Nexe Mups

Indications:
Nexe 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 Nexe MUPS 20 Tablet: Each MUPS tablet contains 133.333 mg (15%w/w) of Nexe MUPS enteric coated pellets equivalent to 20 mg Nexe MUPS (as Nexe MUPS Magnesium Trihydrate USP). Nexe MUPS 40 Tablet: Each MUPS tablet contains 266.67 mg (15% w/w) of Nexe MUPS enteric coated pellets equivalent to 40 mg Nexe MUPS (as Nexe MUPS 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.

Pharmacology
The proton pump inhibitor Esomeprazole inhibits gastric acid by blocking the hydrogen-potassium adenosine triphosphatase (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 esophagitisAdult (≥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 esophagitisAdult (≥18 years): 20 mg once daily. Children & adolescents (12-18 years): 20 mg once daily. Risk reduction in NSAID associated gastric ulcerAdult (≥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 hypersecretionAdult (≥18 years): 40-80 mg twice 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
Nexe MUPS is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Nexe 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 Nexe MUPS does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Nexe MUPS may potentially interfere with CYP2C19, the major Nexe MUPS metabolizing enzyme. Co-administration of Nexe 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. Nexe MUPS inhibits gastric acid secretion. Therefore, Nexe 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 Nexe MUPS. Combination Therapy with Clarithromycin: Co-administration of Nexe MUPS, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of Nexe 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 Nexe 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.

Pregnancy & Lactation
The manufacturer advises caution. It is not known if Esomeprazole or its metabolites appear in human breast milk.

Precautions & Warnings
Nexe MUPS should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Nexe 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.
Storage Conditions

Store in a cool & dry place below 25ºC, protect from light. Keep out of reach of children.

Storage Conditions

Store in a cool & dry place below 25ºC, protect from light. Keep out of reach of children.