Khairabezol (Rabeprazole) TB po intestinal 20 mg N 30

Khairabesol

Khairabesol

(
Hirabezol
) - a drug to reduce gastric acidity, a proton pump inhibitor, and an antiulcer.

Treatment of erosive and ulcerative defects of the stomach and duodenum with the drug Khairabezol is clinically effective and has a persistent antisecretory effect. During a study assessing the effectiveness of Hairabezol, the following was noted. A decrease in pain in the epigastric region is observed from the 2nd day of use of the drug, and by the 7th day of therapy, the pain syndrome, according to the study, disappears. In the vast majority of patients, healing of erosive and ulcerative defects was achieved by the end of the 2nd week. The percentage of daily time pH>4 in the stomach increased by more than 2.5 times, while the percentage of time pH<4 in the esophagus decreased on average by almost 3 times. The total number of refluxes per day decreased on average by almost 4 times (V.A. Akhmedov, O.V. Gaus, etc.).

general information

According to the pharmacological index, Khairabezol belongs to the group “Proton pump inhibitors”.
According to ATC, it belongs to the group “Proton pump inhibitors” and has the code “A02BC04 Rabeprazole”. Proton pump inhibitors (in particular, rabeprazole) are considered the most effective drugs for controlling symptoms and treating complications of GERD, such as reflux esophagitis and Barrett's esophagus (see Fifth Moscow Agreement // XIII Congress of the National Registry, March 12, 2013).

Manufacturer: Highglans Laboratories, India. Dispensed from pharmacies with a doctor's prescription.

Dosage forms and composition of Khairabezol

The active substance of Khairabezol
is
rabeprazole
.

Khairabezol is available in the form of enteric film-coated tablets. The tablets are round, biconvex.

Tablets containing the active ingredient rabeprazole sodium 10 mg

covered with a shell of light to reddish-pink color.

Tablets containing rabeprazole sodium 20 mg

covered with a light yellow or yellow shell.

The tablets contain excipients magnesium oxide, mannitol, corn starch, povidone K30, low-substituted hyprolose, sodium stearyl fumarate.

The enteric-soluble coating contains cellacephate, titanium dioxide and red iron oxide dye (for Hayrabezol 10 mg tablets) or yellow iron oxide dye (for Khairabezol 20 mg tablets).

Indications for use of Khairabezol

From the instructions for the drug Khairabezol it follows that it is prescribed:

• for the treatment of duodenal and gastric ulcers in the acute stage, as well as anastomotic ulcers;
• for the treatment of reflux esophagitis;
• for the treatment of various forms of gastroesophageal reflux disease (GERD): non-erosive, erosive and ulcerative;
• for maintenance therapy of GERD;
• for the treatment of Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion;
• for the combined treatment of peptic ulcer disease associated
  with
  Helicobacter pylori
  .

Directions for use and dosage of Khairabezol

Khairabezol tablets are taken orally whole, without chewing or crushing. The timing of taking Khairabezol and simultaneous food intake do not affect the effectiveness of the drug.

