Esonix 40 mg/vial

Indications

Esonix is prescribed for the following conditions:

• Relief from chronic heartburn and other symptoms linked to GERD.
• Healing and maintenance of erosive esophagitis.
• Eradication of Helicobacter pylori in patients with duodenal ulcers, in combination with amoxicillin and clarithromycin.
• Management of Zollinger-Ellison syndrome.
• Treatment of acid-related dyspepsia.
• Duodenal and gastric ulcers.

Always consult a licensed healthcare provider before use.

Pharmacology

Esomeprazole, a proton pump inhibitor (PPI), works by specifically inhibiting the H+/K+-ATPase enzyme in gastric parietal cells, effectively reducing stomach acid production. As the S-isomer of omeprazole, it offers superior acid suppression compared to its racemic counterparts.

Absorption: Esomeprazole magnesium capsules use an enteric-coated pellet formulation. Peak plasma levels (Cmax) are reached approximately 1.5 hours after oral administration. Cmax increases proportionally with the dosage, and there’s a threefold increase in plasma area under the curve with higher doses.

Dosage and Administration

Oral Dosage:

• Healing of Erosive Esophagitis: 20-40 mg once daily for 4-8 weeks. For those unhealed, an additional 4-8 weeks may be considered.
• Maintenance of Healing: 20 mg once daily for up to 6 months.
• Symptomatic GERD: 20 mg once daily for 4 weeks, extendable to another 4 weeks if symptoms persist.
• H. Pylori Eradication (Triple Therapy): Esomeprazole 40 mg once daily for 10 days with amoxicillin (1000 mg twice daily) and clarithromycin (500 mg twice daily).
• Zollinger-Ellison Syndrome: 20-80 mg once daily, adjusted based on patient response.
• 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.

IV Injection or Infusion:

• Adults with GERD and Erosive Esophagitis: 20-40 mg once daily. IV injection (>3 minutes); IV infusion (10-30 minutes).
• Pediatric Patients (1-17 years): Based on weight, 10-20 mg once daily. For infants aged 1 month to 1 year, 0.5 mg/kg daily.

For Ulcer Rebleeding Prevention (Adults):

• 80 mg IV Infusion over 30 minutes followed by a continuous infusion of 8 mg/h for 72 hours.

Administration Guidelines

• Tablets/Capsules: Swallow whole, one hour before meals.
• Oral Suspension: Mix contents with 15 ml of water, stir, and wait 2-3 minutes before consumption. Ensure the mixture is fully consumed within 30 minutes. For nasogastric or gastric tube administration, use a 15 ml water solution and inject through the tube within 30 minutes.
• IV Injection: Reconstitute the solution with 5 ml of 0.9% sodium chloride. Administer over at least 3 minutes. Use within 12 hours.

Always follow a healthcare provider’s instructions.

Drug Interactions

Esomeprazole is metabolized in the liver by CYP2C19 and CYP3A4 enzymes. There are no significant interactions with drugs processed by CYP enzymes such as phenytoin, warfarin, or amoxicillin. However, co-administration with diazepam may reduce the clearance of diazepam, increasing its plasma levels. Additionally, esomeprazole may impact the absorption of medications that rely on stomach acidity, like ketoconazole, iron supplements, and digoxin.

Contraindications

Esonix is contraindicated for patients with known hypersensitivity to esomeprazole or any component of its formulation.

Side Effects

Common side effects include headache, diarrhea, nausea, flatulence, abdominal discomfort, constipation, and dry mouth. These effects remain consistent between short- and long-term treatments.

Pregnancy and Lactation

Although animal studies show no teratogenic effects, there is limited data on the use of esomeprazole during pregnancy and lactation. It is advised to discontinue breastfeeding if esomeprazole use is essential.

Precautions and Warnings

• A positive response to Esonix does not rule out the possibility of gastric malignancy.
• Esonix should be taken at least one hour before meals. For those who cannot swallow capsules, the contents can be mixed with applesauce and consumed immediately.

Use in Special Populations

• Pediatric Use: Safety and efficacy in children are not well established.
• Geriatric Use: No significant differences in effectiveness between older and younger patients.
• Hepatic Insufficiency: For severe hepatic impairment, limit the dose to 20 mg daily.
• Renal Impairment: No dosage adjustment is needed, as less than 1% of the drug is excreted unchanged.

Overdose

In cases of overdose, symptoms may include reduced motor activity, tremors, and seizures. No specific antidote exists, and treatment is symptomatic. Dialysis is not expected to be effective in removing esomeprazole due to its high protein binding.

Storage Instructions

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.