Esomeprazole is indicated:
For the treatment of heart burn and other symptoms associated with GERD
For the healing of erosive esophagitis
For maintenance of healing of erosive esophagitis
In duodenal and gastric ulcer
In combination with amoxycillin, clarithromycin, esomeprazole is used for the treatment of H. pylori infection and duodenal ulcer disease to eradicate.
Proton Pump Inhibitor
Esomeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell. It is the S-isomer of omeprazole.
Esomeprazole is indicated in:
Symptomatic Gastroesophageal Reflux Disease: 20 mg Once daily for 4 weeks
Healing of Erosive Esophagitis: 20 or 40 mg Once daily for 4-8 weeks
Maintenance of Healing of Erosive Esophagitis: 20 mg Once daily
Duodenal Ulcer: 20 mg Once daily for 2-4 weeks
Gastric Ulcer: 20-40 mg Once daily for 8 weeks
H. pylori eradication reduces the risk of duodenal ulcer recurrence: Triple therapy:
Esomeprazole 40 mg: Once daily for 10 days
Amoxycillin 1000 mg Twice daily for 10 days
Clarithromycin 500 mg Twice daily for 10 days
IV Injcetion: The recommended adult dose is either 20 mg or 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Esomeprazole IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Esomeprazole IV injection should be discontinued as soon as the patient is able to resume treatment with Esomeprazole capsule/tablet. Safety and effectiveness in paediatric patients have not been established.
Injection: Esomeprazole IV injection is obtained by adding 5 ml 0.9% sodium chloride to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 3 minutes. The injection should be used within 12 hours after reconstitution and can be stored at room temperature.
Infusion: Esomeprazole intravenous infusion is prepared by first reconstituting the content of vial with 5 ml of 0.9% Sodium Chloride injection or 5% dextrose injection and further diluting the resulting solution to a final volume of 50 ml. The reconstituted solution should be administered as an intravenous infusion over a period of 10-30 minutes. The reconstituted solution should be used within 12 hours when Esomeprazole is dissolved in 0.9% Sodium Chloride and within 6 hours when dissolved in 5% dextrose. The reconstituted solution can be stored at room temperature.
Drug interaction studies have shown that Esomeparzole does not have any clinically significant interactions with Phenytoin, Warfarin, Quinidine, Clarithromycin or Amoxicillin. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, Ketoconazole, Iron salts and Dogoxin). Coadministration of oral contraceptives, Diazepam, Phenytoin or Quinidine did not seem to change the pharmacokinetic profile of Esomeprazole.
Esomeprazole is contraindicated in patients who have known hypersensitivity to esomeprazole or any component of the formulation.
In general, esomeprazole is well tolerated in both short and long term use. Adverse events reported with esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth.
Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies on the use of Esomeprazole in pregnant women. Therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk. Esomeprazole should be used during pregnancy only if the potential benefit to pregnant women justifies the potential risk to the fetus.
Lactation: Esomeprazole is excreted in human milk. Thus, a decision should be taken to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Symptomatic response to therapy with Esomeprazole does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which Esomeprazole is an enantiomer.
Use in Special Population
Use in children: Children over 1 year are recommended to use oral Esomeprazole.
Geriatric: No dosage adjustment is necessary.
Renal Insufficiency: No dosage adjustment is necessary.
Hepatic Insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment. For patients with severe liver impairment, a dose of 20 mg of Esomeprazole should not be exceeded.