Nexium tabs 20mg #28

Nexium instruction for use

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Form of release, composition and packaging

The tablets covered with a cover of light pink color, oblong, biconcave, with engraving "20 mG" on one side and "A / EN" in the form of a fraction - on another; on the fracture - white with yellow impregnations (such as croup).
1 tab.
esomeprazole magnesium trihydrate 22.3 mg,
which corresponds to the content of esomeprazole 20 mg
Auxiliary substances: glyceryl monostearate 40-55-1.7 mg, giprolose 8.1 mg, hypromellose 17 mg, ferric oxide red oxide (E172) 0.06 mg, iron oxide yellow oxide (E172) 0.02 mg, magnesium stearate 1.2 mg, methacrylic and ethacrylic acid copolymer (1: 1) 35 mg, microcrystalline cellulose 273 mg, paraffin 0.2 mg, macrogol 3 mg, polysorbate 80 0.62 mg, crospovidone 5.7 mg, sodium stearyl fumarate 0.57 mg, sucrose spherical pellets (sugar, spherical granules) (size 0.25-0.355 mm) - 28 mg, titanium dioxide (E171) - 2.9 mg, talcum - 14 mg, triethyl citrate - 10 mg.

pharmachologic 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 parietal cells of the stomach. The S- and R-isomer of omeprazole have similar pharmacodynamic activity.

Mechanism of action

Esomeprazole is a weak base that transforms into an active form in a highly acidic environment of the secretory tubules of parietal cells of the gastric mucosa and inhibits the proton pump - the enzyme H + / K + - ATPase, with both basal and stimulated hydrochloric acid being inhibited.
Effect on the secretion of hydrochloric acid in the stomach
The action of esomeprazole develops within 1 hour after oral administration of 20 mg or 40 mg. With daily intake of Nexium tablets 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 acid concentration 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 esomeprazole at a dose of 20 mg or 40 mg, the intragastric pH above 4 was maintained for an average of 13 and 17 hours out of 24 hours. Against the background of taking esomeprazole at a dose of 20 mg per day, the value of intragastric pH above 4 was maintained 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 concentration of Nexium tablets in plasma and the inhibition of hydrochloric acid secretion (the AUC parameter (the area under the concentration-time curve) was used to estimate the concentration.
The therapeutic effect achieved by inhibiting the secretion of hydrochloric acid. When Nexium is taken in a dose of 40 mg, the healing of reflux esophagitis occurs in approximately 78% of patients after 4 weeks of therapy and in 93% after 8 weeks of therapy.
Treatment with Nexium 20 mg twice daily 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 after a weekly eradication course do not need subsequent monotherapy with drugs that reduce the secretion of the glands of the stomach, to heal ulcers and eliminate symptoms.
The efficacy of Nexium in bleeding from peptic ulcers was shown in a study of patients with peptic ulcer bleeding, endoscopically confirmed.
Other effects associated with inhibition of hydrochloric acid secretion. During treatment with drugs that reduce the secretion of the gland of the stomach, the concentration of gastrin in the plasma increases as a result of reduced acid secretion. Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A (CgA) increases. An increase in CgA concentration may influence the results of the examinations to identify neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors should be stopped 5 to 14 days before the CgA concentration test. If during this time the concentration of CgA did not return to the normal value, the study should be repeated.
In children and adults who have been receiving esomeprazole for a long time, there is an increase in the number of enterochromaffin-like cells, probably due to an increase in the concentration of gastrin in the plasma. Clinical significance of this phenomenon is not.
In patients taking drugs that reduce the secretion of the glands of the stomach, for a long period of time, the formation of glandular cysts in the stomach is more often noted. These phenomena are caused by physiological changes as a result of pronounced inhibition of the secretion of hydrochloric acid. Cysts are benign and undergo reverse development.
The use of drugs that inhibit the secretion of hydrochloric acid in the stomach, including proton pump inhibitors, is accompanied by an increase in the content of the microbial flora in the stomach, 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.
In two comparative studies with ranitidine, Nexium showed better efficacy in healing gastric ulcers in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (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 peptic ulcer in the anamnesis), including selective inhibitors of COX-2.

