Omez solution and tablets: instructions for use, price, reviews of users. Indications for use of the drug

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Medicines

pharmachologic effect

As the abstract indicates, this medicine is an antiulcer drug that belongs to the group of proton pump inhibitors. The active substance omeprazole, which the capsules contain, inhibits the secretion of hydrochloric acid, having a specific effect on the enzyme H+-K+-ATPase of stomach cells. As a result, under its influence the last stage of hydrochloric acid synthesis is blocked. As a result, regardless of the type of stimulus, the level of basal and stimulated secretion decreases.

Effects when taken

The capsules are swallowed with water. After taking the drug, the active substance omesaprozole is quickly absorbed into the blood after entering the stomach. The maximum amount of it in the blood is detected after about an hour. With one-time use, bioavailability is up to 40%; with continuous use, the figure increases to 60%.

It is important to understand why omez is prescribed in order to eliminate negative consequences from its improper use. The active agent, entering the body, provides rapid inhibition of the secretion of hydrochloric acid. At the same time, omez medicine, the instructions indicate this, begins to work most effectively after 4 days.

In addition, the drug omez has bactericidal properties, which makes it possible to successfully combat Helicobacter pylori bacteria. These harmful microorganisms provoke the development of gastritis and increase the risk of developing peptic ulcers. In the complex treatment of pathologies of the digestive organ in combination with antibacterial drugs omez, the instructions focus on this, allowing you to quickly eliminate unpleasant symptoms. In addition, when taking the drug, healing of the mucous membrane and long-term remission of peptic ulcer disease are guaranteed, which reduces the likelihood of complications such as bleeding.

Other effects associated with decreased hydrochloric acid production:

With long-term use of the drug, the formation of benign glandular cysts in the stomach is possible, which resolve over time.
The likelihood of intestinal infections, which can be caused by various harmful bacteria, increases.

Pharmacodynamics and pharmacokinetics

The use of the medicine internally leads to a rapid development of the effect: it manifests itself within 1 hour. Then Omez tablets are valid for 24 hours.

After the medication is stopped, the secretory activity of the exocrine glands of the stomach is restored after about 3-5 days. Omeprazole is characterized by rapid absorption from the intestine. Since the active substance in the drug is contained in acid-resistant granules, they dissolve only in the intestines. In plasma, the highest concentration is observed after 30-60 minutes. The level of bioavailability of omeprazole is 40%. The binding of the drug to plasma proteins is 90%. Metabilized in the liver. Excreted through the kidneys.

When administered intravenously, dose-dependent inhibition of gastric secretion is observed. The half-life of omeprazole after intravenous administration is approximately 40 minutes.

Pharmacological properties of the drug Omez

Omeprazole (5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1–1 N-benzimidazole) is an antiulcer agent that inhibits basal and stimulated secretion of hydrochloric acid by parietal cells stomach due to a specific effect on the enzyme H+/K+-ATPase (proton pump). After oral administration, the effect of the drug develops very quickly, within the first hour, and persists for 24 hours. After stopping the drug, the secretory activity of the glands of the gastric mucosa is restored after 3–5 days. Omeprazole in the drug is contained in acid-resistant granules that dissolve in the intestines. Omeprazole is rapidly absorbed, the maximum concentration in the blood plasma is reached after 0.5–1 hour. Bioavailability is 30–40%, clearance is 500–600 ml/min. About 90% of omeprazole is bound to plasma proteins. Omeprazole is almost completely metabolized in the liver and is excreted primarily in the urine (about 80%). The main metabolic pathway is associated with the polymorphic specific isoform CYP 2C19 (S-mephenithiol hydroxylase), responsible for the formation of hydroxyomeprazole, the main metabolite of omeprazole detected in blood plasma. In patients with chronic liver diseases, the bioavailability of the drug increases to 100%, the half-life increases to 3 hours, and clearance decreases to 70 ml/min. In patients with chronic kidney disease (creatinine clearance 10–62 ml/min), the distribution of omeprazole is the same as in healthy volunteers. Since renal excretion is the main route of elimination of omeprazole metabolites, its elimination from the body slows down in proportion to the decrease in creatinine clearance. In elderly patients, omeprazole elimination is reduced and bioavailability increases. IV administration of omeprazole causes dose-dependent inhibition of gastric secretion. With intravenous administration of omeprazole at a dose of 40 mg, a rapid decrease in gastric secretion is observed, similar to what is achieved with repeated oral administration of the drug at a dose of 20 mg. The degree of inhibition of gastric secretion averages about 90% over 24 hours, both with intravenous jet administration and with intravenous infusion. The average half-life after intravenous administration of omeprazole is approximately 40 minutes; total plasma clearance - 0.3–0.6 l/min.

Indications for use of Omez

Indications for use of Omez are as follows:

peptic ulcers of the duodenum and stomach;
erosive and ulcerative esophagitis;
ulcerative processes that are associated with treatment with non-steroidal anti-inflammatory drugs;
stress-related ulcers;
peptic recurrent ulcers of the gastric or duodenal localization;
Zollinger-Ellison syndrome;
pancreatitis;
gastroesophageal reflux disease;
systemic mastocytosis .

