Instruction for use: Neo-Zext

Active substance Esomeprazol

ATX code A02BC05 Esomeprazol

Pharmacological group

Proton pump inhibitors

Nosological classification (ICD-10)

K21 Gastroesophageal reflux

Biliary reflux esophagitis, gastrocardiac syndrome, Gastroesophageal reflux disease, Gastro-oesophageal reflux disease, Non-erosive reflux disease, syndrome gastrocardiac, Remhelda syndrome, Erosive reflux esophagitis, Ulcerative reflux esophagitis

K21.0 Gastro-oesophageal reflux with oesophagitis

Reflux gastritis, Reflux esophagitis, Erosive and ulcerative esophagitis

K25 Gastric ulcer

Helicobacter pylori, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, Inflammation of the gastric mucosa, Inflammation of the gastrointestinal mucosa, Benign gastric ulcer, The disease of the stomach and duodenum, asotsiirovannoe with Helicobacter pylori, Aggravation gastroduodenita on the background of peptic ulcer, Exacerbation of peptic ulcer, The aggravation of gastric ulcer, The organic gastrointestinal disease, Peptic ulcer of the stomach and duodenum, Postoperative gastric ulcer, Recurrent ulcers, Symptomatic gastric ulcers, Chronic inflammatory disease of the upper gastrointestinal tract, associated with Helicobacter pylori, Helicobacter pylori eradication, Erosive and ulcerative lesions of the stomach, Erosive lesions of the stomach, The erosion of the gastric mucosa, Peptic ulcer disease, Stomach ulcer, Gastric lesion, Ulcerative lesions of the stomach, Symptomatic ulcers of the stomach and duodenum

K26 Duodenal Ulcer

Pain with duodenal ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, The disease of the stomach and duodenum, asotsiirovannoe with Helicobacter pylori, Exacerbation of peptic ulcer, The worsening of duodenal ulcer, Peptic ulcer of the stomach and duodenum, Relapse of duodenal ulcers, Symptomatic ulcers of the stomach and duodenum, Helicobacter pylori eradication, Erosive and ulcerative lesions of the duodenum, Erosive-ulcerative lesions of duodenal ulcers associated with Helicobacter pylori, Erosive lesions of the duodenum, Duodenal ulcer, Ulcerative lesions of the duodenum]

K27 Peptic ulcer, unspecified

Perforation of peptic ulcer, Drug-induced gastrointestinal ulcers, medication ulcers, Peptic ulcer of the digestive tract, Peptic ulcer with Helicobacter pylori, peptic ulcer, Damage of gastrointestinal mucosa caused by NSAID, Symptomatic ulcers digestive tract, stress ulcer, Stress gastric ulcer, Stress damage to the mucous membrane, stress ulcer, duodenal ulcer Stress, Stress ulcer, Stressful GI ulcers, Erosive-ulcerative lesions of the gastrointestinal tract, The erosion of the gastrointestinal tract, Erosion of the mucosa of the upper gastrointestinal tract, The erosion of the gastrointestinal mucosa, gastrointestinal ulcer, ulcer drug, peptic ulcer, postoperative ulcer, stress ulcer, Ulcerative lesions of the gastrointestinal tract, Acute stress ulcer gastrointestinal tract, Symptomatic gastrointestinal ulcers, Complications of peptic ulcers

K31.8.2 * Hyperacidity of gastric juice

Pathological hypersecretion, Hyperacid indigestion, Hyperadic states, Increased secretion of gastric juice, Increased acid formation, Hyperacidosis,Hyper secretion of gastric juice, Increased acidity of gastric juice, High acidity

K86.8.3 * Zollinger-Ellison Syndrome

Adenoma of the pancreas ulzerogennosti, gastrinoma, Zollinger-Ellison Syndrome, gastrinoma

Y45 adverse reactions in therapeutic use of analgesic, antipyretic and anti-inflammatory agents

Composition

Enteric-coated tablets, film-coated 1 tab.