Pharmacokinetics

Absorption and distribution

Esomeprazole is unstable in an acidic medium, therefore for oral use, tablets are used containing granules of the preparation, 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 quickly absorbed: the maximum concentration in the plasma is achieved after 1 -2 hours after ingestion. Absolute bioavailability of esomeprazole after a single dose of 40 mg is 64% and increases to 89% on the background of daily administration once a day. For a dose of 20 mg of esomeprazole, these values ​​are 50% and 68%, respectively. The volume of distribution at equilibrium concentration in healthy people is approximately 0.22 l / kg body weight. Esomeprazole binds to plasma proteins by 97%.
Eating slows and reduces absorption of esomeprazole in the stomach, but this does not have a significant effect on the inhibition of hydrochloric acid secretion.

Metabolism and excretion

Esomeprazole undergoes a metabolism involving the cytochrome P450 system. The main part is metabolized with the participation of a specific polymorphic isoenzyme СUR2С19, with the formation of hydroxylated and desmethylated metabolites of esomeprazole. The metabolism of the remainder is carried out by the isoenzyme CYP3A4; This produces a sulfo derivative of esomeprazole, which is the main metabolite, determined in plasma.
The parameters given below mainly reflect the nature of pharmacokinetics in patients with increased activity of the isoenzyme CYP2C19. The total clearance is approximately 17 l / h after a single dose and 9 l / h - after repeated administration. The half-life is 1.3 hours with a systematic admission once a day. The area under the concentration-time curve (AUC) increases with repeated admission of esomeprazole. The dose-dependent increase in AUC with repeated administration of esomeprazole is non-linear, which is a consequence of a decrease in metabolism during "first passage" through the liver, and a decrease in systemic clearance, probably caused by inhibition of the isoenzyme CYP2C19 with esomeprazole and / or its sulfo derivative. With daily intake once a day, esomeprazole is completely removed from the blood plasma during a break between doses and does not cumulate.
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 with urine, the rest is excreted with feces. In urine, less than 1% of unchanged esomeprazole is found.

Peculiarities of pharmacokinetics in some groups of patients.

Approximately 2.9 ± 1.5% of the population has decreased activity of the isoenzyme CYP2C19. In such patients, the metabolism of esomeprazole is mainly due to the action of CYP3A4. With the systematic administration of 40 mg of esomeprazole, once a day, the mean AUC value is 100% higher than the value of this parameter in patients with increased activity of the isoenzyme CYP2C19. The mean values ​​of maximum plasma concentrations in patients with reduced isoenzyme activity were increased by approximately 60%. These features do not affect the dose and method of use of esomeprazole. In patients of advanced age (71-80 years), the metabolism of esomeprazole does not undergo significant changes.
After a single dose of 40 mg esomeprazole, the average AUC in women is 30% higher than that of men. With daily intake of Nexium tablets once a day, there are no differences in pharmacokinetics in men and women. These features do not affect the dose and method of use of esomeprazole. In patients with mild and moderate hepatic insufficiency, the metabolism of esomeprazole may be impaired. In patients with severe hepatic insufficiency the metabolic rate is reduced, which leads to an increase in the value of AUC for esomeprazole by a factor of 2.
The study of pharmacokinetics in patients with renal insufficiency was not carried out. Because the kidneys exclude not the most esomeprazole, but its metabolites, 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, the AUC and TCmax values ​​in blood plasma were similar to those of AUC and TCmax in adults.

Indications for Nexium tablets

Gastroesophageal reflux disease:
- treatment of erosive reflux esophagitis;
- prolonged maintenance treatment after healing of erosive reflux esophagitis to prevent relapse;
- symptomatic treatment of gastroesophageal reflux disease;
Stomach ulcer and duodenal ulcer

In the combination therapy:

- treatment of duodenal ulcer associated with Helicobacter pylori;
- prevention of recurrences of peptic ulcer associated with Helicobacter pylori.
Long-term acid-suppressing therapy in patients who underwent bleeding from a peptic ulcer (after intravenous administration of drugs that reduce the secretion of the glands of the stomach, for the prevention of recurrence).

Patients taking long-term NSAIDs:

- healing of gastric ulcer associated with the intake of NSAIDs;
- prevention of gastric and duodenal ulcers associated with the administration of NSAIDs in patients at risk.
Zollinger-Ellison syndrome or other conditions characterized by pathological hypersecretion of the glands of the stomach, including idiopathic hypersecretion.

