Nexium

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Nexium is a drug for the prevention and treatment of digestive tract diseases caused by increased secretion of gastric juice and digestive enzymes. It refers to inhibitors of the so-called. proton pump.

Nexium is available in three dosage forms: tablets, lyophilizate for the preparation of a solution for intravenous and pellets, coated with an enteric coating to prepare a suspension for reception inside.

The dose and frequency of application is determined by the attending physician depending on the disease, its severity and the individual characteristics of the patient.

Clinical and pharmacological group

H + -K + -ATPase inhibitor.

Conditions of leave from pharmacies

It is released on prescription.

Price list

How much is Nexium in pharmacies? The average price is at the level of1 600 rubles.

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Form of issue and composition

Nexium is available in the following dosage forms:

  • The tablets covered with a cover: oblong, biconcave, on a break - white color with yellow impregnations; 20 mg - light pink color, on one of the sides engraving in the form of a fraction "A / EN on the other - "20 mG 40 mg - pink, on one side there is an engraving in the form of a fraction "A / EI on the other - "40 mG" (on 7 pcs. in blisters, 1, 2 or 4 blisters in a cardboard bundle);
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  • Pellets, coated with enteric coating, and granules for oral suspension: pale yellow, can meet granules of brown color, of various sizes (304 mg in triple laminated packages, 28 bags in carton pack);
  • Lyophilizate for the preparation of a solution for intravenous administration: almost white or white compressed mass (in glass bottles of 5 ml, 10 bottles in paper stands, 1 tripod in a cardboard box with the control of the first autopsy).

The composition of 1 tablet includes:

  • Active substance: esomeprazole - 20 or 40 mg (in the form of trihydrate of esomeprazole magnesium - 2, or 4, mg);
  • Auxiliary components (tablets of 20/40 mg, respectively): sodium stearyl fumarate 7 /, 1 mg; macrogol - 3 /, mg; magnesium stearate /, mg; giprolose / 11 mg; glyceryl monostearate 40-55 /, mg; microcrystalline cellulose - 273/389 mg; hypromellose - 17/26 mg; red dye iron oxide (E172) 6 /, 5 mg; yellow dye iron oxide (E172) 2/0 mg; copolymer (:) of methacrylic and ethacrylic acid-35/46 mg; paraffin /, mg; polysorbate 80 2 /, mg; triethyl citrate - 10/14 mg; crospovidone /, mg; sugar, pellets of spherical shape (sucrose, granules of spherical shape, from 5 to 55 mm in size) - 28/30 mg; talcum - 14/20 mg; titanium dioxide (E171) /, mg.

The composition of 1 packet of pellets and granules is:

  • Active substance: esomeprazole - 10 mg (in the form of trihydrate of esomeprazole magnesium - 1, mg);
  • Auxiliary components: anhydrous citric acid mg; giprolase - 3, mg; talc mg; copolymer (:) of ethyl acrylate and methacrylic acid mg; sugar, granules of spherical form (sucrose, granules of spherical shape, from 5 to 55 mm in size) mg; hypromellose mg; dextrose - 2813 mg; magnesium stearate 5 mg; triethyl citrate 5 mg; glycerol monostearate 40-55 8 mg; polysorbate 80 7 mg; xanthan gum - 75 mg; dye crospovidone - 75 mg; iron oxide yellow -, mg.

The composition of 1 bottle of lyophilizate for the preparation of the injection solution includes:

  • Active substance: esomeprazole - 40 mg (in the form of esomeprazole sodium - 4, mg);
  • Auxiliary components: edetate dihydrate dihydrate mg; sodium hydroxide -1 mg.

Pharmacological effect

Nexium is the S-isomer of omeprazole, which reduces the secretion of hydrochloric acid in the stomach by inhibiting the proton pump in parietal cells of the stomach

Esomeprazole is a weak base that transforms into an active form in a highly acidic environment of secretory tubules of mucosal parietal cells stomach and inhibits the proton pump - enzyme H + / K + - ATPase, thus inhibiting both basal and stimulated secretion of hydrochloric acid.

