ENTIC FR

General

Esomeprazole is used to treat conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, erosive esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome, a condition wherein the stomach produces too much acid.

General Info

Category:	Gastrointestinal Agents/ Proton Pump Inhibitor
Product information:	Generic name: Esomeprazole 40mg (Fast releasing tablet) Composition: Each film-coated tablet contains: Esomeprazole Magnesium Trihydrate 40mg Therapeutic Category:Gastrointestinal Agents/ Proton Pump Inhibitor Pharmacological Category: Antisecretory Agent Presentation: 15 x 8’s Pregnancy Category: Not recommended (FDA Category Not Assigned) Lactation: Not recommended
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
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.
PHARMACOKINETICS :	Absorption: Rapidly absorbed; bioavailability increases with repeated dosing. Peak Plasma Time: 1 to 2 hours after oral intake. Protein Binding: ~97% Metabolism: Extensively metabolized in the liver (CYP2C19 and CYP3A4 pathways) Excretion: Mainly through urine (80%) and feces (rest). Half-life: 1 to 1.5 hours, but effect lasts longer due to irreversible enzyme inhibition.
DOSAGE INFORMATION:	Route: Oral (Tablet should be swallowed whole with water, without chewing or crushing) Erosive Reflux Esophagitis: 40 mg once daily for 4 weeks Zollinger-Ellison Syndrome: 40 mg twice daily (or as directed by a physician) Best taken on an empty stomach, usually before meals.
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
PRECAUTIONS AND WARNINGS:	Not recommended during pregnancy and lactation unless clearly needed Use with caution in hepatic impairment Long-term use may be associated with: Hypomagnesemia Osteoporosis-related fractures 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