Usual Adult Dose for Cerebral Arteriography

Either ioversol injection 51% (marketed as Optiray 240), ioversol injection 64% (marketed as Optiray 300), or ioversol injection 68% (marketed as Optiray 320) is recommended for cerebral arteriography

The usual individual injection for visualization of the carotid or vertebral arteries is 2 to 12 mL, repeated as necessary. Aortic arch injection for a simultaneous four vessel study requires 20 to 50 mL. Total procedural doses should not usually exceed 200 mL.

Extreme caution is advised in patients with advanced arteriosclerosis, severe hypertension, cardiac decompensation, senility, recent cerebral thrombosis or embolism, and migraine. Cardiovascular reactions that may occur with some frequency are bradycardia and either an increase or decrease in systemic blood pressure. Neurological reactions that may occur are: seizures, drowsiness, transient paresis, and mild disturbances in vision.

Central nervous system reactions with ioversol in controlled clinical studies in cerebral arteriography that were considered drug-related and occurred with frequencies greater than 1% were: headache, bradycardia, blood pressure fluctuation, disorientation, nausea, and vertigo.

Usual Adult Dose for Peripheral Arteriography

Either ioversol injection 64% (marketed as Optiray 300), ioversol injection 68% (marketed as Optiray 320), or ioversol injection 74% (marketed as Optiray 350) is recommended for peripheral arteriography. The usual individual injection volumes for visualization of various peripheral arteries are as follows:

aorta-iliac runoff - 60 mL (range 20 to 90 mL)
common iliac, femoral - 40 mL (range 10 to 50 mL)
subclavian, brachial - 20 mL (range 15 to 30 mL)

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

Pulsation should be present in the artery to be injected. In thromboangiitis obliterans, or ascending infection associated with severe ischemia, angiography should be performed with extreme caution, if at all.

Usual Adult Dose for Visceral Arteriography

Ioversol injection 68% (marketed as Optiray 320) is recommended for visceral arteriography, renal arteriography, and aortography procedures. The usual individual injection volumes for visualization for the aorta and various visceral arteries are as follows:

aorta - 45 mL (range 10 to 80 mL)
celiac - 45 mL (range 12 to 60 mL)
superior mesenteric - 45 mL (range 15 to 60 mL)
renal or inferior mesenteric - 9 mL (range 6 to 15 mL)

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

In aortography, depending on the technique employed, the risks of this procedure also include the following: injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, retroperitoneal hemorrhage from the translumbar approach and spinal cord injury and pathology associated with the syndrome of transverse myelitis. Under conditions of slowed aortic circulation there is an increased likelihood for aortography to cause muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortoiliac obstruction, femoral artery obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, and injection of vasopressors to increase contrast. In these patients the concentration, volume, and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully monitored.

Entry of a large aortic dose into the renal artery may cause, even in the absence of symptoms, albuminuria, hematuria, and an elevated creatinine and urea nitrogen. Rapid and complete return of function usually follows.

Usual Adult Dose for Renal Arteriography

Ioversol injection 68% (marketed as Optiray 320) is recommended for visceral arteriography, renal arteriography, and aortography procedures. The usual individual injection volumes for visualization for the aorta and various visceral arteries are as follows:

aorta - 45 mL (range 10 to 80 mL)
celiac - 45 mL (range 12 to 60 mL)
superior mesenteric - 45 mL (range 15 to 60 mL)
renal or inferior mesenteric - 9 mL (range 6 to 15 mL)

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

In aortography, depending on the technique employed, the risks of this procedure also include the following: injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, retroperitoneal hemorrhage from the translumbar approach and spinal cord injury and pathology associated with the syndrome of transverse myelitis. Under conditions of slowed aortic circulation there is an increased likelihood for aortography to cause muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortoiliac obstruction, femoral artery obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, and injection of vasopressors to increase contrast. In these patients the concentration, volume, and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully monitored.

Entry of a large aortic dose into the renal artery may cause, even in the absence of symptoms, albuminuria, hematuria, and an elevated creatinine and urea nitrogen. Rapid and complete return of function usually follows.

Usual Adult Dose for Coronary Arteriography

Either ioversol injection 68% (marketed as Optiray 320) or ioversol injection 74% (marketed as Optiray 350) is recommended for this procedure. The usual individual injection volumes for visualization of the coronary arteries and left ventricle are:

left coronary - 8 mL (range 2 to 10 mL)
right coronary - 6 mL (range 1 to 10 mL)
left ventricle - 40 mL (range 30 to 50 mL)

These doses may be repeated as necessary. Total procedural dose for the combined procedures should not usually exceed 250 mL. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.

Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure.

There were no cardiovascular system reactions with ioversol in controlled clinical studies in coronary arteriography with left ventriculography that were considered drug-related and occurred with a frequency greater than 1%.

