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Ioversol (Systemic)


VA CLASSIFICATION
Primary: DX101

Commonly used brand name(s): Optiray 160; Optiray 240; Optiray 300; Optiray 320; Optiray 350.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:

Note: Ioversol is a nonionic radiopaque contrast agent.



Diagnostic aid, radiopaque (cardiac disease)—

Diagnostic aid, radiopaque (vascular disease)—

Diagnostic aid, radiopaque (urinary tract disorders)—

Diagnostic aid, radiopaque contrast enhancer in computed tomography—

Diagnostic aid, radiopaque (peritoneal disorders)—

Diagnostic aid, radiopaque (biliary tract disorders)—

Diagnostic aid, radiopaque (joint disease)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Intravascular
Angiocardiography—Ioversol is indicated in angiocardiography (coronary arteriography and left ventriculography) to visualize lesions or malformations of the heart and obstructions or anomalies of the major thoracic vessels. {01} {38}

Angiography
Aortography
Arteriography or
Venography—Ioversol is indicated in aortography, arteriography (cerebral, peripheral, visceral, renal), peripheral venography (phlebography), and intra-arterial and intravenous digital subtraction angiography to visualize specific regions of the vascular system and blood flow in such areas to help in the diagnosis and evaluation of neoplasms (known or suspected) or vascular diseases (congenital or acquired) that may cause changes in normal vascular anatomy or physiology. {01} {32} {38}

Urography, excretory—Ioversol is indicated for excretion urography to evaluate abnormalities of the urinary tract such as urinary tract obstructions. {01} {38}

Brain imaging, computed tomographic—Ioversol is indicated for enhancement of computed tomographic images (CT of the brain) to determine the presence and extent of neoplasms, such as gliomas, glioblastomas, astrocytomas, oligodendrogliomas, ependymomas, medulloblastomas, meningiomas, neuromas, pinealomas, pituitary adenomas, craniopharyngiomas, germinomas, and metastatic lesions, or nonneoplastic lesions such as cerebral infarction or infection. Also, depending on the iodine content of the circulating blood pool, arteriovenous malformations and aneurysms may show contrast enhancement. {01} {38}

Body imaging, computed tomographic—Ioversol is indicated for enhancement of computed tomographic images (CT of the body) to detect and evaluate lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space. {01} {38}

[Herniography]1—Ioversol is used in herniography in adults. {29} {33}

Intraductal
[Pancreatography, endoscopic retrograde]1and
[Cholangiopancreatography, endoscopic retrograde]1— Ioversol is used in adults in endoscopic retrograde pancreatography and endoscopic retrograde cholangiopancreatography for visualization of all portions of the biliary tree. {29} {33}

Intrasynovial
[Arthrography]1— Ioversol is used for arthrography in the diagnosis of post-traumatic or degenerative joint diseases or synovial rupture, for visualization of communicating bursae or cysts, and in meniscography. {29} {33} {61}

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    807.12 {39}


Osmolality
    Low. The osmolalities of the injections with iodine concentrations of 160, 240, 300, 320, and 350 mg per mL are 355, 502, 651, 702, and 792 mOsmol per kg of water, respectively {01}

Note: Ioversol injection is hypertonic as compared to plasma (approximately 1.2 to 2.5 times the osmolality of plasma). {01}


Mechanism of action/Effect:

Organic iodine compounds block x-rays as they pass through the body, thereby allowing body structures containing iodine to be delineated in contrast to those structures that do not contain iodine {49}. The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays. After intravascular administration, ioversol makes opaque those vessels in its path of flow, allowing visualization of the internal structures until significant hemodilution occurs. {01} {32} {33} {37}

Distribution:

Rapidly distributed throughout extracellular fluid following intravenous administration. No significant deposition in tissues. Does not cross blood-brain barrier, but accumulates within the interstitial tissues of malignant tumors and other lesions of the brain due to alterations in blood-brain barrier permeability caused by the tumor or lesions. {01} {07} {37}

