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Esmotac 40

  • Esomeprazole 40

Indication:

Esomeprazole is indicated for the relief of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) and for the healing of erosive esophagitis, a potentially serious condition association with GERD. The FDA approved Esomeprazole for maintenance of healing of erosive esophagitis and in combination with Amoxicillin and Clarithromycin, for the eradication of Helicobacter Pylori infection in patients with duodenal ulcer disease.

Dosage & Administration:

*The majority of patients are healed within 4 to 8 weeks. For patients who do no heal after 4 to 8 weeks, an additional 4 to 8 weeks treatment may be considered. **Controlled studies did not extend beyond 6 months. ***If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered. CONTRAINDICATIONS: Patients with known hypersensitivity to any component of the formulation. ADVERSE REACTIONS: Esomeprazole is well tolerated in both short and long- term use. Common adverse events are headache and diarrhea. Other side effects include nausea, flatulence, abdominal pain, constipation and dry mouth. SPECIAL PRECAUTION: Geriatric: No dosage adjustment is necessary. Paediatric: Safety and effectiveness in pediatric patients have not been established. DRUG INTERACTIONS: Esomeprazole inhibits gastric acid secretion; Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. Ketoconazole, Iron salts and Digoxin). Renal insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment. For patients with severe liver impairment, a dosage of 40 mg of Esmotac should not be exceeded. GENDER: No dosage adjustment is necessary. OVER DOSE: There is no experience to data with deliberate over dose. Data are limited but single dose of 80 mg Esomeprazole were uneventful. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of over dose, treatment should be symptomatic and general supportive measures should be utilized. USE IN PREGNANCY AND LACTATION: Pregnancy: FDA approved pregnancy category B. Esomeprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing mothers: There is no data on the excretion of Esomeprazole into human milk.