LOSEC MUPS 20MG PILL

Indications

Losec® MUPS® intended for the treatment of the following diseases:

- duodenal ulcer;

- stomach ulcer;

- NSAIDs associated ulcers and erosion of the stomach and duodenum;

- Eradication of Helicobacter pylori in peptic ulcer disease;

- Reflux esophagitis;

- symptomatic gastroesophageal reflux disease;

- dyspepsia associated with high acidity;

- Zollinger-Ellison syndrome.

Dosing regimen

Inside Pills losek® MAPS® It is recommended to take in the morning, the pill should be swallowed whole with a liquid. pills can not be chewed or crushed.

Tablets can be dissolved in water or slightly acidified liquid, for example, in fruit juice. The resulting solution should be used within 30 minutes. To be sure of taking the full dose, pour half the liquid back into the glass, shake and drink.

Duodenal ulcer

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

Patients with duodenal ulcer, little susceptible to treatment, usually prescribed Losec® MAPS® 40 mg once a day; ulcer healing usually occurs within 4 weeks.

To prevent relapse in patients with duodenal ulcer recommend Losek® MAPS® 10 mg once a day. If necessary, the dose can be increased to 20-40 mg once a day.

Stomach ulcer

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

Patients with a gastric ulcer, little susceptible to treatment, usually prescribe Losek® MAPS® 40 mg once a day; healing is usually achieved within 8 weeks.

To prevent recurrence, Losec is recommended for patients with a stomach ulcer.® MAPS® 20 mg once a day. If necessary, the dose can be increased to 40 mg 1 time per day.

NSAIDs associated ulcers and erosion of the stomach and duodenum

In the presence of NSAIDs of associated gastric, duodenal ulcers, or gastroduodenal erosions in patients with discontinued or ongoing NSAID therapy, the recommended dose of Losek® MAPS® - 20 mg once a day. The drug provides rapid elimination of symptoms, in most patients, the cure occurs within 4 weeks.In those patients who have not had a cure during the initial therapy period, healing is usually achieved with repeated 4-week intake of the drug.

For the prevention of ulcers and erosions of the stomach and duodenum and dyspepsia symptoms associated with taking NSAIDs, the dose of the drug Losek is recommended® MAPS® - 20 mg once a day.

Modes of eradication of Helicobacter pylori in peptic ulcer.

Three-part treatment regimen:

Losec® MUPS® 20 mg, Amoxicillin 1 g and Clarithromycin 500 mg. All drugs to take 2 times a day for one week

or

Losec® MUPS® 20 mg, Metronidazole 400 mg (or Tinidazole 500 mg) and clarithromycin 250 mg. All drugs to take 2 times a day for one week

or

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

Two-part treatment regimen:

Losec® MUPS® 40-80 mg daily and amoxicillin 1.5 g daily (the 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 is carried out in accordance with the recommendations in the sections "Duodenal ulcer" and "Gastric ulcer."

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

Reflux esophagitis

The recommended dose - one pill Losek® MAPS® 20 mg once a day. The drug provides rapid elimination of symptoms.In most patients, the cure occurs within 4 weeks. In those cases when, after the first course of taking the drug, a complete cure does not occur, usually a repeated 4-week course of treatment is prescribed, in
the course of which is cured.

Patients with severe reflux esophagitis are recommended Losek® MAPS® 40 mg once a day; cure usually occurs within 8 weeks.

Patients with reflux esophagitis in remission are prescribed Losec® MAPS® 10 mg once a day in the form of long courses of maintenance therapy. If necessary, the dose can be increased to 20-40 mg.

Symptomatic gastroesophageal reflux disease.

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

Acid dyspepsia

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

Zollinger-Ellison Syndrome

Patients with Zollinger-Ellison syndrome, the drug is prescribed in an individual dosage. Treatment is continued according to clinical indications 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 when other therapeutic methods did not lead to the desired result, the use of the drug was effective in more than 90% of patients while taking 20-120 mg of Losek® 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.