• For gastric ulcers in the acute stage and anastomotic ulcers, it is recommended to take 10 mg or 20 mg of Hairabezol per day once. The standard course of treatment is 6 weeks, but in some cases it can be extended to 12 weeks.
• For duodenal ulcers in the acute stage, it is recommended to take 20 mg of Khairabezol once a day for 2-4 weeks. The course of treatment can be extended to 8 weeks if necessary. In some cases, the therapeutic effect occurs with a daily dose of 10 mg of the drug.
• For the treatment of erosive GERD or reflux esophagitis, a 4-8 week course of treatment with Khairabezol 10 mg or 20 mg once a day is recommended. Treatment can be extended for another 8 weeks if necessary. For maintenance therapy of GERD, Khairabezol is taken in the same dosage, the duration of treatment is determined by the patient's condition.
• For non-erosive GERD (NERD) without esophagitis, Hairabezol should be taken 10 mg or 20 mg once a day. If symptoms do not disappear after 4 weeks of treatment, additional examination of the patient is necessary. After eliminating the symptoms, in order to avoid their recurrence, a single dose of 10 mg of Hairabezol on demand is recommended.
• Treatment of Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion with Khairabezol involves individual selection of the dosage of the drug. Starting from 60 mg per day, the daily dose is gradually increased to 100 mg in a single dose or 120 mg divided into 2 doses. For some patients, split doses of the drug are preferable. Treatment should be continued as clinically necessary. In cases of Zollinger-Elison syndrome, treatment can last up to one year.
• Combined treatment of duodenal ulcers and chronic gastritis associated with Helicobacter pylori
  involves taking 20 mg of Hairabezol and 500 mg of clarithromycin with 1 mg of amoxicillin or 400 mg of metronidazole twice a day for a week. The use of double doses of Khairabezol increases the effectiveness of three-component therapy (see Fifth Moscow Agreement // XIII Congress of the NOGR. March 12, 2013).

Use of Khairabezol for functional dyspepsia

The choice of Hairabezol as maintenance therapy in patients with functional dyspepsia is justified by the following facts (Butorova L.I. et al.):

• Carrying out a three-month course of maintenance therapy with Khairabezol in a daily dose of 10 or 20 mg in patients with functional dyspepsia significantly reduces the recurrence rate and severity of dyspepsia symptoms compared with the results of using prokinetics and antacids
• the use of Hairabezol at a dose of 20 mg daily allows maintaining clinical remission of the disease in 80% of patients with FD, and at a dose of 10 mg - in 70%
• rapid relief of dyspepsia symptoms when using 20 mg of Khairabezol gives grounds in some cases to recommend maintenance treatment with this drug in an “on demand” mode
• a three-month course of maintenance therapy with Khairabezol was found to be well tolerated; side effects are observed in approximately 3% of patients and are most often expressed in a mild headache that does not require discontinuation of the drug or the use of additional medications
• Khairabezol is safe for long-term use and can be used in conjunction with other medications, including antacids
• Khairabezol has different dosages in tablet form (10, 20 mg) and differs from similar products in lower cost

Restrictions on use and contraindications

Khairabezole should be administered with caution to patients with severe hepatic impairment, since the AUC of rabeprazole in them is approximately 2 times higher than in healthy people.
Elderly patients and patients with renal insufficiency do not require dose adjustment.

Khairabezole should not be prescribed to children and adolescents under 18 years of age, pregnant and lactating women, since there are no sufficient studies to confirm the safety of rabeprazole in these categories of patients.

The FDA Fetal Risk Category for rabeprazole in pregnant women is C (animal studies have shown adverse effects of rabeprazole on the fetus and there have been no adequate studies in pregnant women, but the potential benefits associated with the use of this drug in pregnant women may justify its use despite at the existing risk).

Other medicines containing the active ingredient rabeprazole

In Russia, the following drugs with the active ingredient rabeprazole have been registered for sale in pharmacies: Bereta, Zolispan, Zulbex, Noflux, Ontime, Pariet, Rabelock, Rabeprazole-OBL, Rabeprazole-SZ, Rabiet, Razo. Most of them are available in the form of tablets for oral administration, coated with an intestinal soluble coating, containing 10 or 20 mg of the active substance - rabeprazole.

Side effects of Khairabezol

Side effects when taking Khairabezol most often occur from the digestive system (diarrhea, nausea) and from the nervous system (headache).

