Treatment of duodenal and gastric ulcer. Treatment of reflux oesophagitis. Prevention of reflux oesophagitis. eradicationHelicobacter pylori (in combination therapy with antibiotics) in patients with peptic ulcer disease. Treatment of benign gastric and duodenal ulcers caused by the use of non-steroidal anti-inflammatory drugs in patients requiring long-term treatment with drugs from this group. Prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at increased risk of gastrointestinal disorders requiring long-term use of NSAIDs. Symptomatic gastroesophageal reflux disease. Treatment of Zollinger-Ellison syndrome.
Composition:
1 capsule contains 15 mg or 30 mg of lansoprazole.
Action:
A drug that inhibits the secretion of hydrochloric acid in the lining cells of the stomach as a result of the inhibition of H activity+/ K+-ATP-azy (the so-called proton pump). The effect of the drug depends on the dose and leads to the inhibition of both basal secretion and stimulated secretion. After oral administration of lansoprazole in the form of an enteric capsule, the maximum concentration in the blood occurs after 1.5-2 h. The bioavailability is 80-90%, the food slows down the absorption and reduces the bioavailability of the drug. Lansoprazole is approximately 97% bound to plasma proteins. It is metabolised in the liver, mainly by the CYP2C19 isoenzyme and partly by the CYP3A4 isoenzyme. T0,5 is about 1-2 hours. It is excreted in the faeces (2/3 of the administered dose) and urine (1/3 of the administered dose).
Contraindications:
Hypersensitivity to the components of the preparation. Do not use in patients who are being treated concomitantly with atazanavir. Use in children is not recommended (insufficient clinical data).
Precautions:
Use with caution in patients with impaired hepatic function. In the prevention of peptic ulcers caused by the use of NSAIDs, lansoprazole should only be used in patients at increased risk of gastrointestinal disorders (pre-existing gastrointestinal bleeding, perforation or ulceration, older age, concomitant use of corticosteroids or anticoagulants, severe coexistence disease or long-term use of the largest recommended doses of NSAIDs). Discontinue treatment if severe diarrhea occurs (risk of colitis). The product contains sucrose - the preparation should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
Pregnancy and lactation:
Due to the lack of clinical trials, use during pregnancy and breast-feeding is not recommended.
Side effects:
Common: pain and dizziness, nausea, diarrhea, abdominal pain, constipation, vomiting, flatulence, winds, dry mouth or throat, increased liver enzymes, urticaria, pruritus, rash, fatigue. Uncommon: thrombocytopenia, eosinophilia, leukopenia, depression, muscle and joint pain, edema. Rare: anemia, insomnia, hallucinations, confusion, dizziness, paresthesia, drowsiness, muscular tremors, visual disturbances, 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. Treatment with lansoprazole may lead to a slight increase in the risk of gastrointestinal infections caused by microorganisms such asSalmonella andCamphylobacter.
Dosage:
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 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; eradicationHelicobacter pylori: 30 mg twice daily for 7 days in combination with antimicrobial therapy (clarithromycin 250-500 mg twice daily and Amoxicillin 1 g twice daily or Clarithromycin 250 mg twice daily and Metronidazole 400-500 mg 2 times per day) daily or amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily); mild stomach and duodenal ulcer associated with NSAID use: 30 mg once daily for 4 weeks, if necessary continue for another 4 weeks; prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk who require long-term NSAID treatment: 15 mg once a day, if necessary, the dose may be increased to 30 mg once a day; symptomatic gastroesophageal reflux disease: 15-30 mg once a day, if after 4 weeks of treatment with the 30 mg dose no improvement can be seen, 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. Elderly patients should not exceed 30 mg daily. 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, preferably in the morning, 30 minutes before a meal, washed down with water.