ESVMOFIN-40 Injection with Esomeprazole sodium (equivalent to Esomeprazole) injection as active ingredient comes in 40 mg powder for injection.
Indications :
Esomeprazole injection is used for :
- Gastric antisecretory therapy when administration via the oral route is not feasible
- Gastroesophageal reflux disease (GERD) in patients with esophagitis and/or severe reflux symptoms.
- Healing of gastric ulcers related to NSAID treatment.
- The acute maintenance of hemostasis and antirebleeding in patients after therapeutic endoscopy for bleeding gastric or duodenal ulcers.
Dosae & Administration
DOSAGE :
- Gastric antisecretory treatment when oral administration is not feasible.
- These patients may be treated parenterally with 20 – 40 mg once a day.
- Reflux esophagitis patients are to be treated with 40 mg once a day. Symptomatically treated patients for reflux disease are to be treated with 20 mg once a day.
- For the healing of gastric ulcers caused by NSAID therapy the dose is 20 mg once daily.
- For the prevention of gastric and duodenal ulcers caused by NSAID therapy, the patients at risk should be administered 20 mg once daily.
- Generally, the duration of intravenous treatment will be brief, and switching to oral treatment should be achieved as quickly as possible.
- After therapeutic endoscopy in acute bleeding gastric or duodenal ulcers, 80 mg should be given as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/hour for 3 days (72 hours).
- Parenteral therapy should be followed by oral acid-suppression treatment.
- Esomeprazole IV injection must not be administered in children and adolescents as no data are available.
ADMINISTRATIONS :
FOR SINGLE USE ONLY, discard any unused solution.
- The solution reconstituted should be checked normally for particulates and colour change before administration.
- The clear solution is to be administered.
- The injection solution is obtained by adding 5 mL of 0.9 % intravenous Sodium chloride to the vial of Esomeprazole 40 mg injection. A 40 mg dose of the solution reconstituted is to be administered as an intravenous injection over not less than 3 minutes.
Contradictions
- Esomeprazole injection must not be used together with Atazanavir and Nevirapine.
- Hypersensitivity to the active ingredient Esomeprazole injection or to other substituted Benzimidazoles or to any of the excipients used in this medicinal product.
Warnings & Precautions :
- In the occurrence of any alarm symptom (e.g., notable unintentional weight loss, frequent vomiting, dysphagia, haematemesis or melena) and cases of suspected or existing gastric ulcer, malignancy must be ruled out since treatment with Esomeprazole might relieve symptoms and delay diagnosis.
- Proton pump inhibitor treatment can cause a mildly elevated risk of gastrointestinal infections like Salmonella and Campylobacter.
- Co-administration of Esomeprazole injection with Atazanavir is not advisable. In case the administration of Atazanavir with a proton pump inhibitor is considered unavoidable, dose clinical monitoring is advised along with a dose increase in the Atazanavir to 400 mg along with 100 mg of Ritonavir; Esomeprazole 20 mg should not be used above this.
- Esomeprazole injection is a CYP2C19 inhibitor. With the initiation or discontinuation of treatment with Esomeprazole, consideration should be given to the potential interaction with drugs that are metabolised by CYP2C19. There is an interaction between Clopidogrel and Omeprazole.As a precaution, concomitant administration of Esomeprazole and Clopidogrel should be avoided.
- Esomeprazole injection is to be used only if indicated during pregnancy.
- Since Esomeprazole injection will most likely be excreted in human milk, it is recommended that women discontinue breastfeeding.
Drug Interactions :
- The bioavailability of Ketoconazole and Itraconazole may be reduced during therapy with Esomeprazole injection.
- When Esomeprazole injection is used in combination with drugs which are metabolised by CYP2C19, e.g., Diazepam, Citalopram, Imipramine, Clomipramine, Phenytoin etc., plasma levels of the drugs may be elevated and dose reduction may be required.
- Monitoring plasma levels of Phenytoin should be done when Esomeprazole treatment is started or stopped.
- Monitoring should be done when starting and stopping concurrent Esomeprazole injection treatment with Warfarin or other Coumarine derivatives.
- Esomeprazole injection has been found to have no clinically significant impact on the pharmacokinetics of Quinidine or Amoxicillin.
