Product Information
Registration Status: ActiveULTRAVIST 370 INJECTION 370mg/ML is approved to be sold in Singapore with effective from 1991-05-14. It is marketed by BAYER (SOUTH EAST ASIA) PTE LTD, with the registration number of SIN05845P.
This product contains Iopromide 768.86mg in the form of INJECTION. It is approved for INTRAVENOUS, INTRAVASCULAR, INTRACAVITARY, INTRA-ARTERIAL use.
This product is manufactured by BAYER PHARMA AG in GERMANY.
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.
Description
Iopromide is a low osmolar, non-ionic X-ray contrast agent for intravascular administration. It functions as a contrast agent by opacifying blood vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs. Available as the FDA-approved product Ultravist, iopromide is used in radiographic studies such as intra-arterial digital subtraction angiography (IA-DSA), cerebral and peripheral arteriography, peripheral venography, excretory urography, brain computer tomography (CT), coronary arteriography, left ventriculography, visceral angiography, and aortography.
Indication
Iopromide, as the product Iovist, is indicated for use as an X-ray contrast agent in the following procedures: Intra-arterial digital subtraction angiography (IA-DSA) (150 mg I/mL) Cerebral arteriography and peripheral arteriography (300 mg I/mL) Coronary arteriography and left ventriculography, visceral angiography and aortography (370 mg I/mL) Peripheral venography (240 mg I/mL) Excretory urography (300 mg I/mL) Contrast computed tomography (CT) imaging of head and body (300 mg I/mL and 370 mg I/mL)
Mechanism of Action
Iopromide is a low osmolar, non-ionic X-ray contrast agent for intravascular administration. It functions as a contrast agent by opacifying blood vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs.
Pharmacokinetics
- Absorption
- Following administration, the degree of contrast enhancement is directly related to the iodine content in the administered dose; peak iodine plasma levels occur immediately following rapid intravenous injection. Iodine plasma levels fall rapidly within 5 to 10 minutes, which can be accounted for by the dilution in the vascular and extravascular fluid compartments. Contrast enhancement appears to be greatest immediately after bolus injections (15 seconds to 120 seconds). Thus, greatest enhancement may be detected by a series of consecutive two-to-three second scans performed within 30 to 90 seconds after injection (that is, dynamic computed tomographic imaging). Injection may be visualized in the renal parenchyma within 30–60 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 1–3 minutes, with optimum contrast occurring within 5–15 minutes.
- Distribution
- 16 L
- Metabolism
- Iopromide is not metabolized.
- Elimination
Clearance
The mean total and renal clearances are 107 mL/min and 104 mL/min, respectively.
Toxicity
Most common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
Active Ingredient/Synonyms
N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-N-methylisophthalamide | Iopromide |
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.