active substance:

esomeprazole magnesium dihydrate (in terms of esomeprazole) 21.7 * (20) mg

43.4 * (40) mg

Excipients

core: sugar spherical granules ** - 16.13 / 32.26 mg; hyprolosis (viscosity from 75 to 150 Pa · s (5%, m / m) - 5.94 / 11.88 mg; povidone (viscosity expressed in terms of k value - from 22.5 to 27) - 5.34 / 10 , 68 mg; talc - 6.675 / 13.35 mg; titanium dioxide (E171) - 1.335 / 2.67 mg; methacrylic acid — ethacrylate copolymer 1: 1, dispersion 30% - 33.16 / 66.32 mg; stearic acid monoglyceride 40–55, type 2 - 1.985 / 3.97 mg; propylene glycol - 5.93 / 11.86 mg; stearic acid type 50 - 4.64 / 9.28 mg; polysorbate 80 - 0.78 / 1.56 mg; simethicone - 0.045 / 0.09 mg; MCC (particle size - from 50 to 200 microns) - 240.12 / 480.24 mg; macrogol 6000 - 27.595 / 55.19 mg; crospovidone type A - 6.9 / 13.8 mg; colloidal silicon dioxide - 0.69 / 1.38 m ; Magnesium stearate - 0.69 / 1.38 mg

film cover: hypromellose (viscosity from 4.8 to 7.8 Pa · s - 19.455 / 34.35 mg; macrogol 6000 - 4.785 / 8.45 mg; titanium dioxide (E171) - 4.245 / 4.15 mg; talc - 1.44 / 2.55 mg; iron dye red oxide (E172) - 0.0563 / 0.5 mg; iron dye yellow oxide (E172) - 0.0188 mg / -

* The amount of the substance contained in the tablet indicated on the label reflects the stoichiometric ratio between esomeprazole and magnesium esomeprazole dihydrate

** granule size - from 212 to 300 microns;

composition of granules: sucrose - from 80 to 91.5%; corn starch - from 8.5 to 20%; Dextrose liquid (dextrose, oligo- and polysaccharides) - at least 5%

Description of the dosage form

Tablets of 20 mg: light pink, oval, film coated.

Tablets of 40 mg: pink with a weak brownish shade and impregnations of darker color, oval, film-coated, with a risk on both sides.

On a cross section: tablets of white or almost white color.

pharmachologic effect

Pharmacological action - antiulcer, inhibiting H +, K + -ATP-azu.

Pharmacodynamics

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. Both omeprazole isomers, S- and R-isomers, have similar pharmacodynamic activity.

Mechanism of action

Esomeprazole is a weak base that accumulates in the secretory tubules of the parietal cells in the high-acidic environment of the stomach, where it activates and inhibits the proton pump - the enzyme H + / K + -ATPase. Esomeprazole inhibits both basal and stimulated secretion of hydrochloric acid.

Effect on gastric acid secretion

The effect of esomeprazole develops within 1 hour after oral administration of 20 or 40 mg. When taking the drug daily for 5 days at a dose of 20 mg 1 time per day, the average Cmax 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 GERD and the presence of clinical symptoms after 5 days of daily intake of esomeprazole orally at a dose of 20 or 40 mg, the pH in the stomach was higher than 4 for an average of 13 and 17 out of 24 hours. pH above 4 was maintained for 8, 12 and 16 h 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 acid secretion and plasma concentration of the drug (the AUC parameter was used to estimate the concentration).

Therapeutic effect achieved by inhibiting the secretion of acid

When receiving esomeprazole in a dose of 40 mg / day, the cure of reflux esophagitis occurs in approximately 78% of patients after 4 weeks of therapy and in 93% of patients after 8 weeks of therapy.

Treatment with esomeprazole 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 antisecretory drugs to heal the ulcer and eliminate the symptoms.

Other effects associated with inhibition of acid secretion

During treatment with antisecretory drugs, gastrin plasma levels increase as a result of a decrease in acid secretion.

In patients treated with esomeprazole for a long time, there is an increase in the number of enterochromaffin-like cells, probably due to an increase in plasma gastrin levels.

In patients who have used antisecretory drugs for a long time, the formation of glandular cysts in the stomach is more often observed. This phenomenon is due to physiological changes as a result of inhibition of acid secretion. The cysts are benign and reverse developed.