Contraindications

- hypersensitivity to esomeprazole, substituted benzimidazoles or other ingredients that make up the drug;
- hereditary intolerance to fructose, glucose-galactose malabsorption or sugar-isomaltase deficiency;
- Children under 12 years of age (due to the lack of data on the effectiveness and safety of Nexium tablets in this group of patients) and children over 12 years of age on other indications other than gastroesophageal reflux disease;
- esomeprazole should not be taken together with atazanavir and nelfinavir (see section "Interaction with other drugs and other types of drug interactions").
With caution: severe renal failure (experience with use is limited).

Dosage

Inside. The tablet should be swallowed whole, washed down with liquid. Tablets can not be chewed or crushed.
For patients with difficulty swallowing, you can dissolve tablets in half a glass of still water (do not use other liquids, since the protective shell of microgranules can dissolve), stirring until the tablet disintegrates, after which the slurry of microgranules should be drunk immediately or for 30 minutes, then again fill the glass with water halfway, stir leftovers and drink. Do not chew or grind microgranules.
For patients who can not swallow, the tablets should be dissolved in still water and injected through a nasogastric tube. It is important that the selected syringe and probe are suitable for performing this procedure. Instructions for preparation and administration of the drug through the nasogastric tube are given in the section "Administration of Nexium tablets through a nasogastric tube".
Adults and children from the age of 12

Gastroesophageal reflux disease

Treatment of erosive reflux esophagitis: 40 mg once a day for 4 weeks.
An additional 4-week course of treatment is recommended in cases when after the first course of healing the esophagitis does not come or the symptoms remain.
Long-term maintenance treatment after healing of erosive reflux esophagitis to prevent relapse: 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 eliminating the symptoms, you can go to the medication "if necessary", i.e. Take Nexium 20 mg once a day with the resumption of symptoms. For patients taking NSAIDs and those at risk of developing gastric or duodenal ulcers, treatment is not recommended in the "if necessary" regime.

Adults

Stomach ulcer and duodenal ulcer
In the combination therapy for eradication of Helicobacter pylori:
- treatment of duodenal ulcer associated with Helicobacter pylori: Nexium 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All medications are taken twice a day for 1 week.
- prevention of recurrences of peptic ulcers associated with Helicobacter pylori: Nexium 20 mg, amoxicillin 1 gi clarithromycin 500 mg. All medications are taken twice a day for 1 week.
Long-term acid-suppressing therapy in patients who underwent bleeding from a peptic ulcer (after intravenous use of drugs that reduce the secretion of the glands of the stomach, to prevent relapse)
Nexium 40 mg once a day for 4 weeks after the end of intravenous therapy with drugs that reduce the secretion of the glands of the stomach.

Patients taking long-term NSAIDs:

- healing of gastric ulcer associated with the intake of NSAIDs: Nexium 20 mg or 40 mg once daily. The duration of treatment is 4-8 weeks.
- Prevention of gastric and duodenal ulcers associated with the administration of NSAIDs: Nexium 20 mg or 40 mg once daily.
Conditions associated with pathological hypersecretion of the glands of the stomach, including Zollinger-Ellison syndrome and idiopathic hypersecretion:
The recommended initial dose is Nexium 40 mg twice daily. In the future, the dose is selected individually, the duration of treatment is determined by the clinical picture of the disease. There is an experience of using the drug in doses up to 120 mg twice a day.
Renal failure: dose adjustment is not required. However, the experience of using Nexium in patients with severe renal insufficiency is limited; Therefore, when prescribing Nexium tablets, such patients should be careful (see section "Pharmacokinetics").
Hepatic failure: with mild and moderate hepatic insufficiency, dose adjustment is not required. For patients with severe hepatic insufficiency, the maximum daily dose should not exceed 20 mg.
Elderly patients: dosage adjustment is not required.