If it is not possible to take the drug orally, but there are indications for use, the drug can be administered intravenously.

The list of other things Omez is used for can be expanded by the attending physician.

Among the drugs that affect gastric secretion, proton pump inhibitors (PPIs) have firmly taken a leading position in the treatment of acid-dependent diseases (ADDs) of the gastrointestinal tract (GIT), almost completely replacing H2-histamine receptor blockers (H2-blockers) and significantly by reducing the frequency of patients taking antacids [1]. Over 30 years of use, PPIs have shown high effectiveness in the treatment of patients suffering from various diseases: gastroesophageal reflux disease, duodenal and gastric ulcers (DU), erosive and ulcerative lesions of the gastric and duodenal mucosa (DU) caused by taking acetylsalicylic acid (ASA) and non-steroidal anti-inflammatory drugs (NSAIDs), chronic gastritis associated with Helicobacter pylori

, as well as functional disorders of the upper gastrointestinal tract, the clinical symptoms of which are caused by hypersecretion of gastrocytes. Russian and international standards, as well as clinical recommendations for the diagnosis and treatment of CDZ, based on the vast accumulated evidence-based medicine, contain clear indications for the use and regimens for the use of PPIs, assigning the most important role to drugs in this group [1, 2].

However, quite often, practitioners recommend the use of antacids and/or H2 blockers. About 30-50% of pregnant women take antacids during pregnancy to treat heartburn. These drugs are divided into absorbable (sodium bicarbonate) and non-absorbable (magnesium hydroxide, calcium carbonate, aluminum phosphate, etc.). Despite the ability of sodium bicarbonate to quickly relieve heartburn, its effect is short-lived and heartburn soon returns. In addition, sodium absorbed in the intestines can lead to edema, which is undesirable for pregnant women. Non-absorbable antacids, which are highly effective and have mild side effects, can be prescribed during pregnancy. To date, most of them are considered safe and approved for use in average therapeutic doses, but you should always remember that antacids can adsorb other medications taken during pregnancy. First of all, we are talking about iron supplements, which are necessary for the treatment and prevention of anemia during gestation.

The absence of teratogenic effects of ranitidine (H2-blocker) in experimental conditions and clinical practice proves their safety during pregnancy. The number of studies on the safety of famotidine and nizatidine to date is too small to draw clear conclusions. The duration of the clinical effect of H2 blockers is much shorter, which requires an increase in the frequency and dose of their use, leading to the development of undesirable reactions - dry mouth, changes in appetite, stool disturbances, etc. However, in everyday clinical practice, to relieve the symptoms of chronic diseases: heartburn , belching, a sour taste in the mouth, pain or a burning sensation in the epigastrium, nausea, etc., obstetricians and pregnant women themselves use PPIs (usually omeprazole).

Acid-induced symptoms during pregnancy are either the result of an exacerbation of pre-existing chronic diseases in patients, or develop against the background of a number of processes characteristic of the gestation period. In particular, it has been shown that, due to hormonal changes, there is a disturbance in the tone of the smooth muscles of the gastrointestinal tract, a decrease in the sensitivity of receptors, and with an increase in the uterus and total body weight, an increase in intra-abdominal and intragastric pressure and a violation of motor-evacuation contractions are observed [3].

Data from a manometric study of the esophagus and stomach in 12 pregnant women, conducted by E. Bainbridge et al., showed a decrease in the tone and motor activity of the upper gastrointestinal tract, as well as the pressure of the lower esophageal sphincter (LES), while increasing the frequency of antiperistaltic contractions of the esophagus. These phenomena, according to the authors, contribute to the development of gastroesophageal reflux during pregnancy [4].

Functional disorders of the contractility of the gastrointestinal tract during gestation (hypomotility, antiperistalsis), as a rule, disappear after resolution of pregnancy and do not bother the woman in later life [3]. Increased energy consumption in the body of a pregnant woman entails an increase in the amount of food consumed and, as a consequence, an increase in the functional activity of the digestive organs [5]. Such common phenomena during pregnancy as nausea, constipation, hypersalivation, changes in taste preferences associated with changes in the secretory and motor functions of the digestive system (decrease in the speed and amplitude of waves of esophageal peristalsis, which disrupts its clearance and slows down gastric evacuation) do not prevent adequate intake food into the body [6, 7].

According to many epidemiological studies, more than 60% of pregnant women experience acid-induced symptoms more than 2 times a week in various trimesters of pregnancy. The most common symptom of CVD in pregnant women is heartburn [8, 9]. The manifestation of heartburn only during gestation in the absence of a chronic recurrent disease is defined as heartburn of pregnant women. Heartburn is the leading clinical symptom and the main diagnostic criterion for GERD. Long-term exposure to refluxate on the mucous membrane of the esophagus when gastric contents and/or DC are thrown into it weakens the protective mechanisms of the mucous membrane and triggers inflammation processes: oxidative stress, activation and degranulation of mast cells, release of inflammatory mediators and free radicals, potentiating the cytotoxic effect [10]. In addition, a decrease in pH in the esophageal cavity to less than 4.0 leads to intracellular acidosis with subsequent possible destruction and development of necrosis of esophageal epithelial cells with the formation of erosions and/or ulcers of its mucous membrane [11, 12].

