Losec MAPS, 14 pcs., 20 mg, film-coated tablets

Pharmacodynamics and pharmacokinetics

The medicine is an antiulcer agent. It inhibits the action of H + -K + -ATPase in gastric parietal cells . Thus, the last stage of hydrochloric acid formation is blocked. The effect of the medicine depends on the dose. It effectively inhibits basal and stimulated secretions when used daily.

The drug reaches maximum effectiveness within 4 days. Its action in combination with antibacterial agents causes eradication of Helicobacter pylori . Due to this, the manifestations of the disease are stopped, stable remission is achieved, damage to the gastric mucosa is healed, and the risk of bleeding from the gastrointestinal tract is reduced. When using Losek Maps there is no need for long-term antiulcer therapy.

The tablets are absorbed in the small intestine. Absorption is completed 3-6 hours after consumption. When taking the product again, bioavailability increases to 60%. Eating has no effect on it. Plasma protein binding is approximately 95%.

The half-life from blood plasma is less than an hour. The active substance of the drug is completely broken down by the cytochrome , mainly in the liver. 80% of the drug is excreted in the form of metabolites in the urine, and another 20% in the feces.

Losek maps 20 mg 28 pcs. film-coated tablets

pharmachologic effect

Gastric gland secretion inhibitor, proton pump inhibitor.

Composition and release form Losek maps 20 mg 28 pcs. film-coated tablets

Tablets - 1 tablet:

• Active substance: magnesium omeprazole 20.6 mg (equivalent to omeprazole 20.0 mg);
• Excipients: glyceryl monostearate 40-55 1.4 mg, hyprolose 4.8 mg, hypromellose 15.0 mg, magnesium stearate 0.7 mg, methacrylic and ethacrylic acid copolymer 27.0 mg, microcrystalline cellulose 220.0 mg, paraffin 0.2 mg, macrogol 2.5 mg, polysorbate 80 0.1 mg, crospovidone 4.6 mg, sodium stearyl fumarate 0.5 mg, sucrose;
• Shell: talc 8.3 mg, titanium dioxide (E171) 2.2 mg, triethyl citrate 8.2 mg, iron dye red oxide E172 0.3 mg.

14 or 28 tablets in a bottle made of high-density polyethylene with a screw cap made of polypropylene, equipped with a protective ring that ensures first opening control, and a desiccant capsule mounted inside the cap.

1 bottle with instructions for use in a cardboard box with first opening control.

Description of the dosage form

An oblong, biconvex, pink to light brownish-pink, film-coated tablet, debossed with 20 mG on one side and the symbol on the other side.

Characteristic

10 mg tablets: light pink, biconvex, oblong, coated, with 10 mg engraved on one side and the company logo on the other.

20 mg tablets: pink, biconvex, oblong, coated, with 20 mg engraved on one side and the company logo on the other.

40 mg tablets: red-brown, biconvex, oblong, coated, with 40 mg engraved on one side and the company logo on the other.

Directions for use and doses

Inside. Losek® MAPS® tablets are recommended to be taken in the morning; the tablet should be swallowed whole with liquid. Tablets must not be chewed or crushed.

The tablets can be dissolved in water or a slightly acidified liquid, such as fruit juice. The resulting solution must be used within 30 minutes. To make sure you take the full dose, fill the glass halfway with liquid again, shake and drink.

Adults

Duodenal ulcer

Patients with an active duodenal ulcer are recommended to take Losek® MAPS® 20 mg once a day. The drug provides rapid relief of symptoms. In most patients, ulcer healing occurs within 2 weeks. In cases where complete healing of the ulcer does not occur within 2 weeks, healing is achieved with a subsequent 2-week intake of the drug Losek® MAPS®.

Patients with duodenal ulcers that are poorly responsive to treatment are usually prescribed Losek® MAPS® 40 mg 1 time per day; Ulcer healing usually occurs within 4 weeks.

To prevent relapses, patients with duodenal ulcers are recommended Losek® MAPS® 10 mg once a day. If necessary, the dose can be increased to 20-40 mg 1 time per day.

Stomach ulcer

The recommended dose is Losek® MAPS® 20 mg once a day. The drug provides rapid relief of symptoms. For most patients, cure occurs within 4 weeks. In cases where complete healing does not occur after the first course of taking the drug, a repeated 4-week course of treatment is usually prescribed, during which healing is achieved.

