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Esonix (Esomeprazole)
Therapeutic Group: Gastro Intestinal Disorders » Antiulcerant » PPI
Presentation

Esonix 20 tablet: Each delayed release tablet contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 20 mg.

Esonix 40 tablet: Each delayed release tablet contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 40 mg.

Esonix 20 capsule: Each delayed release capsule contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 20 mg.

Esonix 40 capsule: Each delayed release capsule contains Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 40 mg.

Esonix 40 IV Injection: Each vial contains sterile lyophilized powder of Esomeprazole Sodium INN equivalent to Esomeprazole 40 mg.

Descriptions
Esomeprazole (Esonix) 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.
Indications
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 & Administration
Tablet/Capsule: Esonix delayed release tablet/capsule 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.

Directions for reconstitution of solution
Solution for injection is prepared by adding 5 ml of 0.9% Sodium Chloride for intravenous injection into the vial containing the dry powder. The reconstituted solution for injection is clear and colorless to very slightly yellow.

Administration IV injection must be administered intravenously over a period of at least 3 minutes. Half of the IV injection should be used when 20 mg is to be administered. Prepared solution must be used within 12 hours of preparation and can be exposed to normal indoor lighting at a maximum of 30 °C.

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.
Side Effects
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.
Precautions
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.
Contraindications
Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.
Use in Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies on the use of Esomeprazole in pregnant women. Therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk. Esomeprazole should be used during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus.

Lactation: Esomeprazole is excreted in human milk. Thus, a decision should be taken to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Drug Interaction
Drug interaction studies have shown that Esomeparzole 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 Dogoxin). Coadministration of oral contraceptives, Diazepam, Phenytoin or Quinidine did not seem to change the pharmacokinetic profile of Esomeprazole.
Commercial Packaging
Esonix 20 tablet: Each box contains 5 Alu-Alu blister strips of 10 tablets.
Esonix 40 tablet: Each box contains 3 Alu-Alu blister strips of 10 tablets.
Esonix 20 capsule: Each box contains 7 Alu-Alu blister strips of 8 capsules.
Esonix 40 capsule: Each box contains 5 Alu-Alu blister strips of 6 capsules.
Esonix 40 IV Injection: Each box contains 1 vial of lyophilized Esomeprazole 40 mg, 1 ampoule of 5 ml 0.9% Sodium Chloride injection BP for intravenous injection and one sterile syringe(5ml).
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