Materials for healthcare professionals regarding the use of Hairabezol

Articles

• Akhmedov V.A., Gaus O.V., Kiselev I.E., Kravtsova A.P. Evaluation of the effect of rabeprazole (drug "Hairabezol") 20 mg on 24-hour gastric pH-metry in patients with Hp-negative erosive and ulcerative lesions of the stomach and duodenum // Gastroenterology of St. Petersburg. 2015. No. 1–2. pp. 2–5.
• Akhmedov V.A., Gaus O.V. and others. Evaluation of the effectiveness of the drug hairabezol for the treatment of patients with erosive and ulcerative lesions of the stomach and duodenum // XX Ros. Gastroenterology Week October 6-8. RZHGGK. 2014. No. 5. P. 15.
• Orlov I.N. Diagnostic capabilities of 24-hour gastric pH metry in assessing the clinical effectiveness of the drug “hairabezol” in patients with negative erosive and ulcerative lesions of the stomach and duodenum // Abstracts of the VI International Youth Medical Congress “St. Petersburg Scientific Readings - 2015”. P. 50.
• Butorova L.I., Osadchuk M.A., Osadchuk M.M., Tokmulina G.M., Plavnik T.E., Smirnova N.A.. Optimization of therapeutic tactics for functional dyspepsia syndrome // Doctor.Ru. Gastroenterology. 2015. No. 12 (113). pp. 80-86.
• Spivakovsky Yu.M., Chernenkov Yu.V., Spivakovskaya A.Yu. and others. PPIs in the treatment of chronic gastroduodenitis in children. Materials XIX Ross. congr. "Innovative technologies in pediatrics and pediatric surgery." Russian Bulletin of Perinatology and Pediatrics.2020,65(4)223-4.

On the website GastroScan.ru in the “Literature” section there is a subsection “Rabeprazole”, containing articles devoted to the treatment of diseases of the gastrointestinal tract with rabeprazole preparations.

Video

Still from video by Partsvania-Vinogradova E.V. The role of pH-metry in acid-dependent diseases.

Still from video by E.S. Vyuchnova Tactics for managing patients with duodenogastric/biliary reflux

On the website GastroScan.ru in the “Video” section there is a subsection “For doctors”, containing video recordings of reports, lectures, webinars in various areas of gastroenterology for healthcare professionals, as well as a subsection “For students of medical universities”

Khairabezol has contraindications and side effects. Before use, you should consult a specialist. Back to section

Khairabezol, 15 pcs., 20 mg, enteric-coated tablets

Absorption

Rabeprazole is rapidly absorbed from the intestine and peak plasma concentrations (Cmax) are achieved approximately 3.5 hours after a 20 mg dose. Changes in peak plasma concentrations and area under the pharmacokinetic concentration-time curve (AUC) of rabeprazole are linear in the dose range from 10 to 40 mg. Absolute bioavailability after oral administration of 20 mg (compared to intravenous administration) is approximately 52%. In addition, bioavailability does not change with repeated dosing of rabeprazole. Neither the time of taking the drug during the day nor antacids affect the absorption of rabeprazole. Taking the drug with fatty foods slows down the absorption of rabeprazole by 4 hours or more, but neither Cmax nor the degree of absorption changes.

Distribution

In humans, the degree of binding of rabeprazole to plasma proteins is about 97%. Metabolism

Rabeprazole is metabolized in the body in two ways. A significant part of it is metabolized systemically by a non-enzymatic route with the formation of thioester derivatives. Rabeprazole is also metabolized in the liver via cytochrome P450 to form sulfonic and desmethyl derivatives.

In healthy volunteers, the plasma half-life is approximately 1 hour (varies from 0.7 to 1.5 hours), and the total clearance is 3.8 ml/min/kg.

Removal

After a single oral dose of 20 mg of 14C-labeled rabeprazole, about 90% of the drug is excreted in the urine, mainly in the form of carboxylic acid thioester, its glucuronide and in the form of mercapturic acid derivatives. No unchanged drug is detected in the urine. The remainder of the rabeprazole taken is excreted through the intestines. The total elimination is 99.8%.

