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Active ingredients
Esomeprazole
Release form
Coated pills
Composition
1 tab.: Esomeprazole magnesium trihydrate 22.3 mg, which corresponds to an esomeprazole content of 20 mg. Adjuvants: glyceryl monostearate 40-55 - 1.7 mg, hyprolosis - 8.1 mg, hypromellose - 17 mg, iron dye red oxide (E172) - 60 μg, iron dye yellow oxide (E172) - 20 mcg, magnesium stearate - 1.2 mg, copolymer of methacrylic and ethacrylic acid (1: 1) - 35 mg, microcrystalline cellulose - 273 mg, paraffin - 200 mcg, macrogol - 3 mg, polysorbate 80 - 620 mcg, crospovidone - 5.7 mg, sodium stearyl fumarate - 570 mcg, sucrose spherical granules (sugar, spherical granules) (size 0.250-0.355 mm) - 28 mg, titanium dioxide (E171) - 2.9 mg, talc - 14 mg, triethyl citrate - 10 mg.
Pharmacological effect
Esomeprazole is the S-isomer of omeprazole and reduces the secretion of hydrochloric acid in the stomach by specifically inhibiting the proton pump in the parietal cells of the stomach. The S- and R-isomer of omeprazole have similar pharmacodynamic activity. The mechanism of actionEzomeprazole is a weak base, which becomes active in the highly acidic medium of the secretory tubules of the parietal cells of the gastric mucosa and inhibits the proton pump - the enzyme H + / K + - ATPase, while both basal and stimulated secretion of hydrochloric acid are inhibited. Effects on the secretion of hydrochloric acid in the stomach The effect of esomeprazole develops within 1 hour after oral administration of 20 mg or 40 m year With daily intake of the drug for 5 days at a dose of 20 mg once a day, the average maximum concentration of hydrochloric acid after stimulation with pentagastrin is reduced by 90% (when measuring the concentration of acid 6-7 hours after taking the drug on the 5th day of therapy). In patients with gastroesophageal reflux disease (GERD) and the presence of clinical symptoms after 5 days of daily oral administration of esomeprazole in a dose of 20 mg or 40 mg, the intragastric pH above 4 was maintained for an average of 13 and 17 hours from 24 hours. While receiving esomeprazole at a dose of 20 mg per day, the intragastric pH value above 4 was maintained for at least 8, 12, and 16 hours in 76%, 54%, and 24% of patients, respectively. For 40 mg of esomeprazole, this ratio is 97%, 92% and 56%, respectively. A correlation was found between the plasma concentration of the drug and the inhibition of the secretion of hydrochloric acid (the AUC parameter was used to estimate the concentration. The area under the concentration-time curve). achieved by inhibiting the secretion of hydrochloric acid.When Nexium is taken in a dose of 40 mg, reflux esophagitis heals in approximately 78% of patients after 4 weeks of therapy and in 93% of patients after 8 weeks of therapy. Treatment of Nexium at a dose of 20 mg 2 times a day in combination with appropriate antibiotics for one week leads to successful eradication of Helicobacter pylori in approximately 90% of patients. Patients with uncomplicated peptic ulcer disease after a week-long eradication course do not require subsequent monotherapy with drugs that lower the secretion of gastric glands to heal the ulcer and eliminate of symptoms. The effectiveness of Nexium in bleeding from peptic ulcers was shown in a study of patients with bleeding from peptic ulcers confirmed endoscopically. Other effects associated with inhibition of hydrochloric acid secretion. During treatment with drugs that lower the secretion of the gastric glands, the concentration of gastrin in plasma increases as a result of a decrease in acid secretion. Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A (CgA) increases. Increasing the CgA concentration may influence the results of examinations for the detection of neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors should be suspended 5-14 days prior to the study of CgA concentration. If the CgA concentration did not return to normal during this time, the study should be repeated. Children and adult patients who received esomeprazole for a long time have an increase in the number of enterochromaffin-like cells, probably due to an increase in plasma gastrin concentration. This phenomenon has no clinical significance. In patients taking drugs that lower the secretion of the gastric glands over a long period of time, the formation of glandular cysts in the stomach is more common. These phenomena are due to physiological changes as a result of marked inhibition of the secretion of hydrochloric acid. Cysts are benign and undergo backward development. The use of drugs that suppress the secretion of hydrochloric acid in the stomach, including proton pump inhibitors, is accompanied by an increase in the content of gastric microbial flora, normally present in the gastrointestinal tract.The use of proton pump inhibitors can lead to a slight increase in the risk of infectious diseases of the gastrointestinal tract caused by bacteria of the genus Salmonella spp. and Campylobacter spp. and, in hospitalized patients, probably Clostridium difficile. During the two comparative studies conducted with ranitidine, Nexium showed better efficacy in the healing of gastric ulcers in patients who received non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2) . In two studies, Nexium showed high efficacy in the prevention of gastric and duodenal ulcers in patients who received NSAIDs (age group over 60 years and / or with a peptic ulcer in history), including selective COX-2 inhibitors.
