Index of drugs

Treatment of duodenal and gastric ulcer. Treatment of reflux oesophagitis. Prevention of reflux oesophagitis. Treatment of Zollinger-Ellison syndrome. Treatment of benign gastric and duodenal ulcers associated with the use of NSAIDs in patients requiring continuous NSAID treatment. Prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk and requiring continuous treatment. Symptomatic treatment of gastroesophageal reflux disease. Eradication of infectionHelicobacter pylori in combination therapy with appropriate antibiotic therapy in the treatment of peptic ulcer associated with infectionH. pylori.

One capsule contains 15 mg or 30 mg of lansoprazole. Kaps. 15 mg and 30 mg contain sucrose, moreover, capsules of 30 mg contain azorubin.

Proton pump inhibitor. It inhibits the final stage of gastric acid production by inhibiting the activity of H⁺/ K⁺-ATP -ases in the parietal cells of the stomach. The inhibitory effect is dose-dependent and reversible; applies to both basic and stimulated hydrochloric acid secretion. C_maxoccurs within 1.5-2 h. Bioavailability is 80-90%, food slows absorption and reduces bioavailability by about 50%. Lansoprazole binds to plasma proteins approximately 97%. It is metabolised in the liver, mainly by the CYP2C19 isoenzyme and partly by the CYP3A4 isoenzyme. It is excreted in the faeces (2/3 of the administered dose) and in the urine (1/3 of the administered dose). T_0,5 is 1-2 hours.

Hypersensitivity to the components of the preparation. Do not use in patients who are being treated concomitantly with atazanavir.

Before starting treatment of gastric ulcer, the presence of a malignant gastric cancer should be ruled out, because lansoprazole may mask the symptoms of the disease and delay appropriate diagnosis. Use with caution in patients with severe hepatic impairment. Treatment aimed at preventing the occurrence of peptic ulcers in patients who need to continue using NSAIDs should be limited to high-risk patients (eg previous gastrointestinal bleeding, perforation or ulcer, older age, severe disease or long-term use of the largest recommended doses of NSAIDs, concomitant use of drugs that increase the likelihood of side effects of the upper part of the digestive system, e.g. corticosteroids or anticoagulants). Treatment with lansoprazole may lead to a slight increase in the risk of gastrointestinal infections caused by microorganisms, such asSalmonella andCampylobacter. Discontinuation of treatment should be considered for severe and / or persistent diarrhea (a risk of developing colitis). Due to the limited number of safety data in patients who are undergoing maintenance treatment for more than one year, the results of treatment and the risk / benefit ratio should be regularly evaluated. The product contains sucrose - it should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. The 30 mg capsules contain azorubine, which can cause allergic reactions. The preparation is not recommended in children due to lack of sufficient data.

Due to the lack of clinical trials, use during pregnancy is not recommended. The decision to continue / stop breastfeeding or to continue / stop lansoprazole should be made taking into account the benefits of breastfeeding and the benefits of lansoprazole in the mother.

Common: pain and dizziness, nausea, diarrhea, abdominal pain, constipation, vomiting, flatulence, dry mouth and throat, increased liver enzymes, urticaria, pruritus, rash, fatigue. Uncommon: thrombocytopenia, eosinophilia, leukopenia, depression, muscle and joint pain, edema.Rare: anemia, insomnia, hallucinations, confusion, restlessness, dizziness, paresthesia, drowsiness, tremor, blurred vision, tongue inflammation, esophageal candidiasis, pancreatitis, taste disorders, hepatitis, jaundice, ecchymosis, purpura, alopecia, 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 disease: 30 mg once daily for 4 weeks, if necessary continue for another 4 weeks.Reflux oesophagitis: 30 mg once daily for 4 weeks, if necessary continue for another 4 weeks.Prevention of reflux oesophagitis: 15 mg once a day, if necessary, the dose may be increased to 30 mg once a day.Symptomatic gastro-oesophageal reflux15-30 mg once daily, if no improvement is seen after 4 weeks of treatment with 30 mg, additional tests should be performed.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 two divided doses.eradicationHelicobacter pylori: 30 mg twice daily for 7 days in combination with antimicrobial therapy (amoxicillin 1 g twice daily and Clarithromycin 250-500 mg twice daily or clarithromycin 250 mg twice daily and Metronidazole 400-500 mg 2 times per day) daily, or Amoxicillin 1g twice daily and metronidazole 400-500 mg twice daily), selecting the appropriate combination of drugs should take into account the existing local guidelines regarding bacterial resistance, length of treatment (usually 7 days or sometimes up to 14 days) and proper use of antibacterial, effective eradication of infectionH. pylori up to 90% of patients using clarithromycin in combination with lansoprazole and amoxicillin or Metronidazole, lower eradication rates were observed using the third regimen, this scheme may be appropriate for patients who can not use clarithromycin when local metronidazole resistance indices are low.Łgastric and duodenal ulcer disease associated with the use of NSAIDs in patients requiring continuous NSAID treatment: 30 mg once daily for 4 weeks, if necessary continue for another 4 weeks, in patients with an increased risk of peptic ulcer or peptic ulcer disease difficult to treat, probably a longer course of treatment and / or higher doses should be used.FROMPrevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk (> 65 years or with known peptic ulcer of the stomach or duodenum) requiring long-term NSAID treatment: 15 mg once a day, if necessary, the dose may be increased to 30 mg once a day.Special groups of patients. In elderly patients, the daily dose should not exceed 30 mg, unless there are clear clinical indications. In patients with moderate or severe hepatic impairment, the daily dose should be reduced by 50% and the patient should be monitored regularly. No dosage adjustment is necessary for patients with impaired renal function. The capsules should be taken whole, in the morning, 30 minutes before a meal, with liquid. If the patient can not swallow the capsule, the contents of the capsule can be mixed with water, apple juice, tomato juice or a small amount of soft food (yogurt or grated apple). The contents of the capsule can be mixed with 40 ml of apple juice and administered through a nasogastric tube. The drug should be taken immediately after preparation of the suspension or mixture.