Esonix
Esomeprazol 20 mg tablet

Presentation

Esonix 20 tablet: Each delayed release tablet contains esomeprazole magnesium INN equivalent to esomeprazole 20 mg.

Description

Esonix (esomeprazole) is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Esonix blocks the final step in acid production, thus reducing gastric acidity.

Indication and Usage

  * Treatment of Gastroesophageal Reflux Disease (GERD)

                                    -Healing of Erosive Esophagitis

                                    -Maintenance of Healing of Erosive Esophagitis

                                    -Symptomatic Gastroesophageal Reflux Disease

   *H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

   *Zollinger-Ellison Syndrome

   *Acid Related Dyspepsia

   *Duodenal and Gastric Ulcer

Dosage and Administration

The recommended adult dosages are outlined in the table below. Esonix delayed release tablet should be swallowed whole and taken at least one hour before eating.

 

*The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered.

**If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

 

Geriatric: No dosage adjustment is necessary. Renal Insufficiency: No dosage adjustment is necessary. Hepatic Insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment. For patients with severe liver impairment, a dose of 20 mg of Esonix should not be exceeded.

Use in Pregnancy and Lactation

In Pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

In Lactation: The excretion of esomeprazole in milk has not been studied. As esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Adverse Reaction

In general, esomeprazole was well tolerated in both short- and long-term clinical trials. The most frequently occurring adverse events (  1%) are headache and diarrhea. Nausea, flatulence, abdominal pain, constipation and dry mouth occurred at similar rates among patients taking esomeprazole.

Contraindication

Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

Precaution

Symptomatic response to therapy with esomeprazole 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 is an enantiomer.

Drug Interaction

Drug interaction studies have shown that esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.  Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts and digoxin). Coadministration of oral contraceptives, diazepam, phenytoin or quinidine did not seem to change the pharmacokinetic profile of esomeprazole.

Commercial Pack

Esonix  20: Each box contains 5 Alu-Alu blister strips of 10 tablets.