Renal dysfunction

For patients with impaired renal function, dose adjustment is not required.

Liver dysfunction

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

Elderly patients

For elderly patients, dose adjustment is not required.

Children

Experience with children is limited.

Adverse effects

The following are side effects. not dependent on the dosing regimen of omeprazole, which were noted during clinical trials, as well as post-marketing use.

It was reported about the formation of glandular cysts in the stomach in patients taking drugs that lower
secretion of the glands of the stomach, over a long period of time; benign cysts and pass independently on the background of continued therapy.

Contraindications

- known hypersensitivity to omeprazole, substituted benzimidazoles or other ingredients that make up the drug.

Carefully

In the presence of symptoms such as significant spontaneous weight loss, frequent vomiting, dysphagia, vomiting of blood or melena,and if there is a stomach ulcer (or a stomach ulcer is suspected), the presence of a malignant neoplasm should be excluded, since treatment can lead to masking of the symptoms and, thus, delay the diagnosis.

Use during pregnancy and lactation

Studies have shown no side effect of omeprazole on the health of pregnant women, on the fetus or on the newborn. Losek® MAPS® can be used during pregnancy.

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

Application for violations of the liver

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

Application for violations of kidney function

For patients with impaired renal function, dose adjustment is not required.

Use in children

Experience with children is limited.

Use in elderly patients

For elderly patients, dose adjustment is not required.

special instructions

If there are any alarming symptoms (for example, such as significant spontaneous weight loss, repeated
vomiting, dysphagia, vomiting with blood or melena), as well as in the presence of a stomach ulcer (or if an ulcer is suspected
stomach) should exclude the presence of a malignant neoplasm, because treatment with Losek® MAPS® may lead to smoothing symptoms and delay the diagnosis.

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

According to research results noted pharmacokinetic / pharmacodynamic interaction between Clopidogrel (loading dose 300 mg and maintenance dose 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 a decrease in the maximum inhibition of ADP-induced platelet aggregation by an average of 16%. Therefore, the simultaneous use of omeprazole and clopidogrel should be avoided.

Separate observational studies indicate that proton pump inhibitor therapy may slightly increase the risk of osteoporosis-related fractures, but in other similar studies there has been no increase in risk.

In randomized, double-blind, controlled clinical trials of omeprazole and esomeprazole, including two open-label studies with a duration of therapy of more than 12 years, the connection of fractures against osteoporosis with the use of proton pump inhibitors was not confirmed.

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

Influence on ability to drive a car or other mechanisms

No data on the effect of the drug Losek® MAPS® on the ability to drive a car or other mechanisms. However, due to the fact that during therapy dizziness, blurred vision and drowsiness may be observed, care should be taken when driving vehicles or other mechanisms.

Overdose

Single oral doses of the drug Losek® MAPS® up to 400 mg did not cause any severe symptoms. When taken by adults, 560 mg of omeprazole showed moderate intoxication. With increasing doses, the rate of elimination of the drug did not change (kinetics of the first order), specific treatment was not required.

Symptoms: dizziness, confusion, apathy, headache, dilation of blood vessels, tachycardia, nausea, vomiting, flatulence, diarrhea.

Treatment: symptomatic treatment, if necessary - gastric lavage, the appointment of Activated carbon.

Drug interaction

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 may lead to a decrease or increase in the absorption of other drugs, the absorption of which depends on the acidity of the medium.

Like other drugs that reduce the acidity of gastric juice, treatment with omeprazole can lead to a decrease in the absorption of Ketoconazole , itraconazole and erlotinib, as well as an increase in the absorption of drugs such as Digoxin.

Joint administration of omeprazole in a dose of 20 mg once a day and digoxin increases the bioavailability of digoxin by 10%
(digoxin bioavailability increased by up to 30% in 20% of patients).

Omeprazole has been shown to interact with certain antiretroviral drugs.