Pharmacokinetics
Absorption and distribution Esomeprazole is unstable in an acidic environment, therefore, for oral use, pills containing the granules of the drug are used, the shell of which is resistant to the action of gastric juice. In vivo, only a small fraction of esomeprazole is converted to the R-isomer. The drug is rapidly absorbed: the maximum plasma concentration is reached after 1 -2 hours after administration. The absolute bioavailability of esomeprazole after a single dose of 40 mg is 64% and increases to 89% with daily intake once a day. For a dose of 20 mg of esomeprazole, these figures are 50% and 68%, respectively. The volume of distribution at an equilibrium concentration in healthy people is approximately 0.22 l / kg body weight. Esomeprazole binds to plasma proteins by 97%. Food intake slows down and reduces the absorption of esomeprazole in the stomach, but this does not have a significant effect on the inhibition of secretion of hydrochloric acid. Metabolism and excretion Esomeprazole undergoes metabolism involving the cytochrome P450 system. The main part is metabolized with the participation of the specific polymorphic isoenzyme SUR2C19, with the formation of hydroxylated and desmethylated metabolites of esomeprazole. Metabolism of the remaining part is carried out by CYP3A4 isoenzyme; this produces a sulfose derivative of esomeprazole, which is the main metabolite that is determined in plasma. The parameters below reflect mainly the nature of the pharmacokinetics in patients with an increased activity of the CYP2C19 isoenzyme. The total clearance is approximately 17 l / h after a single dose of the drug and 9 l / h - after multiple doses.The half-life is 1.3 hours with a systematic intake once a day. The area under the concentration-time curve (AUC) increases with repeated administration of esomeprazole. The dose-dependent increase in AUC upon repeated administration of esomeprazole is non-linear, which is a consequence of a decrease in metabolism during the "first pass" through the liver, as well as a decrease in systemic clearance, probably caused by inhibition of the CYP2C19 isoenzyme by esomeprazole and / or its sulfonic. With daily intake once a day, esomeprazole is completely excreted from the blood plasma during the interval between doses and does not accumulate. The main metabolites of esomeprazole do not affect the secretion of gastric acid. When administered orally, up to 80% of the dose is excreted in the form of metabolites in the urine, the rest is excreted in the feces. Less than 1% of unchanged esomeprazole is detected in the urine. Specific pharmacokinetics in some patient groups. Approximately 2.9 ± 1.5% of the population has a reduced activity of the CYP2C19 isoenzyme. In these patients, the metabolism of esomeprazole, mainly carried out as a result of the action of CYP3A4. When systematically receiving 40 mg of esomeprazole once a day, the average AUC value is 100% higher than the value of this parameter in patients with increased activity of the CYP2C19 isoenzyme. Mean values of maximum plasma concentrations in patients with reduced isoenzyme activity are increased by approximately 60%. These features do not affect the dose and method of application of esomeprazole. In elderly patients (71-80 years), the metabolism of esomeprazole does not undergo significant changes. After a single dose of 40 mg of esomeprazole, the average AUC in women is 30% higher than in men. With daily intake of the drug once a day, differences in pharmacokinetics in men and women are not observed. These features do not affect the dose and method of application of esomeprazole. In patients with mild and moderate liver failure, the metabolism of esomeprazole may be disturbed. In patients with severe hepatic insufficiency, the metabolic rate is reduced, which leads to an increase in the AUC value for esomeprazole by 2 times. The study of pharmacokinetics in patients with renal insufficiency was not conducted.Since not the esomeprazole itself but its metabolites are eliminated through the kidneys, it can be assumed that the metabolism of esomeprazole in patients with renal insufficiency does not change. In children aged 12-18 years after repeated administration of 20 mg and 40 mg of esomeprazole, plasma AUC and TCmax blood was similar to the AUC and TCmax values in adults.