According to the results of a study of the clinical manifestations of GERD in 166 pregnant women published in 2015, the prevalence of GERD symptoms in the first trimester of pregnancy was 16.9%, in the second - 25.3% and in the third - 51.2%. At the same time, extraesophageal manifestations of the disease (cough, bronchial asthma) during gestation were much less common than in the general population of patients with GERD [13].

Symptoms of CPZ, reducing appetite, lead to refusal or reduction in the frequency of meals, lengthening the intervals between meals, which provokes an increase in functional disorders of the digestive organs, exacerbation of chronic gastrointestinal diseases, and helps to reduce the body weight of a pregnant woman in the first trimester. The high prevalence of symptoms induced by exposure to hydrochloric acid on the mucous membrane of the upper gastrointestinal tract during gestation requires timely and effective measures to relieve them. This will ensure a complete balanced diet, improve the mother’s digestive processes and embryo trophism, and also improve the quality of life of the expectant mother [8].

The presence of heartburn, sour belching and other symptoms caused by the negative impact of gastric contents on the mucous membrane of the esophagus requires timely diagnosis with determination of the severity of the disease and the risk of recurrence of clinical manifestations after delivery in order to select optimal therapy, which includes modification of lifestyle and a course of drug treatment, the choice of which An important place should be given to patient compliance [12].

The results of studying the safety of PPI use in pregnant women are presented in a meta-analysis by S. Gill et al., performed on the basis of 60 studies (134,940 patients) [14]. It has been shown that there is no relationship between PPI use and the risk of fetal pathology, spontaneous abortion or premature birth. This allowed us to conclude that this group of drugs is safe and recommend them to women who have acid-induced symptoms as a result of functional disorders or exacerbations of CVD during pregnancy. Experts from the US Food and Drug Administration (FDA - Food and Drug Administration) assigned drugs in this group safety category B.

The safety of omeprazole has been primarily studied in animal studies (rats and rabbits). At the same time, a dose-dependent probability of fetal death was established, although teratogenic effects were not identified [15]. In addition, the FDA received information about 12 cases of congenital malformations in children whose mothers took the drug after the 13th week of pregnancy (5 cases of anencephaly and 1 case of hydrocephalus) [16].

On the other hand, the literature describes a large number of observations indicating the safety of omeprazole. M. Harper et al. observed a woman suffering from Zollinger-Ellison syndrome who was prescribed omeprazole during two pregnancies. She first received the drug at a dose of 120 mg per day starting at week 11 and gave birth to a live, full-term baby. During the second pregnancy, she took 180 mg of omeprazole and 450 mg of cimetidine per day and also gave birth to a healthy full-term baby [17].

In a study by G. Brunner et al. 9 women took from 20 to 60 mg of omeprazole during pregnancy, 4 of them in the first trimester. No pregnancy complications, developmental anomalies or congenital deformities were noted in newborns, and the duration of observation of the children was 12 years [18].

There are also several prospective studies confirming the safety of PPIs and, in particular, omeprazole in pregnant women. According to the Swedish Medical Birth Registry, an analysis was conducted of the condition of 262 newborns whose mothers took omeprazole throughout pregnancy [19]. Among them, 8 birth defects were recorded (3.1%). At the same time, the prevalence of congenital anomalies in the general population according to the same Register was 3.9%. Another prospective cohort study compared the pregnancy outcomes of three groups of women: the first included 113 people taking omeprazole; in the second - 113 patients taking H2 blockers; and the third - 113 women who did not take any antisecretory drugs (control group) [20]. There were no significant differences in pregnancy outcomes between the three groups of patients (number of live births, spontaneous miscarriages, premature births, cesarean sections, birth weight) [20]. The incidence of major congenital malformations in newborns whose mothers took omeprazole in the first trimester was 5.1% (4 out of 78); and in the second and third groups - 3.1% (3 out of 98) and 3% (2 out of 66), respectively. The risk of developing congenital deformities was 0.9 for omeprazole, and 1.3 and 1.5 for cimetidine and ranitidine, respectively. There are other observations, the results of which confirm the safety of omeprazole during the gestational period. Thus, according to observations in the UK and Italy, 134 women taking omeprazole gave birth to 139 live newborns (in 11 cases premature births occurred), 5 (3.7%) had congenital deformities, of which 2 were heart defects ( ventricular septal defect) [21].

