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Esomeprazole MUPS tablet is indicated for the relief of heartburn and other symptoms associated with gastro esophageal reflux diseases (GERD) and for the healing of erosive esophagitis, a potentially serious condition associated with GERD. It is also indicated in NSAID induced gastric ulcer and Zollinger-Ellison syndrome. The FDA approved Esomeprazole is also indicated in combination with Amoxicillin and Clarithromycin, for the eradication of Helicobacter pylori infection in patients with duodenal ulcer disease.
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+- ATPase in the gastric parietal cell. The S- and R- isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the acive inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity
Gastroesophageal Reflux Disease, Healing of Erosive Esophagitis: 20 or 40 mg once daily for 4-8 weeks, followed by a further 4-8 weeks if not fully healed. Maintenance of Healing of Erosive Esophagitis: 20 mg once daily. Symptomatic Treatment of Gastroesophageal Reflux Disease: 20 mg once daily for 4 weeks. An additional 4 weeks of treatment may be considered if symptoms do not resolve completely. Risk Reduction of NSAID-Associated Gastric Ulcer: 20 mg once daily for up to 6 months. Helicobacter pylori Associated Ulcer: One MAXIMA® MUPS 20, Amoxicillin (Moxilin) 1 g & Clarithromycin (Claricin) 500 mg all twice daily for 10 days. Zollinger-Ellison Syndrome: 40 mg to 80 mg twice daily. Children: 1-11 years: 10 to 20 mg once daily. 12-17 years: 20-40 mg once daily. Impaired renal function: Dose adjustment is not required in patients with impaired renal function. Impaired hepatic function: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg should not be exceeded. Elderly: Dose adjustment is not required in the elderly patient.
Esomeprazole Mups should not prescribed with Nelfinavir, Atazanavir, Clopidogrel, Ketoconazole, Itraconazole, Voriconazole, Erlitinib, Citalopram, Imipramine or Clomipramine, Diazepam, Phenytoin, Warfarin, Cliostazol, Cisapride, Digoxine, Methotraxate, Tacrolimus and Rifampicin.
Esomeprazole is contraindicated in those patients who have known hypersensitivity to any component of the formulation.
In general, Esomeprazole is well tolerated in both short and long-term use. Common side effects are headache, diarrhea. Other effects include nausea, flatulence, abdominal pain, constipation and dry mouth.
Pregnancy category C. There are no adequate and wellcontrolled studies in pregnant women. Esomeprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Esomeprazole is not recommended for nursing mothers because its safety in infants and newborns has not been studied
There is no experience to data with deliberate overdose. Data are limited but single dose of 80 mg of Esomeprazole were uneventful. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilized.
Store in the original package in order to protect from moisture. Do not store above 30°C
Each MUPS (Multiple-Unit Pellet System) tablet contains 133.333 mg Esomeprazole 15% w/w enteric coated pellets (as Esomeprazole Magnesium Trihydrate USP) equivalent to 20 mg Esomeprazole.