Indications
Gastroesophageal Reflux Disease: - treatment of erosive reflux esophagitis; long-term post treatment after treatment of erosive reflux esophagitis to prevent recurrence; symptomatic treatment of gastroesophageal reflux disease; Peptic ulcer of the stomach and duodenal ulcer; Helicobacter pylori; - prevention of recurrence of peptic ulcers associated with Helicobacter pylori. Durable acid suppression therapy in patients, Transferring bleeding from peptic ulcers (after intravenous administration of drugs that lower the secretion of gastric glands, to prevent recurrence). Patients long-term NSAIDs: - Healing of stomach ulcers associated with taking NSAIDs; - Prevention of gastric and duodenal ulcers associated with the use of NSAIDs risk patients. Zollinger-Ellison syndrome or other conditions characterized by pathological hypersecretion of the gastric glands, including idiopathic hypersecretion.
Contraindications
- hypersensitivity to esomeprazole, substituted benzimidazoles or other ingredients that make up the drug - hereditary fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency; - children under 12 years of age (due to lack of data on the effectiveness and safety of the drug in this group of patients) and child age over 12 years of age according to other indications other than gastroesophageal reflux disease - esomeprazole should not be taken together with atazanavir m and nelfinavir (see "Interaction with other drugs and other types of drug interactions.") Precautions:. severe renal failure (application experience is limited).
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Currently, there is not enough data on the use of Nexium during pregnancy. The results of epidemiological studies of omeprazole, which is a racemic mixture, showed no fetotoxic effect or impaired fetal development. When administering esomeprazole, the animals did not reveal any direct or indirect negative effect on the development of the embryo or fetus. The introduction of the racemic mixture of the drug also did not have any negative effects on animals during pregnancy, childbirth, and postnatal development. The drug should be prescribed to pregnant women only when the expected benefit to the mother exceeds the possible risk to the fetus. It is not known if esomeprazole is excreted in breast milk, therefore Nexium should not be administered during breastfeeding.
Dosage and administration
Inside The tablet should be swallowed whole with a liquid. Tablets should not be chewed or crushed. For patients with difficulty swallowing, pills can be dissolved in half a glass of non-carbonated water (other liquids should not be used, since the protective sheath of microgranules can dissolve), stirring before disintegration of the tablet, after which the suspension of microgranules should be drunk immediately or 30 minutes, then re-fill the glass with water half, stir the residue and drink. Microgranules should not be chewed or crushed. For patients who cannot swallow, pills should be dissolved in non-carbonated water and administered through a nasogastric tube. It is important that the chosen syringe and probe are suitable for this procedure. Instructions on the preparation and administration of the drug through a nasogastric tube are given in the section “Nasogastric tube administration”. Adults and children from 12 years old Gastroesophageal reflux disease Treatment of erosive reflux esophagitis: 40 mg once a day for 4 weeks. An additional 4 is recommended. weekly course of treatment in cases where after the first course the healing of esophagitis does not occur or symptoms persist. Long-term supportive treatment after healing of erosive reflux esophagitis to prevent recurrence Cydive: 20 mg once a day. Symptomatic treatment of gastroesophageal reflux disease: 20 mg once a day - to patients without esophagitis.If after 4 weeks of treatment the symptoms do not disappear, an additional examination of the patient should be carried out. After elimination of symptoms, it is possible to switch to the mode of taking the drug "if necessary", i.e. Take Nexium at a dosage of 20 mg once a day if symptoms recur. For patients who are taking NSAIDs and are at risk of developing gastric or duodenal ulcers, “if necessary” treatment is not recommended. pylori: Nexium 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All drugs are taken twice a day for 1 week. - Prevention of recurrence of peptic ulcers associated with Helicobacter pylori: Nexium 20 mg, amoxicillin 1 g clarithromycin 500 mg. All drugs are taken twice a day for 1 week. Prolonged acid suppression therapy in patients undergoing bleeding from peptic ulcers (after intravenous use of drugs that lower