INDICATIONS AND USAGE
ISOVUE (Iopamidol Injection) is indicated
for angiography throughout the cardiovascular system in adults, including
cerebral and peripheral arteriography, coronary arteriography and
ventriculography, selective visceral arteriography and aortography,
peripheral venography (phlebography), and in pediatric patients for
angiocardiography; or for intravenous use in adult and pediatric for
computed tomographic (CT) imaging of the head and body (see below).
CT 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.
CT Body Imaging
ISOVUE (Iopamidol 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.