Protein binding:

Low (9 to 13%). {36}

Half-life:

Elimination—Approximately 2 hours (with normal renal function). {01} {36} {37}

Time to peak serum concentration:

Immediate, but concentration falls rapidly within 5 to 10 minutes as ioversol is distributed throughout the extravascular compartment. {01} {37}


Time to peak opacification:

Renal calyces and pelves—5 to 15 minutes (with normal renal function). {01} {37}

CT scan (dynamic)—30 to 90 seconds. {37}

Elimination:
    Renal—More than 95% of dose is eliminated unchanged in 24 hours. {01} {37} In patients with impaired renal function, the elimination of ioversol is prolonged depending upon the degree of impairment. {36} {37}
    Fecal—3 to 9%. {36} {37}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to iodine or other iodinated contrast media may be sensitive to ioversol also.

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of ioversol have not been performed. {01}

Pregnancy/Reproduction

Pregnancy—
Adequate and well-controlled studies in humans have not been done. {01} However, other organically bound iodine–containing preparations administered near term, by intra-amniotic injection, have caused hypothyroidism in some neonates. {04} {32}

Also, elective contrast radiography of the abdomen is usually not recommended during pregnancy because of the risks to the fetus from radiation exposure. {01}

Studies in animals have not shown that ioversol causes harm to the fetus.

FDA Pregnancy Category B. {01} {38}

Breast-feeding

Although it is not known whether ioversol is distributed into breast milk, temporary discontinuation of breast-feeding is recommended for at least 24 hours following administration of ioversol. {01} {32} {54}

Pediatrics

Appropriate studies on the relationship of age to the effects of ioversol have not been performed in pediatric patients. {01} However, it is known that pediatric patients, especially those with asthma, allergies, congestive heart failure, or serum creatinine greater than 1.5 mg per dL or those up to 12 months of age, exhibit an increased risk of having severe adverse reactions to radiopaque contrast media. {02} {38}

Dehydration and/or the risk of renal failure may be exacerbated by ioversol in infants and young children, especially those with polyuria, oliguria, diabetes, or pre-existing dehydration; adequate hydration is recommended before and following administration of ioversol. {01} {49}


Geriatrics


Diagnostic studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ioversol in the elderly. However, elderly patients are more likely to have age-related renal function impairment, which may require lower dosage in patients receiving ioversol. {26} {27}

Dehydration and/or the risk of renal failure may be exacerbated by ioversol in geriatric patients, especially those with polyuria, oliguria, diabetes, or pre-existing dehydration; adequate hydration is recommended before and following administration of ioversol. {01}

Elderly patients may be more sensitive to the effects of ioversol on thyroid function. Iodine-induced thyrotoxicosis may occur 4 to 12 weeks following contrast radiography. Thyroid function monitoring may be needed in geriatric patients. {40}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Beta-adrenergic blocking agents    (concurrent intravascular administration of ioversol with beta-adrenergic blocking agents may increase the risk of moderate to severe anaphylactoid reaction and may exacerbate hypotensive effects; discontinuation of the beta-adrenergic blocking agent before administration of contrast media may be advisable in patients with other risk factors {28} {62})


Cholecystographic agents, oral    (may increase the risk of renal toxicity when closely followed by intravascular ioversol, especially in patients with hepatic function impairment {01})


Interleukin-2    (incidence of delayed reactions to intravenous contrast media [e.g., hypersensitivity, fever, skin rash, flu-like symptoms, joint pain, flushing, pruritus, emesis, hypotension, dizziness occurring more than 1 hour after administration] may be increased in patients who have received interleukin-2; some symptoms may resemble a ``recall'' reaction to interleukin-2; supportive medical treatment may be necessary if symptoms are significant; delaying contrast media administration until 6 weeks after administration of interleukin-2 may reduce incidence of these reactions {41} {42} {43} {44} {45} {46})


