Esomeprazole MUPS 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.

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

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

The proton pump inhibitor Esomeprazole inhibits gastric acid by blocking the hydrogen-potassium adenosine triphosphatase enzyme system (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.

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.

Side Effects

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.

What is Esomeprazole?

Esomeprazole is a proton pump inhibitor (PPI). PPIs work by reducing the amount of acid produced in the stomach. Esomeprazole is used to treat gastroesophageal reflux disease (GERD), ulcers, and other conditions that involve too much stomach acid.

What is MUPS Tablet?

MUPS is abbreviation for Multiple-Unit Pellet System. This tablets prepared by compaction of modified release coated multiparticulates or pellets are called as MUPS.

What is Esomeprazole used for?

Esomeprazole has multiple uses. It relieves heartburn and GERD symptoms. It also aids in healing erosive esophagitis, a condition caused by stomach acid damaging the esophagus lining. Additionally, Esomeprazole effectively prevents erosive esophagitis recurrence.

What are the side effects of Esomeprazole?

Esomeprazole may cause common side effects like headaches, diarrhea, nausea, gas, stomach pain, constipation, and dry mouth. There aren't any differences in the types of side effects between long-term (up to 12 months) and short-term use.

Can I take Esomeprazole if I am pregnant or breastfeeding?

Esomeprazole doesn't have any side-effects if you are pregnant or breastfeeding. You still should talk to your doctor about the risks and benefits of taking Esomeprazole.

How long does it take for Esomeprazole to work?

Esomeprazole usually starts to work within a few hours of taking it.

Quick Tips

• Esomeprazole is a well-tolerated medicine and provides relief for a long time.
• Avoid eating late at night or before bedtime.
• Inform your doctor if you get watery diarrhea, fever or stomach pain that does not go away.
• Long-term use of Esomeprazole can cause weak bones and a deficiency of minerals such as magnesium. Take adequate dietary intake of calcium and magnesium or their supplements as prescribed by your doctor.
• Consult your doctor right away if you develop decreased urination, edema (swelling due to fluid retention), lower back pain, nausea, fatigue, and rash or fever. These could be signs of a kidney problem.

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.