Pronex-MUPS (Esomeprazole)

Indications

Pronex-MUPS, a Proton Pump Inhibitor (PPI), is indicated for conditions related to excess gastric acid secretion:

• Gastro-esophageal Reflux Disease ($\text{GERD}$ ) (including Erosive Esophagitis and maintenance of healing).

• Risk reduction in NSAID associated gastric ulcer.

• H. pylori eradication (as part of Triple therapy).

• Zollinger-Ellison syndrome and idiopathic hypersecretion.

Composition & Pharmacology Pronex-MUPS is a Multiple-Unit Pellet System (MUPS ) tablet, containing Esomeprazole Magnesium Trihydrate.

Pharmacology: Esomeprazole works by blocking the hydrogen-potassium adenosine triphosphatase enzyme system (the proton pump) of the gastric parietal cell, thereby inhibiting gastric acid secretion.

MUPS Technology: This formulation combines advantages of capsules and tablets. Its key benefits include greater bioavailability, uniform drug release, and minimizing dose dumping and localized irritation due to the uniform emptying of micro pellets into the small intestine.

Dosage (Adults $\ge 18$ years)

Pediatric Use:

• 12-18 years: Dosing is generally the same as adults for the above indications.

• 1-11 years (Erosive Esophagitis): $10 \text{ mg}$ or $20 \text{ mg}$ once daily, depending on weight, for 8 weeks.

• Below 1 year: Not approved for use.

Administration, Precautions, and Safety

• Administration: Tablets must be swallowed whole with liquid. They should not be chewed or crushed. If necessary, the tablet can be dispersed in half a glass of non-carbonated water and consumed immediately (within 30 minutes). The pellets must still not be chewed.

• Side Effects: The most common events include headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.

• Warnings: Use with caution in patients with severe liver dysfunction and severe renal impairment. Taking a PPI for more than one year may slightly increase the risk of hip, wrist, and spine fracture.

• Interactions: Pronex-MUPS may interfere with the absorption of drugs where gastric $\text{pH}$ is important (e.g., ketoconazole, iron salts, and digoxin). Co-administration with diazepam may decrease diazepam's clearance.

Contraindications: Known hypersensitivity to any of the formulation.

Therapeutic Class: Proton Pump Inhibitor.