OMEPRAZOLE FOR INJECTION 40 MG
Omeprazole for intravenous use is indicated as an alternative to oral therapy for the following indications i.e.
• 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
Each vial contains:
Omeprazole Sodium (Lyophilized)
Equivalent to Omeprazole 40 mg
Method of administration: Powder for solution for injection or infusion.
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.
The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/ vomiting.
In long term toxicity studies, omeprazole was well tolerated in rodents dosed at up to 414 mg.kg' per day, equivalent to some 1400 times the human therapeutic dose, and in dogs receiving up to 138 mg.kg-1 daily. Oral administration of omeprazole for 2 years in the daily dose range 14-140 mg.kg"' induced enterochromaffin-like cell hyperplasia in the rat oxyntic mucosa. Changes ranged from a diffuse increase in EGL cell number, through focal aggregations of cells, to structures of more solid appearance (carcinoids). It is now accepted that carcinoid tumors in rats are a direct and inevitable consequence of hypergastrinemia resulting from prolonged achlorhydria and reflect the extreme sensitivity of rats to the trophic actions of gastrin on EGL cells.
Omeprazole for Injection is available in 10 ml colourless glass vial Type I with a blue bromobutyl rubber stopper, and an aluminium cramping cap with polypropylene cap.
Pack sizes: 1, 5, 10 or 20 vials.