Esonix 40 I.V Injection

What is Esonix Injection?

Esonix Injection is an injectable proton pump inhibitor (PPI) containing Esomeprazole, indicated for patients who cannot take oral medication. It suppresses gastric acid secretion through specific inhibition of the H+/K+-ATPase pump in the gastric parietal cell.

Indications

Esonix is indicated for relief of chronic heartburn and other symptoms associated with GERD, healing of erosive esophagitis, maintenance of healing of erosive esophagitis, eradication of Helicobacter pylori infection (in combination with amoxicillin and clarithromycin), Zollinger-Ellison Syndrome, acid-related dyspepsia, and duodenal & gastric ulcer.

Pharmacology

Esomeprazole, the S-isomer of omeprazole, is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. It is 97% bound to plasma proteins, extensively metabolized in the liver by CYP2C19 and CYP3A4, with a plasma elimination half-life of approximately 1-1.5 hours.

Dosage & Administration

GERD with Erosive Esophagitis (Adults ≥18 years): 20 mg or 40 mg once daily; IV injection over >3 minutes, or IV infusion over 10-30 minutes.
Pediatric Patients (1-17 years): Body weight <55 kg: 10 mg once daily; ≥55 kg: 20 mg once daily; 1 month to <1 year: 0.5 mg/kg once daily; IV infusion over 10-30 minutes.
Risk reduction of rebleeding of gastric/duodenal ulcers following endoscopy (Adults): 80 mg IV infusion over 30 minutes, followed by continuous infusion of 8 mg/h for 72 hours.
Preparation: Reconstitute by adding 5 ml of 0.9% Sodium Chloride for injection into the vial. The reconstituted solution is clear, colorless to very slightly yellow, and must be used within 12 hours of preparation.

Interaction

No clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin. May interfere with CYP2C19 substrates such as diazepam. May affect absorption of pH-dependent drugs (e.g., ketoconazole, iron salts, digoxin).

Contraindications

Contraindicated in patients with known hypersensitivity to esomeprazole or any component of the formulation.

Side Effects

Headache, diarrhoea, nausea, flatulence, abdominal pain, constipation, and dry mouth are the most frequently reported adverse events.

Pregnancy & Lactation

No adequate and well-controlled studies exist in pregnant women; animal studies revealed no teratogenic effects. Breastfeeding should be discontinued if use is considered essential.

Precautions & Warnings

Symptomatic response does not preclude the presence of gastric malignancy. Long-term/high-dose use may be associated with reduced bone mineral density and hypomagnesemia.

Use in Special Populations

Hepatic Insufficiency: Severe impairment should not exceed 20 mg once daily equivalent. Renal Insufficiency: No dose adjustment needed, as less than 1% is excreted unchanged in urine.

Therapeutic Class

Proton Pump Inhibitor (PPI)

Storage Conditions

Store at a temperature not exceeding 30°C, protected from light and moisture. Keep out of reach of children. Use reconstituted solution within 12 hours.