the secretion of the gastric glands to prevent relapse) Nexium 40 mg 1 time per day for 4 weeks the end of intravenous therapy with drugs that lower the secretion of gastric glands. Patients who take NSAIDs for a long time: - healing of a stomach ulcer associated with taking NSAIDs: Nexium 20 mg or 40 mg once a day. The duration of treatment is 4-8 weeks. - Prevention of gastric and duodenal ulcers associated with taking NSAIDs: Nexium 20 mg or 40 mg once a day. Conditions associated with abnormal hypersecretion of the gastric glands, including Zollinger-Ellison syndrome and idiopathic hypersecretion: The recommended initial dose is Nexium 40 mg twice a day. In the future, the dose is selected individually, the duration of treatment is determined by the clinical picture of the disease. There is experience with the use of the drug in doses up to 120 mg 2 times a day. Renal failure: dose adjustment is not required. However, experience with Nexium in patients with severe renal insufficiency is limited; therefore, caution should be exercised in prescribing such patients (see the Pharmacokinetics section). Hepatic insufficiency: With mild and moderate hepatic insufficiency, no dose adjustment is required.For patients with severe liver failure, the maximum daily dose should not exceed 20 mg. Elderly patients: dose adjustment of the drug is not required. Administration of the drug through a nasogastric tube When prescribing the drug through a nasogastric tube1. Place the pill in the syringe and fill the syringe with 25 ml of water and approximately 5 ml of air. For some probes it may be necessary to dilute the drug in 50 ml of drinking water in order to prevent the pellets from clogging the probe with the tablet pellets. 3. Immediately shake the syringe for about two minutes to dissolve the tablet. Hold the syringe tip up and make sure the tip is not clogged. Insert the tip of the syringe into the probe, continuing to hold it up. Shake the syringe and tip it upside down. Immediately enter 5-10 ml of the dissolved drug into the probe. After insertion, return the syringe to its previous position and shake (the syringe should be kept tip up to avoid clogging of the tip) .6. Turn the syringe tip down and inject another 5-10 ml of the drug into the probe. Repeat this operation until the syringe is empty. 7. In the case of the remainder of the drug in the form of sediment in the syringe, fill the syringe with 25 ml of water and 5 ml of air and repeat the operations described in paragraph 5.6. Some probes may require 50 ml of drinking water for this purpose.
Side effects
Below are the side effects that do not depend on the dosing regimen of the drug, noted during the use of Nexium, both in clinical studies and in post-marketing studies. The frequency of side effects is given in the form of the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000). On the side of skin and subcutaneous tissues Infrequently: dermatitis, pruritus, rash, urticaria; Rarely: alopecia, photosensitization; Very rare: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. On the part of musculoskeletal system and connective tissue: Rare: arthralgia, myalgia; Very rare: muscular weakness. On the nervous system side: frequent: headache; Infrequently: dizziness, paresthesia, drowsiness; Rarely: impaired taste. Psychiatric disorders Infrequently: insomnia; Rarely: depression, agitation, confusion; Very seldom: hallucinations,aggressive behavior. From the gastrointestinal tract Frequently: abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting; Infrequent: dry mouth; Rarely: stomatitis, gastrointestinal candidiasis; Very rare: microscopic colitis (confirmed histologically). From the side of the liver and biliary tractPrequently: an increase in the activity of "liver" enzymes; Rarely: hepatitis (with or without jaundice); Very rarely: liver failure, encephalopathy in patients with liver diseases. From the genitals and mammary gland Very rare: gynecomastia. From the side of blood and lymphatic system. Rarely: leukopenia, thrombocytopenia; Very rare: agranulocytosis, pancytopenia. From the side of immune system. Rarely: hypersensitivity reactions (eg, fever, angioedema, edema, anaphylactic / anaphylactic, anaphylactic, / anaphylactic, anaphylactic reaction (antiviral) and mediastinumRedko: bronchospasm. On the part of the kidneys and urinary tract. Very rare: interstitial nephritis. On the part of the organ of vision. Rarely: blurred vision. On the side of metabolism and nutrition. often: peripheral edema; Rarely: hyponatremia; Very rare: hypomagnesemia; hypocalcemia due to severe hypomagnesemia, hypokalemia due to hypomagnesemia. General disorders Rarely: malaise, sweating.
