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Indications of Sergel MUPS 40

Esomeprazole MUPS TABLET is indicated at:

• Gastro-Oesophageal Reflux Disease (GERD).
• Reduction of risks in the gastric ulcer associated with the wing.
• Pylori eradication (triple therapy).
• Zollingerellison syndrome and idiopathic hypersecretion.

Pharmaceutical Name of Sergel MUPS 40

Healthcare Pharmaceuticals Ltd.

Pharmacology

Esomeprazole is a proton pump inhibitor that inhibits gastric acid secretion by specifically inhibiting ATPase H+/K+ in gastric parietal cells. Esomeprazole (omeprazole isomer) is the first single optical isomer of the proton pump inhibitor, it provides better acid control than the racemic proton pump inhibitor.

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.

1. 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 of Sergel MUPS 40

Esomeprazole is largely metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole was not likely to inhibit Cyps 1A2, 2A6, 2C9, 2D6, 2E1, and 3A4. No clinically relevant interaction with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole has no clinically significant interaction with phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin.

Esomeprazole can potentially interfere with CYP2C19, the great metabolic enzyme esomeprazole. Esomeprazole 30 mg Andiazepam, a CYP2C19 substrate leads to a 45x increase in soft diazepam. Expanded plasma levels of diazepam were observed 12 hours after the dosage and the interior. Esomeprazole inhibits the secretion of gastric acid. As a result, Esomeprazole can interfere with drug absorption when gastric pH is a determining factor of bioavailability (for example, ketoconazole, iron, and digoxin salts).

The co-administration of oral contraceptives, diazepam, phenytoin, or quinidine does not seem to change the pharmacokinetic profile of esomeprazole. 

Combined therapy with clarithromycin: Esomeprazole, clarithromycin, and co-administration of amoxicillin increased plasma levels of esomeprazole and 14 hydroxycanaritomycin.

Contraindications

Esomeprazole is contraindicated in patients with known hypersensitivity to any of the formulations.

Side Effects of Sergel MUPS 40

The most common side effects reported with esomeprazole were headache, diarrhea, nausea, bloating, abdominal pain, constipation, and dry mouth. No difference in adverse event categories was observed with maintenance treatment for up to 12 months compared with 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 with care if the patient has severe liver dysfunction and severe renal failure. By taking a proton pump inhibitor, esomeprazole can slightly increase the risk of fracture, pulse, and hip column, especially when taken over more than one year.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

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