Esonix
Esomeprazole tablet and Injection

Presentation
Esonix 20 tablet: Each delayed release tablet contains Esomeprazole Magnesium INN equivalent to Esomeprazole 20 mg.
Esonix 40 tablet: Each delayed release tablet contains Esomeprazole Magnesium INN equivalent to Esomeprazole 40 mg.
Esonix 40 IV Injection: Each vial contains sterile Esomeprazole Sodium INN equivalent to Esomeprazole 40 mg.

Description
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 and Uses
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

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

Dosage And Administration
Tablet:
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.

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.


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.

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.

Use in pregnancy & 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.

Commercial Pack
Esonix 20: Each box contains 5 Alu-Alu blister strips of 10 tablets.
Esonix 40: Each box contains 3 Alu-Alu blister strips of 10 tablets.
Esonix 40 IV Injection: Each box contains 1 vail of lyophilized Esomeprazole 40 mg, 1 ampoule of 5 ml 0.9% Sodium Chloride injection BP for intravenous injection and 1 sterile syringe (5 ml).
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