Administration of the drug through a nasogastric tube

When prescribing Nexium tablets through a nasogastric tube
1. Place the tablet in a syringe and fill the syringe with 25 ml of water and about 5 ml of air. For some probes, dilution of the preparation in 50 ml of drinking water may be required in order to prevent the probe from clogging the pellets with a tablet.
2. Immediately shake the syringe for about two minutes to dissolve the tablet.
3. Hold the syringe with the tip up and make sure that the tip is not clogged.
4. Insert the tip of the syringe into the probe, continuing to hold it upward.
5. Shake the syringe and flip it down with the tip. Immediately insert 5-10 ml of dissolved drug into the probe. After the injection, return the syringe to its previous position and shake it (the syringe should be held up by the tip to avoid clogging the tip).
6. Turn the syringe tip down and insert another 5-10 ml of the drug into the probe. Repeat this until the syringe is empty.
7. In case of the remainder of Nexium tablets in the form of a sludge in a syringe, fill the syringe with 25 ml of water and 5 ml of air and repeat the operations described in paragraph 5.6. For some probes, 50 ml of drinking water may be needed for this purpose.

Side effects of Nexium tablets

Below are the side effects that are independent of the dosing regimen of the drug, noted with the use of Nexium, both during clinical trials 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).
From the skin and subcutaneous tissues
Infrequent: dermatitis, itching, rash, hives;
Rarely: alopecia, photosensitization;
Very rarely: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the musculoskeletal and connective tissue
Rarely: arthralgia, myalgia;
Very rarely: muscle weakness.
From the nervous system
Often: headache;
Infrequent: dizziness, paresthesia, drowsiness;
Rarely: a violation of taste.
Disorders of the psyche
Infrequently: insomnia;
Rarely: depression, agitation, confusion;
Very rarely: hallucinations, aggressive behavior.
From the gastrointestinal tract
Often: abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting;
Infrequent: dry mouth;
Rarely: stomatitis, candidiasis of the gastrointestinal tract;
Very rarely: microscopic colitis (confirmed histologically).
From the liver and biliary tract
Infrequently: increased activity of "liver" enzymes;
Rarely: hepatitis (with jaundice or without);
Very rarely: liver failure, encephalopathy in patients with liver disease.
From the genitals and breast
Very rarely: gynecomastia.
On the part of the blood and lymphatic system
Rarely: leukopenia, thrombocytopenia;
Very rarely: agranulocytosis, pancytopenia.
From the immune system
Rarely: hypersensitivity reactions (eg, fever, angioedema, anaphylactic reaction / anaphylactic shock).
On the part of the respiratory system, the organs of the thorax and the mediastinum
Rarely: bronchospasm.
From the side of the kidneys and urinary tract
Very rarely: interstitial nephritis.
From the side of the organ of vision
Rarely: blurred vision.
From the side of metabolism and nutrition
Infrequent: peripheral edema;
Rarely: hyponatremia;
Very rarely: hypomagnesemia; hypocalcemia due to severe hypomagnesemia, hypokalemia due to hypomagnesemia.
General disorders
Rarely: malaise, sweating.
Overdose
At the moment, very rare cases of deliberate overdose are described. Oral administration of esomeprazole at a dose of 280 mg was accompanied by general weakness and symptoms from the gastrointestinal tract. One-time intake of 80 mg of Nexium did not cause any negative consequences.
Antidot of esomeprazole is unknown. Esomeprazole binds well to plasma proteins, so dialysis is ineffective. In case of an overdose, it is necessary to carry out symptomatic and general supportive treatment.