Overdose
To date, extremely rare cases of deliberate overdose have been described. Oral administration of esomeprazole at a dose of 280 mg was accompanied by general weakness and symptoms of the gastrointestinal tract. A single dose of 80 mg Nexium did not cause any negative effects. The antidote of esomeprazole is unknown. Esomeprazole binds well to plasma proteins, so dialysis is ineffective. In case of overdose, symptomatic and general supportive treatment should be carried out.
Interaction with other drugs
Effect of esomeprazole on the pharmacokinetics of other drugs. Reducing the secretion of hydrochloric acid in the stomach during treatment with esomeprazole and other proton pump inhibitors can lead to a decrease or increase in the absorption of drugs, the absorption of which depends on the acidity of the environment. Like other drugs that reduce the acidity of gastric juice, treatment with esomeprazole can lead to a decrease in the absorption of ketoconazole, itraconazole and erlotinib, and 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% (the bioavailability of digoxin increased by up to 30% in two out of ten patients). It was shown that omeprazole interacts with some 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, during therapy with omeprazole, a decrease in their concentration in serum is noted. Therefore, their simultaneous use is not recommended. The combined use of omeprazole (40 mg once daily) with atazanavir 300 mg / ritonavir 100 mg in healthy volunteers resulted in a significant decrease in the bioavailability of atazanavir (the area under the concentration-time curve, Cmax and Cmin decreased by approximately 75%). Increasing the dose of atazanavir to 400 mg did not compensate for the effects of omeprazole on the bioavailability of atazanavir. With simultaneous use of omeprazole and saquinavir, an increase in serum saquinavir was observed, and when used with some other antiretroviral drugs, their concentration did not change. Given the similar pharmacokinetic and pharmacodynamic properties of omeprazole and esomeprazole, the combined use of esomeprazole with antiretroviral drugs such as atazanavir and nelfinavir is not recommended. Esomeprazole inhibits CYP2C19, the main isoenzyme involved in its metabolism. Accordingly, the combined use of esomeprazole with other drugs whose metabolism involves the CYP2C19 isoenzyme, such as diazepam, citalopram, imipramine, clomipramine, phenytoin, etc., can lead to an increase in plasma concentrations of these drugs, which, in turn, may require dose reduction. This interaction is especially important to remember when using the Nexium in the “as needed” mode. When co-administered with 30 mg of esomeprazole and diazepam, which is a substrate of the CYP2C19 isoenzyme, diazepam clearance decreased by 45%. Use of esomeprazole at a dose of 40 mg resulted in an 13% increase in the residual concentration of phenytoin in patients with epilepsy.In this regard, it is recommended to monitor the plasma phenytoin concentrations at the beginning of treatment with esomeprazole and when it is canceled. The use of omeprazole in a dose of 40 mg once a day increased the area under the concentration-time curve and Cmax of voriconazole (CYP2C19 isoenzyme substrate) by 15 % and 41%, respectively. Combined intake of warfarin with 40 mg of esomeprazole does not change the coagulation time in patients who take warfarin for a long time. However, several cases of a clinically significant increase in the INR index (international normalized ratio) have been reported with the combined use of warfarin and esomeprazole. It is recommended to control the INR at the beginning and at the end of the combined use of esomeprazole and warfarin or other coumarin derivatives. According to the research results, pharmacokinetic / pharmacodynamic interaction between clopidogrel (loading dose 300 mg and maintenance dose 75 mg / day) and esomeprazole (40 mg / day) are noted. inside), which leads to a decrease in the active metabolite of clopidogrel on average by 40% and a decrease in the maximum inhibition of ADP-induced platelet aggregation by an average of 14%. Clinical the significance of this interaction is not clear. In a prospective study in patients receiving placebo or omeprazole at a dose of 20 mg / day. simultaneously with therapy with clopidogrel and acetylsalicylic acid (ACK), and analyzing the clinical outcome of large-scale randomized trials, no increase in the risk of cardiovascular complications was shown when using clopidogrel and proton pump inhibitors, including esomeprazole, together. on the presence or absence of an increased risk of thromboembolic cardiovascular complications on the background of the combined use of clopidogrel and ibitorov proton pompy.Pri clopidogrel together with a fixed combination of 20 