Mode of action

Esomeprazole suppresses gastric acid secretion by specific inhibition of H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.  

Indications

It is indicated for the treatment of following diseases:

• Treatment of gastro-esophageal reflux disease (GERD): Healing of erosive esophagitis, maintenance of healing of erosive esophagitis, symptomatic gastroesophageal reflux diseases.
• H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
• Zollinger-Ellison syndrome.
• Acid related dyspepsia.
• Duodenal and gastric ulcer

 

Dosage & administration

The recommended adult dosages are outlined in the table below. Esomeprazole enteric coated tablet should be swallowed whole and taken at least 1 hour before having meal.

a) Gastro-esophageal reflux disease (GERD):

Healing of erosive esophagitis: 20 mg or 40 mg once daily for 4 to 8 weeks. *

Maintenance of healing of erosive esophagitis: 20 mg once daily.

Symptomatic gastroesophageal reflux diseases: 20 mg once daily for 4 weeks.**

b) H. pylori eradication to reduce the risk of duodenal ulcer recurrence, (Triple therapy):

Esomeprazole 40 mg once daily for 10 days + Amoxicillin 1.0 g twice daily for 10 days + Clarithromycin 500 mg twice daily for 10 days.

* The majority of the patients are healed within 4 to 8 weeks. For patients who not heal after 4 to 8 weeks, an additional 4 to 8 weeks treatment may be considered.

** If symptoms do not resolve completely after 4 weeks, an additional 4 weeks treatment may be considered.

Contraindication

It is contraindicated in known hypersensitivity to Esomeprazole, substituted benzimidazoles or any component of the formulation.

Use in pregnancy, lactation & childhood

There are no adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of Esomeprazole in pediatric patients have not been established.

Side-effects

In general, Esomeprazole was well tolerated in both short and long term clinical trials. The most frequently occurring adverse events (≥1%) are headache and diarrhea. Nausea, flatulence, abdominal pain, constipation and dry mouth occurred at similar rates among patients taking Esomeprazole. 

Precaution

Symptomatic response to therapy with Esomeprazole does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with Omeprazole, of which Esomeprazole is an enantiomer.

Overdosage

There has been no experience with large overdoses with Esomeprazole. No specific antidote for Esomeprazole is known. In the event of overdosage, treatment should be symptomatic and supportive.

Drug interactions

Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salt and digoxin). Co-administration of oral contraceptives, diazepam, phenytoin or quinidine did not seem to change the pharmacokinetic profile of Esomeprazole.

Pharmaceutical precaution

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

Packing

Esomo Fast-20 Capsule: Box containing 5x10/10 x 10 capsules in blister pack.