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Prescribing Information:
Esomeprazole USP. Presentation: Esomeprazole 20: Each capsule contains esomeprazole 20 mg
as esomeprazole magnesium trihydrate USP in coated pellets. Esomeprazole Esomeprazole USP. Presentation: Esomeprazole 20 Each capsule contains esomeprazole 20mg as
esomeprazole magnesium trihydrate USP in enteric coteric coated pellets. Esomeprazole
40 Each capsule contains esomeprazole 40
mg as esomeprazole magnesium trihydrate USP in enteric coated pellets.
Properties and effects: Esomeprazole is a proton pump inhibitor that suppresses
gastric acid secretion by specific
inhibition of the H+%K+-ATPase,the proton Pump of the gastric paric parietal
cell. The plasma elimination half-life of esomeprazole is approximately 1-1.5
hours.
Dosage & Administration : Healing of Erosive Esophagitis: 20 mg or
once Daily for 4-8Weeks. Maintenance of Healing of Erosive Esophagitis: 20mg Once Daily (Clinical studies did not
extend not extend 6 months). Symptomatic GERD:20mg Once Daily for 4 Weeks. If
symptoms do not resolve completely after 4 weeks ,an additional 4 weeks of
treatment may be considered. Helicobactr pyiori Triple Therapy to reduce the risk of
Duodenal Ulcer recurrence –Esomeprazole 40 mg Once Daily for 10
days,Amoxicillin 1000 mg twice daily for 10 days, clarithromycin 500mg twice
daily for 10 days. Acid related Dyspepsia: 20-40 mg once daily for 2-4 weeks
according to response. Duodenal ulcer: 20 mg once daily for 2-4 weeks Gastric
ulcer: 20-40 mg once daily for 4-8 weeks.
Contraindication: Esomeprazole is
contraindicated in- patient with known hypersensitivity to the formulation.
Precaution: symptomatic response to therapy with esomeprazole does not preclude
the presence of gastric malignancy.Pregnancy: There are no adequate and well
–controlled studies in pregnant women.Animal studies have revealed no
teratogeniv effects.
Nursing Mothers: Breast-feeding should be therefore be
discontinued if discontinued if the use of esomeprazole is considered
essential. Undesirable effects: the most jfrequently occurring adverse events
reported with Esomeperazole include headache, diarrhea, nausea, flatulence,
abdominal pain, constipation and dry mouth. Packs: 20 capsule : Each pack
cotains 60 capsulesl (10 6”s). Esomeprazole
40 capsule
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