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Indications

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.

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. 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.

Pharmacology

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.

Dosage

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.

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

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.

Contraindications

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.

Pregnancy & Lactation

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

Precautions & Warnings

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.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

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