Description
Indications
Sergel 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).
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.
- 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.
MUPS ensure rapid and uniform gastric emptying and subsequently uniform drug dissolution of pellets in the gastrointestinal tract due to their small size and larger surface,uniform drug absorption is facilitated which results in consistent and controlled pharmacological action.
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
Dosage
Erosive esophagitis-
- Adult (≥18 years): 40 mg once daily for 4 weeks.
- Children & adolescents (12-18 years): 40 mg once daily for 4 weeks.
Maintenance of healing of erosive esophagitis-
- Adult (≥18 years): 20 mg once daily.
- Children & adolescents (12-18 years): 20 mg once daily.
Risk reduction in NSAID associated gastric ulcer-
- Adult (≥18 years): 20 mg once daily for 4-8 weeks.
H. pylori eradication (Esomeprazole MUPS tablet with 1000 mg Amoxicillin and 500 mg Clarithromycin)-
- Adult (≥18 years): 20 mg twice daily for 7 days.
- Children & adolescents (12-18 years): 20 mg twice daily for 7 days.
Zollinger-Ellison syndrome and idiopathic hypersecretion-
- 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
Children below the age of 1 year: Esomeprazole MUPS tablet is not approved for use in children younger than 1 year.
Administration
Interaction
Sergel MUPS is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Sergel 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 Sergel MUPS does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.
Sergel MUPS may potentially interfere with CYP2C19, the major Sergel MUPS metabolizing enzyme. Co-administration of Sergel 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. Sergel MUPS inhibits gastric acid secretion. Therefore, Sergel 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 Sergel MUPS.
Combination Therapy with Clarithromycin: Co-administration of Sergel MUPS, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of Sergel MUPS and 14-hydroxyclarithromycin.
Contraindications
Side Effects
Pregnancy & Lactation
Precautions & Warnings
Storage Conditions
Chemical Structure
Molecular Formula : | C17H19N3O3S |
Chemical Structure : |
Common Questions about Sergel MUPS 20 mg Tablet
What is Sergel MUPS 20 mg MUPS Table?
What is MUPS Tablet?
What is Sergel MUPS 20 mg MUPS Table used for?
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Can I take Sergel MUPS 20 mg MUPS Table if I am pregnant or breastfeeding?
How long does it take for Sergel MUPS 20 mg MUPS Table to work?
Quick Tips
- Sergel MUPS 20 mg MUPS Table is a well-tolerated medicine and provides relief for a long time.
- Avoid eating late at night or before bedtime.
- Inform your doctor if you get watery diarrhea, fever or stomach pain that does not go away.
- Long-term use of Sergel MUPS 20 mg MUPS Table can cause weak bones and a deficiency of minerals such as magnesium. Take adequate dietary intake of calcium and magnesium or their supplements as prescribed by your doctor.
- Consult your doctor right away if you develop decreased urination, edema (swelling due to fluid retention), lower back pain, nausea, fatigue, and rash or fever. These could be signs of a kidney problem.
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