Patients with gastric ulcers that are poorly responsive to treatment are usually prescribed Losek® MAPS® 40 mg 1 time per day; healing is usually achieved within 8 weeks.

To prevent relapses, patients with gastric ulcers are recommended Losek® MAPS® 20 mg once a day. If necessary, the dose can be increased to 40 mg 1 time per day. NSAID-associated ulcers and erosions of the stomach and duodenum

In the presence of NSAID-associated gastric, duodenal ulcers or gastroduodenal erosions in patients with ongoing NSAID therapy or after its cessation, the recommended dose of Losek® MAPS® is 20 mg 1 time per day. The drug provides rapid relief of symptoms; in most patients, cure occurs within 4 weeks. In those patients who do not heal during the initial period of therapy, healing is usually achieved with a repeat dose of the drug for 4 weeks.

For the prevention of ulcers and erosions of the stomach and duodenum and symptoms of dyspepsia associated with taking NSAIDs, the recommended dose of Losek® MAPS® is 20 mg 1 time per day.

Eradication of Helicobacter pylori in peptic ulcer disease (in combination with appropriate antibacterial therapy)

Helicobacter pylori eradication regimens for peptic ulcer disease

Three-component treatment regimen:

Losek® MAPS® 20 mg, amoxicillin 1 g and clarithromycin 500 mg. Take all medications 2 times a day for one week

or

Losek® MAPS® 20 mg. metronidazole 400 mg (or tinidazole 500 mg) and clarithromycin 250 mg. Take all medications 2 times a day for one week

or

Losek® MAPS® 40 mg once a day, as well as amoxicillin 500 mg and metronidazole 400 mg 3 times a day for one week.

Two-component treatment regimen:

Losek® MAPS® 40-80 mg daily and amoxicillin 1.5 g daily (dose should be divided into parts) for two weeks. During clinical trials, amoxicillin was used in a daily dose of 1.5-3 g, Losek® MAPS® 40 mg once a day and clarithromycin 500 mg 3 times a day for two weeks.

To ensure complete healing, further treatment should be carried out in accordance with the recommendations in the sections “Duodenal Ulcer” and “Gastric Ulcer”.

In cases where, after completing a course of treatment, the test for Helicobacter pylori remains positive, the course of treatment can be repeated.

Reflux esophagitis

The recommended dose is one Losek® MAPS® 20 mg tablet once a day. The drug provides rapid relief of symptoms. For most patients, cure occurs within 4 weeks. In cases where complete cure does not occur after the first course of taking the drug, a repeated 4-week course of treatment is usually prescribed, during which a cure is achieved.

For patients with severe reflux esophagitis, Losek® MAPS® 40 mg 1 time per day is recommended; cure usually occurs within 8 weeks.

Patients with reflux esophagitis in remission are prescribed Losek® MAPS® 10 mg 1 time per day as long-term courses of maintenance therapy. If necessary, the dose can be increased to 20-40 mg.

Symptomatic gastroesophageal reflux disease

The recommended dose is Losek® MAPS® 20 mg once a day. The drug provides rapid relief of symptoms. The therapeutic effect can be achieved with a daily dose of 10 mg, so individual dose selection cannot be ruled out. If after 4 weeks of treatment (Losec® MAPS® 20 mg 1 time per day) symptoms do not disappear, additional examination of the patient is recommended.

Dyspepsia associated with hyperacidity

To relieve pain and/or eliminate discomfort in the epigastric region, with or without heartburn, Losek® MAPS® 20 mg is prescribed once a day. The therapeutic effect can be achieved with a dose of 10 mg 1 time per day, so treatment can be started with this dose. If after 4 weeks of treatment (Losec® MAPS® 20 mg 1 time per day) symptoms do not disappear, additional examination of the patient is recommended.

Zollinger-Ellison syndrome

For patients with Zollinger-Ellison syndrome, the drug is prescribed in an individual dosage. Treatment is continued according to clinical indications for as long as necessary. The recommended starting dose is Losec® MAPS® 60 mg daily. In all patients with a severe form of the disease, as well as in cases where other therapeutic methods did not lead to the desired result, the use of the drug was effective in more than 90% of patients when taking 20-120 mg Losec® MAPS® daily. In cases where the daily dose of the drug exceeds 80 mg, the dose should be divided into two parts and taken 2 times a day.

