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Isovue (Iopamidol Intravascular) - Summary

 
 



NOT FOR INTRATHECAL USE

 

ISOVUE SUMMARY

ISOVUE®-200
Iopamidol Injection 41%
ISOVUE®-250
Iopamidol Injection 51%
ISOVUE®-300
Iopamidol Injection 61%
ISOVUE®-370
Iopamidol Injection 76%

ISOVUE (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration. Each mL of ISOVUE-200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1 mg tromethamine and 0.26 mg edetate calcium disodium. The solution contains approximately 0.029 mg (0.001 mEq) sodium and 200 mg organically bound iodine per mL. Each mL of ISOVUE-250 (lopamidol Injection 51%) provides 510 mg iopamidol with 1 mg tromethamine and 0.33 mg edetate calcium disodium. The solution contains approximately 0.036 mg (0.002 mEq) sodium and 250 mg organically bound iodine per mL. Each mL of ISOVUE-300 (lopamidol Injection 61%) provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. Each mL of ISOVUE-370 (lopamidol Injection 76%) provides 755 mg iopamidol with 1 mg tromethamine and 0.48 mg edetate calcium disodium. The solution contains approximately 0.053 mg (0.002 mEq) sodium and 370 mg organically bound iodine per mL. The pH of ISOVUE contrast media has been adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE (lopamidol Injection) is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively).

ISOVUE (lopamidol Injection) is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography and ventriculography, pediatric angiocardiography, selective visceral arteriography and aortography, peripheral venography (phlebography), and adult and pediatric intravenous excretory urography and intravenous adult and pediatric contrast enhancement of computed tomographic (CECT) head and body imaging (see below).

CECT Head Imaging

ISOVUE may be used to refine diagnostic precision in areas of the brain which may not otherwise have been satisfactorily visualized.

Tumors

ISOVUE may be useful to investigate the presence and extent of certain malignancies such as: gliomas including malignant gliomas, glioblastomas, astrocytomas, oligodendrogliomas and gangliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and in cases of low grade or infiltrative glioma has not been demonstrated.

In calcified lesions, there is less likelihood of enhancement. Following therapy, tumors may show decreased or no enhancement.

The opacification of the inferior vermis following contrast media administration has resulted in false-positive diagnosis in a number of otherwise normal studies.

Nonneoplastic Conditions

ISOVUE may be beneficial in the image enhancement of nonneoplastic lesions. Cerebral infarctions of recent onset may be better visualized with contrast enhancement, while some infarctions are obscured if contrast media are used. The use of iodinated contrast media results in contrast enhancement in about 60 percent of cerebral infarctions studied from one to four weeks from the onset of symptoms.

Sites of active infection may also be enhanced following contrast media administration.

Arteriovenous malformations and aneurysms will show contrast enhancement. For these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool.

Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast media administration may be helpful in ruling out the possibility of associated arteriovenous malformation.

CECT Body Imaging

ISOVUE (lopamidol Injection) may be used for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, abdominal cavity, pelvis and retroperitoneal space.

Enhancement of computed tomography with ISOVUE may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone, and in supplying additional features of the lesions (e.g., hepatic abscess delineation prior to percutaneous drainage). In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (e.g., tumor extension), or may help to define suspicious lesions seen with unenhanced CT (e.g., pancreatic cyst).

Contrast enhancement appears to be greatest within 60 to 90 seconds after bolus administration of contrast agent. Therefore, utilization of a continuous scanning technique (“dynamic CT scanning”) may improve enhancement and diagnostic assessment of tumor and other lesions such as an abscess, occasionally revealing unsuspected or more extensive disease. For example, a cyst may be distinguished from a vascularized solid lesion when precontrast and enhanced scans are compared; the nonperfused mass shows unchanged x-ray absorption (CT number). A vascularized lesion is characterized by an increase in CT number in the few minutes after a bolus of intravascular contrast agent; it may be malignant, benign, or normal tissue, but would probably not be a cyst, hematoma, or other nonvascular lesion.

Because unenhanced scanning may provide adequate diagnostic information in the individual patient, the decision to employ contrast enhancement, which may be associated with risk and increased radiation exposure, should be based upon a careful evaluation of clinical, other radiological, and unenhanced CT findings.


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NEWS HIGHLIGHTS

Media Articles Related to Isovue (Iopamidol Intravascular)

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Published Studies Related to Isovue (Iopamidol Intravascular)

Comparative investigation of i.v. iohexol and iopamidol: effect on renal function in low-risk outpatients undergoing CT. [2012]
CONCLUSION: Although our results were unable to show absolute noninferiority of

Correlative study of indirect computed tomography lymphography using iopamidol and histopathology in a cervical lymph node metastasis model. [2011.04]
OBJECTIVES/HYPOTHESIS: To investigate the potential usefulness of indirect computed tomography lymphography (CT-LG) with iopamidol in the detection of cervical lymph node metastases in a VX2 rabbit tongue cancer model. STUDY DESIGN: Randomized controlled trial... CONCLUSIONS: Indirect CT-LG may be useful for differentiating metastatic from nonmetastatic lymph nodes. Copyright (c) 2011 The American Laryngological, Rhinological, and Otological Society, Inc., Rhinological, and Otological Society, Inc.

Comparison of a low-osmolar contrast medium, iopamidol, and an iso-osmolar contrast medium, iodixanol, in MDCT coronary angiography. [2010.11]
OBJECTIVE: To prospectively compare iopamidol 370, which is a low-osmolar contrast medium and iodixanol 320, which is an iso-osmolar contrast medium, in terms of image quality and nonserious adverse effects that have the potential to influence the image quality in a 16-slice multi-detector row computed tomography coronary angiography... CONCLUSION: The frequency of adverse effects is lower in the iodixanol group than the iopamidol group. Iodixanol 320 can provide both vascular enhancement and image quality, which is similar to iopamidol 370 in a 16-slice multi-detector row computed tomography coronary angiography. There was no significant difference in terms of overall image quality between the patients with and without adverse effects in either of the groups.

Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures. [2009.11]
BACKGROUND: The choice of radiographic contrast media for use in patients at increased risk of contrast-induced nephropathy (CIN) is of ongoing interest... CONCLUSIONS: In the present study, the overall rate of CIN in patients with chronic kidney disease and DM undergoing coronary angiographic procedures was 10.5%. There was no significant difference between iodixanol and iopamidol in either peak increase in SCr or risk of CIN.

Less iodine injected for the same diagnostic performances: comparison of two low-osmolar contrast agents (iobitridol 350 and iopamidol 370) in coronary angiography and ventriculography: a randomized double-blind clinical study. [2010.08]
CONCLUSIONS: This study showed that, with regard to image quality and diagnostic efficacy and using a lower iodine concentration, iobitridol 350 was comparable to iopamidol 370 in adult patients requiring coronary angiography and ventriculography for diagnostic indications.

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Clinical Trials Related to Isovue (Iopamidol Intravascular)

Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography [Recruiting]
The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.

Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography [Recruiting]
It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients [Recruiting]
The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease undergoing coronary angiography.

Isovue in Peripheral Digital Subtraction Angiography [Recruiting]

Pilot Study to Compare ISOVUE®-250 and VISIPAQUEâ„¢ 270 for Motion Artifact and Pain in Peripheral (DSA) [Recruiting]
The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.

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Page last updated: 2014-11-13

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