In the course of two comparative studies with ranitidine, esomeprazole showed the best efficacy in the healing of peptic ulcers in patients who received non-steroidal anti-inflammatory therapy, including selective COX-2 inhibitors.

In two studies evaluating the effectiveness of esomeprazole showed high efficacy in the prevention of peptic ulcers in patients (age group over 60 years and / or with a peptic ulcer in history) who received NSAIDs, including the use of selective COX-2 inhibitors.

Pharmacokinetics

Absorption and distribution

Esomeprazole is unstable in an acidic environment, therefore, for oral administration, tablets are used, having in their composition granules with a shell resistant to the action of gastric juice. The transformation of esomeprazole into the R-isomer under in vivo conditions is not significant.

Absorption of esomeprazole is rapid, Tmax is 1-2 hours after ingestion. Absolute bioavailability is 64% after a single dose of the drug in a dose of 40 mg and rises to 89% after repeated administration. For esomeprazole at a dose of 20 mg, the values were 50 and 68%, respectively. Vd - 0.22 L / kg. Communication with plasma proteins - 97%.

Eating slows down and reduces the absorption of esomeprazole in the stomach, but this does not have a significant effect on the effectiveness of inhibition of the secretion of hydrochloric acid.

Metabolism and excretion

Esomeprazole is completely metabolized by the cytochrome P450 (CYP) system. The main part of esomeprazole is metabolized by the specific polymorphic isoform CYP2C19, and hydroxy- and demethylated metabolites of esomeprazole are formed. The remainder is metabolized by another specific CYP3A4 isoform; this produces a sulfose derivative of esomeprazole, which is the main metabolite, which is determined in plasma.

In patients with active isoenzyme CYP2C19 (fast metabolisers), systemic clearance is 17 l / h after a single dose and 9 l / h after a multiple dose. T1 / 2 - 1.3 hours with a systematic reception in the dosing regimen 1 time per day. AUC increases on the background of repeated administration (non-linear dependence of the dose and AUC during systematic administration, which is a consequence of a decrease in metabolism during the first passage through the liver, as well as a decrease in systemic clearance caused by inhibition of the CYP2C19 isoenzyme by esomeprazole and / or its sulfa-containing metabolite).

With daily intake 1 time per day, esomeprazole is completely removed from the blood plasma during the interval between doses and does not accumulate. The major metabolites of esomeprazole do not affect the secretion of hydrochloric acid in the stomach. When administered orally, up to 80% of the dose taken is excreted by the kidneys in the urine (less than 1% is unchanged), the rest is excreted in the feces.

Pharmacokinetics in some groups of patients

In about (2.9 ± 1.5)% of the population, CYP2C19 is inactive (patients with inactive metabolism), and esomeprazole is metabolized mainly by CYP3A4. When systematically receiving 40 mg of esomeprazole 1 time per day, the average AUC is 100% higher than the value of this parameter in patients with active metabolism (with the participation of the CYP2C19 enzyme). Mean plasma Cmax values in patients with inactive metabolism are increased by approximately 60%. These features do not affect the dosage 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 value in women is 30% higher than in men. With daily intake of the drug 1 time per day, differences in pharmacokinetics in men and women are not observed.

These features do not affect the dosage and method of application of esomeprazole.

Esomeprazole metabolism in patients with mild or moderate liver failure is similar to that in patients with normal liver function. In severe hepatic insufficiency, the metabolic rate is reduced, which is accompanied by an increase in AUC by 2 times, therefore it is recommended to prescribe the maximum daily dose of the drug - 20 mg.

The study of pharmacokinetics in patients with renal insufficiency was not conducted. Since the kidneys remove not the esomeprazole itself, 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 and 40 mg of esomeprazole, the AUC and Tmax values in plasma were similar to those of AUC and Tmax in adults.

Indications

Gastroesophageal Reflux Disease:

treatment of erosive reflux esophagitis;

long-term maintenance treatment after healing of erosive reflux esophagitis to prevent relapse;

symptomatic treatment of gastroesophageal reflux disease.

Peptic ulcer of the stomach and duodenum in combination therapy:

treatment of duodenal ulcers associated with Helicobacter pylori;

prevention of recurrence of peptic ulcers associated with Helicobacter pylori.