Children and teenagers

Reflux esophagitis and symptomatic gastroesophageal reflux disease

Children over the age of 2 years with a body weight of more than 20 kg are prescribed the drug Losek® MAPS® at a dose of 20 mg once a day. If necessary, the dose can be increased to 40 mg once a day. The recommended duration of treatment in case of reflux esophagitis is 4-8 weeks. The recommended duration of treatment for symptomatic gastroesophageal reflux disease is 2-4 weeks. If after 2-4 weeks of treatment control of the symptoms of the disease has not been achieved, additional examination of the patient is recommended.

Duodenal ulcer caused by Helicobacter pylori

When choosing a treatment regimen, official national, regional and local recommendations should be taken into account. concerning the resistance of microorganisms to antibacterial agents, the duration of therapy (most often - 7 days, but in some cases - up to 14 days) and the correct use of antibacterial drugs.

Therapy must be carried out under the supervision of a specialist.

For children over 4 years of age, the following treatment regimen is recommended:

Body weight 15-30 kg - Losek® MAPS® 10 mg, amoxicillin 25 mg/kg and clarithromycin 7.5 mg/kg. Take all medications 2 times a day for a week.
• Body weight 31 -40 kg - Losek® MAPS® 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg. Take all medications 2 times a day for a week.
• Body weight > 40 kg - Losek® MAPS® 20 mg, amoxicillin 1 g and clarithromycin 500 mg. Take all medications 2 times a day for a week.

Special patient groups

Renal dysfunction

For patients with impaired renal function, no dose adjustment is required.

Liver dysfunction

In patients with impaired liver function, the bioavailability and plasma half-life of omeprazole are increased. In this regard, a dose of 10-20 mg per day is sufficient.

Elderly patients

For elderly patients, no dose adjustment is required.

Pharmacodynamics

Mechanism of action

Omeprazole is a weak base. Concentrated in the acidic environment of the secretory tubules of the parietal cells of the gastric mucosa, it is activated and inhibits the proton pump - the enzyme H+, K+-ATPase. The effect of omeprazole on the last stage of the formation of hydrochloric acid in the stomach is dose-dependent and provides highly effective inhibition of basal and stimulated secretion of hydrochloric acid, regardless of the stimulating factor.

Effect on gastric juice secretion

Losek® MLPS®, when administered daily orally, provides rapid and effective inhibition of daytime and nighttime hydrochloric acid secretion. The maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcers, Losek® MAPS® 20 mg causes a sustained decrease in 24-hour gastric acidity by at least 80%. In this case, a decrease in the average maximum concentration of hydrochloric acid after stimulation with pentagastrin by 70% is achieved within 24 hours.

In patients with duodenal ulcers, Losek® MAPS® 20 mg, with daily oral administration, maintains an acidity value in the intragastric environment at a pH level of ≥ 3, on average, for 17 hours a day.

Inhibition of hydrochloric acid secretion depends on the area under the concentration-time curve (AUC) of omeprazole, and not on the plasma concentration of the drug at a given time.

Effect on Helicobacter pylori

Omeprazole has a bactericidal effect against Helicobacter pylori in vitro. Eradication of Helicobacter pylori when using omeprazole in conjunction with antibacterial agents is accompanied by rapid elimination of symptoms, a high degree of healing of defects in the mucous membrane of the gastrointestinal tract and long-term remission of peptic ulcer disease, which reduces the likelihood of complications such as bleeding, as effectively as continuous maintenance therapy.

Other effects associated with inhibition of hydrochloric acid secretion

Patients taking drugs that reduce the secretion of gastric glands for a long period of time are more likely to experience the formation of glandular cysts in the stomach; The cysts are benign and go away on their own with continued therapy. These phenomena are caused by physiological changes resulting from inhibition of hydrochloric acid secretion.

Reducing the secretion of hydrochloric acid in the stomach under the influence of proton pump inhibitors or other agents that reduce gastric acidity leads to an increase in the growth of normal intestinal microflora, which in turn may lead to a slight increase in the risk of developing intestinal infections caused by bacteria of the genus Salmonella spp. and Campylobacter spp., and in hospitalized patients, probably also Clostridium difficile.