End stage renal failure

In patients with stable end-stage renal disease who require maintenance hemodialysis (creatinine clearance <5 ml/min/1.73 m2), the elimination of rabeprazole is similar to that of healthy volunteers. AUC and Cmax in these patients were approximately 35% lower than in healthy volunteers. On average, T1/2 of rabeprazole was 0.82 hours in healthy volunteers, 0.95 hours in patients during hemodialysis and 3.6 hours after hemodialysis. Clearance of the drug in patients with kidney disease requiring hemodialysis was approximately twice as high as in healthy volunteers.

Chronic compensated cirrhosis

Patients with chronic compensated liver cirrhosis tolerate rabeprazole 20 mg once daily, although AUC is doubled and Cmax is increased by 50% compared to healthy volunteers.

Elderly patients

In elderly patients, the elimination of rabeprazole is somewhat slower. After 7 days of taking rabeprazole at a dose of 20 mg 1 time per day in elderly individuals, AUC was approximately twice as high and Cmax was increased by 60% compared to young healthy volunteers; There were no signs of drug accumulation.

СYР2С19 polymorphism

In patients with slow metabolism via the CYP2C19 isoenzyme, after 7 days of taking rabeprazole at a dose of 20 mg per day, the AUC increases by 1.9 times and the half-life by 1.6 times compared with the same parameters in “rapid metabolizers”, while how Cmax increases by 40%.

Khairabezol tablet p/o 20 mg N15 (Hainglas)

Inside. The tablets should be swallowed whole, without chewing or crushing. It has been established that neither the time of day nor food intake affects the activity of rabeprazole. For gastric ulcers in the acute stage and anastomotic ulcers: 10 or 20 mg 1 time per day. Usually, cure occurs after 6 weeks of therapy, but in some cases the duration of treatment can be increased by another 6 weeks. For duodenal ulcer in the acute stage: 20 mg 1 time per day. In some cases, a therapeutic effect occurs when taking 10 mg once a day. The duration of treatment is from 2 to 4 weeks. If necessary, the duration of treatment can be increased by another 4 weeks. When treating erosive GERD or reflux esophagitis, 10 or 20 mg 1 time per day. The duration of treatment is from 4 to 8 weeks. If necessary, the duration of treatment can be increased by another 8 weeks. For maintenance therapy of GERD, 10 or 20 mg 1 time per day. The duration of treatment depends on the patient's condition. For non-erosive GERD (NERD) without esophagitis, 10 or 20 mg 1 time per day. If after 4 weeks of treatment the symptoms do not disappear, additional examination of the patient should be performed. After relief of symptoms, to prevent their subsequent occurrence, the drug should be taken orally at a dose of 10 mg 1 time per day as required. For the treatment of Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion, the dose is selected individually. The initial dose is 60 mg per day, then the dose is increased and the drug is prescribed at a dose of up to 100 mg per day in a single dose or 60 mg 2 times a day. For some patients, fractional dosing of the drug is preferable. Treatment should be continued as clinically necessary. In some patients with Zollinger-Ellison syndrome, the duration of treatment with rabeprazole is up to one year. For the treatment of duodenal ulcer or chronic gastritis associated with H. pylori infection, a course of treatment lasting 7 days with one of the following combinations of drugs is recommended: Patients with renal and hepatic insufficiency. No dosage adjustment is required for patients with renal failure. In patients with mild to moderate hepatic insufficiency, the concentration of rabeprazole in the blood is usually higher than in healthy patients. Caution should be exercised when prescribing Khairabezole to patients with severe hepatic insufficiency. Elderly patients. No dose adjustment is required. Children. The safety and effectiveness of rabeprazole 20 mg for the short-term (up to 8 weeks) treatment of GERD in children aged 12 years and over is confirmed by extrapolation of the results of adequate and well-controlled studies that support the effectiveness of rabeprazole in adults with safety and pharmacokinetic studies in pediatric patients. The recommended dose for children aged 12 years and over is 20 mg once a day for up to 8 weeks. The safety and effectiveness of rabeprazole for the treatment of GERD in children younger than 12 years of age have not been established. The safety and effectiveness of rabeprazole for other indications has not been established in pediatric patients.

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.