Exor-20 Capsule: Each delayed release capsule contains enteric coated pellets of Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg. Exor-40 Capsule: Each delayed release capsule contains enteric coated pellets of Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg. Exor 40 IV Injection: Each vial contains Esomeprazole 40 mg (as lyophilized powder of Esomeprazole Sodium INN) and each ampoule contains 5 ml of 0.9% Sodium Chloride Injection BP.
Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of erosive esophagitis
Maintenance of healing of erosive esophagitis
Symptomatic relief of Gastroesophageal Reflux Disease (GERD)
Risk reduction of NSAID associated gastric ulcer
H. pylori eradication (Triple therapy)
Esomeprazole is contraindicated in those patients who have known hypersensitivity to any other components of the formulation.
Dosage & Administration
Recommended adult dosage schedule of Esomeprazole:Gastroesophageal Reflux Diseases (GERD):
Healing of erosive esophagitis - 20 mg or 40 mg Once daily for 4 to 8 weeks.
Symptomatic relief of GERD - 20 mg Once daily for 4 weeks.
Risk reduction of NSAID associated gastric ulcers - 20 mg Once daily for upto 6 months.
H. pylori eradication (Triple therapy):
Esomeprazole - 20 mg Twice daily for 10 days.
Amoxicillin - 1000 mg Twice daily for 10 days.
Clarithromycin - 500 mg Twice daily for 10 days.
Use in Children (12 years and older)
Short term treatment of GERD: 20 mg or 40 mg once daily for up to 8 weeks
Duodenal ulcer, gastric ulcer, gastrointestinal lesions refractory to H2 blockers, Zollinger-Ellison syndrome - 40 mg per day intravenously
Reflux esophagitis - 20-40 mg per day intravenously
Side effects reported with Esomeprazole include headache, diarrhea and abdominal pain.
Include the possibility of malignancy when gastric ulcer is suspected and before treatment for dyspepsia. When using in combination with antibiotic, refer to the prescribing information of the respective antibiotics.
Use In Pregnancy And Lactation
US FDA Pregnancy Category: B
Teratology studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to Esomeprazole. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Because Esomeprazole is likely to be excreted in human milk a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Esomeprazole appears to be a selective inhibitor of the cytochrome P450 monooxygenase system, there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Esomeprazole on the oral combined contraceptive pill. Further assessment is currently underway. Physiological changes similar to those found with Omeprazole are likely to take place because of the reduction in gastric acid, which is likely to influence the bacterial colonization of the stomach and duodenum and also vitamin B12 absorption.
Exor-20 Capsule: Each box contains 10X10\\\'s capsules in Alu-AIu blister pack.
Exor-40 Capsule: Each box contains 10X10\\\'s capsules in Alu-AIu blister pack.
Exor 40 IV Injection: Each box contains one vial of lyophilized Esomeprazole 40 mg, one ampoule of 5 ml 0.9% Sodium Chloride Injection and one sterile disposable syringe (5 ml).