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OMEPRO OMEPRAZOLE POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL [SIN16330P]
Active ingredients: OMEPRO OMEPRAZOLE POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL
Last updated 26 October 2025
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Product Info
OMEPRO OMEPRAZOLE POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL
[SIN16330P]
Product information
Active Ingredient and Strength | OMEPRAZOLE SODIUM EQV OMEPRAZOLE - 40 MG/VIAL |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Manufacturer and Country | ASPIRO PHARMA LIMITED - INDIA |
Registration Number | SIN16330P |
Licence Holder | HETERO SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A02BC01 |
Therapeutic indications
As alternative treatment of the oral formulation where fast and pronounced acidity inhibition is required for:
Duodenal ulcer
Benign gastric ulcer
Reflux oesphagitis
Zollinger-Ellison syndrome
DOSAGE AND ADMINISTRATION
Dosage
Omeprazole 40mg as once-daily intravenous application is recommended in those incidental cases where oral therapy is inappropriate and pronounced acidity inhibition is essential. The mean reduction of acid production in the stomach during 24hours is circa 90%.
With Zollinger-Ellison patients, the recommended initial dosage is 60mg omeprazole per day. For a 60mg dose, an additional half (5ml) of reconstituted solution should be given as an intravenous injection. Any unused solution should be discarded. Higher dosage can be necessary, and the dosage of more than 60mg per day, the administration of the daily dosage should be spread out the day.
A one-week treatment is usually sufficient.
Administration
Omeprazole sodium for injection is for intravenous administration only and must not be given by any other route.
Direction for reconstitution
Omeprazole sodium for injection should only be dissolved in water for injection. After reconstitution outside validated aseptic conditions, use within 4 hours of preparation and any unused portion should be discarded. The duration of administration should be over 5 minutes.
Use in the elderly
Dosage adjustment is not necessary.
Use in children
There is limited experience of use in children. Therefore, omeprazole injection is not recommended in children.
Impaired renal function
Dose adjustment is not required in patients with impaired renal function.
Impaired hepatic function
As half-life is increased in patients with impaired hepatic function, the dose requires adjustment and a daily dose of 10–20 mg may be sufficient.
CONTRAINDICATIONS
Hypersensitivity to omeprazole, substituted benzimidazoles or to any of the excipients. Omeprazole like other proton pump inhibitors (PPIs) should not be used concomitantly with nelfinavir (See section Drug Interactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).