Indications for use

Coated tablets; pellets, coated with an enteric coating, and granules for the preparation of a suspension for oral administration

  1. Zollinger-Ellison syndrome or other conditions characterized by pathological hypersecretion of the stomach glands, including idiopathic hypersecretion.
  2. Gastroesophageal reflux disease (GERD): therapy of erosive reflux esophagitis; long-term supporting therapy after healing of erosive reflux esophagitis (to prevent relapse); symptomatic therapy GERD;
  3. Peptic ulcer of the stomach and duodenum;
  4. Duodenal ulcer associated with Helicobacter pylori (therapy in combination with other drugs);
  5. Peptic ulcer associated with Helicobacter pylori (prevention of relapses in combination with other drugs);
  6. The condition after bleeding from a peptic ulcer associated with intravenous administration of drug drugs that reduce the secretion of the glands of the stomach (prolonged acid suppression therapy and prevention relapse);
  7. Gastric ulcer associated with long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) (therapy and prevention in patients at risk).

Nexium in the form of lyophilizate is used as an alternative to oral therapy if it is not possible to conduct it:

  1. Children and adolescents from 1 to 18 years: GERD with erosive reflux esophagitis and / or severe symptoms of reflux disease.
  2. Adults: GERD with esophagitis and / or severe symptoms of reflux disease; peptic ulcers associated with the administration of NSAIDs (treatment and prevention in patients at risk); bleeding from peptic ulcer after endoscopic hemostasis (prevention relapse).

Contraindications

Before starting therapy, patients should carefully read the attached instructions. Tablets are contraindicated in the following cases:

  1. Children under 12 years of age due to a lack of clinical experience;
  2. Individual intolerance of components included in the formulation;
  3. Hereditary intolerance to fructose;
  4. Renal failure is a severe form of flow.

Use in pregnancy and lactation

Experimental study of the drug on animals did not reveal any negative impact on the fetus, however, in pregnant women, such tests for understandable ethical reasons are not were conducted. That's why Nexium is not recommended for use in pregnancy. However, if there is a need for the drug, it can be taken by pregnant women only if the intended benefit exceeds all possible risks.

Since it is not known whether Nexium is absorbed into mother's milk, the drug should not be used during the whole period of breastfeeding.

Dosage and route of administration

The instructions for use indicate that Nexium in the form of tablets should be swallowed whole (without chewing and not crushing), squeezed with liquid. If swallowing is difficult, the tablet can be dissolved in 1/2 cup of still water. Drink the resulting suspension of microgranules should be for 30 minutes, after which you need to refill the glass with 100 ml of water, stir the remnants of the drug and drink.

Nexium in the form of pellets and pellets for the preparation of a suspension for oral administration, is usually prescribed to children and patients with difficulty swallowing. To obtain 10 mg of the preparation, the contents of 1 packet should be dissolved in 15 ml of water. The resulting solution should be stirred and allowed to stand for a few minutes (until the suspension is formed). The resulting suspension should be taken for 30 minutes, after which you need to refill the glass with the same volume of water, stir the remains and take it inside.

Do not use carbonated water to dissolve the preparation, nor to crush or chew microgranules.

Patients who can not swallow, diluted in still water tablets or obtained from pellets and pellet suspension are injected through a nasogastric tube.

The following dosing regimen is recommended:

