Esonix 40mg Tab

What is Esonix?

Esonix is a proton pump inhibitor (PPI) containing Esomeprazole, the S-isomer of omeprazole. It works by suppressing gastric acid secretion through specific inhibition of the H+/K+-ATPase pump in the gastric parietal cell, providing better acid control than racemic proton pump inhibitors.

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) in patients with duodenal ulcer disease, Zollinger-Ellison Syndrome, acid-related dyspepsia, and duodenal & gastric ulcer.

Pharmacology

Esomeprazole capsules/tablets contain an enteric-coated pellet formulation of esomeprazole magnesium. Peak plasma levels occur at approximately 1.5 hours after oral administration. At repeated once-daily dosing, systemic bioavailability is approximately 90%. Esomeprazole is 97% bound to plasma proteins and is extensively metabolized in the liver by CYP2C19 and CYP3A4. The plasma elimination half-life is approximately 1-1.5 hours.

Dosage & Administration

Healing of Erosive Esophagitis: 20 mg or 40 mg once daily for 4-8 weeks.
Maintenance of Healing of Erosive Esophagitis: 20 mg once daily.
Symptomatic GERD: 20 mg once daily for 4 weeks.
H. pylori eradication: Esomeprazole 40 mg once daily + Amoxicillin 1000 mg twice daily + Clarithromycin 500 mg twice daily, for 10 days.
Zollinger-Ellison Syndrome: 20-80 mg once daily, adjusted individually.
Acid-related Dyspepsia: 20-40 mg once daily for 2-4 weeks.
Duodenal ulcer: 20 mg once daily for 2-4 weeks. Gastric ulcer: 20-40 mg once daily for 4-8 weeks.
Tablets/capsules should be swallowed whole, taken at least one hour before a meal.

Interaction

Esonix does not have clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin. It may interfere with CYP2C19 substrates such as diazepam, decreasing its clearance. As it inhibits gastric acid secretion, it may affect absorption of drugs where gastric pH affects bioavailability (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. Excretion in breast milk has not been studied; breastfeeding should be discontinued if use is considered essential.

Precautions & Warnings

Symptomatic response does not preclude the presence of gastric malignancy. Long-term use may be associated with reduced bone mineral density and hypomagnesemia. Antacids may be used concurrently if needed.

Use in Special Populations

Paediatric Use: Safety and effectiveness not established for the oral tablet form below approved ages. Geriatric Use: No overall differences in safety/efficacy versus younger patients. Hepatic Insufficiency: Severe impairment should not exceed 20 mg once daily. Renal Insufficiency: No dose adjustment needed.

Therapeutic Class

Proton Pump Inhibitor (PPI)

Storage Conditions

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture. Keep out of reach of children.