Maxima MUPS 40 mg Tablet, 1 strip
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.
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 of 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.
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-
ATPase in the gastric parietal cell thus reducing gastric acidity. After oral administration, peak plasma levels (Cmax) occur at approximately 1.5 hours (Tmax). At repeated oncedaily dosing with 40 mg, the systemic bioavailability is approximately 90%. Esomeprazole is 97% bound to plasma proteins. Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system.
Approximately 80% of an oral dose of Esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the feces.
CLINICAL ADVANTAGE OF ESOMEPRAZOLE MUPS
TABLET COMPARED TO CONVENTIONAL MODIFIEDRELEASE ESOMEPRAZOLE TABLETS AND PELLETFILLED ESOMEPRAZOLE CAPSULES
Ensures greater bioavailablility
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 (peak time and peak plasma concentration)
Ensure 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 absoption 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.
Gastroesophageal Reflux Disease (GERD)
Risk Reduction of NSAID-associated gastric ulcer
H.pylori eradication (Triple Therapy)
Contraindicated in those patients who have known hypersensitivity to Esomeprazole any other components of the product.
WARNING AND PRECAUTIONS
Esomeprazole MUPS tablet should be used carefully if the patients has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Esomeprazole
MUPS may slightly increase the risk of hip, wrist and spine fracture, particularly when it is taken over a period of more than one year.
Common: Headache, abdominal pain, constipation, flatulence, nausea or vomiting.
Rare: Abdominal liver function, aggressive behavior, anemia, blurred vision, bronchospasm.
USE IN PREGNANCY & LACTATION
There are no adequate and well controlled studies in pregnant women. Esomeprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The excretion of Esomeprazole in human milk has not been studied, so a decision should be made whether to discontinue nursing of the drug, taking into account the importance of the drug to the mother.
With Medicine: Do not prescribe Esomeprazole MUPS tablet if the patient take Nelfinavir, Atazanavir, Clopidogrel, Ketoconazole, Itraconazole, Voriconazole, Erlotinib,
Citalopram, Imibpramine or Clomipramine, Diazepam, Phenytoin, Warfarin, Cilostazole Cisapride, Digoxine, Methotrexate, Tacrolimus and Rifampicin.
With Food: There are no specific foods that must exclude from diet when receiving this medication.
Seek medical attention from your physician.
Store below 30ºC & dry place, protected from light. Keep all medicines out of reach of children.
Each box contains 3^10 tablets in Alu-Alu blister strips.