Powder for solution for injection and infusion "Nexium" is used for the indications listed below.
Adults:
Children aged 1 to 18 years: antisecretory therapy when it is impossible to use the oral route of administration, for example, gastroesophageal reflux disease (GERD) in patients with erosive reflux esophagitis and / or severe reflux symptoms.
The active ingredient is esomeprazole (1 bottle contains esomeprazole sodium 42.5 mg, which is equivalent to 40 mg esomeprazole).
Excipients: sodium edetate, sodium hydroxide.
hypersensitivity to the active substance esomeprazole, other substituted benzimidazoles or to any of the excipients of this drug;
Esomeprazole should not be used concomitantly with atazanavir, nelfinavir.
Antisecretory therapy when it is impossible to use the oral route of administration (adults)
For patients who cannot take the drug orally, the drug can be administered parenterally at a dose of 20-40 mg once a day. The dose for patients with reflux esophagitis is 40 mg once daily. The dose for patients receiving symptomatic treatment for reflux disease is 20 mg once daily.
In the treatment of NSAID-associated stomach ulcers, the usual dose is 20 mg once daily. To prevent gastric and duodenal ulcers caused by NSAID therapy, patients at risk are prescribed the drug at a dose of 20 mg once a day.
Usually, treatment with an intravenous drug is short-lived, and patients should be switched to oral drug use as soon as possible.
Short-term maintenance of hemostasis and prevention of rebleeding in patients after endoscopic treatment of acute bleeding due to gastric or duodenal ulcers
After therapeutic endoscopy of acute bleeding of a stomach ulcer or duodenal ulcer, 80 mg of the drug is administered as a bolus infusion for 30 minutes, after which the drug is continued to be administered as a long-term infusion at a rate of 8 mg / hour for 3 days (72 hours).
After parenteral treatment, therapy should be continued with oral agents that inhibit acid secretion.
As a means to suppress gastric secretion if oral administration of the drug is not possible (children aged 1-18)
For patients who cannot take the drug orally, within the period of complete cure for GERD, the drug can be administered parenterally once a day (doses are indicated below).
Typically, treatment with the drug to be administered should be short-lived and patients should be switched to oral medication as soon as possible.
Recommended doses of esomeprazole for intravenous administration:
Erosive reflux esophagitis treatment:
symptomatic treatment of GERD:
Pregnant
The drug should be prescribed with caution to pregnant women.
Esomeprazole should not be used while breastfeeding.
The results of studies of the racemic mixture of omeprazole in animals indicate that there is no effect of omeprazole on fertility in the case of oral administration of the drug.
Drivers
Esomeprazole has minimal effect on the ability to drive vehicles or operate other mechanisms. Adverse reactions such as dizziness (rare) and blurred vision (rare) have been reported. If such disorders are observed, patients should not drive vehicles or work with other mechanisms.
Experience with deliberate overdose is currently very limited. Symptoms that resulted from the oral dose of 280 mg were gastrointestinal symptoms and weakness. A single oral intake of 80 mg of esomeprazole and the administration of 308 mg of esomeprazole for 24 hours did not cause any consequences. The specific antidote is unknown. Esomeprazole binds significantly to blood plasma proteins and is therefore poorly eliminated by dialysis.
As with any overdose, symptomatic treatment and general supportive measures should be taken.
Among the side effects that are most common during clinical trials (as well as during the period of post-registration use of the drug), there are headaches, abdominal pain, diarrhea and nausea.
Store at a temperature not exceeding 30 ° C, out of the reach of children and protected from light.
Shelf life after solution preparation: chemical and physical stability has been demonstrated under the conditions of use for 12 hours at 30 ° C. From a microbiological point of view, the product should be used immediately.
Shelf life is 2 years.
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