WARNING: NOT FOR INTRATHECAL USE
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. [See Contraindications (4).]
ULTRAVIST (iopromide) Injection is a nonionic, water soluble x-ray contrast agent for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device.
ULTRAVIST® Injection is an iodinated contrast agent indicated for:
- 300 mg I/mL for cerebral arteriography and peripheral arteriography
- 370 mg I/mL for coronary arteriography and left ventriculography, visceral angiography, and aortography
- 240 mg I/mL for peripheral venography
- 300 mg I/mL for excretory urography
- 300 mg I/mL and 370 mg I/mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated
*For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration and Use in Specific Populations].
Published Studies Related to Ultravist (Iopromide)
Comparison of contrast-induced nephrotoxicity of iodixanol and iopromide in patients with renal insufficiency undergoing coronary angiography. [2011.07.15]
This prospective, randomized, double-blind study was performed to compare the incidence of contrast-induced nephropathy (CIN) after the administration of the iso-osmolar contrast medium iodixanol to the low-osmolar contrast medium iopromide during coronary angiography in patients with impaired renal function...
Image quality and attenuation values of multidetector CT coronary angiography using high iodine-concentration contrast material: a comparison of the use of iopromide 370 and iomeprol 400. [2010.11]
CONCLUSION: The attenuation values in the coronary arteries after injection of the same amount of two high iodine-concentration contrast materials at the same flow rate with different iodine fluxes are similar with no difference in image quality. With standardization for an iodine flux, the attenuation is significantly higher when using iopromide 370.
Nephrotoxic effects of iodixanol and iopromide in patients with abnormal renal function receiving N-acetylcysteine and hydration before coronary angiography and intervention: a randomized trial. [2009.01]
BACKGROUND: The use of contrast agents during coronary intervention can result in nephropathy, particularly in patients with renal dysfunction. We aimed to determine whether the use of iso-osmolar iodixanol is less nephrotoxic than that of low-osmolar iopromide when patients are adequately prehydrated and have received N-acetylcysteine... CONCLUSION: There remains a high incidence of CIN despite prehydration and routine use of N-acetylcysteine in patients with pre-existing renal dysfunction undergoing coronary interventional procedures. Although our study is underpowered, iodixanol was not associated with a statistically significant lower incidence of CIN when compared with iopromide.
A prospective, double-blind, randomized, controlled trial on the efficacy and cardiorenal safety of iodixanol vs. iopromide in patients with chronic kidney disease undergoing coronary angiography with or without percutaneous coronary intervention. [2008.12.01]
OBJECTIVES: This study was undertaken to compare the renal safety as well as cardiovascular (CV) effects and diagnostic image quality of iso-osmolar iodixanol vs. low-osmolar iopromide in patients with chronic kidney disease (CKD) undergoing coronary interventions. BACKGROUND: With the growing number of contrast-enhanced procedures being performed for coronary artery disease management, the safety and efficacy of iodinated contrast media (CM) have come under increased scrutiny... CONCLUSIONS:: Consistent with several previous trials comparing iso-osmolar iodixanol and low-osmolar comparator CM, iodixanol was associated with a lower incidence of CIN and fewer CV events than iopromide. Copyright 2008 Wiley-Liss, Inc.
High iodine concentration contrast material for noninvasive multislice computed tomography coronary angiography: iopromide 370 versus iomeprol 400. [2006.03]
CONCLUSION: The intravenous administration of iomeprol 400 provides higher attenuation of the coronary arteries and of the great arteries of the thorax as compared with iopromide 370 using the same injection parameters.
Clinical Trials Related to Ultravist (Iopromide)
Ultravist: Safety and Efficacy in Computed Tomography of Head and Body [Completed]
This is a research study involving the use of a contrast agent called Ultravist Injection.
Ultravist, the study drug, is used to improve the pictures obtained using computed
tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read.
In the case of this study, it will be injected into a vein in the patient's arm; from there,
it travels through the blood stream and to the areas to be examined. CT scans will then be
taken of the patient's head and/or body as ordered by his/her physician.
Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When
Administered Intravenously, in Volumes up to 162. 2 ml, for Clinically Indicated Contrast
Enhanced Computed Tomography (CECT) of the Head and/or Body
The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST) [Completed]
A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients [Completed]
The investigators intend to find out which contrast agent has less kidney toxicity in renal
impaired patients undergoing cardiac angiography or percutaneous coronary intervention
PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination [Completed]
The purpose of this study is to obtain data on the safety and efficacy of Ultravist
application in usual daily use. The radiologist will administer the contrast medium to the
patient as he/she would have done without the study. No other examinations will be performed
than would have been done routinely.
Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With Ultravist 370 INJ.(Iopromide 768.86mg) in Abdominal CT [Completed]
Comparison of NEOVIST 370 INJ.(Iopromide 768. 86mg) with Ultravist 370 INJ.(Iopromide
768. 86mg) in abdominal CT
Page last updated: 2011-12-09