Epragut

Description

Epragut Tablet: Medication Details

Generic Name: Esomeprazole Magnesium Trihydrate BP

Manufacturer: THE MADRAS PHARMACEUTICALS

Availability: Nepal

Uses (Indications): Epragut Tablet is prescribed for various conditions related to stomach acid production, including:

• Heartburn
• Acid-Related Dyspepsia
• Peptic ulcer disease (including Duodenal and Gastric Ulcer)
• Zollinger-Ellison syndrome
• Gastroesophageal reflux disease (GERD)
• Helicobacter pylori infection (typically as part of a combination therapy)
• Erosive Esophagitis
• Gouty arthritis (listed as an indication, though Esomeprazole’s primary action is on acid)

Dosage:

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

    • 12 years: 20-40 mg PO qDay for up to 8 weeks.

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

      • 3.5-7.5 kg: 5 mg PO qDay for up to 6 weeks.

      • 7.5 kg: 10 mg PO qDay for up to 6 weeks.

    • 1-12 years:
      • <20 kg: 10 mg PO qDay for 8 weeks.

      • 20 kg: 10-20 mg PO qDay for 8 weeks.

    • 12 years: 20-40 mg PO qDay for 4-8 weeks.

    • Maintenance (>12 years): 20 mg PO qDay up to 6 months.
• Renal Dose: No dosage adjustment needed for renal impairment.

Administration:

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

Contraindications: Esomeprazole is contraindicated in patients with a known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.

Precautions:

• Use with caution in pediatric patients, during pregnancy and lactation.
• Monitor patients with malignancy and hepatic impairment.
• There is an increased risk of developing certain infections, such as community-acquired pneumonia.
• For patients with severe liver impairment, a dose of 20 mg should not be exceeded.
• Lactation: It is unknown whether esomeprazole is distributed into breast milk; consider discontinuing the drug or refraining from nursing.

Interactions:

• Increased risk with: Digoxin (cardiotoxic effects), diuretics (hypomagnesaemia).
• May increase serum concentration/effects of: Warfarin (INR and prothrombin time), tacrolimus, saquinavir, methotrexate, and 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% (Less Common/Serious): 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). It suppresses gastric acid secretion by specifically inhibiting the H+/K+ ATPase enzyme (the proton pump) in the gastric parietal cells. It is the S-isomer of omeprazole.

Note: Farmaco Nepal drug index information on Epragut Tablet is not intended for diagnosis, medical advice, or treatment; neither is it intended to be a substitute for the exercise of professional judgment.