Usual Adult Dose for Left Ventriculography

Either ioversol injection 68% (marketed as Optiray 320) or ioversol injection 74% (marketed as Optiray 350) is recommended for this procedure. The usual individual injection volumes for visualization of the coronary arteries and left ventricle are:

left coronary - 8 mL (range 2 to 10 mL)
right coronary - 6 mL (range 1 to 10 mL)
left ventricle - 40 mL (range 30 to 50 mL)

These doses may be repeated as necessary. Total procedural dose for the combined procedures should not usually exceed 250 mL. When large individual volumes are administered, as in ventriculography and aortography, it has been suggested that several minutes be permitted to elapse between each injection to allow for subsidence of possible hemodynamic disturbances.

Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure.

There were no cardiovascular system reactions with ioversol in controlled clinical studies in coronary arteriography with left ventriculography that were considered drug-related and occurred with a frequency greater than 1%.

Usual Adult Dose for Intra-arterial Digital Subtraction Angiography

Ioversol injection 34% (marketed as Optiray 160) is recommended for intra-arterial digital subtraction angiography (IA-DSA). As a general rule, the volume and concentration used for IA-DSA is about 50% or less of that used for conventional procedures. The actual dosage and flow rate will vary depending on the selectivity of the injection site and the area being examined.
The following suggested volumes per injection are intended only as a guide. Injections may be repeated as necessary. It is advisable to inject at rates approximately equal to the flow of the vessel being injected.

Carotid Arteries 6 to 10 mL
Vertebral Arteries 4 to 8 mL
Aorta 25 to 50 mL
Subclavian or Brachial Arteries 2 to 10 mL
Major Branches of the Abdominal Aorta 2 to 20 mL

Dosage should not usually exceed 250 mL.

Usual Adult Dose for Venography

Either ioversol injection 51% (marketed as Optiray 240), ioversol injection 64% (marketed as Optiray 300), ioversol injection 68% (marketed as Optiray 320), or ioversol injection 74% (marketed as Optiray 350), is recommended for venography.

Usual dose: 50 to 100 mL per extremity with smaller or larger volumes indicated in some cases.

Dosage should not usually exceed 250 mL.

Special care is required when venography is performed in patients with suspected thrombosis, phlebitis, severe ischemic disease, local infection or a totally obstructed venous system. In order to minimize extravasation during injection, fluoroscopy is recommended.

Following the procedure, the venous system should be flushed with Sodium Chloride Injection U.S.P. or 5% Dextrose in Water (D5W). Massage and elevation are also helpful for clearing the contrast medium from the extremity.

Usual Adult Dose for Head Imaging

Usual dosage is 50 to 150 mL of ioversol injection 74%, 68%, or 64% or 100 to 250 mL of ioversol injection 51%. Scanning may be performed immediately after completion of the intravenous administration. Dosage should not usually exceed 150 mL of ioversol injection 74%, 68%, or 64% or 250 mL of ioversol injection 51%.

Tumors: Ioversol 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: Ioversol 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 medium is used. The use of iodinated contrast media results in enhancement in about 60% of cerebral infarctions studied from one to four weeks from the onset of symptoms.

Sites of active infection may also be enhanced following contrast medium 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 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.

Usual Adult Dose for Body Imaging

Ioversol injection 74%, 68%, 64%, or 51% may be administered by bolus injection, by rapid infusion, or by a combination of both.

Usual doses:
ioversol injection 74% (marketed as Optiray 350) - bolus injection: 25 to 75 mL, infusion: 50 to 150 mL
ioversol injection 68% (marketed as Optiray 320) - bolus injection: 25 to 75 mL, infusion: 50 to 150 mL
ioversol injection 64% (marketed as Optiray 300) - bolus injection: 25 to 75 mL, infusion: 50 to 150 mL
ioversol injection 51% (marketed as Optiray 240) - bolus injection: 35 to 100 mL, infusion: 70 to 200 mL
Dosage should not usually exceed 150 mL of ioversol injection 74%, 68% or 64% or 250 mL of 51%.

Ioversol may be useful for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space. Enhancement of computed tomography with ioversol may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (i.e., tumor extension) or may help to define suspicious lesions seen with unenhanced CT (i.e., pancreatic cyst).

Usual Adult Dose for Intravenous Digital Subtraction Angiography

Usual dosage: Ioversol injection 74% (marketed as Optiray 350) may be injected centrally, in either the superior or inferior vena cava or right atrium; or peripherally into an appropriate arm vein. For central injections, catheters may be introduced at the antecubital fossa into either the basilic or cephalic vein or at the leg into the femoral vein and advanced to the distal segment of the corresponding vena cava. For peripheral injections, the catheter is introduced at the antecubital fossa into an appropriate size arm vein. In order to reduce the potential for extravasation during peripheral injection, a catheter of approximately 20 cm in length should be employed.
Depending on the area to be imaged, the usual dose range per injection is 30 to 50 mL. Injections may be repeated as necessary. The total procedural dose should not exceed 250 mL.
Injection rates will vary depending on the site of catheter placement and vessel size. Central catheter injections are usually made at a rate of between 10 and 30 mL/second. Peripheral injections are usually made at a rate of between 12 and 20 mL/second. Since the injected medium can sometimes remain in the arm vein for an extended period, it is advisable to flush the vein immediately following injection with an appropriate volume (20 to 25 mL) of sodium chloride injection U.S.P. or 5% dextrose in water (D5W).

