Index of drugs

Treatment of erosive reflux oesophagitis. Maintenance therapy for erosive reflux oesophagitis and heartburn. Short-term treatment of heartburn and acid regurgitation associated with refractory symptomatic gastroesophageal reflux disease (GERD). The drug is indicated for use in adult patients.

One modified-release capsule contains 30 mg or 60 mg of dexlansoprazole. The capsules contain sucrose.

Proton pump inhibitor. Dexlanzoprazole is the R-enantiomer of lansoprazole. It inhibits the last phase of hydrochloric acid production by inhibiting the activity of H + / K + ATPase in gastric parietal cells. The process is reversible and dose-dependent, it concerns basal as well as stimulated gastric acid secretion. Dexlanzoprazole accumulates in the parietal cells, becomes active in their acidic environment, reacts with the sulfhydryl group ATP-ase H + / K +, causing inhibition of enzyme activity. The pharmaceutical form of the preparation is based on the technology of dual delayed release, providing a plasma concentration profile of dexlansoprazole with two distinct peaks: the first occurs 1-2 hours after administration and the second within 4-5 hours._maxin plasma occurs within 4-6 h. The plasma protein binding of dexlansoprazole is approximately 97%. It is metabolised mainly by CYP2C19 and CYP3A4 isoenzymes and excreted as metabolites in urine and faeces._0,5 is 1-2 hours.

Hypersensitivity to the active substance or to any of the excipients. Do not use with atazanavir or nelfinavir.

Before using the preparation, the presence of a malignant gastric cancer should be ruled out because dexlansoprazole may mask its symptoms and delay the diagnosis. Use with caution in patients with moderate hepatic impairment. The use of dexlansoprazole in patients with severe hepatic impairment is not recommended. Reduced gastric acidity for any reason, including the use of proton pump inhibitors (PPI) leads to an increase in the stomach of the number of bacteria normally found in the gastrointestinal tract. PPI treatment may slightly increase the risk of gastrointestinal infections with such microorganisms as:Salmonella, CampylobacterandClostridium difficile. Because of the limited safety data for patients treated for more than one year, regular efficacy analyzes and a thorough risk / benefit assessment should be performed. In patients treated with PPI for at least 3 months and in the majority of patients taking PPI, there have been reports of heavy hypomagnesaemia for one year. In most patients, it resolved after supplementing Magnesium deficiency and discontinuing PPI. For patients presumed long-term or taking PPI including Digoxin or other drugs that may cause hypomagnesaemia (e.g. diuretics), consideration should be given to determining the magnesium levels in the blood prior to treatment initiation and to periodically measuring during treatment. Due to the risk of colitis, if severe and / or persistent diarrhea occurs, discontinuation of treatment should be considered. The use of PPI, especially in high doses and long-term therapy (> year) may slightly increase the risk of hip fractures, carpal or spinal bones, especially in elderly patients or people with other risk factors; PPI can increase the overall risk of fractures by 10-40%. Patients at risk for osteoporosis should be treated in accordance with current guidelines to ensure that adequate doses of vitamin D and Calcium are taken. Patients taking high-dose Methotrexate should consider temporarily discontinuing dexlansoprazole. The efficacy and safety of the preparation in children and adolescents under 18 years have not been established.Due to the sucrose content, patients with inherited disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this preparation.

No data or only limited data on the use of dexlansoprazole in pregnant women. As a precautionary measure, avoid using the product during pregnancy. It is not known whether dexlansoprazole is excreted in human milk. Penetrates into animal milk. A danger for newborns / infants can not be excluded. A decision should be made whether to discontinue breast-feeding or discontinue the preparation, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Common: headache, diarrhea, abdominal pain, nausea, discomfort in the abdomen, bloating, constipation. Uncommon: hip fracture, carpal or spinal bones, insomnia, depression, dizziness, taste disturbances, hypertension, hot flushes, cough, vomiting, dry mouth, abnormal liver function tests, urticaria, pruritus, rash, asthenia appetite disorders. Rarely: auditory hallucinations, convulsions, paresthesia, visual disturbances, dizziness, candidiasis. Not known: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic shock, hypomagnesaemia, blurred vision, deafness, drug-induced hepatitis. Hypersensitivity reactions were more frequently observed in women.

Orally.Eczema treatment of reflux oesophagitis: 60 mg once daily for 4 weeks. In patients who will not be fully cured during this period, treatment may be continued with the same dose for a further 4 weeks.Maintenance therapy for erosive reflux oesophagitis and heartburn: 30 mg once a day for up to 6 months.Non-liver symptomatic form of gastroesophageal reflux disease (GERD)30 mg once a day until 4 weeksSpecial groups of patients: in elderly patients, it may be necessary to adjust the dose according to individual needs, do not use a daily dose of more than 60 mg if there are no relevant clinical indications. No dose adjustment is necessary in patients with renal impairment or with mild hepatic impairment. Patients with moderate hepatic impairment should be monitored regularly; a maximum daily dose of 30 mg should be considered. The use of dexlansoprazole in patients with severe hepatic impairment is not recommended.
The capsules should be swallowed whole with liquid, regardless of the meal. Capsules can be opened and the granules mixed with a spoon of apple purée. The medicine should be administered immediately after mixing. Do not suck or chew the granules.