Esonix 20 mg

Description

Esonix 20 mg Tablet

Indications Esonix is prescribed for the following conditions:

• Relief from chronic heartburn and symptoms associated with Gastroesophageal Reflux Disease (GERD)
• Healing of erosive esophagitis
• Maintenance therapy to prevent recurrence of erosive esophagitis
• Combination therapy with amoxicillin and clarithromycin for the eradication of Helicobacter pylori infection in patients with duodenal ulcers
• Zollinger-Ellison Syndrome
• Acid-related dyspepsia
• Treatment of duodenal and gastric ulcers

Pharmacology Esomeprazole, the active ingredient in Esonix, is a proton pump inhibitor (PPI) that effectively reduces gastric acid secretion. It works by selectively inhibiting the H+/K+-ATPase enzyme in the stomach’s parietal cells. Esomeprazole, the S-isomer of omeprazole, provides superior acid control compared to racemic proton pump inhibitors.

Absorption Esonix capsules contain enteric-coated pellets of esomeprazole magnesium, ensuring stability and absorption in the intestines. Following oral administration, peak plasma concentration (Cmax) is achieved approximately 1.5 hours post-dose (Tmax). Plasma levels increase proportionally with dosage, and the area under the plasma concentration-time curve (AUC) exhibits a three-fold increase with higher doses.

Dosage and Administration

Oral Dosage Form:

• Healing of Erosive Esophagitis: 20 mg or 40 mg once daily for 4-8 weeks. Additional treatment may be considered if necessary.
• Maintenance of Healing of Erosive Esophagitis: 20 mg once daily (Clinical studies have not extended beyond six months).
• Symptomatic GERD: 20 mg once daily for four weeks, with an additional four weeks if symptoms persist.
• H. pylori Eradication (Triple Therapy for Duodenal Ulcer Prevention):
  • Esomeprazole 40 mg once daily for 10 days
  • Amoxicillin 1000 mg twice daily for 10 days
  • Clarithromycin 500 mg twice daily for 10 days
• Zollinger-Ellison Syndrome: 20-80 mg once daily, adjusted individually based on clinical response.
• Acid-Related Dyspepsia: 20-40 mg once daily for 2-4 weeks depending on response.
• Duodenal Ulcer: 20 mg once daily for 2-4 weeks.
• Gastric Ulcer: 20-40 mg once daily for 4-8 weeks.

Intravenous (IV) Administration:

• GERD with Erosive Esophagitis:
  • Adults (≥18 years): 20 mg or 40 mg once daily
  • IV Injection: Administer over 3 minutes
  • IV Infusion: Administer over 10-30 minutes
• Pediatric Patients (1-17 years):
  • Body weight <55 kg: 10 mg once daily
  • Body weight ≥55 kg: 20 mg once daily
  • 1 month to <1 year: 0.5 mg/kg once daily
  • IV Infusion: Administer over 10-30 minutes
• Prevention of Rebleeding After Gastric or Duodenal Ulcer Endoscopy (Adults):
  • Initial dose: 80 mg via IV infusion over 30 minutes
  • Followed by continuous infusion of 8 mg/hour for 72 hours

Administration Guidelines

• Tablets and Capsules: Swallow whole with water at least one hour before meals.
• Oral Suspension: Dissolve entire packet contents in 15 ml of water, stir, wait 2-3 minutes to thicken, then stir again and drink within 30 minutes. If any remains, add more water, stir, and consume immediately.
• Nasogastric/Gastric Tube Administration: Use a 15 ml syringe to mix the suspension, allow 2-3 minutes to thicken, then administer promptly through the tube.
• IV Injection: Reconstitute with 5 ml of 0.9% sodium chloride. The solution should be clear and must be administered within 12 hours of preparation.

Drug Interactions Esonix is metabolized in the liver by CYP2C19 and CYP3A4. It does not significantly inhibit other CYP enzymes such as CYP1A2, 2A6, 2C9, 2D6, or 2E1. However, caution should be exercised when co-administering drugs metabolized by CYP2C19, such as diazepam, as Esonix may reduce their clearance by 45%, leading to increased plasma levels.

Esonix may also alter the absorption of drugs dependent on gastric pH, such as ketoconazole, iron salts, and digoxin. No significant interactions have been observed with phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin.

Contraindications

• Known hypersensitivity to esomeprazole or any component of the formulation.

Side Effects Common side effects include:

• Headache
• Diarrhea
• Nausea
• Flatulence
• Abdominal pain
• Constipation
• Dry mouth There are no significant differences in the adverse event profile between short-term and long-term (up to 12 months) therapy.

Pregnancy and Lactation There are no well-controlled studies in pregnant women. Animal studies have not shown teratogenic effects. It is unknown whether esomeprazole is excreted in human breast milk, so breastfeeding should be discontinued if its use is essential.

Precautions and Warnings

• Symptom relief does not exclude the possibility of gastric malignancy.
• Capsules should be taken at least one hour before meals.
• Patients with difficulty swallowing can mix the capsule contents with applesauce and swallow immediately without chewing.
• Long-term use may lead to bone weakening and deficiencies in calcium or magnesium.
• Seek medical attention if experiencing reduced urination, swelling, lower back pain, nausea, or rash, as these may indicate kidney issues.

Use in Special Populations

• Pediatric: Safety and efficacy have not been fully established.
• Geriatric: No major differences in safety and efficacy, though older patients may exhibit greater sensitivity.
• Hepatic Impairment: No dosage adjustments are needed for mild to moderate liver disease, but in severe cases, doses should not exceed 20 mg per day.
• Renal Impairment: Since esomeprazole is minimally excreted in urine, no dose adjustment is necessary.

Overdose Management In animal studies, high doses of esomeprazole have led to reduced motor activity, breathing changes, tremors, and convulsions. There have been no reported human overdoses, and no specific antidote exists. In case of overdose, supportive treatment should be provided as dialysis is ineffective in removing esomeprazole.

Storage Instructions

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

Molecular Formula: C17H19N3O3S