ESOREST Tablet

For GERD including:

- Symptomatic treatment of GERD

- Erosive reflux esophagitis

- Long-term management of patients with healed esophagitis

- The eradication of H.pylori in combination with appropriate antibiotics

- H.pylori-associated duodenal ulcer

Dosage and Administrations

Treatment of erosive esophagitis: 40mg once daily for 4-8weeks.

Symptomatic GERD/Maintenance of erosive esophagitis: 20mg once daily for 4 weeks.

H.pylori: 40mg once daily for 10 days in combination with appropriate antibiotics.

ESOREST should be taken at least 1 hour before meals.

In patients with previous hypersensitivity reactions to Esomeprazole, a component of the product formulation or to substituted benzimidazoles.

The adverse events associated with ESOREST therapy are similar to those seen with placebo or omeprazole therapy and similar to other PPIs available.

The most common adverse events reported in clinical trials were: diarrhea, abdominal pain, flatulence, gastritis, nausea and headache.

- Changes in gastric pH can affect bioavailability of certain medications. (e.g. Ketoconazole, iron salts)

- ESOREST can decrease the clearance of Diazepam by 45% and increase the plasma levels of Diazepam.

- No drug-drug interaction found between Esomeprazole, phenytoin, r-warfarin, quinidine, amoxicillin and clarithromycin.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Sporadic reports have been received of congenital abnormalities occurring in infants born to women who have received omeprazole during pregnancy.

Omeprazole is classified as Pregnancy Category C. The manufacturer recommends that Omeprazole be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Esomeprazole an enantiomer of Omeprazole is classified as Pregnancy Category B.

Symptomatic response to therapy with ESOREST does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with Omeprazole, of which Esomeprazole magnesium is an enantiomer.

Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the H+/K+ in the gastric parietal cell. Esomeprazole is the first single isomer PPI developed for the treatment of acid- related diseases.

The S- and R- isomers are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, ESOREST blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20-40mg and leads to inhibition of gastric acid secretion.