ESOR Capsule

Indications:

ESOR (Esomeprazole) indicated for:

1. Gastroesophageal Reflux Disease (GERD)

• Treatment of erosive reflux esophagitis

• Long term management of patients with healed esophagitis to prevent relapse.

• Symptomatic treatment of gastroesophageal reflux disease (GERD) without esophagitis.

2. As a triple therapy (Esomeprazole plus amoxicillin and Clarithromycin) for the eradication of helicobacter pylori

• Healing of duodenal ulcer associated with helicobacter pylori infection.

• Prevention of relapse of peptic ulcers in patients with helicobacter pylori associated ulcers.

Dosage:

1. Gastroesophageal Reflux Disease:

Healing of erosive esophagitis 20mg or 40mg: Once daily 4 to 8 weeks (an additional 4-8 weeks treatment may be considered if symptoms persist or esophagitis does not heal).

Maintenance of healing erosive esophagitis 20mg: Once daily.

Symptomatic gastroesophageal reflux disease without esophagitis 20mg or 40mg: Once daily for 4 weeks (an additional 4-8 weeks treatment may be considered if symptoms does not resolve completely)

2. H.Pylori eradication to reduce the risk of duodenal ulcer recurrence:

Esor 40mg: once daily for 10 days.

Amoxicillin 1000mg: Twice daily for 10 days.

Clarithromycin 500mg: Twice daily for 10 days.

ESOR (Esomeprazole) is contraindicated in patients with known hypersensitivity to drug or to substituted benzimidazoles.

The following adverse drug reactions have been reported during therapy of esomeprazole. None found to be dose-related.

Common: Headache, abdominal pain, diarrhoea, flatulence, nausea/vomiting, constipation.

Uncommon: Dermatitis, pruritus, urticaria, dizziness, dry mouth.

Rare: Hypersensitivity reactions e.g. angioedema, anaphylactic reaction.

The following adverse drug reactions have been observed for the racemate omeprazole and may occur with esomeprazole.

Central and peripheral nervous system:

Paraesthesia, somnolence, insomnia, vertigo. Reversible mental confusion, agitation, aggression, depression and hallucinations, predominantly in severely ill patents.

Endocrine: Gynecomastia.

Gastrointestinal: Stomatitis and gastrointestinal candidiasis.

Haematological: Leukopenia, thrombocytopenia, agranulocytosis and pancytopenia.

Hepatic: Increased liver enzymes, encephalopathy in patients with pre-existing severe liver disease, hepatitis with or without jaundice, hepatic failure.

Skin: Rash, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), alopecia.

Other: Malaise, hypersensitivity reactions e.g. fever, bronchospasm, interstitial nephritis. Increased sweating, peripheral oedema, blurred vision, taste disturbance & hyponatraemia.

In common with use of other inhibitors of acid secretion or antacids the absorption of ketoconazole and itraconazole can decrease during treatment with esomeprazole due to decreased intragastric acidity during treatment with esomeprazole.

Esomeprazole inhibits CYP2C19, the major esomeprazole metabolism enzyme. Thus, when esomeprazole combined with drugs matabolised by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin etc, the plasma concentrations of these drugs may be increased and a dose reduction could be needed.

General

• In the presence of any alarming symptoms (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis. Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance since the symptomatic response to therapy with esomeprazole does not preclude the gastric malignancy.

• Atrophic gastritis has been noted ocassionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which esomeprazole is an enantiomer.

• Patients undergoing on-demand treatment should be instructed to contact their physician if their symptoms change in character.

• When prescribing esomeprazole for on-demand therapy, the implications for interactions with other pharmaceuticals, due to fluctuating plasma concentrations of esomeprazole should be considered.

• When prescribing esomeprazole for eradication of helicobacter pylori infections possible drug interactions for other components in the triple therapy should be considered.

• Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Esomeprazole works by binding irreversibly to the H+/K+ ATPase in the proton pump. Because the proton is the final pathway for secretion of hydrochloric acid by the parietal cells in the stomach, its inhibition dramatically decreases the secretion of hydrochloric acid into the stomach and alters gastric pH.