Treatment of duodenal ulcer and stomach confirmed endoscopically or radiologically. Treatment of reflux oesophagitis. Prevention of reflux oesophagitis. Zollinger-Ellison syndrome. eradicationHelicobacter pylori (in combination therapy with antibiotics) and prevention of ulcer recurrence in patients with peptic ulcer associated with infectionH. pylori. 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 the permanent use of NSAIDs. Symptomatic gastroesophageal reflux disease.
Composition:
1 enteral capsules contain 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 blood concentration occurs after 1.5-2 h. The bioavailability is 80-90%, the food slows down the absorption of the drug and reduces the bioavailability. About 95% is 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 h. 15-50% of the metabolites are excreted in the urine, the remaining part in the feces.
Contraindications:
Hypersensitivity to the components of the preparation. Concomitant use with atazanavir.
Precautions:
Before starting treatment, the cancerous nature of the disease should be ruled out, because lansoprazole may mask the clinical picture and delay the diagnosis of cancer. Use with caution in patients with moderate or severe hepatic impairment. Due to limited data on safety of therapy for more than a year, the effectiveness of the treatment and the risk-benefit assessment should be regularly assessed. In very rare cases, colitis has been reported in patients using lansoprazole. In case of severe diarrhea, discontinuation of the drug should be considered. Use of the drug to prevent peptic ulcer disease in patients requiring constant NSAID treatment should be limited only to people at high risk (for example, previous gastrointestinal bleeding, ulcer perforation, advanced age, simultaneous taking medicines that increase the probability of side effects in the upper gastrointestinal tract for example, corticosteroids or anticoagulants, the presence of severe co-morbidities or the prolonged use of the maximum recommended doses of NSAIDs). Lansoprazole should not be used in children (the safety and efficacy of this medicine has not been established in this age group). The product contains sucrose - the preparation should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. If visual disturbances occur during long-term (> 1 year) use of lansoprazole, treatment should be discontinued and optician should be prescribed.
Pregnancy and lactation:
There are no clinical data on exposure to lansoprazole during pregnancy. Animal studies do not indicate any direct or indirect harmful effects of the drug on pregnancy, embryonal / fetal development, parturition or postnatal development. It is not recommended to use the drug during pregnancy. It is not known whether lansoprazole is excreted in human milk. Animal studies have shown that lansoprazole is excreted in milk. When deciding whether to continue / discontinue breast-feeding or to continue / discontinue treatment with the preparation, the child's benefit of breastfeeding and the benefits for the mother due to lansoprazole should be taken into account.
Side effects:
Common: nausea, diarrhea, abdominal pain, constipation, vomiting, flatulence, dry mouth or throat, rash, urticaria and pruritus, headache and dizziness, fatigue, increase in liver enzymes. Uncommon: depression, thrombocytopenia, eosinophilia, leukopenia, pain in the joints and muscles, edema. Rare: tongue inflammation, oesophageal candidiasis, pancreatitis, dysgeusia, ecchymosis, purpura, hair loss, erythema multiforme, photosensitivity, restlessness, insomnia, drowsiness, hallucinations, confusion, dizziness, paresthesia, tremor, hepatitis, jaundice , interstitial nephritis, anemia, blurred vision, gynecomastia, fever, excessive sweating, loss of appetite, impotence, angioneurotic edema. Very rare: enteritis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, pancytopenia, anaphylactic shock, increased cholesterol and triglyceride levels, hyponatremia. Treatment with lansoprazole may lead to a slight increase in the risk of gastrointestinal infections due to microorganisms such asSalmonella andCamphylobacter.
Dosage:
Orally. Adults -duodenal ulcer disease: 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 can be increased to 30 mg once a day;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 1 g twice daily and metronidazole 400-500 mg twice daily);mild stomach and duodenal ulcer associated with the use of NSAIDs: 30 mg once a day for 4 weeks, if necessary continue for another 4 weeks, you can also increase the dose and extend the treatment period again;prevention of gastric and duodenal ulcers associated with the use of NSAIDs in patients at risk who require continuous NSAID treatment: 15 mg once a day, if necessary, the dose can be increased to 30 mg once a day;symptomatic gastroesophageal reflux disease15-30 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. Elderly patients should not exceed 30 mg daily. In patients with moderate or severe hepatic impairment, it is recommended to reduce the daily dose by 50%. There is no need to change the dosage in patients with renal insufficiency. Capsules are best taken once a day in the morning (except for eradicationH. pylori - 2 times a day), at least 30 min. before meals; swallow whole with liquid. People with difficulty swallowing can open the capsules and mix the granules with a small amount of water, apple juice or yogurt, etc.
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