Instructions for Lansoprol capsules 15 mg No. 28
Composition
active ingredient: lansoprazole;
1 capsule contains lansoprazole 15 or 30 mg;
excipients: spherical sugar, mannitol (E 421), sodium starch glycolate (type A), light magnesium carbonate, povidone, sucrose, poloxamer, hypromellose, methacrylate copolymer dispersion, talc, triethyl citrate, simethicone.
Gelatin capsule No. 1 contains: titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), patent blue V (E 131), gelatin.
Gelatin capsule No. 2 contains: titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), gelatin.
Dosage form
Capsules.
Main physicochemical properties:
hard gelatin capsules No. 2 with an orange cap and body, containing spherical micropellets of white or almost white color (15 mg);
Hard gelatin capsules No. 1 with a green cap and an orange body, containing spherical micropellets of white or almost white color (30 mg).
Pharmacotherapeutic group
Drugs for the treatment of peptic ulcer and gastroesophageal reflux disease. Proton pump inhibitors. ATC code A02B C03.
Pharmacological properties
Pharmacodynamics.
Lansoprazole inhibits the activity of the H+/K+-ATPase proton pump in the parietal cells of the gastric mucosa. In this way, Lansoprazole® inhibits the final stage of gastric acid formation, reduces the amount and acidity of gastric juice, as a result of which the harmful effects of gastric juice on the mucosa are reduced.
The degree of inhibition is determined by the dose and duration of treatment. Even a single dose of 30 mg of lansoprazole inhibits gastric acid secretion by 70-90%. The onset of action is observed within 1-2 hours and lasts for 24 hours.
Pharmacokinetics.
Lansoprazole is absorbed from the intestine. In healthy volunteers, after a single oral dose of 30 mg lansoprazole, peak plasma concentrations of 0.75-1.15 mg/l are achieved within 1.5-2 hours. Peak plasma concentrations and bioavailability are patient-specific and do not vary with the frequency of dosing.
The binding of the drug to blood plasma proteins is 98%.
Lansoprazole is excreted from the body with bile and urine (only in the form of metabolites - lansoprazole sulfone and hydroxyl lansoprazole), with 21% of the dose excreted in the urine per day. The half-life is 1.5 hours.
The half-life is prolonged in patients with severe hepatic impairment and in patients over the age of 69. In patients with renal impairment, the absorption of lansoprazole is practically unchanged.
Indication
Benign peptic ulcer of the stomach and duodenum, including those associated with the use of nonsteroidal anti-inflammatory drugs; gastroesophageal reflux disease; Zollinger-Ellison syndrome; for the eradication of Helicobacter pylori (in combination with antibiotics).
Contraindication
Hypersensitivity to lansoprazole or any other component of the drug; simultaneous use with atazanavir; malignant neoplasms of the digestive tract.
Interaction with other medicinal products and other types of interactions
Lansoprazole, like other proton pump inhibitors, reduces the concentration of atazanavir (an HIV protease inhibitor), the absorption of which depends on gastric acidity, and therefore may affect the therapeutic effect of atazanavir and the development of resistance to HIV infection. The simultaneous use of atazanavir and lansoprazole is contraindicated.
Lansoprazole may increase the plasma concentration of drugs metabolized by CYP3A4 (warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisolone, diazepam, clarithromycin, or terfenadine).
Drugs that inhibit CYP2C19 (fluvoxamine) lead to a significant increase (4-fold) in the plasma concentration of lansoprazole. With simultaneous use, dose adjustment of lansoprazole is required.
CYP2C19 and CYP3A4 inducers (rifampicin, St. John's wort) may significantly reduce plasma concentrations of lansoprazole. When used simultaneously, dose adjustment of lansoprazole is required.
Lansoprazole causes long-term inhibition of gastric secretion, so it is theoretically possible that lansoprazole may affect the bioavailability of drugs for which the pH value is important during absorption (ketoconazole, itraconazole, ampicillin esters, iron salts, digoxin).
Concomitant use of lansoprazole and digoxin may lead to increased plasma digoxin levels. Therefore, careful monitoring of plasma digoxin levels and adjustment of the digoxin dose, if necessary, is required when initiating and discontinuing treatment with lansoprazole.
