Indications

Adults (from the age of 18 years) Gastroesophageal reflux disease (GERD) Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation) Maintenance treatment of NERD (i.e. heartburn and regurgitation) Reflux esophagitis or erosive esophagitis ... Read more Adults (from the age of 18 years) Gastroesophageal reflux disease (GERD) Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation) Maintenance treatment of NERD (i.e. heartburn and regurgitation) Reflux esophagitis or erosive esophagitis Maintenance treatment of patients with reflux esophagitis Healing of NSAID associated gastric ulcers Reduction of risk of NSAID associated gastric ulcers Zollinger-Ellison Syndrome H. pylori eradication Pediatrics (12-17 years of age) Gastroesophageal reflux disease (GERD) Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation) Reflux esophagitis or erosive esophagitis.

Composition

• 20 mg tablet : It contains Esomeprazole Magnesium Trihydrate USP enteric coated micro pellets equivalent to Esomeprazole 20 mg.
• 40 mg tablet : It contains Esomeprazole Magnesium Trihydrate USP enteric coated micro pellets equivalent to Esomeprazole 40 mg.
• 20 mg capsule : It contains Esomeprazole Magnesium Trihydrate USP enteric coated micro pellets equivalent to Esomeprazole 20 mg.
• 40 mg capsule : It contains Esomeprazole Magnesium Trihydrate USP enteric coated micro pellets equivalent to Esomeprazole 40 mg.

Pharmacology

The proton pump inhibitor Esomeprazole inhibits gastric acid by blocking the hydrogen-potassium adenosine triphosphatase enzyme system (the proton pump) of the gastric parietal cell. Proton pump inhibitors are effective for short-term treatment of gastric and duodenal ulcers. Esomeprazole is also used in the prevention and treatment of NSAID associated gastric ulcers.

Dosage & Administration

Adults (from the age of 18 years) - Gastroesophageal reflux disease (GERD): Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation): 20 mg Once daily for 24 weeks Maintenance treatment of NERD (i.e. heartburn and regurgitation): 20 mg Once daily Reflux esophagitis or erosive esophagitis: 20 mg or 40 mg Once daily for 4-8 weeks Maintenance therapy of healing of reflux esophagitis: 20 mg Once daily Healing of NSAID associated gastric ulcers: 20 mg Once daily for 4-8 weeks Risk reduction of NSAID associated gastric ulcers: 20 mg Once daily Zollinger-Ellison Syndrome: 40 mg Twice daily H. pylori eradication (Esomeprazole with amoxicillin 1000 mg and clarithromycin 500 mg): 20 mg tab. twice daily for 7 days or 40 mg cap. once daily for 10 days Pediatrics (12 to 17 years) - Gastroesophageal reflux disease (GERD): Non-erosive reflux disease (NERD) (i.e. heartburn and regurgitation): 20 mg Once daily for 2-4 weeks Reflux esophagitis or erosive esophagitis: 20 mg or 40 mg Once daily for 4-8 weeks.

Contraindications

Esomeprazole is contraindicated in patient with known hypersensitivity to any of the formulation.

Side Effects

The most common side effects of esomeprazole are nausea, vomiting, abdominal pain, flatulence, diarrhea, constipation and headache. Less frequent side effects include dry mouth, peripheral edema, dizziness, sleep disturbances, fatigue, paraesthesia, arthralgia, myalgia, rash and pruritus. Other side effects reported rarely or very rarely include taste disturbance, stomatitis, hepatitis, jaundice, hypersensitivity reactions (including anaphylaxis, bronchospasm), fever, depression, hallucinations, confusion, gynaecomastia, interstitial nephritis, hyponatraemia, blood disorders (including leucopenia, leukocytosis, pancytopenia, thrombocytopenia), visual disturbances, sweating, photosensitivity, alopecia, Stevens-Johnson Syndrome and toxic epidermal necrolysis.

Pregnancy & Lactation

Pregnancy : For esomeprazole, limited clinical data on exposed pregnancies are available. Esomeprazole should only be given to pregnant women if its use is considered essential. Lactation : It is not known whether esomeprazole is excreted in breast milk. Therefore esomeprazole should not be used during breast-feeding.

Precautions & Warnings

Esomeprazole should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Esomeprazole may slightly increase the risk of hip, wrist and spine fracture, particularly when it is taken over a period of more than one year.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Store in a cool & dry place below 25ºC, protect from light. Keep out of reach of children.