Ezomer (esomeprazole) gastroresistive tablets 40 mg. №28

Description

Ezomer Composition
active substance: esomeprazole;

1 tablet contains esomeprazole magnesium dihydrate 43.38 mg, which is equivalent to esomeprazole 40 mg;

excipients: cellulose and mannitol mixture (Avicel®), glycerin monostearate, lures, methacrylate copolymer (type A), paraffin, polyvinylpyrrolidone, polysorbate 80, sodium stearyl fumarate, spherical sugar, triethyl citrate;

film shell: hypromellose, iron oxide yellow (E172), iron oxide red (E172), macrogol (PEG 4000), talc, titanium dioxide (E 171).

Ezomer Dosage form
Gastro-resistant tablets.

Basic physical and chemical properties: pink, oval-shaped film-coated tablets.

Ezomer Pharmacotherapeutic group
Means for the treatment of peptic ulcer and gastroesophageal reflux disease. Proton pump inhibitors.

ATX code А02В С05.

Pharmacodynamics
Esomeprazole is the S-isomer of omeprazole, which reduces gastric acid secretion through a specifically targeted mechanism of action. It is a specific inhibitor of the proton pump in the parietal cell. The R- and S-isomers of omeprazole have the same pharmacodynamic activity.

Esomeprazole is a weak base, it concentrates and becomes active in the highly acidic environment of the secretory tubules of the parietal cell, where it inhibits the H + K + -ATPase enzyme – the proton pump, and also suppresses basal and stimulated acid secretion.

After taking 20 mg and 40 mg of esomeprazole, the effect is observed within an hour. After repeated administration of 20 mg of esomeprazole 1 time per day for 5 days, the average peak acid release after stimulation with pentagastrin decreases by 90% when determining this indicator 6-7 hours after taking the dose on the 5th day.

After 5 days of taking esomeprazole 20 mg and 40 mg orally, the pH of the stomach was more than 4 on average for 13 and 17 hours, respectively, and more than 24 hours in patients with symptomatic reflux esophagitis. The proportion of patients whose stomach pH was greater than 4 within 8, 12 and 16 hours after taking 20 mg of esomeprazole was 76%, 54% and 24%, respectively. The corresponding proportions for esomeprazole 40 mg were 97%, 92% and 56%.

Using AUC as an indirect indicator of plasma concentration, the dependence of the suppression of acid secretion on the exposure of the drug was demonstrated.

Indications
Adults.

Gastroesophageal reflux disease (GERD):

treatment of erosive reflux esophagitis;
Prevention of recurrent bleeding from peptic ulcers of the stomach or duodenum after intravenous treatment with esomeprazole.
Treatment of Zollinger-Ellison syndrome.
Children over the age of 12.

Gastroesophageal reflux disease (GERD):

treatment of erosive reflux esophagitis.

Contraindications
Hypersensitivity to esomeprazole, substituted benzimidazole or other components of the drug. Concomitant use with nelfinavir is contraindicated. Should not be used concomitantly with atazanovir.