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Esoprazel 40

Esomeprazole 40
40mg
SinoHealth Pharmaceuticals LTD

Description

💊 Esopraxel 40 – Esomeprazole 40

Manufacturer: SinoHealth Pharmaceuticals LTD

1. Presentation:

  • Tablet: 20 mg / 40 mg (as marketed)

  • Capsule: 20 mg / 40 mg delayed-release formulation

  • IV Injection: 20 mg / 40 mg vial (for reconstitution)

2. Description / Pharmacology:

Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specifically inhibiting the Hâē/Kâē-ATPase enzyme in the gastric parietal cells.
It is the S-isomer of omeprazole and provides stronger, longer-lasting acid suppression and faster symptom relief compared to racemic PPIs.

Pharmacological actions:

  • Inhibits gastric acid secretion at the final step of acid production

  • Promotes healing of erosive esophagitis

  • Relieves symptoms of GERD and acid-related dyspepsia

  • Prevents recurrence of peptic ulcers

  • Provides effective acid suppression throughout 24 hours

3. Indications:

Esopraxel 40 is indicated in —

  • Gastroesophageal Reflux Disease (GERD)

  • Erosive esophagitis (healing and maintenance)

  • Chronic heartburn and acid reflux symptoms

  • Duodenal and gastric ulcers

  • Eradication of Helicobacter pylori (in combination with antibiotics)

  • Zollinger–Ellison Syndrome

  • Acid-related dyspepsia

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4. Dosage & Administration:

Oral administration:

  • GERD / Erosive Esophagitis: 20–40 mg once daily for 4–8 weeks

  • Maintenance therapy: 20 mg once daily (up to 6 months)

  • Symptomatic GERD: 20 mg once daily for 4 weeks; may continue for another 4 weeks if needed

  • H. pylori eradication (Triple Therapy):

    • Esomeprazole 40 mg once daily

    • Amoxicillin 1000 mg twice daily

    • Clarithromycin 500 mg twice daily for 10 days

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

  • 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 administration:

  • GERD with erosive esophagitis: 20–40 mg once daily

  • Ulcer rebleeding prevention: 80 mg IV infusion over 30 minutes, followed by 8 mg/hour continuous infusion for 72 hours

💡 Tablets or capsules should be swallowed whole, one hour before a meal.

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5. Drug Interactions:

  • CYP2C19 / CYP3A4 inhibitors (e.g., diazepam, phenytoin, warfarin) — may increase plasma concentration.

  • Drugs requiring acidic pH (e.g., ketoconazole, iron salts, digoxin) — absorption may be reduced.

  • Combination with clarithromycin and amoxicillin — increases esomeprazole plasma levels (clinically useful in triple therapy).

  • Antacids may be used concomitantly.

6. Contraindications:

  • Hypersensitivity to esomeprazole or other substituted benzimidazoles.

  • Severe hepatic impairment without dose adjustment.

7. Side Effects:

Generally well tolerated.
Common side effects include:

  • Headache

  • Diarrhea

  • Nausea

  • Abdominal pain

  • Constipation

  • Flatulence

  • Dry mouth

Prolonged use may cause:

  • Hypomagnesemia

  • Bone mineral loss (osteoporosis-related fracture)

  • Vitamin B12 deficiency (rare with long-term therapy)

8. Pregnancy & Lactation:

  • Pregnancy: Animal studies show no teratogenic effects; use only if clearly necessary.

  • Lactation: May be excreted in breast milk — avoid unless benefits outweigh risks.

  • Driving / Machinery: Esopraxel does not impair alertness or coordination.

9. Precautions & Warnings:

  • Rule out gastric malignancy before therapy.

  • Use with caution in severe hepatic impairment (max 20 mg/day).

  • Prolonged use requires monitoring of magnesium and bone health.

  • Avoid long-term therapy unless clinically justified.

  • Sudden discontinuation may cause acid rebound symptoms.

10. Use in Special Populations:

  • Children: Safety not established under 1 year.

  • Elderly: No dosage adjustment usually required.

  • Renal impairment: No dose adjustment necessary.

  • Hepatic impairment: Reduce dose to 20 mg/day in severe cases.

11. Overdose Effects:

Symptoms: Drowsiness, tremor, confusion, and ataxia.
Treatment:

  • Symptomatic and supportive care.

  • No specific antidote.

  • Esomeprazole is not removed by dialysis.

12. Therapeutic Class:

Proton Pump Inhibitors (PPIs) / Antiulcer Agents

13. Storage Conditions:

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

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