mg of esomeprazole and 81 mg ASA exposure of the active metabolite of clopidogrel decreased by almost 40% compared to a monotherapy clopidogrel, with maximal levels of inhibition of ADP-induced platelet aggregation were identical, which probablyassociated with the simultaneous administration of ASK in a low dose. The use of omeprazole in a dose of 40 mg resulted in an increase in Cmax and AUC (area under the concentration-time curve) of cilostazol by 18% and 26%, respectively; for one of the active metabolites of Cilostazol, the increase was 29% and 69%, respectively. Combined intake of cisapride with 40 mg of esomeprazole leads to an increase in the values of pharmacokinetic parameters of cisapride in healthy volunteers: AUC - by 32% and half-life by 31%, but the maximum concentration of cisapride in plasma, it does not significantly change. A slight lengthening of the QT interval, which was observed with cisapride monotherapy, did not increase with the addition of Nexium (see the section "Special Instructions"). With simultaneous use of esomeprazole and tacrolimus, an increase in serum tacrolimus was noted. Some patients noted an increase in methotrexate concentration in the background combined use with proton pump inhibitors. When using high doses of methotrexate, the possibility of temporary withdrawal of esomeprazole should be considered. Nexium does not cause clinically significant changes in the pharmacokinetics of amoxicillin and quinidine. Studies evaluating the short-term co-administration of esomeprazole and naproxen or rofecoxib did not reveal any clinically significant pharmacokinetic interactions. esomeprazole is involved enzymes CYP2C19 and CYP3A4. The combined use of esomeprazole with clarithromycin (500 mg 2 times a day), which inhibits the CYP3A4 isoenzyme, leads to an increase in the AUC value of esomeprazole by 2 times. The combined use of esomeprazole and the combined inhibitor of CYP3A4 and CYP2C19 isoenzymes, for example, voriconazole, can lead to a more than 2-fold increase in the AUC value for esomeprazole. As a rule, in such cases, dosage adjustment of esomeprazole is not required. Dose adjustment of esomeprazole may be required in patients with severely impaired liver function and its prolonged use. Medications that induce CYP2C19 and CYP3A4 isoenzymes, such as rifampicin and Hypericum perforatum preparations, can lead to a decrease in the concentration of esomeprazole by reducing it; by accelerating the metabolism of esomeprazole.
special instructions
If there are any alarming symptoms (for example, such as significant spontaneous weight loss, repeated vomiting, dysphagia, vomiting with blood or melena), and also in the presence of a stomach ulcer (or if a stomach ulcer is suspected), the presence of a malignant neoplasm should be excluded, since Nexium treatment can lead to a smoothing of symptoms and delay the diagnosis. In rare cases, patients who have taken omeprazole for a long time can undergo histological examination of biopsies of the stomach mucous membrane and atrophic detected gastrit.Patsienty taking the drug for a long period (more particularly years) should be under regular supervision. Patients taking Nexium “as needed” should be instructed to contact their physician when symptoms change. Taking into account fluctuations in the concentration of esomeprazole in plasma in the appointment of therapy "as needed", you should consider the interaction of the drug with other drugs (see the section "Interaction with other drugs and other types of drug interactions"). In appointing Nexium for the eradication of Helicobacter pylori, the possibility of drug interactions for all components of triple therapy should be taken into account. Clarithromycin is a potent inhibitor of CYP3A4, so when prescribing eradication therapy to patients receiving other drugs metabolized with CYP3A4 (for example, cisapride), it is necessary to take into account possible contraindications and interactions of clarithromycin with these drugs. fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. According to the results of studies on The pharmacokinetic / pharmacodynamic interaction between clopidogrel (a loading dose of 300 mg and a maintenance dose of 75 mg / day) and esomeprazole (40 mg / day orally) is noted, which leads to a decrease in the active metabolite of clopidogrel by an average of 40% and a decrease in the maximum inhibition of ADP- induced platelet aggregation by an average of 14%.Therefore, the simultaneous use of esomeprazole and clopidogrel should be avoided. such studies did not show an increased risk. In randomized, double-blind, controlled clinical trials of omeprazole and esomeprazole, including I have two open-label studies of long-term therapy (more than 12 years), the connection of fractures due to osteoporosis with