Emep (Esomeprazole)
Therapeutic Group : Antiulcerant
Presentation:
Emep-20 Capsule: Each capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg as enteric coated pellets.
Emep-40 Capsule: Each capsule contains Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 40 mg as enteric coated pellets.
Emep Tablet: Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate USP equivalent to esomeprazole 20 mg.
Emep IV Injection: Each vial contains lyophilized Esomeprazole Sodium equivalent to Esomeprazole 40 mg.
Dosage & Administration:
Emep Tablet / Capsule:
Esomeprazole tablet/capsule should be taken one hour before meal.
| Indications | Dose | Frequency |
|---|---|---|
| Symptomatic Gastroesophageal Reflux Disease | 20 mg | Once daily for 4 weeks |
| Healing of Erosive Esophagitis | 20 or 40 mg | Once daily for 4-8 weeks* |
| Maintenance of Healing of Erosive Esophagitis | 20 mg | Once daily |
| Duodenal Ulcer | 20 mg | Once daily for 2-4 weeks |
| Gastric Ulcer | 20-40 mg | Once daily for 8 weeks |
| H. pylori eradication reduces the risk of duodenal ulcer recurrence | ||
| Triple therapy | ||
| Emep | 40 mg | Once daily for 10 days |
Amoxycillin | 1000 mg | Twice daily for 10 days |
| Clarithromycin | 500 mg | Twice daily for 10 days |
* The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks treatment may be considered.
Emep IV Injcetion:
The recommended adult dose is either 20 mg or 40 mg Esomeprazole given once daily by intravenous injection (not less than 3 minutes) or intravenous infusion (10 to 30 minutes). Emep IV injection should not be administered concomitantly with any other medications through the same intravenous site. Treatment with Emep IV injection should be discontinued as soon as the patient is able to resume treatment with Emep capsule/tablet.
Injection:
Esomeprazole IV injection is obtained by adding 5 ml 0.9% sodium chloride to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 3 minutes. The injection should be used within 12 hours after reconstitution and can be stored at room temperature.
Infusion:
Esomeprazole intravenous infusion is prepared by first reconstituting the content of vial with 5 ml of 0.9% Sodium Chloride injection or 5% dextrose injection and further diluting the resulting solution to a final volume of 50 ml. The reconstituted solution should be administered as an intravenous infusion over a period of 10-30 minutes. The reconstituted solution should be used within 12 hours when Esomeprazole is dissolved in 0.9% Sodium Chloride and within 6 hours when dissolved in 5% dextrose.
Contrainidications:
Esomeprazole is contraindicated in patients who have known hypersensitivity to esomeprazole or any component of the formulation.
Warning & Precautions:
Geriatric patients: No dosage adjustment is necessary.
Renal insufficiency: No dosage adjustment is necessary.
Hepatic insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment. For patients with servere liver impairment a dose of 20 mg of esomeprazole should not be exceeded.
Side effects:
In general, esomeprazole is well tolerated in both short and long term use. Adverse events reported with esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth.
Drug interaction:
Esomeparzole is extensively metabolized in the liver. Drug interactions studies have shown that esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxycillin. Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. ketoconazole, iron salts and digoxin).
Use in special groups:
Use in pregnancy: This drug should be used during pregnancy only if clearly needed.
Use in lactation: Esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in children: Children over 1 year are recommended to use oral Esomeprazole.
Packing:
Emep-20 Capsule: Each box contains 60\\\\\\\’s capsules in Alu-Alu blister pack.
Emep-40 Capsule: Each box contains 40\\\\\\\’s capsules in Alu-Alu blister Pack.
Emep Tablet: Each box contains 60\\\\\\\’s tablets in Alu-Alu blister pack.
Emep IV Injection: Each box contains one vial of lypholized Esomeprazole Sodium powder with 1 ampoule of 5 ml Sodium Chloride 0.9% BP injection, 5 ml disposable syringe, body needle,, bandage and alcohol pad.
