Esoprex MUPS 20 | Tablet | 20 mg | 1 pcs

Esomeprazole 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.

Proton Pump Inhibitor

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. It is a pharmaceutical solid dosage form produced by compressing a mixture of drug-containing pellets and powder excipients. MUPS is one of the more recent and challenging technologies that combine the advantages of both tablets and pellet-filled capsules in one dosage form.

Esomeprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to sulfhydryl groups of cysteines found on the H⁺/K⁺-ATPase enzyme at the secretory surface of gastric parietal cells. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of esomeprazole to the H⁺/K⁺-ATPase enzyme is irreversible and new enzyme needs to be expressed in order to resume acid secretion, esomeprazole’s duration of antisecretory effect that persists longer than 24 hours.

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.

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.

Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole 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 Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 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. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole 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 Esomeprazole.

Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.

Esomeprazole is contraindicated in patient with known hypersensitivity to any of the formulation.

The most frequently occurring adverse events reported with Esomeprazole 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.

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

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 fracture, particularly when it is taken over a period of more than one year.

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