ESOSTAD 20 Capsule

- Erosive oesophagitis

- Peptic ulcer disease

- NSAID-associated ulceration

- Zollinger-Ellison syndrome

- Gastro-oesophageal reflux diseases.

Dosage and Administration

Esostad 20 should be taken at least 1 hour before a meal, swallowed whole and the contents should not be crushed or chewed.

-Erosive oesophagitis

Adult: 40mg once daily for 4 weeks, extended for a further 4 weeks if necessary. For maintenance: 20mg once daily.

-Peptic ulcer disease

Adult: As a component of a triple therapy regimen with amoxicillin and clarithromycin, are the equivalent of 20mg esomeprazole orally twice daily for 7 days, or 40mg once daily for 10 days.

-NSAID-associated ulceration

Adult: 20mg daily, for 4-8 weeks.

- Zollinger-Ellison syndrome

Adult: The recommended initial dose is 40mg twice daily. The majority of patients can be controlled on dose between 80 and 160mg daily. Doses>80mg daily should be given in 2 divided doses.

- Gastro-oesophageal reflux disease

Adult: The recommended adult dosage for patients without erosive esophagitis is 20mg once daily for 4 weeks; additional 4-week may be considered in patients whose symptoms have not completely resolved after the first course of treatment.

- Hepatic impairment

Severe impairment a daily dose of 20mg should not be exceeded.

- Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituent of the formulation

- Pregnancy in the first trimester.

- Common: headache, abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting

- Uncommon: peripheral oedema, insomnia, dizziness, paraesthesia, somnolence, vertigo, dry mouth, increased liver enzymes, dermatitis, pruritus, rash, urticaria.

See the package insert about the details below:

- Medicinal products with pH dependent absorption (such as ketoconazole, itraconazole, atazanavir, ritonavir)

- Drugs metabolised by CYP2C19 (such as diazepam, citalopram, imipramine, clomipramine, phenytoin, warfarin, amoxicillin, quinidine)

- Treatment with PPI may lead to slightly increased risk of gastrointestinal infections such as salmonella and campylobacter and possibly clostridium difficile.

Pregnancy

There are no adequate and controlled studies to date using esomeprazole in pregnant women, and the drug should be used during pregnancy only when clearly needed.

Lactation

It is not known whether esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Therefore esomeprazole should not be used during breast-feeding.

- 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 esomeprazole.

- Administration of PPI has been associated with an increased risk for developing certain infections (e.g. community-acquired pneumonia).

- Safety and efficacy in children younger than 18 years of age have not been established.

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Esomeprazole is the S-isomer of omeprazole, that are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton-pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20-40mg and leads to inhibition of gastric acid secretion.