During treatment with drugs that reduce the secretion of gastric glands, the concentration of gastrin in the blood serum increases. Due to decreased secretion of hydrochloric acid, the concentration of chromogranin A (CgA) increases. An increase in CgA concentration may affect the results of examinations to detect neuroendocrine tumors (see section "Special Instructions"). To prevent this effect, therapy with proton pump inhibitors must be suspended at least 5 days before testing CgA concentrations. If CgA and gastrin concentrations have not returned to normal during this time, the study should be repeated 14 days after stopping omeprazole.

In children and adult patients taking omeprazole for a long time, an increase in the number of enterochromaffin-like cells was observed, probably associated with an increase in the concentration of gastrin in the blood serum. This phenomenon has no clinical significance.

Pharmacokinetics

Distribution

Omeprazole is absorbed in the small intestine, usually within 3-6 hours. Bioavailability after oral administration is approximately 60%. Food intake does not affect the bioavailability of omeprazole.

The binding rate of omeprazole to plasma proteins is about 95%. the volume of distribution is 0.3 l/kg.

Metabolism

Omeprazole is completely metabolized in the liver. The main enzymes involved in the metabolic process. CYP2C19 and CYP3A4. The resulting metabolites - sulfone, sulfide and hydroxyomeprazole do not have a significant effect on the secretion of hydrochloric acid.

The total plasma clearance is 0.3-0.6 l/min. The bioavailability of omeprazole increases by approximately 50% with repeated doses compared to a single dose.

Excretion

The half-life is approximately 40 minutes (30-90 minutes). About 80% is excreted as metabolites by the kidneys, and the rest by the intestines.

Special patient groups

There were no significant changes in the bioavailability of omeprazole in elderly patients or in patients with impaired renal function. In patients with impaired liver function, there is an increase in the bioavailability of omeprazole and a significant decrease in plasma clearance.

Indications for use Losek maps 20 mg 28 pcs. film-coated tablets

Adults:

• duodenal ulcer;
• stomach ulcer;
• NSAID-associated ulcers and erosions of the stomach and duodenum;
• eradication of Helicobacter pylori in peptic ulcer disease (in combination with appropriate antibacterial therapy);
• reflux esophagitis;
• symptomatic gastroesophageal reflux disease;
• dyspepsia associated with high acidity;
• Zollinger-Ellison syndrome.

Children and teenagers

Children over 2 years old weighing at least 20 kg:

• reflux esophagitis;
• symptomatic gastroesophageal reflux disease.

Children over 4 years old and teenagers:

• Duodenal ulcer caused by Helicobacter pylori.

Contraindications

• Known hypersensitivity to omeprazole, substituted benzimidazoles or other ingredients included in the drug.
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
• Concomitant use with erlotinib, posaconazole.
• Children under 2 years of age.
• Children over 2 years of age for indications other than the treatment of reflux esophagitis and symptomatic gastroesophageal reflux disease.
• Children over 4 years of age for indications other than the treatment of reflux esophagitis, symptomatic gastroesophageal reflux disease and duodenal ulcers caused by Helicobacter pylori.

Carefully:

Patients with osteoporosis.

If symptoms such as significant spontaneous weight loss, frequent vomiting, dysphagia, haematemesis or melena are present, or if a gastric ulcer is present (or a gastric ulcer is suspected), malignancy should be excluded as treatment may mask symptoms and , thus delaying diagnosis.

Application of Losek maps 20 mg 28 pcs. film-coated tablets during pregnancy and breastfeeding

The research results showed no side effects of omeprazole on the health of pregnant women, the fetus or the newborn.

Losek® MAPS® can be used during pregnancy.

Omeprazole passes into breast milk, however, when used in therapeutic doses, exposure to the child is unlikely.

special instructions

If any alarming symptoms are present (eg, significant spontaneous weight loss, repeated vomiting, dysphagia, hematemesis, or melena), or if a gastric ulcer is present (or if a gastric ulcer is suspected), malignancy should be excluded because Treatment with Losek® MAPS® can lead to a smoothing of symptoms and delay diagnosis.

The combined use of omeprazole with drugs such as atazanavir and nelfinavir is not recommended.

