Index of drugs

The drug is used in disease states in which it is necessary to reduce the secretion of gastric acid, such as: duodenal ulcer, gastric ulcer, treatment of infectionH. pylori (combination therapy with antibiotics), reflux oesophagitis - treatment and prevention, treatment of benign gastric and duodenal ulceration associated with the treatment of non-steroidal anti-inflammatory drugs (NSAIDs) in patients requiring constant NSAID treatment, prevention of gastric and duodenal ulcer associated with NSAID treatment in patients at risk permanent treatment, symptomatic gastroesophageal reflux disease, Zollinger-Ellison syndrome.

1 capsule contains 15 mg or 30 mg of lansoprazole. The drug contains sucrose.

Proton pump inhibitor. It inhibits the secretion of gastric juice in the parietal cells of the stomach as a result of blocking H activity⁺/ K⁺-ATP-azy (the so-called proton pump). The action of the drug is reversible, depends on the dose and leads to inhibition of both basal and stimulated secretion. A single oral administration of 30 mg of lansoprazole inhibits gastric excretion of gastric acid by about 80% stimulated by pentagastrin. After 7 days of regular use, production of gastric acid decreases by approx. 90%. Lansoprazole is rapidly absorbed from the gastrointestinal tract, reaching C_max within 1.5-2 h. Bioavailability is 80-90%, food slows absorption and reduces the bioavailability of the drug. It is 97% bound to plasma proteins. It is metabolised in the liver, mainly by the CYP2C19 isoenzyme and partly by the CYP3A4 isoenzyme. T_0,5 is 1-2 hours, in the elderly it increases by about 50-100%. Excreted in 1/3 in the form of metabolites in the urine, the remainder in the faeces. Exposure to lansoprazole increases 2-fold in patients with mild hepatic impairment and significantly more pronounced in patients with moderate or severe hepatic impairment.

Hypersensitivity to lansoprazole or other ingredients of the preparation. Do not use in patients who are being treated concomitantly with atazanavir.

The safety of the preparation in children has not been established. Caution should be exercised in patients with moderate or severe hepatic impairment. Treatment with lansoprazole may cause a slight increase in the risk of gastrointestinal infections caused by bacteria such asSalmonella andCampylobacter. Patients with gastric and duodenal ulcer disease should be aware of the possibility of infectionH. pylori as a causative agent of the disease. If the maintenance treatment lasts for more than a year, regular monitoring with the assessment of possible benefits and risks for the patient is recommended. If severe and / or persistent diarrhea occurs, discontinue use. Prevention of peptic ulcers in patients requiring long-term NSAID treatment should only be used in risk groups (eg gastrointestinal bleeding, perforation or ulcer history, advanced age, concomitant use of drugs known to increase the risk of adverse events on the upper gastrointestinal tract, coexistence of severe diseases or long-term use of NSAIDs at the highest recommended doses). The product contains sucrose - the preparation should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. Kaps. 15 mg - due to the content of azo dye, the drug may cause allergic reactions.

The use of the drug during pregnancy is not recommended (no studies). During breastfeeding, use only if the expected benefits to the mother outweigh the potential danger to the baby being fed.

Common: headache, dizziness; nausea, diarrhea, abdominal pain, constipation, vomiting, flatulence and dryness in the mouth or throat; increase in liver enzymes; urticaria, pruritus, exanthema; fatigue. Uncommon: thrombocytopenia, eosinophilia, leukopenia; depression; muscle pain, joint pain, edema.Rare: anemia; insomnia, hallucinations, confusion; anxiety, dizziness with impaired balance, paresthesia, drowsiness, muscular tremors; blurred vision; tongue inflammation, esophageal candidiasis, pancreatitis, dysgeusia; hepatitis, jaundice; ecchymosis, purpura, loss of hair, erythema multiforme, hypersensitivity to light; interstitial nephritis; gynecomastia, fever; increased sweating, angioneurotic edema, anorexia, impotence. Very rare: agranulocytosis, pancytopenia, colitis, oral mucositis, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic shock, increased cholesterol and triglycerides in the blood, hyponatremia.

Orally. Adults. Duodenal ulcer: 30 mg once daily for 2 weeks, if necessary continue for another 2 weeks. Peptic ulcer: 30 mg once daily for 4 weeks, if necessary continue for another 4 weeks Reflux oesophagitis: 30 mg once a day for 4 weeks, if necessary continue for another 4 weeks Preventing reflux oesophagitis: 15 mg once a day, if necessary increase the dose to 30 mg. eradicationH. pylori: 30 mg twice daily for 7 days in combination with antimicrobial therapy (amoxicillin 1000 mg twice daily and Clarithromycin 250-500 mg twice daily or clarithromycin 250 mg twice daily and Metronidazole 400-500 mg 2 times per day) hours). Treatment of benign gastric and duodenal ulceration in patients requiring constant NSAID treatment: 30 mg once daily for 4 weeks, if necessary continue for another 4 weeks; in patients with difficult to treat ulcers or the risk of ulcers, the treatment should probably be continued for a long time and / or higher doses. Prevention of gastric and duodenal ulcers associated with NSAID treatment in patients at risk who require continuous NSAID treatment: 15 mg once a day, if necessary, increase the dose to 30 mg. Symptomatic gastroesophageal reflux disease: 15-30 mg per day, individual dose selection should be considered. Zollinger-Ellison syndrome: individually, 60-180 mg per day, there is no prescribed maximum period of use of the drug, a daily dose of more than 120 mg should be given in 2 divided doses. In patients with moderate or severe liver disease, it is recommended to reduce the daily dose by half. Do not exceed 30 mg daily in elderly patients. Kaps. should be taken whole, in the morning or in the evening (preferably on an empty stomach). If the patient can not swallow the capsules, the contents of the capsules can be mixed with apple juice. In patients with nasogastric tube, the contents of capsules can be given by gavage, after mixing with 40 ml of apple juice.