The mechanisms and clinical significance of these interactions are not always known. Increasing the pH value during omeprazole therapy may affect the absorption of antiretroviral drugs. Interaction at the level of an isoenzyme CYP2C19 is also possible. With the joint use of omeprazole and some antiretroviral drugs, such as atazanavir and nelfinavir, a decrease in their concentration in serum is observed during therapy with omeprazole. Therefore, the combined use of omeprazole with antiretroviral drugs such as atazanavir and nelfinavir is not recommended.

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

Omeprazole inhibits CYP2C19 - the main isoenzyme involved in its metabolism. Combined use of omeprazole with other drugs that are involved in the metabolism of CYP2C19 isoenzyme, such as diazepam, Warfarin (R-warfarin) or other vitamin K antagonists, phenytoin and Cilostazol, can slow the metabolism of these drugs.It is recommended that patients taking phenytoin and omeprazole be monitored, and phenytoin dose reduction may be necessary. However, concomitant treatment with omeprazole at a daily dose of 20 mg does not affect the concentration of phenytoin in the blood plasma of patients who take the drug for a long time. When omeprazole is used by patients receiving warfarin or other vitamin K antagonists, monitoring of the international normalized ratio is necessary; in some cases, a reduction in the dose of warfarin or another vitamin K antagonist may be necessary. At the same time, concomitant treatment with omeprazole in a daily dose of 20 mg does not change the coagulation time in patients who take warfarin for a long time.

The use of omeprazole in a dose of 40 mg once a day 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 research results, pharmacokinetic / pharmacodynamic interaction between clopidogrel (loading dose 300 mg and maintenance dose 75 mg / day) and omeprazole (80 mg / day inside) is observed, which leads to a decrease in the active metabolite of clopidogrel, by an average of 46% and reduce the maximum inhibition of ADP-induced platelet aggregation, on average, by 16%.

The clinical significance of this interaction is not clear. Increased risk of cardiovascular complications with
the combined use of clopidogrel and proton pump inhibitors, including omeprazole, has not been shown in
A prospective, randomized, incomplete study involving more than 3,760 patients who received placebo or omeprazole at a dose of 20 mg / day simultaneously with clopidogrel and Acetylsalicylic acid (ASA) therapy, and not
confirmed by additional non-randomized analysis of the clinical outcome of large-scale, prospective, randomized trials involving more than 47,000 patients.

The results of a number of observational studies are inconsistent and do not give a definite answer about the presence or
the absence of an increased risk of thromboembolic cardiovascular complications due to the combined use of clopidogrel and proton pump inhibitors.

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

Omeprazole does not affect the metabolism of drugs metabolized by a CYP3A4 isoenzyme, such as cyclosporine, Lidocaine , quinidine, estradiol, Erythromycin and Budesonide.

There was no interaction of omeprazole with the following drugs: caffeine, theophylline, S-warfarin, Piroxicam , Diclofenac , Naproxen , Metoprolol , propranolol and ethanol.

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

Some patients noted an increase in the concentration of Methotrexate on the background of joint use with proton pump inhibitors. When prescribing high doses of methotrexate, the possibility of temporary discontinuation of omeprazole should be considered.

The effect of drugs on the pharmacokinetics of omeprazole

In the metabolism of omeprazole isoenzymes CYP2C19 and CYP3 A4 are involved. The combined use of omeprazole and CYP2C19 and CYP3A4 isoenzyme inhibitors, such as clarithromycin and voriconazole, can lead to an increase in plasma plasma concentration of omeprazole by slowing down the metabolism of omeprazole. The combined use of voriconazole and omeprazole leads to a more than twofold increase in the AUC of omeprazole. Due to the good tolerability of high doses of omeprazole, with a brief joint use of these drugs does not require correction of the dose of omeprazole.

Drugs that induce CYP2C19 and CYP3A4 isoenzymes, such as rifampicin and Hypericum perforatum drugs, when used together with omepraole can lead to a decrease in the concentration of omeprazole in the blood plasma by accelerating the metabolism of omeprazole.

Terms and conditions of storage

Store at a temperature not higher than 25 ° С. After application, close the bottle cap tightly. Keep out of reach of children.