Patients for a long time taking NSAIDs:

the healing of gastric ulcers associated with taking NSAIDs;

prevention of gastric and duodenal ulcers associated with taking NSAIDs in patients at risk;

Zollinger-Ellison syndrome or other conditions characterized by pathological hypersecretion.

Contraindications

hypersensitivity to esomeprazole, substituted benzimidazoles and other components of the drug;

hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency;

simultaneous administration with atazanavir and nelfinavir (like other proton pump inhibitors);

lactation period;

children's age up to 12 years (efficiency and safety are not established);

Children over the age of 12 years for other indications, except gastroesophageal reflux disease.

With care: pregnancy; severe renal impairment (experience of use is limited).

pregnancy and lactation

Currently, there is not enough data on the use of esomeprazole during pregnancy.

With the introduction of esomeprazole animals did not reveal any direct or indirect negative impact on the development of the embryo or fetus. The introduction of the racemic drug also did not have any negative effect on animals during pregnancy, childbirth, and also during postnatal development.

It is necessary to appoint drug to pregnant women only in that case when the expected advantage for mother exceeds possible risk for a fruit.

Use of the drug during lactation is contraindicated.

Side effects

The indicated side effects were not dose dependent. Reactions are classified according to the frequency of occurrence - often ≥1 / 100, <1/10; infrequently ≥1 / 1000, <1/100; rarely ≥1 / 10,000, <1/1000; very rarely <1/10000; unknown (cannot be estimated based on available data).

From the hematopoietic system: rarely - leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia.

From the side of the central nervous system and sensory organs: often - headache; infrequently - insomnia, dizziness, paresthesia, drowsiness, blurred vision; rarely - agitation, confusion, depression; very rarely - aggression, hallucinations.

On the part of the digestive tract: often - abdominal pain, constipation, diarrhea, flatulence, nausea / vomiting; infrequently - dry mouth; rarely - a violation of taste, stomatitis, gastrointestinal candidiasis, hepatitis with or without jaundice; very rarely - liver failure, encephalopathy in patients who have had liver disease; frequency unknown - microscopic colitis (confirmed histologically).

On the part of the respiratory system: rarely - bronchospasm.

On the part of the skin: infrequently - dermatitis, pruritus, rash, urticaria; rarely - alopecia, photosensitivity, malaise, excessive sweating; very rarely, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN).

On the part of the musculoskeletal system: rarely - arthralgia, myalgia; very rarely - muscle weakness.

From the genitourinary system: very rarely - interstitial nephritis.

From the reproductive system and mammary glands: very rarely - gynecomastia.

Allergic reactions: rarely hypersensitivity reactions such as fever, angioedema, and anaphylactic reaction / shock.

Disturbances of metabolism and nutrition: infrequently - peripheral edema; rarely, hyponatremia; very rarely, hypomagnesemia, severe hypomagnesemia may be correlated with hypocalcemia.

Laboratory indicators: infrequently - increased activity of hepatic transaminases ..

Interaction

Effect of esomeprazole on the pharmacokinetics of other drugs

Reduced acidity in the stomach during treatment with esomeprazole can lead to a decrease or increase in the absorption of other drugs, the mechanism of absorption of which depends on the acidity of the environment. As with other drugs that suppress the secretion of hydrochloric acid, or antacid agents, treatment with esomeprazole may reduce the absorption of ketoconazole or itraconazole and erlotinib, and increase the absorption of drugs like digoxin. Joint administration of omeprazole in a dose of 20 mg once a day and digoxin increases the bioavailability of digoxin by 10% (in 20% of patients, the bioavailability of digoxin increased by up to 30%).

Omeprazole has been shown to interact with certain antiretroviral drugs. The mechanisms and clinical significance of this interaction 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 appointment of omeprazole and some antiretroviral drugs, such as atazanavir and nelfinavir, a decrease in their concentration in serum is observed during therapy with omeprazole. Therefore, their simultaneous use is not recommended. Co-administration 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 (AUC, Cmax and Cmin in plasma 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 the simultaneous appointment of omeprazole and saquinavir, an increase in the concentration of saquinavir in serum was noted, and when administered 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. The combined use of esomeprazole with other drugs in the metabolism of which is involved, the participation of CYP2C19 isoenzyme, such as diazepam, citalopram, imipramine, clomipramine, phenytoin can lead to an increase in plasma concentrations of these drugs and require a dose reduction. When ozomeprazole is taken orally at a dose of 30 mg and diazepam, the clearance of diazepam, which is a substrate of CYP2C19, is reduced by 45%.