According to the study results, a pharmacokinetic/pharmacodynamic interaction was noted between clopidogrel (loading dose of 300 mg and maintenance dose of 75 mg/day) and omeprazole (80 mg/day orally), which leads to a decrease in exposure to the active metabolite of clopidogrel by an average of 46% and reducing the maximum inhibition of ADP-induced platelet aggregation by an average of 16%. Therefore, the simultaneous use of omeprazole and clopidogrel should be avoided.

Individual observational studies indicate that proton pump inhibitor therapy may modestly increase the risk of osteoporosis-related fractures, but other similar studies have not reported an increased risk.

Randomized, double-blind, controlled clinical trials of omeprazole and esomeprazole, including two open-label studies with treatment durations of more than 12 years, did not confirm the association of osteoporotic fractures with the use of proton pump inhibitors.

Although a causal relationship between the use of omeprazole/esomeprazole and osteoporotic fractures has not been established, patients at risk of developing osteoporosis or osteoporotic fractures should be under appropriate clinical supervision.

Increased concentrations of CgA may affect the results of examinations for the detection of neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors must be suspended at least 5 days before testing CgA concentrations. If CgA and gastrin concentrations have not returned to normal during this time, the study should be repeated 14 days after stopping omeprazole.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of the drug Losek® MAPS® on the ability to drive vehicles and machines. However, due to the fact that dizziness, blurred vision and drowsiness may occur during therapy, caution should be exercised when driving vehicles and machinery.

Overdose

Single oral doses of Losec® MAPS® up to 400 mg did not cause any severe symptoms. When adults took 560 mg of omeprazole, moderate intoxication was observed. As the dose was increased, the rate of drug elimination did not change (first-order kinetics), and no specific treatment was required.

Symptoms: dizziness, confusion, apathy, headache, vascular dilatation, tachycardia, nausea, vomiting, flatulence, diarrhea.

Treatment: symptomatic treatment, gastric lavage if necessary, administration of activated charcoal.

Side effects Losek maps 20 mg 28 pcs. film-coated tablets

The following are side effects, independent of the dosage regimen of omeprazole, that were noted during clinical studies, as well as during post-marketing use.

Often (>1/100,

Uncommon (>1/1000,

Rarely (>1/10000,

Not known: Hypomagnesemia, hypocalcemia due to severe hypomagnesemia, hypokalemia due to hypomagnesemia.

Cases of the formation of glandular cysts in the stomach have been reported in patients taking drugs that reduce the secretion of gastric glands for a long period of time; The cysts are benign and go away on their own with continued therapy.

Drug interactions

The effect of omeprazole on the pharmacokinetics of other drugs

A decrease in the secretion of hydrochloric acid in the stomach during treatment with omeprazole and other proton pump inhibitors can lead to a decrease or increase in the absorption of other drugs, the absorption of which depends on the acidity of the environment.

Like other drugs that reduce gastric acidity, treatment with omeprazole may result in decreased absorption of ketoconazole, itraconazole, posaconazole and erlotinib, and increased absorption of drugs such as digoxin. Co-administration of omeprazole 20 mg once daily and digoxin increases the bioavailability of digoxin by 10% (the bioavailability of digoxin increased by up to 30% in 20% of patients). Concomitant use of Losec® MAPS® with erlotinib or posaconazole is contraindicated (see section “Contraindications”). Omeprazole has been shown to interact with some antiretroviral drugs. The mechanisms and clinical significance of these interactions are not always known. An increase in pH during omeprazole therapy may affect the absorption of antiretroviral drugs. Interaction at the level of the CYP2C19 isoenzyme is also possible. When omeprazole is co-administered with certain antiretroviral drugs, such as atazanavir and nelfinavir, a decrease in their serum concentrations is observed during omeprazole therapy. In this regard, the combined use of omeprazole with antiretroviral drugs such as atazanavir and nelfinavir is not recommended.

With the simultaneous use of omeprazole and saquinavir, an increase in the concentration of saquinavir in the serum was noted; when used with some other antiretroviral drugs, their concentration did not change.