  1. Peptic ulcer of the stomach and duodenum (simultaneously with other drugs) for the eradication of Helicobacter pylori, as well as treatment of duodenal ulcer associated with Helicobacter pylori, and prevention of relapses associated with this bacterium peptic ulcers in patients with peptic ulcer disease (adults): 2 times a day for 20 mg of Nexium, 500 mg of clarithromycin and 1000 mg amoxicillin. Therapy is carried out for 7 days;
  2. Treatment of erosive reflux esophagitis (children 1-11 years old with a body weight of 10 kg, Nexium in the form of granules and pellets): a single dose for children weighing 10-20 kg is 10 mg, more than 20 kg - 10-20 mg. Multiplicity of admission - once a day, duration of therapy - 8 weeks;
  3. Symptomatic treatment of gastroesophageal reflux disease (children 1-11 years old with a body weight of 10 kg, Nexium in the form of granules and pellets): 1 time per day for 10 mg for up to 8 weeks;
  4. Treatment of erosive reflux esophagitis (adults and children from 12 years): 1 time per day for 40 mg per month. An additional four-week course of treatment is recommended to be performed while maintaining the symptoms of the disease or in the event that after the first course of treatment the esophagitis does not come;
  5. Long-term maintenance therapy to prevent relapse (adults and children 12 years of age): 20 mg once a day;
  6. Symptomatic therapy of gastroesophageal reflux disease without esophagitis (adults and children from 12 years): 20 mg once a day. If after a month of therapy the symptoms do not go away, you need to conduct an additional examination. After improvement, it is possible to switch to Nexium reception mode "as needed i.e. the drug is taken if symptoms occur before they are taken off at a daily dose of 20 mg per 1 dose. For patients taking non-steroidal anti-inflammatory drugs, and patients belonging to the group risk of developing gastric or duodenal ulcers, "if necessary" therapy is not recommended;
  7. Long-term acid-suppressing therapy in patients after bleeding from a peptic ulcer after intravenous administration of antisecretory drugs, for the prevention of recurrence (adults): 1 time per day for 40 mg for 30 days (after the end of intravenous therapy with antisecretory drug means);
  8. Healing of gastric ulcers associated with prolonged use of non-steroidal anti-inflammatory drugs (adults): once a day for 20 or 40 mg, the duration of the course is 1-2 months;
  9. Prevention of gastric ulcer and duodenal ulcer associated with the use of non-steroidal anti-inflammatory drugs: once a day for 20 or 40 mg;
  10. Conditions characterized by pathological hypersecretion, including Zollinger-Ellison syndrome and idiopathic hypersecretion: the initial dose is 2 times a day for 40 mg. In the future, the dose is selected individually, the duration of the course is determined by the clinical picture of the disease.
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Side effects

In patients who do not exceed the prescribed dosages, side effects are observed quite rarely. With individual hypersensitivity, there is a possibility of developing allergic reactions - skin itch and rash, angioedema and bronchospasm.

Sometimes during the treatment of Nexium are noted:

  • intestinal candidiasis;
  • blurred vision;
  • hair loss;
  • increased sensitivity of the skin to solar ultraviolet;
  • erythema multiforme;
  • change in taste perception;
  • paresthesia;
  • high emotional lability:
  • depression;
  • headache;
  • dyspeptic disorders;
  • intestinal dysfunction (diarrhea or constipation);
  • general malaise and muscle weakness;
  • drowsiness during the day;
  • hyperhidrosis (increased sweating);
  • dry mouth;
  • stomatitis;
  • painful swelling of the mammary glands;
  • hepatitis.

With hepatic insufficiency, the development of encephalopathy is not ruled out.

Overdose

Very little data on cases of esomeprazole overdose. It is known that the use of Nexium in a dose of 80 mg does not cause any pronounced toxic effects. After using the drug at a dose of 280 mg, there is general weakness, signs of impaired gastrointestinal tract.

There is no specific antidote for esomeprazole. Conducting hemodialysis is ineffective, since the drug is mostly associated with plasma proteins. In case of overdose symptoms, supportive and symptomatic therapy is performed.

special instructions

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.

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 in the presence of a stomach ulcer (or suspected gastric ulcer), the presence of malignant neoplasm should be excluded, since treatment with Nexium can lead to a smoothing of the symptoms and delay the setting diagnosis.

Nexium tablets contain sucrose, which is why they are contraindicated in patients with hereditary intolerance to fructose, glucose-galactose malabsorption or sugar-isomaltase deficiency.

Pharmacokinetic / pharmacodynamic interaction between clopidogrel (loading dose 300 mg and maintenance dose 75 mg / day) and esomeprazole (40 mg / day Inside), 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, on average 14%. Therefore, simultaneous use of esomeprazole and clopidogrel should be avoided. section "Interaction with Other Drugs and Other Types of Drug Interactions").

Some observational studies indicate that proton pump inhibitor therapy may be slightly increase the risk of osteoporosis-related fractures, but in other similar studies noted.

In randomized, double-blind, controlled clinical trials of omeprazole and esomeprazole, including two open studies of long-term therapy (more than 12 years), the connection of fractures against the background of osteoporosis with inhibitors proton pump.

Although the causal relationship of omeprazole / esomeprazole with fractures against osteoporosis is not established, patients with a risk of developing osteoporosis or fractures against it should be placed under the appropriate clinical observation.

Patients taking the drug 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 the fluctuations in the plasma esomeprazole concentration when the therapy is administered "as needed the interaction of the drug with other drugs should be taken into account (cf. 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, in the appointment of eradication therapy to patients receiving other drugs metabolized with the participation of CYP3A4 (for example, cisapride), it is necessary to take into account the possible contraindications and interactions of clarithromycin with these drugs.

