| DESCRIPTION |
Esoral is a preparation of esomeprazole. It is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of H+/K+-ATPase in the gastric parietal cell. Esomeprazole blocks the final step in acid production thus reduces gastric acidity. This effect is dose related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion. |
| INDICATIONS |
Gastro-oesophageal Reflux Disease
- Treatment of erosive oesophagitis
- Long-term management of patients with healed oesophagitis to prevent relapse
- Symptomatic treatment of gastro-oesophageal reflux disease(GERD)
Eradication of Helicobacter pylori in combination with appropriate antibiotics
- Healing of H. pylori associated duodenal ulcer
- Prevention of relapse of peptic ulcer in patients with H.
- pylori associated ulcer
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| DOSAGE AND ADMINISTRATION |
| Indication |
Dose and frequency |
| Healing of erosive oesophagitis : |
20-40 mg once daily for 4-8 weeks. If not healed an additional 4-8 weeks of treatment may be considered. |
| Maintenance of healing of erosive oesophagitis : |
20 mg once daily (controlled studies have not exceeded 6 months). |
| Symptomatic gastro- oesophagealreflux disease : |
20 mg once daily for 4 weeks. If symptoms persist an additional 4 weeks of treatment may be considered. |
| Eradication of H. pylori to reduce therisk of duodenal ulcer recurrence : |
10 days of triple therapy with esomeprazole 40 mg once daily, amoxicillin 1g twice daily and clarithromycin 500 mg twice daily is recommended. |
Impaired renal function : No dosage adjustment is necessary in patients with mild, moderate or severe renal insufficiency .
Impaired hepatic function : No dosage adjustment is necessary in mild or moderate hepatic impairment. For patients with severe hepatic impairment, the dose should not exceed 20 mg.
Elderly : No dosage adjustment is necessary.
Children : Safety and effectiveness in children have not been established.
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| CONTRAINDICATIONS |
It is contraindicated in patients with known hypersensitivity to esomeprazole or to substituted benzimidazoles.
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| PRECAUTIONS |
In the presence of any alarming symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present. The possibility of malignancy should be excluded. Because treatment with esomeprazole may alleviate symptoms and delay diagnosis, patients on long-term treatment should be kept under regular surveillance. When prescribing esomeprazole with other antibiotics for eradication of H. pylori, risk of drug interaction should be considered.
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| USE IN PREGNANCY AND LACTATION |
Pregnancy
There are no adequate and well-controlled studies with esomeprazole in pregnant women. Caution should be exercised when prescribing this drug to pregnant women.
Nursing mothers
The excretion of esomeprazole in human breast milk has not been studied. Therefore, esomeprazole should not be used during breast-feeding.
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| SIDE-EFFECTS |
The safety of esomeprazole was evaluated worldwide in over 10000 patients (aged 18 - 84 years). In clinical trials the most frequently occurring adverse events were headache, diarrhoea, nausea, flatulence, abdominal pain and constipation. Rarely dermatitis, pruritus, urticaria, dizziness and dry mouth were reported.
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| PHARMACEUTICAL PRECAUTION |
Store in a cool, dry place, away from light. Keep out of reach of children.
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| PACKAGING |
Esoral 20 mg tablet : Box containing 2 strips of 10 tablets each. Each enteric coated tablet contains esomeprazole magnesium trihydrate INN equivalent to
esomeprazole 20 mg.
Esoral 40 mg tablet : Box containing 2 strips of 10 tablets each. Each enteric coated tablet contains esomeprazole magnesium trihydrate INN equivalent to esomeprazole 40 mg.
Manufactured by:
ESKAYEF BANGLADESH LTD
DHAKA, BANGLADESH
® REGD.TRADEMARK |
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