Duodenal and gastric ulcer disease, reflux oesophagitis, long-term prophylaxis of reflux oesophagitis. In combination therapy with antibiotics: eradicationHelicobacter pylori and prevention of relapse of peptic ulcers, caused byHelicobacter pylori. Zollinger-Ellison syndrome.
Composition:
One capsule contains 30 mg of lansoprazole.
Action:
A drug that inhibits the secretion of hydrochloric acid in the parietal cells of the stomach as a result of selective blocking 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, the drug is rapidly absorbed from the small intestine, reaching a maximum concentration in the blood within 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. Lansoprazole is extensively metabolised in the liver to inactive compounds. T0,5 is 1-2 hours. 15-50% of the metabolites are excreted in the urine, the remainder in the faeces.
Contraindications:
Hypersensitivity to the components of the preparation. The drug should not be used by patients with fructose intolerance, malabsorption of glucose-galactose, deficiency of sucrase-isomaltase. Use in children is not recommended (insufficient clinical data).
Precautions:
Carefully use in patients with impaired liver function, in the case of severe liver failure - do not use. If visual disturbances occur during long-term (> 1 year) use of lansoprazole, treatment should be discontinued and optician should be prescribed. Proton pump inhibitors, especially at high doses and in long-term therapy (> 1 year), may slightly increase the risk of hip fractures, carpal bones and spine, especially in the elderly or in patients with other known risk factors. Patients at risk for osteoporosis should receive care in accordance with current clinical guidelines and take the appropriate dose of vitamin D and calcium. For patients presumed long-term or taking proton pump inhibitors together with Digoxin or other agents that may cause hypomagnesaemia (e.g. diuretics), consideration should be given to measuring Magnesium in the blood prior to initiating treatment with proton pump inhibitors and periodic measurements during treatment.
Pregnancy and lactation:
Due to the lack of clinical trials, use during pregnancy and breast-feeding is not recommended.
Side effects:
Common: vomiting, nausea, diarrhea, constipation, abdominal pain, flatulence and indigestion; rash, urticaria, pruritus; pain and dizziness; fatigue. Uncommon: dry mouth or throat, anorexia; increase in liver enzymes; fracture of the wrist, hip or spine bones; taste disorders. Rare: pancreatitis, esophageal candidiasis, inflammation of the tongue; erythema multiforme, ecchymosis, hair loss, hyperhidrosis, purpura; depression, hallucinations, convulsion, insomnia or drowsiness, lethargy, dizziness, tremors and paresthesia, restlessness; hepatitis, jaundice; interstitial nephritis; thrombocytopenia, eosinophilia, pancytopenia, anemia, leukopenia; palpitations, chest pain; peripheral edema; aching muscles and joints; blurred vision; angioneurotic edema, bronchospasm, fever. Very rare: colitis, inflammation of the mouth, blackness of the tongue; Stevens-Johnson syndrome, toxic epidermal necrolysis; agranulocytosis; gynecomastia, mlekotok; anaphylactic shock, impotence, malaise; increase in cholesterol and triglycerides. Frequency unknown: hypomagnesemia.
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, increase the dose to 30 mg if necessary. eradicationHelicobacter pylori: 30 mg twice daily for 7 days in combination with antimicrobial therapy (amoxicillin 1 g twice daily and Clarithromycin 500 mg twice daily or clarithromycin 250 mg twice daily and Metronidazole 400-500 mg twice daily or Amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily). 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 divided doses. In patients with renal insufficiency, mild hepatic or elderly failure, do not exceed the 30 mg dose per day, in patients with moderate hepatic insufficiency do not exceed the dose of 15 mg per day. Do not use combination therapy with clarithromycin in patients with hepatic impairment. The capsules should be taken whole, before a meal (preferably on an empty stomach).
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