No clinical manifestations of interactions between lansoprazole and amoxicillin were observed.
Sucralfate and antacids may reduce the bioavailability of lansoprazole, which is why lansoprazole should be taken at least 1 hour after taking these drugs.
Concomitant administration of lansoprazole with theophylline (CYP1A2, CYP3A) has been shown to result in a modest increase (up to 10%) in theophylline clearance, but the clinical significance of the interaction is unlikely. However, to maintain clinically effective theophylline concentrations, individual patients may require adjustment of theophylline dose at the start or after discontinuation of lansoprazole treatment.
Lansoprazole does not affect the pharmacokinetics of warfarin and prothrombin time.
Increased INR and prothrombin time can lead to bleeding and even death.
Concomitant use of lansoprazole and tacrolimus may increase plasma concentrations of tacrolimus, particularly in transplant patients. Therefore, plasma tacrolimus levels should be monitored at the start and after discontinuation of combination therapy with lansoprazole.
Application features
Before prescribing Lansoprazole®, the possibility of malignant neoplasms in the stomach and esophagus should be excluded, as the drug may mask symptoms and thus delay correct diagnosis, therefore, endoscopic control with biopsy should be performed before starting and after completing the course of treatment with lansoprazole.
When performing combination therapy with clarithromycin and amoxicillin, precautions regarding the use of these drugs should be referred to in the instructions for medical use of clarithromycin and amoxicillin, and a history of hypersensitivity reactions to penicillins, cephalosporins, and other allergens should also be taken into account before starting the use of amoxicillin and clarithromycin.
When using antibacterial agents, pseudomembranous colitis may occur, sometimes life-threatening, so it is important to consider this when patients have diarrhea.
In patients with renal failure, binding to blood proteins is reduced by 1-1.5%.
In patients with chronic liver failure, the plasma half-life increases from 1.5 hours to 3.2-7.2 hours, depending on the degree of liver function impairment. Patients with severe liver failure should reduce the dose of the drug. Treatment should be started with half of the indicated dose, gradually increasing to the recommended doses, but not more than 30 mg per day.
Under the influence of lansoprazole, the acidity of gastric juice decreases, which leads to an increased risk of developing gastrointestinal infections caused by opportunistic microorganisms such as Salmonella and Campylobacter.
In patients with gastric and duodenal ulcers, the possibility of H. pylori infection should be considered as an etiological factor. If lansoprazole is used in combination with antibiotics for H. pylori eradication therapy, the instructions for medical use of these antibiotics should be followed.
Treatment and prevention of peptic ulcer should be restricted to patients who require long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or are at risk, such as patients with a history of gastrointestinal bleeding, perforation or ulceration, elderly patients, concomitant use of drugs that increase the risk of upper gastrointestinal disease (corticosteroids or anticoagulants), the presence of severe comorbidities or prolonged use of maximum recommended doses of NSAIDs.
Severe hypomagnesemia has been observed in patients taking proton pump inhibitors such as lansoprazole for at least three months, and in most cases for a year. Severe manifestations of hypomagnesemia, such as fatigue, seizures, delirium, convulsions, dizziness, and ventricular arrhythmias, may occur, but their onset may be very abrupt. In most patients, symptoms of hypomagnesemia resolved after magnesium replacement therapy and after discontinuation of the proton pump inhibitor.
For patients likely to receive prolonged therapy or who are taking proton pump inhibitors concomitantly with digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), healthcare professionals should consider measuring magnesium concentrations before initiating proton pump inhibitor treatment and periodically during therapy.
Proton pump inhibitors, especially those used in high doses and for long periods (more than 1 year), may slightly increase the risk of hip, wrist, or vertebral fractures, especially in elderly patients or those with other identified risk factors. Experimental studies suggest that proton pump inhibitors may increase the overall risk of fractures by 10-40%. Some of these cases may be due to other risk factors. Patients at risk of osteoporosis should be monitored by a physician in accordance with current clinical guidelines. They should consume adequate calcium and vitamin D.
Due to limited safety data on the use of lansoprazole as maintenance therapy for more than 1 year, the risk/benefit ratio should be regularly assessed for this group of patients.
Treatment of ulcers in elderly patients is practically no different from treatment in younger patients. Adverse reactions and laboratory changes in elderly patients are the same as in younger patients.
