Description
Formulation:
Each vial contains:
Omeprazole (as sodium) 40mg
Packaging/Availability:
10 ML Type II Amber Glass Vial Sealed with Gray Butyl Rubber Stopper and Blue Aluminum Plastic Cap + 10mL Sterile Water for Injection in Type I Colorless and Transparent Glass Ampoule. (Box of 1’s)
Indication & Dosage
Indication:
Used in benign gastric and duodenal ulcers, Zollinger-Ellison syndrome, gastric acid reduction, gastroesophageal reflux disease, acid reflux disease, acid-related dyspepsia.
Dosage and Administration:
Adults
Alternative to oral therapy
In patients where 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 dose 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 solution for injection must be given only as an intravenous injection and it must not be added to infusion solutions. After reconstitution, the injection should be given slowly over the period of at least 2.5 minutes at a maximum rate of 4 mL per minute, or as prescribed by the physician.
Special Populations
Patients with impaired renal function
Dose adjustment is not needed in patients with impaired renal function.
Patients with impaired Hepatic function
in patients with impaired Hepatic function a daily dose 10-20 mg may be sufficient.
Older people
Dose adjust is not needed to the elderly.
Pediatric population
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 colorless, clear, practically free from visible particles.
See insert for complete information.
Distribution
Distributed by:
ASIANMEDS, INC.
8F RBMT Bldg., corner C3 & 5th Avenue,
Grace Park, Caloocan City
Imported by:
EURO-CARE PRODUCTS, PHILS.
Tinio St., San Nicolas
Gapan City, Nueva Ecija
Manufactured by:
REYOUNG PHARMACEUTICAL CO., LTD.
Shandong, China
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