Drug Interactions

The effect of esomeprazole on the pharmacokinetics of other drugs.
Propagation of hydrochloric acid secretion in the stomach against the background of treatment with esomeprazole and other inhibitors of the proton pump can lead to a decrease or increase in the absorption of drugs, the absorption of which depends on the acidity of the medium. Like other drugs that reduce the acidity of gastric juice, treatment with esomeprazole may lead to a decrease in the absorption of ketoconazole, itraconazole and erlotinib, and an increase in the absorption of drugs such as digoxin. The simultaneous administration of omeprazole at a dose of 20 mg once a day and digoxin increases the bioavailability of digoxin by 10% (the bioavailability of digoxin was increased by up to 30% in two out of ten patients).
It has been shown that omeprazole interacts with some antiretroviral drugs. The mechanisms and the clinical significance of these interactions are not always known. An increase in pH on the background of omeprazole therapy may affect the absorption of antiretroviral drugs. It is also possible to interact at the level of the isoenzyme CYP2C19. In the combined use of omeprazole and some antiretroviral drugs, such as atazanavir and nelfinavir, against the background of omeprazole therapy, there is a decrease in their concentration in the serum. Therefore, their simultaneous application is not recommended. The simultaneous 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%). An increase in the dose of atazanavir to 400 mg did not compensate for the effects of omeprazole on the bioavailability of atazanavir.
With the simultaneous use of omeprazole and saquinavir, an increase in the concentration of saquinavir in the serum was noted, while with use 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 joint use of esomeprazole with other drugs in the metabolism of which the CYP2C19 isoenzyme, such as diazepam, citalopram, imipramine, clomipramine, phenytoin, etc., may contribute to an increase in plasma concentrations of these drugs, which in turn may require dose reduction. This interaction is especially important to remember when applying Nexium in the "if necessary" mode. With the simultaneous administration of 30 mg of esomeprazole and diazepam, which is a substrate of the isoenzyme CYP2C19, a decrease in clearance of diazepam by 45% is noted.
The use of esomeprazole at a dose of 40 mg resulted in an increase in the residual concentration of phenytoin in patients with epilepsy by 13%. In this regard, it is recommended to monitor the concentrations of phenytoin in the plasma at the beginning of treatment with esomeprazole and when it is withdrawn.
The use of omeprazole at a dose of 40 mg once a day led to an increase in the area under the concentration-time curve and Cmax voriconazole (substrate of the isoenzyme CYP2C19) by 15% and 41%, respectively.
Co-administration of warfarin with 40 mg of esomeprazole does not lead to a change in coagulation time in patients taking warfarin for a long time. However, several cases of a clinically significant increase in the INR index (an international normalized ratio) have been reported with the combined use of warfarin and esomeprazole. It is recommended to monitor the INR at the beginning and after the end of the joint use of esomeprazole and warfarin or other coumarin derivatives.
Pharmacokinetic / pharmacodynamic interaction between clopidogrel (loading dose 300 mg and maintenance dose 75 mg / day) and esomeprazole (40 mg / day inwards), which leads to a decrease in the exposure of the active metabolite of clopidogrel by an average of 40% and a decrease the maximum inhibition of ADP-induced platelet aggregation by an average of 14%.
The clinical significance of this interaction is not clear. In a prospective study in patients treated with placebo or omeprazole at a dose of 20 mg / day. concurrent with clopidogrel and acetylsalicylic acid (ACK) therapy, and in the analysis of the clinical outcomes of large-scale randomized trials, there was no evidence of an increased risk of cardiovascular complications in the combined use of clopidogrel and proton pump inhibitors, including esomeprazole.
The results of a number of observational studies are contradictory and do not give an unambiguous answer about the presence or absence of an increased risk of thromboembolic cardiovascular complications against the combined use of clopidogrel and proton pump inhibitors.
When clopidogrel was used together with a fixed combination of 20 mg of esomeprazole and 81 mg of ASA, the exposure of the active metabolite of clopidogrel decreased by almost 40% compared to clopidogrel alone, with the maximum levels of inhibition of ADP-induced platelet aggregation being the same, probably due to simultaneous administration ASA in a low dose.
The use of omeprazole at a dose of 40 mg resulted in an increase of 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.
Joint use of cisapride with 40 mg of esomeprazole leads to an increase in the pharmacokinetic parameters of cisapride in healthy volunteers: AUC by 32% and a half-life of 31%, but the maximum concentration of cisapride in the plasma does not change significantly. The slight elongation of the QT interval, which was observed with cisapride monotherapy, did not increase with the addition of Nexium (see section "Special instructions").
With the simultaneous use of esomeprazole and tacrolimus, an increase in tacrolimus concentration in serum was noted.
Some patients reported increased concentrations of methotrexate against a background of 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 joint use of esomeprazole and naproxen or rofecoxib have not revealed a clinically significant pharmacokinetic interaction.

Effect of drugs on the pharmacokinetics of esomeprazole.

