Composition: Each MUPS (Multiple Unit Pellet System) tablet contains Esomeprazole Magnesium USP enteric-coated pellets equivalent to Esomeprazole 20 mg.

Pharmacology: The Multiple Unit Pellet System (MUPS) tablet is a kind of multiparticulate system that combines the features of both modified-release tablets and capsules in one dosage form.

Indications:

  • Gastro-Esophageal Reflux Disease (GERD)
  • Risk reduction in NSAID-associated gastric ulcer
  • H. pylori eradication (Triple therapy)
  • Zollinger-Ellison syndrome and idiopathic hypersecretion


Dosage and Administration:
Maxora MUPS tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed.
Indication Adult (≥18 years) Children & Adolescents (12-18 years)
Gastro-Esophageal Reflux Disease (GERD)
Erosive esophagitis		 40 mg once daily for 4 weeks 40 mg once daily for 4 weeks
Maintenance of healing of erosive esophagitis 20 mg once daily 20 mg once daily
Risk reduction in NSAID-associated gastric ulcer 20 mg once daily for 4-8 weeks _
H. pylori eradication
(with 1000 mg Amoxicillin and 500 mg Clarithromycin)		 20 mg twice daily for 7 days 20 mg twice daily for 7 days
Zollinger-Ellison syndrome & idiopathic hypersecretion 40-80 mg twice daily _

Children 1-11 years:
Gastro-Esophageal Reflux Disease (GERD):
  • 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: Maxora MUPS tablet is not approved for use in children younger than 1 year.

Contraindications: Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.

Precautions: Esomeprazole should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Esomeprazole may slightly increase the risk of hip, wrist, and spine fractures, particularly when taken for more than one year.

Side Effects: Common side effects include headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. No differences in adverse events were seen during maintenance treatment for up to 12 months compared to short-term treatment.

Use in Pregnancy & Lactation: It is not known if Esomeprazole or its metabolites appear in human breast milk.

Drug Interactions: Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. Drug interactions have been observed with diazepam (a CYP2C19 substrate), leading to increased plasma levels of diazepam. Esomeprazole may interfere with drugs where gastric pH affects bioavailability (e.g., ketoconazole, iron salts, and digoxin).

Overdose: Overdose symptoms include weakness, loose stools, and nausea.

Storage: Keep below 30°C, protect from light and moisture. Keep out of reach of children.

Commercial Pack: Maxora MUPS 20 Tablet: Each box contains 30 (3x10’s) MUPS tablets in Alu-Alu blister pack.