When ozomeprazole was taken orally at a dose of 40 mg and phenytoin in patients with epilepsy, the residual plasma concentration of phenytoin increased by 13%. In this regard, it is recommended to control the concentration of phenytoin in plasma at the beginning of treatment with esomeprazole and during its withdrawal.

The use of omeprazole in a dose of 40 mg once a day resulted in an increase in the AUC and Cmax of voriconazole (substrate of the isoenzyme CYP2C19) by 15 and 41%, respectively.

With the use of esomeprazole orally at a dose of 40 mg in patients receiving warfarin, the coagulation time remained within acceptable limits. However, several cases of a clinically significant increase in the MHO index have been reported with the combined use of warfarin and esomeprazole. In this regard, it is recommended to monitor MHO at the beginning and at the end of the joint use of these drugs.

The use of omeprazole in a dose of 40 mg 1 time per day led to an increase in Cmax and AUC of Cilostazol by 18 and 26%, respectively; for one of the active metabolites of Cilostazol, the increase was 29 and 69%, respectively.

In healthy volunteers, oral co-administration of esomeprazole at a dose of 40 mg and cisapride increased AUC by 32% and increased T1 / 2 of cisapride by 31%; At the same time, Cmax of cisapride in plasma did not significantly change. The slight lengthening of the QT interval, which was observed with cisapride monotherapy, did not increase with the addition of esomeprazole. Esomeprazole has not been shown to cause clinically significant changes in the pharmacokinetics of amoxicillin and quinidine.

The effect of drugs on the pharmacokinetics of esomeprazole

CYP2C19 and CYP3A4 isoenzymes are involved in the metabolism of esomeprazole. Joint oral administration of esomeprazole and clarithromycin, an inhibitor of the isoenzyme CYP3A4 (500 mg 2 times 1 day) leads to a twofold increase in the AUC value for esomeprazole.

The combined use of esomeprazole and a combined inhibitor of CYP3A4 and CYP2C19 isoenzymes, such as voriconazole, can lead to an increase in the AUC of esomeprazole by more than 2 times. As a rule, in such cases, dose adjustment of esomeprazole is not required. Dose adjustment of esomeprazole may be required in patients with severely impaired liver function and with prolonged use.

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

Dosage and administration

Inside The tablet should be swallowed whole with water. Tablets should not be chewed or broken. For patients with difficulty swallowing, tablets 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 until the tablet disintegrates, after which the suspension of microgranules should be drunk immediately or within 15 minutes after then re-fill the glass with water by half, stir the residue and drink. Do not chew or crush microgranules. For patients who cannot swallow, tablets should be dissolved in non-carbonated water and administered through a gastric tube. It is important that the chosen syringe and probe be thoroughly tested. Instructions for the preparation and administration of the drug through a stomach tube are given in this section below.

Adults and children from 12 years

GERD

- treatment of erosive reflux esophagitis - 40 g of esomeprazole 1 time per day for 4 weeks. An additional 4-week course of treatment is recommended in cases where after the first course esophagitis does not heal or symptoms persist;

- long-term maintenance treatment after healing of erosive reflux esophagitis to prevent relapse - 20 mg once a day;

- symptomatic treatment of GERD - 20 mg 1 time per 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 the symptoms are eliminated, it is possible to switch to the mode of taking the drug if necessary, i.e. take esomeprazole 20 mg 1 time per day when symptoms recur. For patients taking NSAIDs and those at risk of developing gastric or duodenal ulcers, treatment is not recommended if necessary.

Adults

Peptic ulcer of the stomach and duodenum as part of combination therapy for Helicobacter pylori eradication

- treatment of duodenal ulcers associated with Helicobacter pylori - esomeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All drugs are taken 2 times a day for 7 days;

- prevention of recurrence of peptic ulcers associated with Helicobacter pylori - esomeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All drugs are taken 2 times a day for 7 days.

