Indication

• Gastroesophageal Reflux Disease (GERD)
• Risk reduction in NSAID associated gastric ulcer
• H. pylori eradication (Triple therapy)
• Zollinger-Ellison syndrome and idiopathic hypersecretion

Pharmacology

Esomeprazole could be a proton pump inhibitor that smothers gastric corrosive discharge by the specific hindrance of the H+/K+ ATPase within the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the primary single optical isomer of proton pump inhibitors, gives superior corrosive control than racemic proton pump inhibitors.

Dosage and administration

Exium 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.

Children 1-11 years:

Gastroesophageal Reflux Disease (GERD)

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.

Interaction

Exium Mups 20 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 and diazepam, 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)

Contraindication

Exium Mups 40 is contraindicated in patients with known hypersensitivity to any of the formulation

Side effects

The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. There is no difference in types of related adverse events seen during maintenance treatment up to 12 months compared to short-term treatment.

Pregnancy and lactation

Manufacturers advise caution. It is not known if Exium Mups 40 or its metabolites appear in human breast milk.

Precautions & Warnings

Exium Mups 20 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. 

Storage Conditions

Pharmaceutical Name

Radiant Pharmaceuticals Ltd.

Generic

Esomeprazole Magnesium Trihydrate

Related Products

• Esonix 20
• Esotid 20