Omeprazole inhibits CYP2C19, the main isoenzyme involved in its metabolism. Concomitant use of omeprazole with other drugs metabolized by the CYP2C19 isoenzyme, such as diazepam, warfarin (R-warfarin) or other vitamin K antagonists, phenytoin and cilostazol, may lead to a slower metabolism of these drugs. Monitoring of patients taking phenytoin and omeprazole is recommended; a dose reduction of phenytoin may be required. However, concomitant treatment with omeprazole at a daily dose of 20 mg does not affect the concentration of phenytoin in the blood plasma in patients taking the drug for a long time. When using omeprazole in patients receiving warfarin or other vitamin K antagonists, monitoring of the international normalized ratio is necessary; in some cases, it may be necessary to reduce the dose of warfarin or another vitamin K antagonist. At the same time, concomitant treatment with omeprazole at a daily dose of 20 mg does not lead to a change in coagulation time in patients taking warfarin for a long time.

The use of omeprazole at a dose of 40 mg once daily led to an increase in Cmax and AUC of cilostazol by 18% and 26%, respectively; for one of the active metabolites of cilostazol, the increase was 29% and 69%, respectively.

According to the study results, a pharmacokinetic/pharmacodynamic interaction was noted between clopidogrel (loading dose of 300 mg and maintenance dose of 75 mg/day) and omeprazole (80 mg/day orally), which leads to a decrease in exposure to the active metabolite of clopidogrel by an average of 46 % and reducing the maximum inhibition of ADP-induced platelet aggregation by an average of 16%.

The clinical significance of this interaction is unclear. An increased risk of cardiovascular events with concomitant use of clopidogrel and proton pump inhibitors, including omeprazole, was not shown in a prospective, randomized, open-label study of more than 3,760 patients receiving placebo or omeprazole 20 mg/day. concomitantly with clopidogrel and acetylsalicylic acid (ASA) therapy, and was not confirmed by additional non-randomized analysis of clinical outcomes from large prospective randomized trials involving more than 47,000 patients.

The results of a number of observational studies are contradictory and do not provide a clear answer about the presence or absence of an increased risk of thromboembolic cardiovascular complications during the combined use of clopidogrel and proton pump inhibitors.

When clopidogrel was used together with a fixed combination of 20 mg esomeprazole and 81 mg ASA, exposure to the active metabolite of clopidogrel decreased by almost 40% compared with clopidogrel monotherapy, while the maximum levels of inhibition of ADP-induced platelet aggregation were the same, which is likely due to simultaneous taking ASA in a low dose.

Omeprazole does not affect the metabolism of drugs metabolized by the CYP3A4 isoenzyme, such as cyclosporine, lidocaine, quinidine, estradiol, erythromycin and budesonide.

No interaction of omeprazole with the following drugs has been identified: antacids, caffeine, theophylline, S-warfarin, piroxicam, diclofenac, naproxen, metoprolol, propranolol and ethanol.

With the simultaneous use of omeprazole and tacrolimus, an increase in the concentration of tacrolimus in the blood serum was noted.

Some patients experienced a slight increase in methotrexate concentrations when combined with proton pump inhibitors. If high doses of methotrexate are prescribed, temporary discontinuation of omeprazole should be considered.

Effect of drugs on the pharmacokinetics of omeprazole

The isoenzymes CYP2C19 and CYP3A4 are involved in the metabolism of omeprazole. The combined use of omeprazole and inhibitors of the CYP2C19 and CYP3A4 isoenzymes, such as clarithromycin and voriconazole, may lead to increased plasma concentrations of omeprazole by slowing down the metabolism of omeprazole. Concomitant use of voriconazole and omeprazole results in a more than twofold increase in the AUC of omeprazole. Due to the good tolerance of high doses of omeprazole, short-term joint use of these drugs does not require dose adjustment of omeprazole.

Co-administration of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in the blood plasma.

Drugs that induce CYP2C19 and CYP3A4 isoenzymes. such as rifampicin and St. John's wort preparations, when used together with omeprazole, can lead to a decrease in the concentration of omeprazole in the blood plasma by accelerating the metabolism of omeprazole.

Indications for use

The medicine is prescribed for:

• acid-dependent dyspepsia;
• gastric ulcer caused by Helicobacter pylori;
• Zollinger-Ellison syndrome;
• peptic ulcer of the stomach and duodenum (including if the disease is caused by NSAIDs );
• gastroesophageal reflux.