Patients for a long time taking NSAIDs

- the healing of gastric ulcers associated with taking NSAIDs, esomeprazole 20 or 40 mg 1 time per day. The duration of treatment is 4-8 weeks;

- prevention of gastric and duodenal ulcers associated with taking NSAIDs in patients at risk, esomeprazole 20 or 40 mg 1 time per day.

Zollinger-Ellison syndrome or other conditions characterized by pathological hypersecretion

The recommended initial dose of esomeprazole 40 mg 2 times 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 of use in the range from 80 to 120 mg of esomeprazole per day. When using the drug in a dose above 80 mg, you must divide the dose of the drug into 2 doses per day.

Renal failure. Dose adjustment of the drug is not required.

Liver failure. With mild to moderate liver failure, dose adjustment is not required. For patients with severe hepatic impairment, the maximum daily dose of 20 mg should not be exceeded.

Elderly patients. Dose adjustment of the drug is not required.

The introduction of the drug through the gastric tube

When prescribing the drug through a gastric tube, you must:

1. Place a pill in a syringe and fill the syringe with 25 ml of water and approximately 5 ml of air. Some probes may require dilution of the drug in 50 ml of drinking water in order to prevent the pellets from clogging the probe with tablet pellets.

2. Immediately shake the contents of the syringe for about 2 minutes to dissolve the tablet.

3. Hold the syringe tip up and make sure that the tip is not clogged.

4. Insert the syringe tip into the probe, continuing to hold it upwards.

5. Shake the syringe and tip it upside down. Immediately inject 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. If a part of the drug remains in the syringe in the syringe, fill the syringe with 25 ml of water and 5 ml of air and repeat the operations described in points 5 and 6. For some probes, 50 ml of drinking water may be needed for this purpose.

Overdose

Symptoms: at the moment, extremely rare cases of deliberate overdose are 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 esomeprazole at a dose of 80 mg did not cause any negative effects.

Treatment: the specific antidote is unknown. Esomeprazole binds to plasma proteins, so dialysis is ineffective. In case of overdose, symptomatic and general supportive treatment should be carried out.

special instructions

If there are any alarming symptoms (such as significant spontaneous weight loss, frequent vomiting, dysphagia, vomiting with blood or melena), as well as the presence of a stomach ulcer (or if a stomach ulcer is suspected), the possibility of a malignant neoplasm should be excluded, since treatment with esomeprazole can lead to a smoothing of symptoms, and so on. delay the correct diagnosis.

Patients taking the drug for a long period (especially more than 1 year), should be under the regular supervision of a physician.

During treatment with proton pump inhibitors, the concentration of gastrin in plasma increases as a result of reduced intragastric secretion of hydrochloric acid.

In patients taking proton pump inhibitors for a long time, the formation of glandular cysts in the stomach is more often noted. These phenomena are due to physiological changes as a result of inhibition of the secretion of hydrochloric acid. The cysts are benign and tend to disappear.

Patients on a treatment regimen as needed should be instructed to contact their physician when symptoms change. Taking into account fluctuations in the concentration of esomeprazole in the plasma in the appointment of the drug in the mode of therapy as needed, the interaction of the drug with other drugs should be considered.

When prescribing esomeprazole for the eradication of Helicobacter pylori, consideration should be given to the possibility of drug interactions for all components of triple therapy. Clarithromycin is a potent inhibitor of CYP3A4, therefore, 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 interaction of clarithromycin with these drugs.

Tablets contain sucrose, therefore, esomeprazole should not be given to patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.

Special precautions when disposing of unused medication. There is no need for special precautions in the destruction of unused drug Neo-sext.

Influence on the ability to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions. During the period of treatment with esomeprazole, care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.

Release form

Enteric-coated tablets, film-coated, 20 mg, 40 mg. At 7 tab. placed in an aluminum-aluminum blister. 2 or 4 blisters are placed in a carton box.

Pharmacy sales terms

On prescription.

Storage conditions

At a temperature not higher than 25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiration date printed on the package.