OMNIPAQUE INJECTION 350mg I/ML

Product Information

Registration Status: Active

OMNIPAQUE INJECTION 350mg I/ML is approved to be sold in Singapore with effective from 1991-05-17. It is marketed by GE HEALTHCARE PTE LTD, with the registration number of SIN05923P.

This product contains Iohexol 350mg/ml in the form of INJECTION. It is approved for INTRAVASCULAR use.

This product is manufactured by GE HEALTHCARE IRELAND LIMITED (by Parametric Release) in IRELAND,GE HEALTHCARE AS (by Parametric Release) in NORWAY, andGE HEALTHCARE (SHANGHAI) CO. in CHINA.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Iohexol

Description

Iohexol is an effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality. [PubChem]

Indication

Iohexol ia used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures.

Mechanism of Action

Organic iodine compounds block x-rays as they pass through the body, thereby allowing body structures containing iodine to be delineated in contrast to those structures that do not contain iodine. The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays. After intrathecal administration into the subarachnoid space, diffusion of iohexol in the CSF allows the visualization of the subarachnoid spaces of the head and spinal canal. After intravascular administration, iohexol makes opaque those vessels in its path of flow, allowing visualization of the internal structures until significant hemodilution occurs.

Pharmacokinetics

Absorption
Small amounts are absorbed through the bladder via intravesical instillation. Following intrauterine instillation, the majority of the medium within the uterine cavity is discharged into the vagina immediately upon termination of procedure. However, any medium retained in the uterine or peritoneal cavity is absorbed systemically within 60 minutes. May not be absorbed for up to 24 hours if tubes are obstructed and dilated.
Distribution
* 350-849 mL/kg
Metabolism
Elimination

Clearance

* 109 mL/min [Adult patients receiving 16-18 ml of iohexol (180 mgI/mL) by lumbar intrathecal injection]

Toxicity

Non-ionic radiocontrast agents like iohexol are cytotoxic to renal cells. The toxic effects include apoptosis, cellular energy failure, disruption of calcium homeostasis, and disturbance of tubular cell polarity, and are thought to be linked to oxidative stress.

Active Ingredient/Synonyms

Iohexolum | N,N'-Bis(2,3-dihydroxypropyl)-5-(N-(2,3-dihydroxypropyl)acetamido)-2,4,6-triiodoisophthalamide | Iohexol |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank