Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Bracco UK, Ltd, Unit 15, Valley Business Centre, Gordon Road, High Wycombe, Buckinghamshire HP13 6EQ-UK
Iopamidol is a contrast medium belonging to the new generation of non-ionic compounds whose solubility is due to the presence of hydrophilic substituents in the molecule. This results in a solution of low osmolality when compared with ionic media.
Iopamidol has been shown to be effective as an X-ray contrast medium in neuroradiology, angiography, venography, arthrography, urography, cerebral angiography, and left ventriculography, coronary arteriography, and investigations of the gastrointestinal tract. Its toxicity, particularly cardiac and CNS toxicity, is less than those of ionic contrast media.
Serum iopamidol concentration curves conform to an open two compartment pharmacokinetic model with first order elimination. Iopamidol is very poorly absorbed (about 1-2%) after oral or rectal administration.
Distribution volume is equivalent to extracellular fluid.
Following parenteral administration elimination is almost completely through the kidneys. Less than 1% of the administered dose has been recovered in the faeces up to seventy two hours after dosing. Renal elimination is rapid and up to half the administered dose may be recovered in the urine within the first two hours of dosing.
There is no evidence of biotransformation.
Serum protein binding is negligible.
In animals, Gastromiro was well tolerated after repeated oral administration. After 4 weeks adminstration of Gastromiro equivalent to 9 gI/kg day, i.e. about 20 times higher than the recommended clinical dose, no severe symptoms of sub-acute intoxication were observed in rats. Following intraperitoneal injection of Gastromiro in rats, iopamidol was rapidly cleared and almost totally eliminated by the renal route within the first 24 hours.
The intraperitoneal acute toxicity was relatively low. Necroscopic examination revealed no irritant effects on the peritoneal membrane. Gastromiro also showed good local tolerability after both local intratracheal installation and systemic administration . It therefore offers a good margin of safety for examination in which there is the risk of an accidental inspiration of the diagnostic medium.
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