A cohort study was conducted in Denmark to determine the association between PPI use and the risk of major birth defects. We compared the incidence of fetal pathology in women who took PPIs 4 weeks before conception and during 12 weeks of gestation (first trimester), as well as those who took PPIs only during the first trimester of pregnancy. Developmental defects of all live-born children were detected during the 1st year of their life. It was found that among 840,968 women examined (childbirth resulted in a live birth), 5,100 took PPIs 4 weeks before conception and throughout the entire first trimester of pregnancy (group 1), 3,651 pregnant women took PPIs only during the first trimester (group 2 ). In children of women from group 1, 174 (3.4%) serious congenital malformations were identified, while in the group who did not take PPIs, 21,811 (2.6%) malformations were identified. In group 2, out of 3651 subjects, 118 (3.2%) major birth defects were identified. In a secondary analysis of the effect of individual PPIs on the risk of developing congenital pathologies, no significantly significant differences were identified (insufficient data were obtained for rabeprazole). In conclusion, we can say that taking PPIs 4 weeks before conception and during the first trimester of pregnancy does not significantly increase the risk of developing birth defects [22].

Thus, we can agree with the conclusion of J. Richter that omeprazole is safe when prescribed to pregnant women [4].

Omez (omeprazole) is approved for use during pregnancy and lactation. The drug is listed in the US Food and Drug Administration (FDA) Orange Book as a PPI with proven therapeutic equivalence category A.

According to a report received by the Federal Service for Surveillance in Healthcare on the results of drug safety monitoring, omez is characterized by a high safety profile. No serious adverse events have been reported with the use of the drug. Omez (omeprazole) is approved by 16 regulatory authorities worldwide [23].

The choice of antisecretory therapy increases the doctor's responsibility regarding the development of possible side effects from the drug, which often leads the doctor to choose less effective therapy. However, it cannot be excluded that the presence of acid-induced symptoms and the risk of developing complications of CDZ, especially bleeding from the upper gastrointestinal tract, in the absence of adequate assistance, can lead to a violation of the quality of life, refusal of pregnancy and its premature resolution due to the severe course of CDZ.

The generalized results of world research have made it possible to authorize the use of omeprazole drugs during pregnancy, provided that the instructions for use of the drug indicate that omeprazole in the specified dose and duration of administration does not have side effects on the health of pregnant women and the development of the fetus.

Conflict of interest:

The materials in the article are advisory in nature and do not address conflicts of interest.

Side effects of Omez

In general, side effects during treatment with this drug are rare. The following side effects are possible:

Digestive system : abdominal pain, nausea, flatulence , taste disturbances, increased activity of liver enzymes.
Hematopoietic organs: thrombocytopenia, leukopenia , agranulocytosis.
Nervous system: headache, dizziness, depression.
Musculoskeletal system : myasthenia gravis, arthralgia , myalgia .
Skin : rash, itchy skin, photosensitivity.
Allergic manifestations : urticaria , fever, bronchospasm.
In addition, in rare cases, visual disturbances, malaise, and severe sweating may occur.

Instructions for use of Omez (Method and dosage)

The patient should swallow the capsules without opening or chewing. When to take Omez tablets? In the morning, before meals.

If Omez tablets are prescribed for peptic ulcers or reflux esophagitis , the instructions for use stipulate that the medicine is used at a dose of 20 mg per day, in the morning, on an empty stomach. The drug should be taken for 14 days. If the peptic ulcer does not heal during the treatment period, treatment can continue for another two weeks. As a rule, when taking the drug, scarring of a peptic ulcer of the duodenum occurs after 4 weeks.

Treatment of Zollinger-Ellison syndrome involves taking 60 mg of the drug per day. The instructions also indicate how to drink it - before or after meals: the drug is taken before meals. Maintenance doses are then prescribed by the doctor.

For gastritis , treatment lasts from 1 to 2 weeks. Treatment for gastritis is aimed at eliminating the symptoms of an irritable stomach. In this case, 1 capsule per day is prescribed. In addition, your doctor will tell you how to take Omez for gastritis after making a diagnosis.

For pancreatitis, it is prescribed as part of complex treatment. It is assumed that this treatment helps relieve the patient of heartburn, reduce pain and stress on the pancreas. The duration of treatment depends on the severity of symptoms. Initially, two capsules are prescribed per day, then maintenance therapy is practiced - 1 capsule per day. For heartburn, it should not be used without prior approval from a physician.

Intravenous administration, depending on the disease, is carried out in a dose of 40 mg to 80 mg per day. If the dose is 60 mg or more, it can be divided into two administrations. After the acute symptoms are relieved, switching to oral administration of the drug is practiced. The prepared solution is good for 24 hours.

