Symptoms of reversal of gastric contents into the esophagus and symptomatic gastro-oesophageal reflux (burning in the esophagus - heartburn) in adult patients.
Composition:
One capsule contains 10 mg of omeprazole. The tablets contain sucrose.
Action:
Proton pump inhibitor (H+, K+ ATP-ases) in the parietal cells of the stomach. It inhibits the secretion of hydrochloric acid, both basic and after stimulation. The onset of action occurs after 1 hour, and the maximum effect after 2 hours. After 24 hours after administration, the secretory activity of parietal cells is halted and this effect lasts up to 72 hours. The Omeprazole effect increases gradually as the Next doses of the preparation are administered, stationary state is determined after 4 days. After discontinuation of the preparation, the secretory activity returns to normal within 3-5 days. Omeprazole increases gastrin levels in the first 1-2 weeks of treatment. It does not affect cholinergic and histamine receptors. After oral administration, omeprazole is rapidly absorbed from the gastrointestinal tract, reaching a maximum blood concentration within 0.5-3.5 h. The oral bioavailability is 30-40% (compared to intravenous administration) in the 20-40 mg dose range. . It binds to 95% of plasma proteins. It is completely metabolised in the liver. It is excreted mainly in the urine (less than 0.1% of the dose in unchanged form, about 60% in the form of metabolites), and only a small amount is excreted in the faeces. T0,5 is 0.5- h; in patients with chronic liver failure it is extended to almost 3 hours.
Contraindications:
Hypersensitivity to omeprazole or other components of the preparation. Do not use with atazanavir.
Precautions:
The use of drugs that reduce the secretion of hydrochloric acid slightly increases the risk of gastrointestinal infections with bacteria such asSalmonella andCampylobacter. In case of any disturbing symptoms (ie significant, unexpected weight loss, recurrent vomiting, dysphagia, vomiting with admixture of blood, tarry stools, symptoms of peptic ulcer, jaundice or other diseases, e.g. liver and kidney failure, surgical procedures in interview), the possibility of a cancerous nature of the disease should be ruled out, because omeprazole treatment may alleviate the symptoms and delay the diagnosis. Monitoring of liver enzymes should be performed, especially in patients with liver disease. Patients over 45 years of age who have recently developed new symptoms should inform their doctor or pharmacist immediately. In patients treated with proton pump inhibitors (PPI) for at least 3 months and in the majority of patients taking PPI for one year, cases of heavy hypomagnesaemia have been reported. In patients most affected by the disease, hypomagnesaemia decreased after supplementing Magnesium deficiency and discontinuing PPI. For patients presumed long-term or taking PPI including Digoxin or other agents that may cause hypomagnesaemia (eg diuretics), consideration should be given to measuring magnesium levels before treatment and periodic measurements during treatment. Due to the sucrose content, the preparation should not be used in patients with rare inherited disorders associated with sucrose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
Pregnancy and lactation:
It can be used during pregnancy and breastfeeding only when the benefit to the mother outweighs the potential risk to the fetus or breastfed infant. Occasional birth defects have been reported in children born to mothers receiving omeprazole during pregnancy.
Side effects:
Common: diarrhea, epigastric pain, nausea, vomiting, constipation, bloating, pain and dizziness, backache. Uncommon: increased AST, ALT, GGTP, alkaline phosphatase, drowsiness, paraesthesia, rash, dermatitis, urticaria, pruritus, malaise.Rare: chest pains, tachycardia, bradycardia, palpitations, edema, increase in blood pressure; respiratory tract infection, cough, bronchospasm, nosebleeds, sore throat; hepatitis (sometimes with jaundice), increased bilirubin in the blood, liver failure, hepatic encephalopathy (isolated cases in patients with a history of liver dysfunction), oral mucositis, candidiasis, stool discoloration, dry mouth , taste disorders, anorexia, irritable bowel syndrome, pancreatitis, atrophy of the tongue, depression, aggression, hallucinations, confusion, insomnia, apathy, nervousness, anxiety, interstitial nephritis, urinary tract infections, frequent urination, proteinuria, hematuria, glycosuria, testicular pain, gynecomastia, increased blood creatinine, muscle spasms, pain in the limbs, arthralgia, alopecia, hyperhidrosis, hypersensitivity to light, bullous rash, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, leukopenia , thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia, leukocytosis, hypoglycaemia, hyponatremia, weight gain, fever, fatigue, blurred vision, allergic reactions (angioneurotic edema, anaphylactic shock). Frequency unknown: hypomagnesemia.
Dosage:
Orally. Adults: The starting dose is 20 mg per day. If the symptoms improve, the dose should be reduced to 10 mg daily. In some patients, the 10 mg dose may be sufficient and may be taken as the starting dose. If the symptoms of heartburn recur, the dose may be increased to 20 mg daily. If symptoms do not improve after 2 weeks of treatment with a 20-mg daily dose, further diagnostic tests are recommended.Special groups of patients. In patients with impaired liver function, a daily dose of more than 20 mg should not be given. In patients with renal insufficiency and in elderly patients, no dose reduction is necessary.Way of giving. The capsule should be taken in the morning, before breakfast, washed down with water. The capsule should be swallowed whole, it should not be chewed or crushed. In the case of swallowing disorders, the capsule can be opened and its content poured into fruit juice or other acidic liquid, mix and drink.
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