Esomelodan I.V. is a proton pump inhibitor (PPI), indicated for the treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis (EE) in adults and pediatric patients greater than one month of age, when oral therapy is not possible or appropriate. Esomelodan I.V. for Injection is supplied as a freeze-dried powder containing 20 mg or 40 mg of esomeprazole per single-use vial.
DOSAGE AND ADMINISTRATION
- Adults: Dose is either 20 mg or 40 mg esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes).
- Pediatric, from 1 year to 17 years, when body weight less than 55 kg: 10 mg, given once daily as an intravenous infusion over 10 minutes to 30 minutes.
- Pediatric, from 1 year to 17 years, when body weight 55 kg or greater: 20 mg, given once daily as an intravenous infusion over 10 minutes to 30 minutes.
- Pediatric, 1 month to less than 1 year of age: 0.5 mg/kg , given once daily as an intravenous infusion over 10 minutes to 30 minutes.
- How is Esomelodan I.V. given? Esomeprazole for intravenous is to be administered in an intravenous infusion for 20-30 minutes. After reconstitution the solution is colourless, clear, practically free from visible particles.
- What is Esomelodan I.V. used for? This medicine is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as gastric or duodenal ulcer, Zollinger-Ellison syndrome.
- How do you inject Esomelodan? Powder for injection, 40 mg vial, to be dissolved in 100 ml of 0.9% sodium chloride or 5% glucose, for IV infusion. Adult dosage: 40 mg once daily to be administered over 20 to 30 minutes.
- How long does Esomelodan I.V. take to work? With repeated once daily dosing the maximum effect is usually achieved within four days of commencing treatment. A single dose of 40 mg intravenously will achieve immediate and maximal control of acid production, similar to that observed following five days continuous oral administration of esomeprazole 20 mg.
- Can Esomelodan be injected I.M.? Esomeprazole Injection 40 mg should be given as a slow intravenous injection. The solution for IV injection is obtained by adding to the vial 10 ml of the solvent provided. (No other solvent should be used). Discoloration may occur if incorrect reconstitution technique is used.
Patients with known hypersensitivity to any component of the formulation (angioedema and anaphylaxis have occurred).
WARNINGS AND PRECAUTIONS
- Symptomatic response to therapy with Esomelodan does not preclude the presence of gastric malignancy.
- Atrophic gastritis has been noted with long-term omeprazole therapy.
- Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
- Hypomagnesemia has been reported rarely with prolonged treatment with PPIs .
Most common adverse reactions (>1%): Headache, flatulence, nausea, abdominal pain, injection site reaction, diarrhea, dry mouth, dizziness/vertigo, constipation and pruritus.
- Esomelodan I.V. inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. ketoconazole, iron salts and digoxin).
- Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.
- Esomelodan I.V. may reduce the plasma levels of atazanavir, nelfmavir, and saquinavir.
- Concomitant treatment with a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may result in more than doubling of the esomeprazole exposure.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Based on animal data, may cause fetal harm. Limited human data.
- Nursing Mothers: Caution should be exercised when administered to a nursing woman.
- Hepatic Insufficiency: For patients with severe liver impairment (Child Pugh Class C), a dose of 20 mg of Esomelodan should not be exceeded.
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