Use of the drug Omez

Capsules are taken whole, without breaking or chewing. For peptic ulcer of the duodenum and stomach, reflux esophagitis, a dose of 20 mg is prescribed once a day (before breakfast) for 2 weeks. If after the first 2-week course of therapy the ulcer has not healed, the course of treatment is extended for another 2 weeks or until complete healing. When Omez is prescribed at a dose of 40 mg/day, the duodenal ulcer usually scars within 4 weeks after the start of treatment, and gastric ulcers and erosive reflux esophagitis after 8 weeks. For patients with Zollinger-Ellison syndrome, Omez is prescribed at an initial dose of 60 mg/day. The duration of therapy depends on the dynamics of clinical manifestations. The maintenance dose for Zollinger-Ellison syndrome is set individually and is 20–120 mg/day. If it is necessary to use the drug in a dose exceeding 80 mg/day, it must be divided into 2 doses. Helicobacter pylori eradication is carried out according to standard international schemes. In adult patients with gastric and duodenal ulcers or reflux esophagitis, it is administered as an infusion at a dose of 40 mg once a day. For patients with Zollinger-Ellison syndrome, the recommended initial dose of Omez in the form of intravenous infusion is 60 mg/day. It may be necessary to prescribe higher daily doses. If the daily dose exceeds 60 mg, it should be divided into 2 administrations. There is no need for dose adjustment in patients with impaired renal function and elderly patients. For patients with impaired liver function, the daily dose is 10–20 mg. Omez 40 mg is administered as an intravenous infusion (over 20–30 minutes), including for the eradication of Heliciobacter pylori . The contents of one bottle are dissolved in 100 ml of 0.9% sodium chloride solution or 100 ml of 5% dextrose solution for infusion. The solution should be used within 24 hours. For peptic ulcers complicated by gastrointestinal bleeding, Omez is prescribed IV at a dose of 80 mg (8 mg/h) and then 20 mg orally (from the 3rd to the 21st). th day).

special instructions

It is possible to take capsules simultaneously with food, from which the medicine does not lose its effectiveness.

Before you start taking capsules or administering Omez intravenously, you should rule out malignant processes, since therapy can mask symptoms, thereby delaying diagnosis.

Sometimes there are circumstances when it is necessary to avoid swallowing a whole capsule, for which the drug is used in the following way: the capsule is opened and its contents are mixed with soft apple puree (1 tablespoon). You cannot take the contents of the capsule in any other way.

The drug is unlikely to affect the ability to drive vehicles and operate precision equipment.

Omez's analogs

Level 4 ATC code matches:
Khairabesol

Noflux

Lancid

Barol

Beret

Ontime

Gastrozol

Omeprazole

Pantoprazole

Proxium

Lansoprazole

Zulbex

Ultop

Epicurus

Pariet

Losek MAPS

Losek

Sanpraz

Emanera

Omez Insta

There are imported and Russian analogues of Omez, but it is not recommended to select a substitute yourself. Omeprazole , Demeprazole , Chrismel , Zerotsid , Omecaps , Omezol , Gastrozol , Ultop , etc. have a similar effect on the body

Nolpaza or Omez - which is better?

Nolpaza has a similar effect, reducing the level of hydrochloric acid and relieving the symptoms of gastrointestinal diseases . Nolpaz contains the active component Pantoprazole . This medicine sometimes works more quickly.

Omez or Ranitidine – which is better?

Ranitidine contains the active ingredient ranitidine hydrochloride and is used for the same conditions and diseases as Omez. Which drug is preferred depends on the doctor's prescription.

Which is better - Omez or Ultop?

Ultop contains the active ingredient omeprazole. Its action is based on inhibition of gastric juice activity. Which drug should be chosen should be asked by a specialist and the diagnosis taken into account.

Orthanol or Omez - which is better?

Orthanol is another drug whose active ingredient is omeprazole. Like Omez, this drug is prescribed for peptic ulcers, hypersecretory conditions, etc.

Which is better - Omez or Pariet?

Pariet contains the active ingredient rabeprazole sodium. However, the indications for use of this medicine are the same as those of Omez capsules.

Which is better - Omez or De Nol?

De Nol is an antiulcer agent that contains bismuth subcitrate. How to take Omez and De Nol depends on the severity and characteristics of the disease. But this should be done according to the scheme prescribed by the doctor.

Which is better - Omez or Omez D?

Many patients are interested in the difference between Omez and Omez D. The difference between these drugs is that Omez D contains not only omeprazole, but also domperidone as an active substance.

