powder lyophilized for solution for injections and Ezonex's infusions is applied at indications which are provided below.

Adult:

• anti-secretory therapy in cases when it is impossible to apply an oral way of introduction, for example:
  • a gastroesophageal reflux disease at patients with an esophagitis and/or heavy symptoms of a reflux;
  • treatment of the stomach ulcers connected with therapy by non-steroidal anti-inflammatory medicaments (NPVS);
  • prevention of the stomach ulcers and a duodenum tied with therapy of NPVP at patients who enter into risk group;
• short-term maintenance of a hemostasis and prevention of repeated bleeding at patients after endoscopic treatment of acute bleeding of stomach ulcer or a duodenum.

Children and teenagers aged from the 1st up to 18 years: anti-secretory therapy in cases when it is impossible to apply an oral way of introduction, for example, a gastroesophageal reflux disease (GERD) at patients with an erosive reflux esophagitis and/or heavy symptoms of a reflux.

Structure

Active ingredient: esomeprazole;

1 bottle contains esomeprazole of sodium 42.5 mg that is equivalent esomeprazole of 40 mg;

Excipients: dinatrium edetat, sodium hydroxide.

Contraindication

• Hypersensitivity to esomeprazole, other substituted benzimidazoles or to any of excipients of this medicine.
• Esomeprazole should not be applied along with atazanaviry, nelfinaviry.

Route of administration

Adult

Anti-secretory therapy, in case of impossibility of oral administration.

to Patients who cannot accept medicine orally can administer the medicament parenterally in a dose of 20 - 40 mg once a day. The dose for patients with a reflux esophagitis makes 40 mg once a day. The dose for the patients receiving symptomatic treatment of a reflux disease makes 20 mg once a day.

At treatment of the stomach ulcers caused by reception NPVS, the usual dose makes 20 mg once a day. For prevention of the stomach ulcers and a duodenum caused by therapy of NPVP, to patients of risk group appoint medicine in a dose of 20 mg once a day.

Usually treatment by means of medicine for intravenous administration is short-term, it is necessary to transfer patients to oral administration of medicine as soon as possible.

Short-term maintenance of a hemostasis and prevention of repeated bleeding at patients after endoscopic treatment of acute bleeding owing to stomach ulcer or a duodenum

After therapeutic endoscopy of acute bleeding of stomach ulcer or a duodenum enter 80 mg of medicine in the form of bolyusny infusion lasting 30 minutes then continue administration of medicament by long intravenous infusion with a speed of 8 mg/hour within 3 days (72 hours).

After parenteral treatment by means of the oral means oppressing acid secretion.

Feature of use

Pregnant

esomeprazole to pregnant women with care.

Children

to children aged from 1 year as means to anti-secretory therapy in case oral administration of medicament is impossible.

It is improbable

that esomeprazole of sodium affected ability to drive the car and to work with mechanisms. During treatment, side reactions from nervous system or organs of sight can be observed.

Overdose

Experience of intentional overdose is very limited to

now. Manifestations from digestive tract and weakness were symptoms which resulted from oral administration of a dose of 280 mg. Single oral administration of 80 mg of esomeprazole and intravenous administration of 308 mg of esomeprazole within 24 hours of consequences did not cause. Specific antidote is unknown. Esomeprazole considerably contacts proteins of blood plasma and therefore it is badly removed by means of dialysis. As well as in case of any overdose, it is necessary to provide symptomatic treatment and to take the general supporting measures.

Side effects

General disturbances and reactions in the injection site: an indisposition, the strengthened sweating.

in isolated cases at critically sick patients receiving omeprazolum in the form of an intravenous injection, especially in high doses, however relationship of cause and effect is not established.

Interaction

Esomeprazole is metabolized by CYP2C19 and CYP3A4. The accompanying oral administration of esomeprazole and CYP3A4 inhibitor of a klaritromitsin (500 mg twice a day) led to doubling of exposure (AUC) of esomeprazole. Simultaneous use of esomeprazole and the combined CYP2C19 and CYP3A4 inhibitor can lead to esomeprazole exposure growth more than twice. CYP2C19 and CYP3A4 inhibitor vorikonazol increased AUC omeprazolum by 280%. Dose adjustment of esomeprazole is not always necessary in such situations. However it can be necessary for patients with heavy abnormal liver functions and in cases when long-term treatment is shown.

Drugs capable to stimulate CYP2C19 or CYP3A4 or both these enzymes (such as rifampicin and St. John's wort) can reduce concentration of esomeprazole in blood plasma by strengthening of his metabolism.

to Store

in original packing at a temperature not above 30 °C.

Bottles can be stored by

without secondary packing under the influence of usual room lighting till 24 o'clock.

to Store

out of children's reach.

Expiration date - 2 years.