The isozymes CYP2C19 and CYP3A4 are involved in the metabolism of esomeprazole. Joint use of esomeprazole with clarithromycin (500 mg twice daily), which inhibits the isozyme CYP3A4, leads to an increase in the value of AUC esomeprazole by 2 times. The combined use of esomeprazole and a combined inhibitor of CYP3A4 and CYP2C19 isozymes, 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 correction of esomeprazole is not required. Correction of the dose of esomeprazole may be required in patients with severe impairment of liver function and with prolonged use.
Drugs that induce isoenzymes CYP2C19 and CYP3A4, such as rifampicin and preparations of St. John's wort, when administered together with esomeprazole, can lead to a decrease in the plasma esomeprazole concentration by accelerating the metabolism of esomeprazole.

special instructions

In the presence of any anxiety symptoms (for example, such as significant spontaneous weight loss, repeated vomiting, dysphagia, vomiting with a trace of blood or melena), and if there is a stomach ulcer (or suspected gastric ulcer), the presence of a malignant tumor treatment with Nexium can lead to a smoothing of the symptoms and delay the diagnosis.
In rare cases, patients who had been taking omeprazole for a long time, at histological examination of biopsy specimens of the mucous membrane of the body of the stomach, showed atrophic gastritis.
Patients taking Nexium tablets for a long period (especially more than a year) should be under regular medical supervision. Patients taking Nexium "as needed" should be instructed to contact their physician if the symptoms change. Taking into account fluctuations in the plasma esomeprazole concentration with the appointment of therapy "as necessary", it is necessary to take into account the interaction of the drug with other drugs (see the section "Interaction with other drugs and other types of drug interactions"). When Nexium is prescribed 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, therefore, when prescribing eradication therapy for patients receiving other drugs metabolized with CYP3A4 (eg, cisapride), possible contraindications and interactions of clarithromycin with these drugs must be considered.
Nexium tablets contain sucrose, which is why they are contraindicated in patients with hereditary intolerance to fructose, glucose-galactose malabsorption or sugar-isomaltase deficiency.
The pharmacokinetic / pharmacodynamic interaction between clopidogrel (loading dose 300 mg and maintenance dose 75 mg / day) and esomeprazole (40 mg / day inwards), which leads to a decrease in exposure to 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, simultaneous use of esomeprazole and clopidogrel should be avoided (see section "Interaction with other drugs and other types of drug interactions").
Separate observational studies indicate that proton pump inhibitor therapy may slightly increase the risk of osteoporosis-related fractures, but other similar studies have not shown an increased risk.
In randomized, double-blind, controlled clinical trials of omeprazole and esomeprazole, including two open long-term studies (more than 12 years), the connection of fractures against osteoporosis with proton pump inhibitors was not confirmed.
Although the causal relationship between the use of omeprazole / esomeprazole with fractures against osteoporosis is not established, patients with a risk of developing osteoporosis or fractures against it should be under appropriate clinical supervision.

Impact on the ability to drive vehicles and manage mechanisms

Due to the fact that during the therapy with Nexium, dizziness, blurred vision and drowsiness may occur, caution should be exercised when driving vehicles and other mechanisms.

Pregnancy and lactemia

At present, there is insufficient data on the use of Nexium tablets during pregnancy. The results of epidemiological studies of omeprazole, which is a racemic mixture, showed no fetotoxic effect or impaired fetal development.
With the introduction of esomeprazole, no direct or indirect adverse effects on the development of the embryo or fetus have been identified in animals. The introduction of the racemic mixture of the preparation also did not have any negative effect on animals during pregnancy, childbirth, and also during postnatal development.
Prescribe Nexium tablets to pregnant women only if the expected benefit to the mother exceeds the possible risk to the fetus.
It is not known whether esomeprazole is excreted in breast milk, so do not prescribe Nexium during lactation.

Application in childhood

Contraindicated for children under 12 years.

In case of violations of kidney function

Correction of the dose is not required. However, the experience of using Nexium in patients with severe renal insufficiency is limited; Therefore, when prescribing the drug, such patients should be careful (see section "Pharmacokinetics").

With violations of liver function

With mild and moderate hepatic insufficiency, dose adjustment is not required. For patients with severe hepatic insufficiency, the maximum daily dose should not exceed 20 mg.

Application in old age

Correction of the dose is not required.

Conditions of leave from pharmacies

You can buy Nexium without a prescription.

Terms and conditions of storage

At temperatures not higher than 30 ° C, in the original packaging, in places not accessible to children. Shelf life - 3 years.