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Esoprazel 20

Esomeprazole
20mg
SinoHealth Pharmaceuticals LTD

Description

💊 Esoprazel 20 – Esomeprazole 20

Manufacturer: SinoHealth Pharmaceuticals LTD

1. Indications

Esoprazel 20 is indicated for:

  • Relief of chronic heartburn and other GERD symptoms

  • Healing of erosive esophagitis

  • Maintenance of healing of erosive esophagitis

  • Helicobacter pylori eradication (with amoxicillin & clarithromycin) in duodenal ulcer patients

  • Zollinger-Ellison Syndrome

  • Acid-related dyspepsia

  • Duodenal and gastric ulcers

Use only under the supervision of a registered physician.

2. Composition

Each capsule contains 20 mg Esomeprazole (as Esomeprazole Magnesium).

3. Pharmacology

  • Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting H+/K+-ATPase in gastric parietal cells.

  • It is the S-isomer of omeprazole and provides better acid control than racemic PPIs.

  • Absorption: Peak plasma levels occur at ~1.5 hours after oral administration.

4. Dosage & Administration

Oral (Capsule / Tablet):

  • Healing of Erosive Esophagitis: 20–40 mg once daily for 4–8 weeks

  • Maintenance of Healing: 20 mg once daily

  • Symptomatic GERD: 20 mg once daily for 4 weeks

  • H. pylori Eradication (Triple Therapy): 40 mg once daily with amoxicillin 1000 mg BID + clarithromycin 500 mg BID for 10 days

  • Zollinger-Ellison Syndrome: 20–80 mg once daily, adjust individually

  • Acid-related Dyspepsia: 20–40 mg once daily for 2–4 weeks

  • Duodenal Ulcer: 20 mg once daily for 2–4 weeks

  • Gastric Ulcer: 20–40 mg once daily for 4–8 weeks

IV Injection / Infusion:

  • Adults: 20–40 mg once daily (IV injection >3 min; infusion 10–30 min)

  • Pediatric (1 month–17 years): Dose according to weight; 0.5 mg/kg–20 mg once daily

  • Risk Reduction of Rebleeding after Endoscopy: 80 mg IV infusion followed by 8 mg/h continuous infusion for 72 hours

Administration Instructions:

  • Capsules/tablets: swallow whole, 1 hour before meals

  • For patients with difficulty swallowing: sprinkle capsule pellets on applesauce and swallow immediately

  • Do not chew or crush pellets

  • Oral suspension: drink within 30 minutes of preparation

  • IV: use reconstituted solution immediately; infusion over specified time

Use only under physician supervision

5. Interactions

  • Metabolized by CYP2C19 and CYP3A4

  • Minimal interactions with phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin

  • May interfere with absorption of drugs dependent on gastric pH (e.g., ketoconazole, iron, digoxin)

  • May increase plasma levels of co-administered diazepam (CYP2C19 substrate)

6. Contraindications

  • Known hypersensitivity to esomeprazole or formulation components

7. Side Effects

Common side effects:

  • Headache, diarrhea, nausea, flatulence, abdominal pain, constipation, dry mouth

8. Pregnancy & Lactation

  • No adequate human studies; animal studies show no teratogenicity

  • Unknown if excreted in human milk; breastfeeding should be discontinued if treatment is essential

9. Precautions & Warnings

  • Response to therapy does not rule out gastric malignancy

  • Take capsules 1 hour before meals; pellets can be mixed with applesauce if needed

  • Use cautiously in severe liver or renal impairment

  • Long-term use may increase risk of fractures and mineral deficiencies

  • Ensure adequate intake of calcium and magnesium

10. Special Populations

  • Paediatric: Safety not established for children <1 year

  • Geriatric: No significant differences observed

  • Hepatic: Max 20 mg once daily in severe insufficiency

  • Renal: No dose adjustment required

11. Overdose Effects

  • Symptoms in animals: tremor, ataxia, clonic convulsions, respiratory changes

  • No specific antidote; treatment is supportive and symptomatic

12. Storage Conditions

  • Store below 30°C in a dry place

  • Protect from light and moisture

  • Keep out of reach of children

13. Chemical Structure

  • Molecular Formula: C17H19N3O3S

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