Composition and form of issue
Tablets, film-coated light pink color, oblong, convexoconvex, engraved with "20 mg" on one side and "A / EH" on the other.

1 tab.
esomeprazole magnesium trihydrate 22.3 mg,
including esomeprazole 20 mg

Other ingredients: glyceryl monostearate 40-50, hydroxypropyl cellulose, hypromellose, iron oxide (red-brown, yellow) (E172), magnesium stearate, copolymer of metacrylic acid (1:1) dispersion of 30%, microcrystalline cellulose, synthetic paraffin, macrogol 6000 , polysorbate 80, crosspovidon, sodium stearyl fumarate, sugar granules (sucrose and corn starch), talc, titanium dioxide (E171), triethyl citrate.
7 pcs. - Packaging Valium outline (1) - packs cardboard.
7 pcs. - Packaging Valium contour (2) - packs cardboard.
7 pcs. - Packaging Valium contour (4) - packs cardboard.
Tablets, film-coated pink color, oblong, convexoconvex, engraved with "40 mg" on one side and "A / EI" on the other.
1 tab.
esomeprazole magnesium trihydrate 44.5 mg,
including esomeprazole 40 mg

7 pcs. - Packaging Valium outline (1) - packs cardboard.
7 pcs. - Packaging Valium contour (2) - packs cardboard.
7 pcs. - Packaging Valium contour (4) - packs cardboard.
Registration number:
tab., cover. shell, 20 mg, 40 mg: 7, 14 or 28 pieces. - P # 013775/01-2002 26.02.02

Pharmacological action

Inhibitor of the N +-K +-ATPASE. The active substance of the preparation Nexium - esomeprazole, S-isomer of omeprazole, reduces the secretion of hydrochloric acid in the stomach by specific inhibition of the acid pump in the parietal cells. S-and R-isomer of omeprazole have similar pharmacodynamic activity.
Esomeprazole is a weak base and is active in the acidic environment of the secretory tubules of parietal cells of gastric mucosa, which inhibits the activity of H +-K +-ATPASE and blocks the final stage secreting hydrochloric acid. Nexium inhibits both basal, and stimulirovannuyu jeludocnuu secretion.
The action of the drug is achieved within 1 h after his reception inside the dose of 20 mg or 40 mg. Daily admission of the drug for 5 days at 20 mg 1 time / day, the mean maximum concentration of acids in the gastric contents after stimulation pentagastrin reduced by 90% (in the measurement of the concentration of acid in 6-7 hours after administration of doses of 5-th day of treatment).
In patients with symptoms of gastroesophageal reflux disease after five days the daily administration Nexium inside, in the dose of 20 mg or 40 mg of pH in the stomach with daily monitoring was above 4 for an average of 13 and 17 hours, respectively. Among the patients who received 20 mg of the drug in the day, the maintenance of acidity at the level of pH above 4 for 8, 12 and 16 h was achieved in 76%, 54 24% and%, respectively. For the 40 mg of esomeprazole, the ratio was 97%, 92% and 56%, respectively.
Analysis of pharmacokinetic data allowed to reveal the relationship between the secretion of acid and the concentration of the drug in plasma (for the estimation of the concentration of the parameter used AUC).
When receiving 40 mg drug per day cure reflux-esophagitis occurs in 78% of patients after four weeks of therapy and in 93% after 8 weeks of therapy.
Treatment Nexium in the dose of 20 mg twice / day in combination with the appropriate antibiotics for one week leads to a successful eradication of Helicobacter pylori in approximately 90% of patients.
Patients with uncomplicated duodenal ulcers after week course of eradication therapy does not require further treatment antisecretory preparations for the healing of the ulcers.
During the preparation level of gastrin in the plasma increases as a result of reduced intragastric secretion of acid.
In patients using antisecretorne drugs for a long time, often marked education of ferruginous cysts in the stomach. This phenomenon is due to physiological changes as a result of inhibition of gastric secretion. Cysts are benign and are tending to disappear.
In connection with the fact that esomeprazole is unsustainable in the acidic environment, the tablets contain granules of the active substance, covered with a stable to the action of gastric juice shell.

Indications

Gastroesophageal reflux disease:
- Treatment of erosive reflux-esophagitis;
- Continuous maintenance therapy to prevent relapses in patients with healed by esophagitis;
- Symptomatic treatment of gastroesophageal reflux disease.
Eradikation Helicobacter pylori (in combination with antibacterial therapy), and also:
- Treatment of ulcers duodenal ulcers associated with Helicobacter pylori;
- Prevention of relapse of peptic ulcers associated with Helicobacter pylori.