Omez

Instructions for use of the medicinal product for medical use OMEZ®

Registration number: LSR-004124/09 Trade name of the drug: OMEZ® International nonproprietary name of the drug: omeprazole. Dosage form: lyophilisate for the preparation of solution for infusion. Composition Each bottle contains: Active substance: omeprazole 40 mg. Excipients: sodium hydroxide 5.28 mg, disodium edetate 1.00 mg. Description: white or almost white lyophilisate in the form of a homogeneous porous cake or parts thereof or in powder form. Pharmacotherapeutic group: gastric gland secretion reducing agent - proton pump inhibitor. ATC code: A02BC01 Pharmacological properties Pharmacodynamics Specific proton pump inhibitor: inhibits the activity of H+/K+-ATPase in the parietal cells of the stomach, blocking the final stage of hydrochloric acid secretion, thereby reducing acid production. Reduces basal and stimulated secretion regardless of the nature of the stimulus. Omeprazole is a prodrug and is activated in the acidic environment of the secretory tubules of the parietal cells of the stomach. The effect is dose-dependent and provides effective inhibition of both basal and stimulated acid secretion, regardless of the nature of the stimulating factor. The antisecretory effect after taking 20 mg occurs within the first hour, maximum after 2 hours. Inhibition of 50% of maximum secretion continues for 24 hours. A single dose per day provides rapid and effective inhibition of daytime and nighttime gastric secretion, reaching its maximum after 4 days of treatment and disappearing by the end of 3-4 days after the end of treatment. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains intragastric pH at 3 for 17 hours. During the use of drugs that reduce the secretion of gastric glands, the concentration of gastrin in the blood plasma increases. Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A increases (see section “Special instructions”). Pharmacokinetics: Connection with plasma proteins - 90-95% (albumin and acidic alpha1-glycoprotein). The half-life (T1/2) for the final phase of the pharmacokinetic concentration-time curve in the blood plasma after intravenous administration of omeprazole is about 40 minutes (for liver failure - 3 hours); the total plasma clearance is from 0.3 to 0.6 l/min. There is no change in the half-life during treatment. Almost completely metabolized in the liver with the participation of the cytochrome P450 (CYP) enzyme system with the formation of six pharmacologically inactive metabolites: hydroxyomeprazole, sulfide and sulfone derivatives and others. A significant part of the metabolism of omeprazole depends on the polymorphically expressed specific isoform CYP2C19 (S-mephenytoin hydroxylase), which is responsible for the formation of hydroxyomeprazole, the main plasma metabolite. It is an inhibitor of the CYP2C19 isoenzyme. Excretion by the kidneys (70−80%) and bile (20−30%). In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance. In elderly patients, excretion decreases and bioavailability increases. Indications for use As an alternative to oral therapy if it is not possible:

for peptic ulcers of the stomach and duodenum (including prevention of relapses);
for gastroesophageal reflux disease (GERD);
for hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis);
for the prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by the use of nonsteroidal anti-inflammatory drugs (NSAID gastropathy): dyspepsia, erosion of the mucous membrane, peptic ulcer;
to prevent aspiration of acidic stomach contents into the respiratory tract during general anesthesia (Mendelssohn syndrome).

Contraindications Hypersensitivity to omeprazole or other components of the drug. Concomitant use with erlotinib, posaconazole, nelfinavir and atazanavir. Breastfeeding period. Children under 18 years of age (efficacy and safety have not been established for this dosage form). With caution Renal failure (omeprazole dose adjustment is not required). Liver failure (see section "Method of administration and dosage regimen"). Osteoporosis. Although a causal relationship between the use of omeprazole and osteoporotic fractures has not been established, patients at risk of developing osteoporosis or osteoporotic fractures should be under appropriate clinical supervision. Pregnancy. Concomitant use with clopidogrel, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampicin, St. John's wort preparations. Use during pregnancy and breastfeeding Use of the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. During lactation, breastfeeding should be stopped. Method of administration and dosage The drug Omez® is administered intravenously over 20-30 minutes. It is recommended to administer the infusion solution immediately after its preparation. Doses are selected individually, sometimes a higher dose is required. If the daily dose exceeds 60 mg, then the dose should be divided into two doses.

As an alternative to oral therapy if it is not possible:
for gastric and duodenal ulcers (including prevention of relapses), it is recommended to prescribe an infusion of the drug Omez® at a dose of 40 mg once a day;
for gastroesophageal reflux disease (GERD), it is recommended to prescribe an infusion of the drug Omez® at a dose of 40 mg once a day;
for hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis), initial intravenous administration of the drug Omez® is recommended at a dose of 60 mg per day;
for the prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by the use of non-steroidal anti-inflammatory drugs - NSAID gastropathy (dyspepsia, erosion of the mucous membrane, peptic ulcer), it is recommended to prescribe an infusion of the drug Omez® at a dose of 40 mg once a day.

To prevent aspiration of acidic stomach contents into the respiratory tract during general anesthesia (Mendelssohn syndrome), the drug is prescribed the night before at a dose of 40 mg and at least 2 hours before anesthesia/surgery at a dose of 40 mg.

After completion of parenteral therapy, antisecretory therapy with oral dosage forms (for example, omeprazole 40 mg once daily for 4 weeks) is recommended to suppress acid secretion. Use of the drug in special cases: Impaired renal function. No dose adjustment is required. Liver dysfunction. In patients with impaired liver function, the bioavailability and clearance of omeprazole are increased. In this regard, the therapeutic dose should not exceed 20 mg per day. Elderly age. The rate of metabolism of omeprazole in the elderly is reduced, but no dose adjustment is required. Instructions for preparing solution for infusion The solution for infusion is prepared by dissolving lyophilized omeprazole powder in 100 ml of 5% dextrose (glucose) solution for infusion or in 100 ml of saline infusion solution. An infusion solution containing 5% dextrose (glucose) should be used within 6 hours. The saline infusion should be used within 12 hours. Before administration, you should ensure that there are no suspended particles in the solution. Preparation of solution for infusion in bottles 1. Draw 5 ml of solution for infusion from the bottle with a syringe. 2. Add the solution for infusion into a bottle with lyophilized omeprazole powder, shake the bottle until the drug is completely dissolved. 3. Draw omeprazole solution into the syringe. 4. Transfer the omeprazole solution into the vial. 5. Repeat steps 1-4 in order to transfer all the drug from the bottle. Preparation of solution for infusion in a soft container 1. To prepare solution for infusion, use a double-sided needle (adapter). Pierce the membrane of the infusion bag with one end of the needle, and connect the other end of the needle to a bottle of lyophilized omeprazole. 2. Dissolve omeprazole powder by pumping the infusion solution from the bag into the bottle and back. 3. Make sure that the powder is completely dissolved, then disconnect the empty bottle and remove the needle from the infusion bag.

