Esonix 40 mg

Description

Esonix 40 mg Tablet

Indications Esonix is prescribed for:

• 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 duodenal ulcer patients
• Zollinger-Ellison Syndrome
• Acid-related dyspepsia
• Treatment of duodenal and gastric ulcers

Use this medication only as directed by a registered physician.

Pharmacology Esomeprazole, the active ingredient in Esonix, is a proton pump inhibitor (PPI) that reduces gastric acid production by selectively inhibiting the H+/K+-ATPase enzyme in gastric parietal cells. As the S-isomer of omeprazole, esomeprazole offers superior acid control compared to racemic PPIs.

Absorption: The capsule contains enteric-coated pellets of esomeprazole magnesium. After oral administration, peak plasma levels are reached in about 1.5 hours. The maximum concentration (Cmax) increases in proportion to the dose, with a three-fold rise in plasma exposure when the dose is increased.

Dosage and Administration

Oral Dosage Form:

• Healing of Erosive Esophagitis: 20 mg or 40 mg once daily for 4-8 weeks. If necessary, an additional 4-8 weeks may be considered.
• Maintenance of Healing of Erosive Esophagitis: 20 mg once daily (studies have not extended beyond 6 months).
• GERD Symptom Relief: 20 mg once daily for 4 weeks, with an additional 4 weeks if symptoms persist.
• H. pylori Eradication (Triple Therapy): Esomeprazole 40 mg once daily for 10 days, along with Amoxicillin 1000 mg twice daily and Clarithromycin 500 mg twice daily for 10 days.
• Zollinger-Ellison Syndrome: 20-80 mg once daily, adjusted individually based on clinical needs.
• 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.
  • Pediatric patients (1-17 years):
    • <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: 10-30 minutes.
• Prevention of Rebleeding from Gastric or Duodenal Ulcers:
  • 80 mg IV infusion over 30 minutes, followed by a continuous infusion of 8 mg/hour for 72 hours.

Use this medication only as directed by a registered physician.

Administration Instructions

• Capsules or Tablets: Swallow whole with water at least one hour before meals.
• Oral Suspension: Dissolve the full contents in 15 ml of water, stir well, let it thicken for 2-3 minutes, then stir again and drink within 30 minutes. If some remains, add more water, stir, and drink immediately.
• Nasogastric or Gastric Tube Administration: Use a 15 ml syringe, shake the mixture, let it thicken for 2-3 minutes, then inject within 30 minutes.
• IV Injection: Reconstitute with 5 ml of 0.9% sodium chloride and administer over at least 3 minutes. The prepared solution must be used within 12 hours at room temperature.

Drug Interactions Esonix is metabolized by liver enzymes CYP2C19 and CYP3A4. It does not significantly interact with drugs metabolized by CYP1A2, 2A6, 2C9, 2D6, or 2E1. However, it can reduce the clearance of diazepam, leading to increased plasma levels. Since Esonix reduces gastric acid secretion, it may affect the absorption of drugs like ketoconazole, iron salts, and digoxin. No significant interaction has been observed with oral contraceptives, warfarin, phenytoin, or quinidine.

Contraindications Esonix should not be used by individuals with known hypersensitivity to esomeprazole or any of its components.

Side Effects Commonly reported side effects include:

• Headache
• Diarrhea
• Nausea
• Flatulence
• Abdominal pain
• Constipation
• Dry mouth

No major differences in adverse effects have been observed between short-term and long-term use (up to 12 months).

Pregnancy & Lactation There are no sufficient clinical studies on the use of esomeprazole in pregnant women. Animal studies have not shown teratogenic effects. The excretion of esomeprazole in breast milk is unknown, so breastfeeding should be discontinued if the medication is deemed necessary.

Precautions & Warnings

• Symptomatic relief does not rule out the presence of gastric malignancy.
• Patients who have difficulty swallowing capsules may open them and mix the pellets with applesauce, swallowing immediately without chewing.
• Long-term use may lead to weak bones and a deficiency in minerals like magnesium. Ensure an adequate intake of calcium and magnesium or take supplements as prescribed.

Use in Special Populations

• Pediatric Use: Safety and efficacy in pediatric patients have not been fully established.
• Geriatric Use: No significant differences in safety or effectiveness have been observed in elderly patients.
• Hepatic Impairment: Patients with mild to moderate liver impairment do not require dose adjustments. However, those with severe hepatic insufficiency should not exceed 20 mg daily.
• Renal Impairment: Since less than 1% of esomeprazole is excreted unchanged in urine, renal impairment is not expected to affect drug levels significantly.

Overdose Effects In animal studies, very high doses caused reduced motor activity, tremors, ataxia, and convulsions. No specific antidote exists for esomeprazole overdose. Treatment should be supportive and symptomatic.

Storage Conditions

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