This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Use during pregnancy or breastfeeding
The drug is not used during pregnancy and breastfeeding.
If necessary, use of the drug should stop breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When driving or operating machinery, it is necessary to take into account the possibility of adverse reactions from the nervous system and visual organs, such as dizziness, vertigo, visual disturbances and drowsiness. In these conditions, the ability to react may be reduced.
Method of administration and doses
Adults are administered orally. The usual dose is 30 mg once daily 30-40 minutes before meals, the capsules are taken without chewing, with 150-200 ml of water. If this is not possible, the capsule can be opened and its contents dissolved in a small amount of apple juice (approximately 1 full spoon) and swallowed immediately, without chewing. The same procedure should be performed if the drug is administered through a nasogastric tube.
The dosage and duration of treatment are decided by the doctor depending on the clinical situation and the nature of the disease.
The maximum daily dose of the drug is 60 mg; for patients with impaired liver function - 30 mg. In patients with Zollinger-Ellison syndrome, the dose may be increased.
If 2 daily doses are required, the patient should take one before breakfast and the other before dinner.
If the patient misses a dose, he should take it as soon as possible. However, if it is almost time for the next dose, the patient should not take the missed dose.
Duodenal ulcer
The dose for the treatment of active ulcers is 30 mg once daily for 2-4 weeks. The dose for the treatment of ulcers caused by taking nonsteroidal anti-inflammatory drugs is 30 mg once daily. The treatment lasts 4-8 weeks.
The dose for the prevention of ulcers caused by long-term NSAID treatment in patients at risk (age over 65 or history of gastritis or duodenal ulcer) is 15 mg per day. If treatment is ineffective, a dose of 30 mg per day is prescribed.
Benign peptic ulcer of the stomach
The dose for the treatment of active ulcers is 30 mg once daily for 8 weeks. The dose for the treatment of ulcers caused by NSAIDs is 30 mg once daily for 4-8 weeks.
The dose for the prevention of ulcers caused by long-term NSAID treatment in patients at risk (age over 65 or history of gastritis or duodenal ulcer) is 15 mg per day. If treatment is ineffective, a dose of 30 mg per day is prescribed.
Gastroesophageal reflux disease, reflux esophagitis
The recommended dose for the treatment of gastroesophageal reflux disease is 15-30 mg per day. Improvement of symptoms occurs rapidly. Individual dose selection should be considered. If symptoms do not improve within 4 weeks at a dose of 30 mg per day, additional tests are recommended.
For moderate to severe esophagitis, the recommended dose is 30 mg once daily for 4 weeks. If erosive esophagitis is not cured within 4 weeks, the duration of treatment may be doubled.
The dose for long-term prevention of relapse of erosive esophagitis is 15-30 mg once daily. The safety and efficacy of maintenance therapy with lansoprazole has been confirmed for 12 months of administration.
Helicobacter pylori eradication
The dose is 30 mg of the drug 2 times a day (before breakfast and before dinner). The patient should take the drug along with antibiotics according to approved regimens for 1-2 weeks.
Zollinger-Ellison syndrome
The dose of the drug is selected individually by the doctor so that the basal acid secretion does not exceed 10 mmol/h. The recommended initial dose of the drug is 60 mg 1 time per day before breakfast. If the patient takes doses greater than 120 mg, then he should take the first half of the daily dose before breakfast, and the second half - before dinner. Treatment continues until the disappearance of clinical indications.
Renal and hepatic failure
Patients with mild or moderate hepatic and renal impairment do not require dose adjustment.
Patients with severe liver dysfunction should take the lowest effective dose of the drug and not more than 30 mg per day.
Elderly patients
There is no need to adjust the dose when using the drug.
Children
Do not use in children.
Overdose
Treatment. There is no specific antidote. Hemodialysis is ineffective. Activated charcoal should be administered to reduce absorption. In case of overdose, symptomatic and supportive treatment is provided.
Adverse reactions
During treatment, adverse reactions such as abdominal pain, diarrhea, nausea are commonly reported; most commonly diarrhea. Headache has also been reported in more than 1% of cases.
Cardiovascular system: angina pectoris, cerebrovascular changes, hypertension, hypotension, myocardial infarction, palpitations, shock (circulatory insufficiency), vasodilation.