Side effects The frequency of adverse drug reactions is presented in accordance with the following gradation: very often (>1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000, including isolated cases). Disorders of the skin and subcutaneous tissues: infrequently - dermatitis, itching, skin rash, urticaria; rarely - alopecia, photosensitivity reactions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Musculoskeletal and connective tissue disorders: uncommon – fractures of the hip, wrist bones, vertebrae; rarely – arthralgia, myalgia, muscle weakness. Nervous system disorders: often – headache; uncommon – dizziness, paresthesia, drowsiness; rarely – taste disturbance. Mental disorders: infrequently – insomnia; rarely - increased excitability, aggressiveness, impaired consciousness, depression, hallucinations. Gastrointestinal disorders: often – abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; rarely - dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis. Disorders of the liver and biliary tract: infrequently - increased activity of liver enzymes; rarely - hepatitis with/without jaundice, liver failure, encephalopathy in patients with previous severe liver diseases. Disorders of the genital organs and breast: rarely - gynecomastia. Blood and lymphatic system disorders: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia. Immune system disorders: rarely - hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock. Disorders of the respiratory system, chest and mediastinal organs: rarely - bronchospasm. Renal and urinary tract disorders: rarely – interstitial nephritis. Hearing and labyrinthine disorders: uncommon – vertigo. Visual disturbances: rarely – blurred vision. Metabolic and nutritional disorders: rarely – hyponatremia; very rarely - hypomagnesemia, hypocalcemia due to severe hypomagnesemia, hypokalemia due to hypomagnesemia. General disorders: infrequently – malaise; rarely – increased sweating, peripheral edema.

Overdose

According to clinical studies, with intravenous administration of up to 270 mg of the drug per day and at a dose of up to 650 mg for three days, no dose-dependent side effects were identified. Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia. Treatment: symptomatic. Hemodialysis is not effective enough.

Interaction with 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 lead to decreased absorption of ketoconazole, itraconazole, posaconazole, erlotinib, iron supplements and cyanocobalamin. Their co-administration with omeprazole should be avoided. The bioavailability of digoxin when used simultaneously with omeprazole increases by 10% (adjustment of the digoxin dosage regimen may be required). Caution should be exercised when these drugs are used concomitantly in elderly patients. When used simultaneously with omeprazole, it is possible to increase the plasma concentration and increase the half-life of warfarin, diazepam, phenytoin, cilostazol, imipramine, clomipramine, citalopram, hexobarbital, disulfiram, as well as other drugs metabolized in the liver with the participation of the CYP2C19 isoenzyme (a dose reduction of these drugs may be required ). 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. When used simultaneously with omeprazole, the area under the pharmacokinetic concentration-time curve of atazanavir decreases by 75%. In this regard, the combined use of omeprazole with antiretroviral drugs such as atazanavir and nelfinavir is contraindicated. With simultaneous use of omeprazole with clopidogrel, a decrease in the antiplatelet effect of the latter is observed. When methotrexate was co-administered with proton pump inhibitors, a slight increase in plasma methotrexate concentrations was observed in some patients. When treated with high doses of methotrexate, omeprazole should be temporarily discontinued. With simultaneous use of omeprazole and tacrolimus, an increase in the concentration of tacrolimus in the blood serum was noted, which may require dose adjustment. Concomitant use with inhibitors of the CYP2C19 and CYP3A4 isoenzymes (such as clarithromycin, erythromycin, voriconazole) may lead to an increase in the plasma concentration of omeprazole, which may require dose adjustment of omeprazole in patients with severe hepatic impairment in case of long-term use. Inducers of the CYP2C19 and CYP3A4 isoenzymes, such as rifampicin, preparations of St. John's wort (Hypéricum perforatum), 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. When omeprazole is taken together with clarithromycin or erythromycin, the concentration of omeprazole in the blood plasma increases. Co-administration of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in the blood plasma.

There was no effect of omeprazole on antacids, theophylline, caffeine, quinidine, lidocaine, propranolol, ethanol.