The dosage

For the treatment of erosive reflux-esophagitis the drug is administered in a single dose of 40 mg 1 time / day for 4 weeks. The additional four-week course of therapy is recommended to carry out in the cases, when after the first course are saved symptoms of the disease.
For long-term maintenance treatment of patients with healed by esophagitis to prevent the recurrence of the drug is administered to 20 mg 1 time / day.
For symptomatic treatment of gastroesophageal reflux disease without esophagitis the preparation is administered in a dose of 20 mg 1 time / day. If, after 4 weeks of treatment, the symptoms do not disappear, should carry out an additional examination of the patient. After the elimination of symptoms you can go to the mode of reception of a preparation "if necessary", ie take Nexium 20 mg one time / day in the case of symptoms prior to their withdrawal.
For eradication of Helicobacter pylori, for the treatment of ulcers duodenal ulcers associated with Helicobacter pylori, for the prevention of relapse of peptic ulcers associated with Helicobacter pylori, Nexium is administered in a single dose of 20 mg, amoxicillin 1 g and clarithromycin 500 mg. All drugs are taken two times per day for 7 days.
In appointing the drug to patients with impaired renal function no dosage adjustment is required. With caution use the drug in patients with severe renal insufficiency because of limited clinical experience of its use in this category of patients.
In the appointment of Nexium patients with impaired hepatic function mild or moderate dose adjustment is not required. Patients with severe violations of the liver applied dose should not exceed 20 mg / sut.
The elderly correction of dosing regimen is not required.
Tablets should be swallowed whole, liquid squeezed. Tablets should not be chewed or kibble. Patients with difficulty swallowing can dissolve the tablet in half of glass of plain water, stir until disintegration pills and drink suspension of its micro granules immediately or within 30 min. Then again fill a glass of water half, stir balances and drink. You should not use other liquids, so as a protective shell of its micro granules can be dissolved. You should not chew or break up microgranules.

Side effect

In the application of esomeprazole may be expected rare side effects of racemic drug (omeprazole). In clinical studies esomeprazole such effects are not described.
In clinical studies have identified the following side effects:
From the digestive system: frequent (> 0.01, but <0.1) - pain in the abdomen, diarrhoea, nausea, vomiting, constipation; rarely (> 0.001, but <0.01) - dryness of mouth.
Central nervous system: frequent (> 0.01, but <0.1) - headache; rare (> 0.001, but <0.01) - dizziness.
Dermatological reactions: rare (> 0.001, but <0.01), dermatitis, itching, urticaria.
None of these effects do not depend on the dose.
The following adverse effects were observed in the application of racemic drug (omeprazole) and may be expected also in the application of esomeprazole.
From the side of the central nervous system and peripheral nervous system: paresthesia, somnolence, insomnia, dizziness, reversible sputannosti consciousness, anxiety, excitement, depression, hallucinations (especially in seriously ill patients).
From the endocrine: gynecomastia.
From the digestive system: stomatitis, gastro-intestinal candidiasis; increased activity of liver enzymes, encephalopathy in patients with long-term severe diseases of the liver, hepatitis (with or without jaundice, liver failure.
Haemopoiesis: lakopenia, thrombocytopenia, agranulozitos, pancitopenia.
From the musculoskeletal system: pain in the joints, muscle weakness and myalgia.
Dermatological reactions: skin rashes, photosensitization, multiformnaya erythema, syndrome Stevens-Johnson, toxic epidermal necrolysis, alopecia.
Allergic reactions: angioneuroticeski swelling, fever, bronchospasm, interstitial nephritis and anaphylactic shock.
Other: general weakness, increased sweating, peripheral edema, blurred vision, changes in taste and giponatriemia.

Contraindications

- Hypersensitivity to esomeprazole, substituted benzimidazole or other components of the preparation.

Pregnancy and lactation

At the present time there are no data on the use of Nexium in pregnancy. The appointment of the drug during this period it is possible only in case, if the expected benefit to the mother outweighs the potential risk to the fetus.
At the present time is not known, stands out whether esomeprazole in breast milk, so you should not assign Nexium in the period of breast-feeding.
In experimental studies in animals have not revealed any adverse effects of esomeprazole on the development of the embryo or fetus. The introduction of racemic drug is also not had any adverse impact on the course of pregnancy in animals, childbirth and the period of post-natal development.

Special instructions

Before esomeprazole should exclude the possibility of malignant neoplasms, because the treatment Nexium can lead to alleviate symptoms and delay diagnosis.
Patients taking the drug for a long period of time (especially more than a year), should be under regular supervision of a physician.
Patients under the regime of "therapy-on-demand"