| Category: |
Gastrointestinal Agents/ Proton Pump Inhibitor
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| Product information: |
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Esomeprazole 40mg (Fast releasing tablet)
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- Composition: Each film-coated tablet contains:
Esomeprazole Magnesium Trihydrate 40mg
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- Therapeutic Category:Gastrointestinal Agents/ Proton Pump Inhibitor
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- Pharmacological Category: Antisecretory Agent
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- Pregnancy Category: Not recommended (FDA Category Not Assigned)
- Lactation: Not recommended
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| INDICATIONS : |
ENTIC FR is used in the management of acid-related gastrointestinal conditions:
- Erosive reflux esophagitis
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison Syndrome
- Peptic ulcers (as part of combination therapy)
- Prevention of gastric ulcers in NSAID users
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| MECHANISM OF ACTION: |
Esomeprazole is a prodrug and a weak base, which becomes active in the acidic environment of the parietal cell canaliculi in the stomach.
Once activated, it inhibits the H⁺/K⁺-ATPase enzyme (the gastric acid pump), leading to a significant reduction in gastric acid secretion – both basal (resting) and stimulated (food-induced) acid output.
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| PHARMACOKINETICS : |
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Rapidly absorbed; bioavailability increases with repeated dosing.
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- Peak Plasma Time: 1 to 2 hours after oral intake.
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- Metabolism: Extensively metabolized in the liver (CYP2C19 and CYP3A4 pathways)
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- Excretion: Mainly through urine (80%) and feces (rest).
- Half-life: 1 to 1.5 hours, but effect lasts longer due to irreversible enzyme inhibition.
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| DOSAGE INFORMATION: |
Route: Oral (Tablet should be swallowed whole with water, without chewing or crushing)
- Erosive Reflux Esophagitis:
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40 mg once daily for 4 weeks
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- Zollinger-Ellison Syndrome: 40 mg twice daily (or as directed by a physician)
- Best taken on an empty stomach, usually before meals.
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| SIDE EFFECTS: |
Common:
- Headache
- Abdominal pain
- Nausea
- Diarrhoea
- Flatulence
Rare/Serious:
- Low magnesium levels (long-term use)
- Vitamin B12 deficiency (long-term use)
- Increased risk of bone fracture (long-term use)
- Skin rash or allergic reactions
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| PRECAUTIONS AND WARNINGS: |
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- Not recommended during pregnancy and lactation unless clearly needed
- Use with caution in hepatic impairment
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- Long-term use may be associated with:
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- Osteoporosis-related fractures
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- Clostridium difficile infections in hospitalized patients
- Evaluate for malignancy in case of persistent gastric symptoms
- May interact with drugs like clopidogrel, warfarin, diazepam (due to CYP metabolism
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