Lyophilized powder for solution for injection and infusion "Pemozar" is used for the indications listed below.
adults:
antisecretory therapy in cases where it is not possible to use the oral route of administration, for example: gastroesophageal reflux disease in patients with esophagitis and/or severe reflux symptoms; treatment of gastric ulcers associated with therapy with nonsteroidal anti-inflammatory drugs (NSAIDs); prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk; short-term maintenance of hemostasis and prevention of rebleeding in patients after endoscopic treatment of acute bleeding of gastric or duodenal ulcers.
Children and adolescents aged 1 to 18 years: antisecretory therapy in cases where the oral route of administration is not possible, e.g. gastroesophageal reflux disease (GERD) in patients with erosive reflux esophagitis and/or severe reflux symptoms.
Composition
The active substance is esomeprazole (1 vial contains esomeprazole sodium equivalent to esomeprazole 40 mg).
Excipients: disodium edetate, sodium hydroxide (for pH adjustment).
Contraindication
Hypersensitivity to esomeprazole or other components of the drug, to benzimidazole derivatives. Esomeprazole sodium, like other proton pump inhibitors, should not be used together with atazanavir, nelfinavir.
Method of application
Adults
Antisecretory therapy when oral administration is not possible. Patients who cannot take the drug orally are prescribed parenteral administration of esomeprazole at a dose of 20-40 mg 1 time per day. Patients with reflux esophagitis should be prescribed a dose of 40 mg 1 time per day. Patients with GERD receiving symptomatic treatment should be prescribed a dose of 20 mg 1 time per day. For the treatment of gastric and duodenal ulcers associated with NSAID therapy, the usual dose is 20 mg 1 time per day. For the prevention of gastric and duodenal ulcers associated with NSAID therapy, patients at risk should be prescribed a dose of 20 mg 1 time per day. Usually the course of intravenous treatment is short. The patient should be transferred to oral treatment as soon as possible.
Maintenance of haemostasis and prevention of rebleeding of gastric and duodenal ulcers. After endoscopic treatment of acute bleeding of gastric or duodenal ulcers, a dose of 80 mg should be administered as an infusion over 30 minutes, followed by a continuous infusion of 8 mg/h for 3 days (72 hours). After parenteral therapy, acid suppression therapy should be administered with esomeprazole sodium, 40 mg tablets once daily for 4 weeks.
Children aged 1-18 years
Antisecretory therapy when oral administration is not possible. Patients who cannot take the drug orally may be given intravenously once daily as part of a course of treatment for GERD. Usually, the course of intravenous treatment should be short, and the patient should be transferred to oral treatment as soon as possible. Recommended doses of esomeprazole for intravenous administration:
1-11 years: treatment of erosive reflux esophagitis: body weight <20 kg - 10 mg 1 time per day; body weight ≥ 20 kg - 10 mg or 20 mg 1 time per day; symptomatic treatment of GERD - 10 mg 1 time per day; 12-18 years: treatment of erosive reflux esophagitis - 40 mg 1 time per day; symptomatic treatment of GERD - 20 mg 1 time per day.
Application features
Pregnant women
There are limited data on the use of esomeprazole during pregnancy. Animal studies do not indicate direct or indirect harmful effects of esomeprazole on embryonal/foetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing esomeprazole to pregnant women.
It is not known whether esomeprazole is excreted in human milk. Studies in breastfeeding women have not been conducted. Therefore, it should not be used during breastfeeding.
Drivers
Esomeprazole sodium is unlikely to affect the ability to drive or use machines. During treatment, adverse reactions from the nervous system or the eyes may occur.
Overdose
Data on overdose are limited and are related to intentional overdose. Gastrointestinal symptoms and weakness were observed with oral administration of esomeprazole at a dose of 280 mg. A single oral dose of esomeprazole at a dose of 80 mg and intravenous administration of esomeprazole at a dose of 308 mg within 24 hours did not cause symptoms.
There is no specific antidote known. Esomeprazole is highly bound to plasma proteins and is therefore not readily dialysable. As in any case of overdose, treatment should be symptomatic with general supportive measures.
Side effects
The following side effects have been reported during clinical trials and after the introduction of esomeprazole into widespread medical practice.
Immune system disorders: Hypersensitivity reactions such as fever, angioedema and anaphylactic reaction/shock.
Metabolic disorders: edema, hyponatremia, hypomagnesemia; severe hypomagnesemia can lead to hypocalcemia.
On the part of the psyche: insomnia, agitation, depression, confusion, aggression, hallucinations.
From the nervous system: headache, dizziness, paresthesia, drowsiness, taste disturbance.
On the part of the organ of vision: blurred vision.
On the part of the organs of hearing: vestibular dizziness.
Respiratory system: bronchospasm.
Gastrointestinal tract: abdominal pain, constipation, diarrhea, bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis.
Hepatobiliary system: increased liver enzymes, hepatitis with or without jaundice, hepatic failure, encephalopathy in patients with liver disease.
Skin: injection site reactions, dermatitis, pruritus, rash, urticaria, alopecia, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Musculoskeletal system: arthralgia, myalgia, muscle weakness.
From the urinary system: interstitial nephritis.
From the reproductive system: gynecomastia.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 2 years.
