Indications of Othera 20

Esomeprazole MUPS tablet is indicated in:

• Gastro-esophageal Reflux Disease (GERD) is a disease that affects the esophagus and (GERD).
• NSAID-related stomach ulcer risk is reduced.
• elimination of Helicobacter pylori (Triple therapy).
• Idiopathic hypersecretion and Zollinger-Ellison syndrome

Pharmaceutical Name of Othera 20

ACI Limited

Pharmacology

Esomeprazole is a proton pump inhibitor that inhibits the H+/K+ ATPase in the gastric parietal cell, suppressing gastric acid output. The first single optical isomer of a proton pump inhibitor, esomeprazole (S-isomer of omeprazole), provides superior acid control than racemic proton pump inhibitors.

Dosage & Administration

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.

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 Othera 20

Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that esomeprazole is unlikely to inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes are expected. Drug interaction studies have shown that esomeprazole has no clinically significant interaction with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Esomeprazole may interfere with CYP2C19, the main metabolic enzyme of esomeprazole. The co-administration of 30 mg of esomeprazole and diazepam (a CYP2C19 substrate) resulted in a 45-fold increase in diazepam clearance. An increase in the plasma concentration of diazepam was observed 12 hours after ingestion. Esomeprazole works by inhibiting gastric acid secretion. Therefore, esomeprazole may affect the absorption of the drug, where gastric pH is an important determinant of bioavailability (such as ketoconazole, iron salts, and digoxin).

Concurrent use of oral contraceptives, diazepam, phenytoin, or quinidine does not seem to change the pharmacokinetic characteristics of esomeprazole.

Clarithromycin combination therapy: The combination of esomeprazole, clarithromycin and amoxicillin increases the plasma concentrations of esomeprazole and 14-hydroxy clarithromycin.

Contraindications

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

Side Effects of Othera 20

Headache, diarrhoea, nausea, flatulence, abdominal pain, constipation, and dry mouth are the most common side effects reported with Esomeprazole. When compared to short-term treatment, there is no difference in the categories of linked adverse events noticed with maintenance treatment up to 12 months.

Pregnancy & Lactation

Caution is advised by the manufacturer. Esomeprazole or its metabolites are not known to occur in human breast milk.

Precautions & Warnings

If the patient has severe liver failure and renal impairment, esomeprazole should be administered with caution. Proton pump inhibitors, such as Esomeprazole, may marginally increase the risk of hip, wrist, and spine fractures, especially when used for more than a 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.

Generic of Othera 20

Esomeprazole Magnesium Trihydrate