ESOME Capsule

ESOME (Esomeprazole) is contraindicated in patients with known hypersensitivity to drug or any component of the formulation or to substituted benzimidazoles.

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

Common: Headache, abdominal pain, diarrhea, 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 recemate 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 patients.

Endocrine: Gynecomatia.

Gastrointestinal: stomatis and gastrointestinal candidiasis.

Haematological: Leukopenia, throbocytopenia, 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, hypersentivity reactions e.g. fever, bronchospasm, interstitial nephritis. Increased sweating, peripheral oedema, blurred vision, taste disturbance and hyponatraemia.

- In common with the use of other inhibitors of acid secretion or anacids, 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 metabolising enzyme. Thus, when esomeprazole is combined with drugs metabolised 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.

There are no adequate and well-controlled studies in pregnant woment. Esomeprazole should be used during pregnancy only if clearly needed.

General

- In the presence of any alarming symptoms (e.g. significant unintentional 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 esomprazole should be considered.

- When prescribing esomeprazole for eradication of helicobacter pylori infection 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-insomaltase insufficiency should not take this medicine.

Esomeprazole works by binding irreversibly to the H+/K+ ATPase in the proton pump. Because the proton pump 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.