Intravenous digital subtraction angiography (IV DSA) is a radiographic modality which allows dynamic imaging of the arterial system following intravenous injection of iodinated x-ray contrast media through the use of image intensification, enhancement of the iodine signal and digital processing of the image data. Temporal subtraction of the images obtained prior to and during the “first arterial pass” of the injected contrast medium yields images which are devoid of bone and soft tissue. IV DSA is most frequently used to examine the heart, including coronary by-pass grafts; the pulmonary arteries; arteries of the brachiocephalic circulation; the aortic arch; the abdominal aorta and its major branches; the iliac arteries; and the arteries of the extremities.

No special patient preparation is required for IV DSA. However, it is advisable to insure that patients are well hydrated prior to examination.

In addition to the general precautions previously described, the risks associated with IV DSA include those usually attendant with catheter procedures and include intramural injections, vessel dissection and tissue extravasation. The potential risk is reduced when small test injections of contrast medium are made under fluoroscopic observation to insure that the catheter tip is properly positioned and, in the case of peripheral placement, that the vein is of adequate size.
Patient motion, including respiration and swallowing, can result in misregistration leading to image degradation and non-diagnostic studies.

Usual Adult Dose for Intravenous Urography

Either ioversol injection 74% (marketed as Optiray 350), ioversol injection 68% (marketed as Optiray 320), ioversol injection 64% (marketed as Optiray 300), or ioversol injection 51% (marketed as Optiray 240) is recommended for routine and high dose excretory urography. Preparatory dehydration is dangerous and may contribute to acute renal failure.

Usual dose for routine excretory urography: 50 to 75 mL of ioversol injection 74%, 68%, or 64% or 75 to 100 mL of ioversol injection 51%

Higher dosages may be indicated to achieve optimum results where poor visualization is anticipated (e.g., elderly patients or patients with impaired renal function). In these patients, high dose urography may be preferred, using ioversol injection 74% (marketed as Optiray 350) at a dose of 1.4 mL/kg (maximum 140 mL), ioversol injection 68% (marketed as Optiray 320) at a dose of 1.5 to 2 mL/kg (maximum 150 mL), ioversol injection 64% (marketed as Optiray 300) at a dose of 1.6 mL/kg (maximum 150 mL) or ioversol injection 51% (marketed as Optiray 240) at a dose of 2 mL/kg (maximum 200 mL).

Usual Pediatric Dose for Pediatric Angiocardiography

Either ioversol injection 74% (marketed as Optiray 350) or ioversol injection 68% (marketed as Optiray 320) is recommended for this procedure. The usual single ventricular injection of ioversol injection 74% or ioversol injection 68% is 1.25 mL/kg of body weight with a range of 1 mL/kg to 1.5 mL/kg. When multiple injections are given, the total administered dose should not exceed 5 mL/kg up to a total volume of 250 mL.

Mandatory prerequisites to the procedure are specialized personnel, ECG monitoring apparatus, and adequate facilities for immediate resuscitation and cardioversion. Electrocardiograms and vital signs should be routinely monitored throughout the procedure. Pediatric patients at higher risk of experiencing adverse events during contrast medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dL, or those less than 12 months of age.

Usual Pediatric Dose for Head Imaging

Recommended dose: 1 mL/kg to 3 mL/kg of ioversol injection 68% (marketed as Optiray 320)

Tumors: Ioversol 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: Ioversol 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 medium is used. The use of iodinated contrast media results in enhancement in about 60% of cerebral infarctions studied from one to four weeks from the onset of symptoms.

Sites of active infection may also be enhanced following contrast medium 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 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.

Usual Pediatric Dose for Body Imaging

Recommended dose: 1 mL/kg to 3 mL/kg of ioversol injection 68% (marketed as Optiray 320), with a usual dose of 2 mL/kg.

Ioversol may be useful for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space. Enhancement of computed tomography with ioversol may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (i.e., tumor extension) or may help to define suspicious lesions seen with unenhanced CT (i.e., pancreatic cyst).

Usual Pediatric Dose for Intravenous Urography

Children: Ioversol injection 68% (marketed as Optiray 320) at doses of 0.5 mL/kg to 3 mL/kg of body weight has produced diagnostic opacification of the excretory tract.

Usual dose for children: 1 mL/kg to 1.5 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total administered dose should not exceed 3 mL/kg.

Preparatory dehydration is dangerous and may contribute to acute renal failure.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Only the lowest dose necessary to obtain adequate visualization should be used. A lower dose may reduce the possibility of an adverse reaction. Most procedures do not require use of either the maximum volume or the highest concentration of ioversol.

The combination of volume and concentration of ioversol to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. Other factors such as anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed should be considered.

Precautions

US BOXED 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.

Dialysis

Data not available

Other Comments

It is desirable that intravascularly administered iodinated contrast agents be at or close to body temperature when injected.

If during administration a reaction occurs, the injection should be stopped until the reaction has subsided.