Side effects

As a rule, the medicine is well tolerated by patients. Undesirable side reactions are usually mild and pass quickly. Among them are:

• skin – rash, itching , photosensitivity, alopecia , erythema multiforme ;
• CNS – drowsiness , headache , vertigo , dizziness , paresthesia , insomnia , confusion , depression , agitation, hallucinations ;
• liver - liver dysfunction, increased levels of enzymes , encephalopathy (in liver diseases with complications), hepatitis ;
• circulatory system – leukopenia , agranulocytosis , thrombocytopenia , pancytopenia ;
• musculoskeletal system - muscle weakness , pain in joints and muscles;
• Gastrointestinal tract - diarrhea , pain in the abdominal area, vomiting, constipation , flatulence , dry mouth, candidiasis , stomatitis ;
• endocrine system – gynecomastia ;
• others - urticaria , fever , interstitial nephritis , angioedema , bronchospasm , anaphylactic shock , severe sweating , blurred vision, decreased sodium levels in the blood, peripheral edema , impaired taste, malaise .

Instructions for use Losek Maps (Method and dosage)

The instructions for use of Losec Maps tablets (and not Losec Max, as many believe) indicate that they are intended for oral use. Swallow whole without chewing. It is advisable to drink liquid. In addition, the tablets can be dissolved in fruit juice or water. This solution should be drunk within half an hour after preparation.

Instructions for use Losek Maps informs that the exact scheme of use of the medicine depends on the disease:

• stomach and duodenal ulcers in the acute phase - the patient should take 20 mg of the medicine every day. The course lasts 2 weeks. If complete scarring has not occurred, re-therapy can be carried out for another 2 weeks;
• the need to prevent exacerbation of duodenal ulcer - the patient should take 10 mg of medication every day. If necessary, the dosage is increased to 20-40 mg;
• stomach ulcer resistant to therapy - 40 mg of medication per day. Recovery is usually within eight weeks;
• erosive and ulcerative lesions in the gastrointestinal tract (gastroduodenal department) in HIV-infected patients - 20 mg is used once a day. Compatible with HIV therapy. The course lasts on average 4 weeks. If complete cure has not occurred, therapy can be repeated;
• stomach ulcer caused by Helicobacter pylori - three different treatment regimens are possible. 1) 20 mg Losec Maps, 500 mg Clarithromycin and 1 g Amoxicillin . 2) 20 mg Losec Maps, 250 mg Clarithromycin and 500 mg Tinidazole (or 400 mg Metronidazole ). All medications must be taken 2 times daily for a week. 3) For a week, take every day 20 mg Losec Maps 1 time, 400 mg Metronidazole 3 times, 500 mg Amoxicillin 3 times. In addition, the doctor may prescribe “dual therapy.” In this case, Losek Maps is drunk daily in a dosage of 40-80 mg, and Amoxicillin - 1.5 g (the dose is divided into parts). The course lasts two weeks. After eradication of Helicobacter pylori, subsequent therapy is carried out according to the usual regimen, as for duodenal and gastric ulcers . If at the end of the course the test for Helicobacter pylori is positive, treatment can be repeated;
• duodenal ulcer resistant to therapy - 40 mg of medication daily. Healing in most cases occurs within a month;
• stomach ulcer in the acute phase - you need to take 20 mg of medication per day. Therapy is designed for 4 weeks. If the ulcer has not completely healed at the end of the course, treatment can be repeated;
• the need to prevent exacerbations of stomach ulcers - you should take 20 mg of medication per day. If necessary, the daily dosage is increased to 40 mg;
• the need to prevent exacerbations of gastric and duodenal ulcers , the appearance of dyspeptic symptoms due to gastric ulcers , as well as erosive lesions of the gastroduodenal region - experts prescribe patients to take 20 mg of medication daily;
• esophageal reflux – 20 mg of medication per day. Therapy lasts an average of a month. If the patient is not completely cured, the course can be repeated;
• esophageal reflux in remission - experts prescribe taking 10 mg of Losec Maps per day, if necessary, the dose can be increased to 20-40 mg. The appointment is designed for a long course of maintenance therapy;
• pain, discomfort and heartburn in the epigastric region associated with acid-dependent dyspepsia - start with a daily dosage of 10 mg, which, if necessary, can be increased to 20 mg. Therapy is designed for 4 weeks. If the symptoms do not disappear upon completion of the course, it is advisable to change the treatment regimen;
• severe form of esophageal reflux - 40 mg of medication per day. Therapy is usually designed for 2 months;
• symptomatic gastroesophageal reflux - dosages are determined in each case individually. Usually take 10-20 mg daily. Therapy is designed for 4 weeks. If the symptoms have not disappeared at the end of the treatment, it is advisable to change the Losek Maps treatment regimen;
• Zollinger-Ellison syndrome - dosages are individual in each case. The recommended dose to start therapy is 60 mg every day. If the daily dosage is more than 80 mg, it must be divided into 2 doses.