Hypotension-producing medications, other (See Appendix II )    (the risk of severe hypotension may be increased if ioversol is given concurrently with other medications that produce hypotension {01} {54})


Nephrotoxic medications, other (See Appendix II )    (concurrent intravascular administration of ioversol with other nephrotoxic medications may increase the potential for nephrotoxicity {54})


Vasopressors    (increased risk of neurologic effects when followed by arterial injection of ioversol {01} {36})


Diagnostic interference
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With other diagnostic test results
Blood pool imaging    (intravascular administration of ioversol decreases technetium Tc 99m–labeling of red blood cells, which may impair blood pool imaging {54})


Prothrombin time (PT) and
Thromboplastin time    (may be increased with ioversol since in vitro studies with animal blood have shown other nonionic contrast media to slightly inhibit all stages of coagulation {01} {54})


Skeletal imaging    (intravenous administration of ioversol immediately after administration of technetium Tc 99m medronate, technetium Tc 99m oxidronate, technetium Tc 99m pyrophosphate, and technetium Tc 99m [pyro- and trimeta-] phosphates may cause renal and hepatic uptake of these technetium Tc 99m–labeled agents {54} {55})


Thyroid function determinations and
Thyroid imaging    (intravascular or intrathecal administration of ioversol may alter serum protein–bound iodine [PBI] concentrations and radioactive iodine or pertechnetate ion uptake for up to 2 weeks; thyroid test should be performed prior to administration of ioversol. Other thyroid function tests not based on measurement of iodine, such as resin triiodothyronine uptake, may not be affected {01} {38} {40})

With physiology/laboratory test values
Creatinine, serum    (concentration may be increased with ioversol since temporary increases of serum creatinine have occurred with other nonionic contrast media {23} {36} {37})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist {01}

For all procedures (especially those requiring intravascular administration):
Allergic reaction (anaphylaxis) to penicillins or to skin allergens, previous    (although the risk of anaphylactoid reaction may be less with ioversol than with high-osmolality contrast agents, caution is recommended when administering ioversol to patients who have had a previous reaction to penicillins or to skin allergens {48} {50} {51} {52})


Allergies or asthma, history of    (although the risk of idiosyncratic response or anaphylactoid reaction may be less with ioversol than with high-osmolality contrast agents, caution is recommended when administering ioversol to patients with a history of allergies or asthma {01} {47} {48} {50} {51} {52})


» Dehydration, especially associated with pre-existing renal disease, advanced vascular disease, or diabetes mellitus, or in pediatric and elderly patients    (osmotic diuretic action of ioversol may exacerbate dehydration and increase risk of acute renal failure {01} {33} {34} {38})


Hyperthyroidism    (administration of ioversol may precipitate thyroid storm {01} {38})


» Pheochromocytoma    (use of ioversol may precipitate severe hypertension; amount of ioversol injected should be kept to a minimum and blood pressure should be monitored during the procedure; also, pretreatment with the alpha-adrenergic blocking agent phentolamine is recommended {01} {34} {38})


Renal function impairment, severe    (elimination of ioversol may be delayed; although the risk of contrast-induced nephrotoxicity in the presence of renal insufficiency [serum creatinine ³ 132.6 micromoles/L] may be less with ioversol than with high-osmolality contrast agents, caution is recommended {25} {26} {27} {36} {38} {56} {57} {58} {59} {60})


» Sensitivity to iodinated contrast media    (increased risk of anaphylactoid reaction in patients with history of prior reaction to contrast media {28} {36})


Sickle cell disease    (ioversol may promote sickling in patients who are homozygous for sickle cell disease; however, sickling potential of ioversol is less than that of high-osmolality ionic agents {01})


For angiocardiography:
Angina, unstable    (increased risk of a severe cardiac reaction {53})


Cardiac failure, incipient    (fluid overload, pressure changes, and expansion of blood volume may aggravate condition)


