Esomeprazole

Indications
Oral
Erosive oesophagitis
Adult: 40 mg once daily for 4 wk, extended for another 4 wk if necessary. Maintenance: 20 mg once daily.
Child: <20 kg: 10 mg once daily for 8 wk; ≥20 kg: 10-20 mg once daily for 8 wk.
Hepatic impairment: Severe impairment (Child-Pugh class C): Not more than 20 mg daily.
Oral
Peptic ulcer
Adult: 20 mg bid for 7 days or 40 mg once daily for 10 days given as a triple therapy with amoxicillin and clarithromycin.
Hepatic impairment: Severe impairment (Child-Pugh class C): Not more than 20 mg daily.
Oral
NSAID-associated ulceration
Adult: 20 mg once daily for 4-8 wk.
Hepatic impairment: Severe impairment (Child-Pugh class C): Not more than 20 mg daily.
Oral
Zollinger-Ellison syndrome
Adult: Initially, 40 mg twice daily. Usual range: 80-160 mg daily. Doses >80 mg should be given in 2 divided doses.
Hepatic impairment: Severe impairment (Child-Pugh class C): Not more than 20 mg daily.
Oral
Gastro-oesophageal reflux disease
Adult: For patients without erosive oesophagitis: 20 mg once daily for 4 wk. Additional 4 wk may be considered in patients whose symptoms have not fully resolved after the 1st course.
Child: 10 mg once daily for up to 8 wk.
Hepatic impairment: Severe impairment (Child-Pugh class C): Not more than 20 mg daily.
Intravenous
Gastro-oesophageal reflux disease
Adult: For short term treatment only. 20 or 40 mg once daily for ≤10 days. Convert to oral therapy as soon as possible. May be administered by inj over at least 3 minutes, intermittent infusion (10-30 minutes) or continuous infusion (over up to 72 hr).
Hepatic impairment: Severe impairment (Child-Pugh class C): Not more than 20 mg daily.

Special Populations: Max dose for patients with severe hepatic impairment is 20 mg.

Reconstitution: Each single-use vial contains 20 or 40 mg of esomeprazole. For IV inj: Reconstitute each vial with 5 ml of normal saline. For IV infusion: Reconstitute each vial with 5 ml of normal saline, lactated Ringer's inj or dextrose 5% inj, then further dilute the resultant solution to a final volume of 50 ml.
Contraindications
Hypersensitivity.
Warnings / Precautions
Paediatric; pregnancy, lactation. Malignancy and hepatic impairment. Increased risk of developing certain infections such as community-acquired pneumonia.
Adverse Reactions
Headache, diarrhoea, abdominal pain, nausea, flatulence, dry mouth, constipation, hyponatraemia, photosensitivity, angioedema, anaphylaxis.
Drug Interactions
May interfere with the elimination of drugs metabolised by CYP2C19. Changes in gastric pH can affect the bioavailability of ketoconazole and Fe salts. Clarithromycin and amoxicillin may increase plasma level. May cause changes to prothrombin time when used with warfarin. Avoid concurrent use with clopidogrel.
See Below for More esomeprazole Drug Interactions
Lab Interactions
Increased creatinine, uric acid, bilirubin, alkaline phosphatase, ALT, AST. Altered thyroid function tests.
Food Interactions
Absorption delayed with food.
Mechanism of Actions
Esomeprazole is a PPI that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase in the gastric parietal cell.
Absorption: Rapid (oral). Peak plasma levels after 1-2 hrs; food delays and decreases absorption.
Distribution: Protein-binding: 97%
Metabolism: Extensively hepatic; converted to hydroxy and desmethyl metabolites.
Excretion: Urine (as metabolites); 1.3 hrs (elimination half-life).
Administration
Delayed-release cap: Should be taken on an empty stomach. (Take on an empty stomach 1 hr before meals.)
Tab: May be taken with or without food.
Storage Conditions
Intravenous: Pwd for inj: Store at 25°C (77°F). Protect from light. Reconstituted solution for inj should be stored at room temperature up to 30°C and administered within 12 hr after preparation. Reconstituted solution for infusion should be stored at room temperature up to 30°C and administered within 12 hr (if normal saline or lactated Ringer's inj is used as the diluent) or 6 hr (if dextrose 5% inj is used as the diluent). Oral: Store at 25°C.
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Storage
Intravenous: Pwd for inj: Store at 25°C (77°F). Protect from light. Reconstituted solution for inj should be stored at room temperature up to 30°C and administered within 12 hr after preparation. Reconstituted solution for infusion should be stored at room temperature up to 30°C and administered within 12 hr (if normal saline or lactated Ringer's inj is used as the diluent) or 6 hr (if dextrose 5% inj is used as the diluent). Oral: Store at 25°C.
Available As
  • Esomeprazole 10 mg
  • Esomeprazole 20 mg
  • Esomeprazole 30 mg
  • Esomeprazole 40 mg
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