of the capsule with a slightly acidic liquid, e.g. fruit juice, apple purée or after mixing with water. The prepared suspension should be taken immediately (or within 30 minutes of preparation); in any case, the suspension should be mixed immediately before drinking, and after drinking it, drink half a glass of 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.