Escool 20

Description

Escool 20 Tablet: Medication Information

Generic Name: Esomeprazole Magnesium Trihydrate BP

Manufacturer: Curex Pharmaceuticals Pvt. Ltd.

Availability: Nepal

Uses (Indications): Escool 20 Tablet is used to treat a range of conditions related to stomach acid, including:

• Heartburn
• Acid-Related Dyspepsia (indigestion)
• Peptic ulcer disease (including Duodenal and Gastric Ulcer)
• Zollinger-Ellison syndrome (a condition causing excessive acid production)
• Gastroesophageal Reflux Disease (GERD)
• Helicobacter pylori infection (as part of combination therapy)
• Erosive Esophagitis (damage to the esophagus from acid)
• Gouty arthritis (listed as an indication, though primary action is acid suppression)

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 is not possible or appropriate: 20-40 mg intravenously (IV) qDay for up to 10 days; switch to oral administration once the patient can 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 dose 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): Do not 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 (other similar medications).

Precautions:

• Use with caution in pediatric patients, pregnant or lactating individuals.
• 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, the dose should not exceed 20 mg/day.
• Lactation: It is unknown whether 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 serum concentration/effects of: Warfarin (INR and prothrombin time), tacrolimus, saquinavir, 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):

• Common (>10%): Headache (2-11%)
• Less Common (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%).
• Rare (<1% and Serious): Blood and lymphatic system disorders (agranulocytosis, pancytopenia), blurred vision, GI disorders (pancreatitis, stomatitis, microscopic colitis), hepatobiliary disorders (hepatic failure, hepatitis with or without jaundice), anaphylactic reaction/shock, GI candidiasis, hypomagnesemia, musculoskeletal disorders (muscular weakness, myalgia, bone fracture), nervous system disorders (hepatic encephalopathy, taste disturbance), psychiatric disorders (aggression, agitation, depression, hallucination), interstitial nephritis, gynecomastia, bronchospasm, skin and subcutaneous tissue disorders (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 does this by inhibiting the H+/K+ ATPase enzyme (the gastric proton pump) located in the gastric parietal cells. Esomeprazole is the S-isomer of omeprazole.

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