Ezolong-40 (esomeprazole) coated tablets 40 mg. №14

Description

Ezolong-40 Storage
active substance: esomeprazole;

1 film-coated tablet contains esomeprazole magnesium trihydrate equivalent to esomeprazole 20 mg or 40 mg;

excipients: microcrystalline cellulose, sodium bicarbonate, colloidal anhydrous silica, crospovidone, magnesium stearate, talc;

shell (Opadry White 58901), povidone (K-30), talc, iron oxide yellow (E 172) – available in film-coated tablets, 20 mg, iron oxide red (E 172) – available in tablets , film-coated, 40 mg, mint flavor).

Ezolong-40 Dosage form
Film-coated tablets.

Main physical and chemical properties: oval, biconvex tablets, film-coated pink (40 mg) or light yellow (20 mg), with a score line on one side.

Ezolong-40 Pharmacotherapeutic group
Remedies for peptic ulcer and gastroesophageal reflux disease. Proton pump inhibitors. Esomeprazole. ATX code A02B C05.

Pharmacological properties

Pharmacodynamics.

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

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

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

After 5 days of taking esomeprazole 20 mg and 40 mg orally, gastric pH was greater than 4 on average over 13 and 17 hours, respectively, and more than 24 hours in patients with symptomatic reflux esophagitis. The proportion of patients whose gastric pH was greater than 4 for 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%.

Indication
Adults

Gastroesophageal reflux disease (GERD):

treatment of erosive reflux esophagitis;
long-term treatment with cured esophagitis to prevent recurrence;
symptomatic treatment of gastroesophageal reflux disease.
In combination with suitable antibacterial drugs for the eradication of Helicobacter pylori:

treatment of duodenal ulcer associated with Helicobacter pylori;
prevention of recurrence of peptic ulcers in patients with ulcers caused by Helicobacter pylori.
Treatment and prevention of ulcers caused by long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs):

treatment of ulcers caused by NSAID therapy;
prevention of gastric and duodenal ulcers caused by NSAIDs in patients at risk.
Long-term treatment after intravenous administration of the drug to prevent recurrence of bleeding from peptic ulcers.

Treatment of Zollinger-Ellison syndrome.

Children from 12 years old

Gastroesophageal reflux disease (GERD):

treatment of erosive reflux esophagitis;
long-term treatment of patients with cured esophagitis to prevent recurrence;
symptomatic treatment of gastroesophageal reflux disease (GERD).
In combination with antibiotics in the treatment of duodenal ulcers caused by Helicobacter pylori.

Contraindication
Hypersensitivity to esomeprazole, to substituted benzimidazoles or to other components of the drug is known. Esomeprazole should not be used concomitantly with atazanavir, nelfinavir (see section “Interaction with other medicinal products and other forms of interaction”).