Alimentary System-Antacids and Defrothicants
Alimentary System-Gastro-intestinal sedatives
= Additional active ingredients
Esomeprazole 40 mg.
PRESENTATION AND DOSSAGE
VIAL: (powder for solution): 10 x 40 mg.
For gastroesophagal reflux disease in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate.Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.
Hypersensitivity to the esomeprazole, to other substituted benzimidazoles or to any of the excipients.
In the presence of any alarm symptom (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, hematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis. Impaired renal function: Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution. Impaired hepatic function: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg should not be exceeded. Should not be used in children since no data is available. Pregnancy and lactation: Caution should be exercised when treating pregnant women. Should not be used during breast-feeding.
Headache. Abdominal pain, diarrhea, flatulence, nausea/vomiting, constipation. Administration site reactions.
Drugs metabolised by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin etc. Warfarin or other coumarin derivatives.
MANUFACTURER & DISTRIBUTER:
License Holder: AstraZeneca Israel