- Approval Id
- 837ba3c1cc71193c
- Drug Name
- OMEPRO OMEPRAZOLE POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL
- Product Name
- OMEPRO OMEPRAZOLE POWDER FOR SOLUTION FOR INJECTION 40MG/VIAL
- Approval Number
- SIN16330P
- Approval Date
- 2021-09-22
- Registrant
- HETERO SINGAPORE PTE. LTD.
- Licence Holder
- HETERO SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Dosage
- **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.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **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
- Contraindications
- **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_).
- Atc Code
- A02BC01
- Atc Item Name
- omeprazole
- Pharma Manufacturer Name
- HETERO SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/923002e427d763bc/hetero-singapore-pte-ltd
