Opredax


Prescription

All pharmacodynamic effects observed can be explained by the effect of omeprazole on acid secretion. Intravenous omeprazole produces a dose dependent inhibition of gastric acid secretion in humans.

Composition

Each vial contains:
Omeprazole Sodium BP
Equivalent to Omeprazole 40 mg
(In the form of Omeprazole sodium, suitably buffered)

Indications for use

Opredax for intravenous use is indicated as an alternative to oral therapy for the following indications:
Adults:

  • Treatment of duodenal ulcers;
  • Prevention of relapse of duodenal ulcers;
  • Treatment of gastric ulcers;
  • Prevention of relapse of gastric ulcers;
  • In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease;
  • Treatment of NSAID-associated gastric and duodenal ulcers;
  • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk;
  • Treatment of reflux oesophagitis;
  • Long-term management of patients with healed reflux oesophagitis;
  • Treatment of symptomatic gastro-oesophageal reflux disease;
  • Treatment of Zollinger-Ellison syndrome.

Mode of administration

Alternative to oral therapy
In patients where the use of oral medicinal products is inappropriate, Omeprazole IV 40 mg once daily is recommended. In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided and given twice daily. Omeprazole is to be administered in an intravenous infusion for 20-30 minutes.
For instructions on reconstitution of the product before administration.
Special populations
Impaired renal function
Dose adjustment is not needed in patients with impaired renal function.
Impaired hepatic function
In patients with impaired hepatic function a daily dose of 10-20 mg may be sufficient .
Elderly (> 65 years old)
Dose adjustment is not needed in the elderly .
Paediatric patients
There is limited experience with Omeprazole for Injection use in children.
Method of administration
Omeprazole for injection is mixed with Sterile water for injection for reconstitution.
Omeprazole for Injection is to be administered in an intravenous infusion for 20-30 minutes.