Eposoft

Description

Eposoft Tablet: Medication Details

Generic Name: Esomeprazole Magnesium Trihydrate BP

Manufacturer: THE MADRAS PHARMACEUTICALS

Availability: Nepal

Uses (Indications): Eposoft Tablet is used for the treatment of various acid-related conditions, including:

• Heartburn
• Acid-Related Dyspepsia
• Peptic ulcer disease (including duodenal and gastric ulcers)
• Zollinger-Ellison syndrome
• Gastroesophageal reflux disease (GERD)
• Helicobacter pylori infection
• Erosive Esophagitis
• Gouty arthritis (though its direct role is unclear from the mechanism, it’s listed under indications)

Dosage:

• Adults:
  • GERD Without Erosive Esophagitis: 20 mg orally once daily for 4 weeks; an additional 4 weeks may be considered if symptoms persist.
  • GERD With Erosive Esophagitis: 20-40 mg orally once daily for 4-8 weeks.
  • IV Administration (if oral therapy is not possible): 20-40 mg intravenously (IV) once daily for up to 10 days, then switch to oral therapy.
  • Maintenance (GERD): 20 mg orally once daily for up to 6 months.
  • Risk Reduction of NSAID-Associated Gastric Ulcer: 20-40 mg orally once daily for up to 6 months.
  • NSAID-Induced Gastric Ulcer: 20 mg orally once daily for 4-8 weeks.
  • Zollinger-Ellison Syndrome: Initial dose of 80 mg orally divided twice daily (q12hr); adjust based on efficacy, up to 240 mg orally once daily, or 120 mg orally twice daily (q12hr) for some patients.
  • Elderly: No dosage adjustment is typically needed.
• Hepatic Impairment (Adults):
  • Mild to Moderate (Child-Pugh A/B): No dosage adjustment required.
  • Severe (Child-Pugh C): Do not exceed 20 mg per day.
• Children:
  • GERD Without Erosive Esophagitis (Oral):
    • <1 year: Safety and efficacy not established.
    • 1-12 years: 10-20 mg orally once daily for up to 8 weeks.

    • 12 years: 20-40 mg orally once daily for up to 8 weeks.

  • GERD With Erosive Esophagitis (Healing) (Oral):
    • <1 month: Safety and efficacy not established.
    • 1 month to 1 year:
      • 3.5 kg: 2.5 mg orally once daily for up to 6 weeks.

      • 3.5-7.5 kg: 5 mg orally once daily for up to 6 weeks.

      • 7.5 kg: 10 mg orally once daily for up to 6 weeks.

    • 1-12 years:
      • <20 kg: 10 mg orally once daily for 8 weeks.

      • 20 kg: 10-20 mg orally once daily for 8 weeks.

    • 12 years: 20-40 mg orally once daily for 4-8 weeks.

    • Maintenance (>12 years): 20 mg orally once daily for up to 6 months.
• Renal Impairment: No dosage adjustment is typically needed.

Administration:

• Delayed-release capsules: Should be taken on an empty stomach, 1 hour before meals.
• Tablets: May be taken with or without food.

Contraindications: Eposoft is contraindicated in patients with known hypersensitivity to any component of its formulation or to other substituted Benzimidazoles.

Precautions:

• Use with caution in pediatric patients, pregnant or lactating women.
• Monitor in patients with malignancy and hepatic impairment.
• May increase the risk of certain infections, such as community-acquired pneumonia.
• For severe liver impairment, the daily dose should not exceed 20 mg.
• Lactation: It is unknown if esomeprazole is distributed into breast milk; consider discontinuing the drug or refraining from nursing.

Interactions:

• Increased risk of: Digoxin-induced cardiotoxic effects, hypomagnesaemia with diuretics.
• May increase: INR and prothrombin time with warfarin, serum concentrations of tacrolimus, saquinavir, and methotrexate.
• May interfere with the elimination of: Drugs metabolized by CYP2C19 (e.g., diazepam).
• May decrease the bioavailability of: Ketoconazole, erlotinib, and iron (Fe) salts.
• Potentially Fatal Interactions: May decrease serum concentration and pharmacological effects of rilpivirine, atazanavir, and nelfinavir. May decrease the antiplatelet effects of clopidogrel.

Adverse Effects (Side Effects of Esomeprazole Magnesium Trihydrate BP):

• >10%: Headache (2-11%)
• 1-10%: Flatulence (10%), indigestion (6%), nausea (6%), abdominal pain (1-6%), diarrhea (2-4%), dry mouth (xerostomia) (3-4%), dizziness (2-3%), constipation (2-3%), somnolence (1-2%), pruritus (1%).
• <1% (Serious or Rare): Agranulocytosis, pancytopenia, blurred vision, pancreatitis, stomatitis, microscopic colitis, hepatic failure, hepatitis (with or without jaundice), anaphylactic reaction/shock, GI candidiasis, hypomagnesemia, muscular weakness, myalgia, bone fracture, hepatic encephalopathy, taste disturbance, aggression, agitation, depression, hallucination, interstitial nephritis, gynecomastia, bronchospasm, alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal).

Mechanism of Action: Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion. It achieves this by specifically inhibiting the H+/K+ ATPase enzyme (the proton pump) located in the gastric parietal cells. It is the S-isomer of omeprazole.

Important Note: This information, derived from the Farmaco Nepal drug index, is for informational purposes only and is not intended for diagnosis, medical advice, or treatment. It should not be considered a substitute for professional medical judgment