On the part of the digestive tract: anorexia, cardiospasm, cholelithiasis, constipation, vomiting, hepatotoxicity, jaundice, hepatitis, candidiasis of the mucous membranes of the digestive tract, dry mouth/thirst, dyspepsia, dysphagia, eructation, esophageal stenosis, esophageal ulcer, esophagitis, stool discoloration, flatulence, gastric polyps, gastroenteritis, colitis, gastrointestinal bleeding, vomiting with blood, increased or decreased appetite, increased salivation, melena, rectal bleeding, stomatitis, taste disorders, glossitis, pancreatitis, tenesmus, ulcerative colitis.
Metabolism: hypomagnesemia.
On the part of the endocrine system: diabetes mellitus, goiter, hyperglycemia/hypoglycemia.
From the blood and lymphatic system: anemia (including aplastic and hemolytic anemia), hemolysis, agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, eosinophilia, thrombotic and thrombocytopenic purpura.
Musculoskeletal system: arthritis/arthralgia, musculoskeletal pain, myalgia.
Nervous system: agitation, amnesia, increased excitability, apathy, depression, dizziness/syncope, vertigo, hallucinations, hemiplegia, hostility, fear, decreased libido, nervousness, insomnia, drowsiness, tremor, paresthesia, impaired thinking, confusion.
On the part of the respiratory system: shortness of breath, cough, pharyngitis, rhinitis, upper and lower respiratory tract infections (bronchitis, pneumonia), asthma, nosebleeds, pulmonary hemorrhage, hiccups.
Skin and subcutaneous tissue disorders: angioedema, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, acne, facial flushing, alopecia, pruritus, rash, urticaria, purpura, petechiae, hyperhidrosis, photosensitivity.
From the sensory organs: blurred vision, eye pain, visual field defects, tinnitus, deafness, otitis media, changes in taste, speech disorders.
From the genitourinary system: interstitial nephritis, which can lead to renal failure, kidney stone formation, urinary retention, glycosuria, hematuria, albuminuria, menstrual cycle disorders, breast enlargement/gynecomastia, breast tenderness, impotence.
Combination therapy with amoxicillin and clarithromycin:
There are no specific adverse reactions characteristic of combination therapy when lansoprazole is administered with amoxicillin and clarithromycin. Adverse reactions that may occur with combination therapy are characteristic of lansoprazole, amoxicillin and clarithromycin.
The most common adverse reactions in patients receiving triple therapy (lansoprazole/clarithromycin/amoxicillin) for 14 days are diarrhea, headache, and taste changes. The most common adverse reactions in patients receiving dual therapy with lansoprazole and amoxicillin are diarrhea and headache. Adverse reactions are short-lived and do not require discontinuation of treatment.
Laboratory indicators: increased levels of AST, ALT, alkaline phosphatase, creatinine, globulins, gammaglutamyl transpeptidase, impaired albumin-globulin ratio. Also noted is an increase/decrease in leukocyte levels, changes in the number of erythrocytes, bilirubinemia, eosinophilia, hyperlipidemia, increase/decrease in electrolyte levels, increase/decrease in cholesterol, decrease in hemoglobin, increase in potassium, urea, increase in glucocorticoid levels, increase in low-density lipoprotein levels, increase/decrease in platelets, increase in gastrin levels, positive test for occult blood. In the urine - albuminuria, glycosuria, hematuria, appearance of salts.
There are reports of patients with elevated liver enzymes to more than 3 times the upper limit of normal at the end of treatment with lansoprazole, but no jaundice was observed.
Other: anaphylactoid reactions, anaphylactic shock, asthenia, fatigue, candidiasis, chest pain (not always specific), edema, fever, flu-like syndrome, bad breath, infections (not always specific), weakness.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
7 capsules in a blister, 2 or 4 blisters in a cardboard box.
14 capsules in a blister, 1 or 2 blisters in a cardboard box.
4 capsules in a blister, 1 blister in a cardboard box.
Vacation category
According to the recipe.
Producer
NOBEL ILACH SANAI VE TJARET A.Sh.
Location of the manufacturer and its business address
Sancaklar Koyu 81100 m. Duzce, Turkey.