If the patient has problems with liver function, the bioavailability and clearance of the active substance Losec Maps increases, so the daily dosage should usually not exceed 20 mg.

Reviews

According to patient reviews, Losek is a fairly effective drug with a complex nature. (This is another argument in favor of taking it only with the consent of your doctor.)

Let us list theses that summarize the available information about the effectiveness and tolerability of Losek.

• The effect of oral administration is noticeable within 2-4 days; Patients note almost complete attenuation of symptoms and heartburn on the 5-7th day. The frequency of relapses after a course of treatment with Losek is low: many people forget about diseases that previously seemed chronic for decades.
• Drinking Losek occasionally, as an emergency aid for stomach pain, is irrational. There are complaints that 10-15 hours after taking the pill, which helped initially, the “rhythm” of gastric juice production is disrupted: acidity (according to subjective sensations) increases more than before taking the drug.
• Lyophilisate for drip administration is well tolerated by the body, without obsessive side effects. Persistent improvement in the patient's condition with intravenous administration of Losek occurs approximately on the 5th day.
• The most common side effects are migraine, nausea, weakness and dizziness. There are also reports of severe visual impairment. Many of the patients whose intensity of side effects were tolerable managed without stopping the drug: after 2-4 days of the adaptation period, the adverse effects disappeared on their own.

Reviews from our readers about the drug Losek are given below, after the final section.

Interaction

The combination of Losec Maps and Ketoconazole may lead to a decrease in the degree of absorption of the latter.

In addition, the drug may increase the elimination time of Warfarin , Phenytoin and Diazepam . Therefore, dosage adjustments may be necessary. But daily use of 20 mg Losec Maps does not affect the level of Phenytoin in the blood plasma during long-term therapy, and also does not change the coagulation during long-term use of Warfarin .

The combined use of omeprazole and Clarithromycin causes an increase in their plasma concentrations.

Storage conditions

MAPS tablets - 3 years in a dry, dark place, away from children.

A bottle of d/in powder in the original packaging – 2 years at a temperature not exceeding 25◦C.

Ready solution with 5% dextrose - 6 hours, with 0.9% sodium chloride solution - 12 hours.

Other solvents for the intravenous form of Losek are not used, because it is possible that the stability of omeprazole as a chemical compound may decrease.

Analogues of Losek Maps

Level 4 ATC code matches:
Khairabesol

Noflux

Lancid

Barol

Beret

Ontime

Gastrozol

Omeprazole

Pantoprazole

Proxium

Lansoprazole

Zulbex

Ultop

Epicurus

Pariet

Losek

Sanpraz

Emanera

Omez Insta

Omez

The most common analogues of Losek Maps:

• Ultop;
• Losek;
• Helicid;
• Omeprazole;
• Omitox.

Each of these medications has its own nuances of use, so you should not take them on your own, without a doctor’s prescription.

Analogs

More than 4 dozen trade names of omeprazole-containing drugs are registered in the Russian Federation. In Ukrainian pharmacies you can also buy Swiss Gasec and 4-5 Omeprazoles from various local pharmaceutical plants. So, Losek’s analogues are:

• drugs with complex names containing the word Omeprazole (Omeprazole-Acri, etc.);
• Omez, as well as Omez Insta and Omez-D with additional components in the composition;
• Omezol, Omeprus and other drugs consonant with them;
• Gastrozol, Demeprazole, Zolser, Zhelkizol, Ortanol, Pepticum, Romesec, Ulkozol, Cisagast, Helicid, Helol, etc.

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Losek Maps price, where to buy

The price of tablets depends on the form of release. The cost of 10 mg (14 pieces in a package) is about 200 rubles. And the price of Losek Maps 20 mg is approximately 230 rubles.

• Online pharmacies in RussiaRussia

ZdravCity

• Losek Maps tablets p.p.o.
  20 mg 28 pcs. AstraZeneca 413 rub. order
• Losek Maps tablets p.p.o. 20 mg 14 pcs AstraZeneca AB

  RUB 213 order