Drug Interactions

When using the drug, it is necessary to take into account the interaction with other drugs:

  1. With caution combine the drug with warfarin and cisapride.
  2. When a combination of esomeprazole with drugs such as ketoconazole and intraconazole, the absorption of drugs from the digestive tract may be disrupted.
  3. For people suffering from epilepsy, caution should be taken. Medications for epilepsy (phenytoin) do not fit well with Nexium.
  4. Simultaneous reception with funds in the assimilation of which CYP2C19 participates will lead to an increase in their effect. These drugs include imipramine, diazepam, clomipramine, citalopram, phenytoin.
  5. Atazanavir, nelfinavir, omeprazole when combined with Nexium become less effective. However, when combined with saquinavir, its concentration in the serum increases.

Reviews

We picked up some reviews of people who used the drug Nexium:

  1. Julia. Accepted "Nexium healed the duodenal ulcer well. She did not notice any side effects. Was ready to pay any money, if only the medicine helped. Because it was difficult to live with constant nausea. Took in the morning of 20 mg for 30 minutes before a meal, and in the evening just drank 20 mg at bedtime. The drug is perfectly combined with antibiotics. And, as the doctor said, it is very important to take the medicine simultaneously with properly selected antibiotics, for example, with "Amoxicilin" and "Klabaksom." Nausea and abdominal pain began to subside almost 2-3 days after taking the drug.
  2. Dmitriy. I have a standard set of stomach problems (gastritis, duonitis, etc.) - Nexium did not help me at all! Has drunk a full course (with dop. drugs - strictly according to the prescription of the doctor) - result zero! My sincere advice to you - before buying any expensive medicine from the series Nexium / Pariet / Nolpaz, etc. for the whole course, buy one package and look at the reaction of your body, because different people have different reactions to different drugs (sorry for the banality), despite the similarity of the action of these medicines. And doctors, unfortunately, when they write out a specific brand, are often guided solely by their own monetary or other benefits derived from the manufacturers of these medicines.
  3. Marina. I was treated for a long time in the clinic for stomach ulcer and decided to go to a gastroenterologist in a private clinic. I was examined there well and prescribed a non-oxyum. The first impression is expensive! The second impression - it helps just like the simpler (and cheaper) medicine. I did not notice the special advantages of Nexium over previously taken medications from peptic ulcer ...

Analogues

On the pharmaceutical market there are analog preparations and synonyms of Nexium. Synonyms include drugs containing the same active substance as Nexium. Analogues include drugs that have similar therapeutic effects, but contain an active ingredient other than Nexium substance.

Synonyms of Nexium are the following medicines:

  • Neo-Text;
  • Esomeprazole tablets;
  • Emanera capsules.

The following drugs are analogues of Nexium:

  • Acrylase;
  • Vero Omeprazole;
  • Gastrozole;
  • Demeprazole;
  • Zhelezolic;
  • A zerocide;
  • Zipantola;
  • Zolispan;
  • Zolser;
  • Zulbeks;
  • Controllers;
  • Chrismel;
  • Crosatide;
  • Lanzabel;
  • Lanzap;
  • Lansoptol;
  • Lansoprazole;
  • Lansofed;
  • Lancid;
  • Losek;
  • Loenzar sanovel;
  • Nolpaz;
  • Omez;
  • Omez Insta;
  • Omesol;
  • Omekaps;
  • Omeprazole;
  • Omepros;
  • Omeface;
  • OmiPix;
  • Ontime;
  • Ortanol;
  • Ozid;
  • Pantaz;
  • Panum;
  • Parries;
  • Pepazol;
  • Pepticum;
  • Pomez;
  • Puloreph;
  • Rabelock;
  • Rabeprazole;
  • Romesque;
  • Sunpras;
  • Ulzol;
  • Ulcozol;
  • Ulter;
  • Ultop;
  • Hirabesol;
  • Helicid;
  • Helol;
  • Cisagast;
  • Epicurus.

Before using analogues, consult your doctor.

Storage conditions and shelf life

Tablets and lyophilizate should be stored at a temperature of no more than 30 ° C, pallets and granules not more than 25 ° C. Keep away from children.

Shelf life of tablets, granules and pallets is 3 years, lyophilizate is 2 years. A bottle with powder without a cardboard bundle can be stored under room lighting for no more than 24 hours.


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