Special instructions If you suspect a gastric ulcer in the early stages, it is necessary to undergo an X-ray or endoscopic examination to establish the correct diagnosis and prescribe adequate treatment. In the presence of any alarming symptoms, such as significant spontaneous weight loss, frequent vomiting, dysphagia, hematemesis or melena, as well as in the presence of a gastric ulcer (or suspected gastric ulcer), the possibility of malignancy should be excluded, since treatment with Omez® may lead to smoothing of symptoms and delay diagnosis. Patients at risk of developing osteoporosis or osteoporotic fractures should be under appropriate clinical supervision, although a causal relationship between the use of omeprazole/esomeprazole and osteoporotic fractures has not been established. Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A (CgA) increases. Increased concentrations of CgA in blood plasma may affect the results of examinations to detect neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors should be suspended 5 days before the CgA concentration study. If during this time the CgA concentration has not returned to normal, the study should be repeated.

Impact on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions. During treatment with omeprazole, dizziness, drowsiness, and blurred vision may occur, so care should be taken when driving vehicles and performing other potentially hazardous activities that require increased concentration attention and speed of psychomotor reactions.

Release form

Lyophilisate for the preparation of solution for infusion, 40 mg. The drug is in a bottle made of colorless transparent glass type I (Eur Ph), sealed with a chlorobutyl stopper, crimped with an aluminum cap with a safety plastic lid. Each bottle, along with instructions for use, is placed in a cardboard box.

Storage conditions

List B. In a dry place, protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children!

Best before date

2 years. Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies:

On prescription.

Manufacturer : Dr. Reddy's Laboratories Ltd., Hyderabad, Andhra Pradesh, India.

Manufactured by: Sofarimex Industria Kimica e Pharmasuetica Lda., Portugal Av. Industrias - Alto do Colaride, Agualva - 2735-213 Casem, Portugal.

Information about complaints and adverse drug reactions should be sent to the following address: Representative office: 115035, Moscow, Ovchinnikovskaya embankment, 20, building 1 tel. fax

Reviews about Omez

There are numerous positive reviews about Omez. Reviews from those taking this remedy indicate that it effectively treats peptic ulcers, helps overcome attacks of heartburn , and eliminates the symptoms of acute gastritis. Reviews of Omez on the forms are also positive; people note that it can be taken at any time, and it works equally effectively. In addition, the drug improves the condition of the gastrointestinal tract during treatment with other drugs that irritate the stomach and intestines. The disadvantage is often mentioned that the product is quite expensive.

Omez price, where to buy

The price of Omez 10 mg tablets is on average 70 rubles for 10 capsules. Price Omez 20 mg – from 160 rubles per pack of 30 capsules. The price of Omez in Moscow and other Russian cities is similar.

You can buy Omez 20 mg in Ukraine (Kyiv, Kharkov, other cities) for an average of 80 UAH. (pack of 30 pcs.) Cost of 10 mg - on average 52 UAH. How much the drug costs can be found out more accurately directly at the place of sale.

Online pharmacies in RussiaRussia
Online pharmacies in UkraineUkraine
Online pharmacies in KazakhstanKazakhstan

ZdravCity

Omez caps.
intestinal 40 mg 28 pcs. Dr. Reddy's lab. RUB 275 order
Omez capsules 20 mg 30 pcs. Dr. Reddy's lab.
RUB 159 order
Omez liof. for prig solution for inf. 40 mg Sofarimex Industria Kimica e Pharmasuetica, S.A.
155 rub. order
Omez capsules enteric solution. 10mg 10 pcs.Dr. Reddy's lab.
72 RUR order

Pharmacy Dialogue

Omeprazole (Omez)-Teva capsules 20 mg No. 28Teva
85 rub. order
Omez capsules 20 mg No. 30Dr. Reddy's
RUB 161 order
Omez (caps. 10 mg No. 10)Dr. Reddy's
73 rub. order
Omeprazole (Omez)-Akrikhin (caps. intestinal 20 mg No. 30) Akrikhin JSC
66 RUR order
Omez (lyof. d/add. solution vial. 40 mg)Dr. Reddy's
147 RUR order

Pharmacy24

Omez 40 mg N28 capsules Dr. Reddy's Laboratories Ltd., India
105 UAH.order
Omez D No. 30 capsules Torrent Pharmaceuticals Ltd., India
111 UAH order
Omez DSR No. 30 capsules Dr. Reddy's Laboratories Ltd., India
144 UAH order
Omez 20 mg No. 30 capsules Dr. Reddy's Laboratories Ltd., India
77 UAH order
Omez 10 mg N30 capsules Dr. Reddy's Laboratories Ltd., India
46 UAH order

PaniPharmacy

Omez capsule Omez caps. 20mg No. 30 India, Dr. Reddy's
80 UAH order
Omez bottle Omez Liof. d/p r-ra d/in. 40mg fl. No.1 India, Naprod Life Sciences
138 UAH order
Omez capsule Omez caps. 10mg No. 30 India, Dr. Reddy's
52 UAH order
Omez capsule Omez caps. 40 mg No. 28 India, Dr. Reddy's
118 UAH order