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Esoral Mumps 20mg Tablet 1 strip
item code: 951548
Esoral MUPS tablet is indicated in:
- Gastro-esophageal Reflux Disease (GERD).
- Risk reduction in NSAID associated gastric ulcer.
- H. pylori eradication (Triple therapy).
- Zollinger-Ellison syndrome and idiopathic hypersecretion.
Composition
Esomeprazole MUPS 20 Tablet: Each MUPS tablet contains 133.333 mg (15%w/w) of Esomeprazole enteric coated pellets equivalent to 20 mg Esomeprazole (as Esomeprazole Magnesium Trihydrate USP).
Esomeprazole MUPS 40 Tablet: Each MUPS tablet contains 266.67 mg (15% w/w) of Esomeprazole enteric coated pellets equivalent to 40 mg Esomeprazole (as Esomeprazole Magnesium Trihydrate USP).
Esomeprazole MUPS 40 Tablet: Each MUPS tablet contains 266.67 mg (15% w/w) of Esomeprazole enteric coated pellets equivalent to 40 mg Esomeprazole (as Esomeprazole Magnesium Trihydrate USP).
Description
MUPS is abbreviation for Multiple-Unit Pellet System. However, from pharmaceutical industry and research perspective, the term in general refers to MUPS compacted into tablets. Thus, the resulting tablets prepared by compaction of modified release coated multiparticulates or pellets are called as MUPS. It is the more recent and challenging technologies that combine the advantages of both tablets and pellet-filled capsules in one dosage form.
A further reduction in inter- and intra-subject variability in drug absorption and clinical response is facilitated since the number of pellets per MUPS dosage form is much more than a conventional
pellet-filled capsule and possibility of dose dumping (in stomach) and incomplete drug release is further minimized.
- Ensures greater bioavailability.
- Ensures uniform emptying of micro pellets from stomach into small intestine facilitates rapid dissolution of enteric coating and drug release resulting in early Tmax and Cmax
- Ensures lesser possibility of dose dumping.
- Is a combination of fast acting and sustained action.
- Ensures uniform drug release.
- Once daily dosing.
- Ensures lesser chance of localized irritation.
- Ensures better and more uniform drug absorption.
- Is better than capsules in reducing the esophageal residence time.
- Minimizes fluctuation in plasma concentration of drug.
A further reduction in inter- and intra-subject variability in drug absorption and clinical response is facilitated since the number of pellets per MUPS dosage form is much more than a conventional
pellet-filled capsule and possibility of dose dumping (in stomach) and incomplete drug release is further minimized.
Pharmacology
The proton pump inhibitor Esomeprazole inhibits gastric acid by blocking the hydrogen-potassium adenosine triphosphatase enzyme system (the proton pump) of the gastric parietal cell. Proton pump inhibitors are effective for short-term treatment of gastric and duodenal ulcers. Esomeprazole is also used in the prevention and treatment of NSAID associated gastric ulcers.
Dosage
Erosive esophagitis-
Children 1-11 years:
- Adult (≥18 years): 40 mg once daily for 4 weeks.
- Children & adolescents (12-18 years): 40 mg once daily for 4 weeks.
- Adult (≥18 years): 20 mg once daily.
- Children & adolescents (12-18 years): 20 mg once daily.
- Adult (≥18 years): 20 mg once daily for 4-8 weeks.
- Adult (≥18 years): 20 mg twice daily for 7 days.
- Children & adolescents (12-18 years): 20 mg twice daily for 7 days.
- Adult (≥18 years): 40-80 mg twice daily.
Children 1-11 years:
- Erosive esophagitis: Weight <20 kg: 10 mg once daily for 8 weeks. Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks
- Maintenance of healing of erosive esophagitis: 10 mg once daily
Administration
Esomeprazole MUPS tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. If required, the tablets can also be dispersed in half a glass of non-carbonated water (mineral water is not suitable). No other liquids should be used. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.
Interaction
Esoral MUPS is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esoral MUPS is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esoral MUPS does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.
Esoral MUPS may potentially interfere with CYP2C19, the major Esoral MUPS metabolizing enzyme. Co-administration of Esoral MUPS 30 mg anddiazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esoral MUPS inhibits gastric acid secretion. Therefore, Esoral MUPS may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esoral MUPS.
Combination Therapy with Clarithromycin: Co-administration of Esoral MUPS, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of Esoral MUPS and 14-hydroxyclarithromycin.
Esoral MUPS may potentially interfere with CYP2C19, the major Esoral MUPS metabolizing enzyme. Co-administration of Esoral MUPS 30 mg anddiazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esoral MUPS inhibits gastric acid secretion. Therefore, Esoral MUPS may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esoral MUPS.
Combination Therapy with Clarithromycin: Co-administration of Esoral MUPS, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of Esoral MUPS and 14-hydroxyclarithromycin.
Contraindications
Esomeprazole is contraindicated in patient with known hypersensitivity to any of the formulation.
Side Effects
The most frequently occurring adverse events reported with Esoral MUPS include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.
Note:
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