Preclinical safety assessment of iomeprol for injection as contrast medium for myelography.
A series of pharmaco-toxicological investigations were carried out in animals in order to assess the neurotolerance of iomeprol, a new nonionic iodinated contrast medium. After intrathecal administration iomeprol was completely eliminated from the cerebrospinal fluid, rapidly cleared from the plasma and excreted unchanged through the kidneys. When administrated intrathecally, iomeprol did not significantly alter the behavioural functions or the physiological activities of the brain. Unlike other contrast media, iomeprol was devoid of any epileptogenic activity. The acute neurotoxicity of iomeprol was comparable with that of iopamidol, but less than that of iohexol, iotrolan and iodixanol. Iomeprol was well tolerated in both rats and dogs following weekly intrathecal administrations for four weeks of doses up to three times higher than those foreseen for clinical use. High neurotolerance in animals and favourable physico-chemical characteristics make iomeprol particularly suitable as a contrast medium for both myelography and cerebral ventriculography.
Research and Development Division, Bracco SpA, Milan, Italy.
A
A
La Noce
F
F
Bertani
V
V
Lorusso
F
F
Luzzani
P
P
Tirone
C
C
de Haën
D000818:Animals; D000927:Anticonvulsants / Q000494:pharmacology; D001769:Blood; D003287:Contrast Media / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology* / Q000633:toxicity; D004285:Dogs; D004326:Drinking / Q000187:drug effects; D004347:Drug Interactions; D004569:Electroencephalography / Q000187:drug effects; D004827:Epilepsy / Q000139:chemically induced; D005260:Female; D007276:Injections, Intraventricular; D007278:Injections, Spinal; D007479:Iopamidol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000494:pharmacology / Q000633:toxicity; D008297:Male; D051379:Mice; D008813:Mice, Inbred ICR; D009192:Myelography; D011485:Protein Binding; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D012449:Safety; D012640:Seizures / Q000139:chemically induced; D012709:Serum Albumin / Q000378:metabolism; D013649:Taste / Q000187:drug effects; D014556:Urine
D000927:Anticonvulsants; D003287:Contrast Media; D012709:Serum Albumin; C057937:iomeprol; D007479:Iopamidol