Omeprazole for intravenous use is indicated as an alternative to oral therapy for the following indications i.e.

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

Posology

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, see section 6.6.

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 intravenous use in children.

Method of administration

Omeprazole 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.