Pulmonary hypertension, severe    (hypervolemic effect of ioversol may further increase pulmonary artery and venous pressures due to an increase in cardiac output and a rise in left ventricular end-diastolic and left atrial pressures {32} {33})


For aortography {01} {38}:
Abdominal compression or
Hypertension or
Hypotension or
Obstruction, aortoiliac and/or femoral artery    (increased risk of serious neurological complications, including paraplegia)


For cerebral arteriography:
Arteriosclerosis, advanced or
Cardiac decompensation or
Cerebral embolism, recent or
Hypertension, severe or
Migraine or
Senility or
Thrombosis, recent{01}{38}    (increased risk of vessel occlusion)


» Homocystinuria    (procedure may increase risk of thrombosis and embolism {38})


For peripheral arteriography:
» Buerger's disease    (procedure may induce severe arterial or venous spasms {01} {37} {38})


» Ischemia, severe, associated with ascending infection{37}{38}
For venography {01} {38}:
Infection, local or
Ischemia, severe or
Phlebitis or
Thrombosis or
Venous stasis or
Venous system obstruction    (procedure may cause venous inflammatory changes, thrombosis, or gangrene; irrigation with normal saline is recommended following the procedure to decrease the risk of thrombosis)


For excretory urography:
» Anuria or
» Diabetes mellitus    (administration of ioversol may increase risk of acute renal failure {32})


For arthrography:
» Infection in or near joint to be examined    (procedure may increase risk of complications {61})



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Blood pressure determinations    (may be required during procedure, especially in patients with known or suspected pheochromocytoma or hemodynamic compromise or instability {01} {49})


Thyroid function determinations    (iodine-induced thyrotoxicosis may occur 4 to 12 weeks following contrast radiography in geriatric patients; thyroid function monitoring may be needed {40})




Side/Adverse Effects

Note: Adverse effects may vary directly with the concentration of the agent, the amount and technique used, and the underlying pathology. Increases in osmolality, volume, concentration, viscosity, and rate of administration of the solution may increase the incidence and severity of adverse effects. {01}
Most of the adverse effects are usually self-limited and of short duration. {38}
Overall incidence of adverse effects with nonionic contrast agents, such as ioversol, has been reported to be less than with ionic contrast agents. {08}
Nonionic contrast media, such as ioversol, have been reported to produce fewer and less severe alterations in cardiac hemodynamics and electrocardiograms than standard ionic contrast agents during cardiac angiography. {03} {06} {07} {36} {38}
Low-osmolality contrast agents, such as ioversol, are reported to cause less heat and pain on injection than high-osmolality agents, such as diatrizoates and iothalamate. {24} {36} {38}
Thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with nonionic contrast media; however, these events appear to be technique-related. {01} {09} {33}
Dehydration may be exacerbated by the osmotic diuretic action of the hypertonic contrast solutions of ioversol, in some cases resulting in a shock-like state, following intravascular administration of ioversol in geriatric, azotemic, and dehydrated or debilitated patients. {38}
Transient global amnesia has been reported in 2 patients after cerebral angiography, in which 20 mL of another low-osmolality nonionic contrast agent (containing the equivalent of 240 mg of iodine per mL) was administered into the ascending aorta. The possibility that ioversol may cause a similar response must be considered. {56}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
With all procedures
    
Pseudo-allergic reaction (skin rash or hives, stuffy nose, swelling of face or skin, thickening of the tongue, wheezing, tightness in chest, or troubled breathing{11}{38}{54})
Note: Pseudo-allergic reactions are usually transient. However, they may be initial manifestations of more severe anaphylactic reactions. The anaphylactoid reaction may progress to respiratory arrest and vasomotor collapse if appropriate treatment is not administered. {51}



With intravascular administration
    
Angina pectoris (chest pain{38})
    
arrhythmia, transient, and/or bradycardia (slow or irregular heartbeat{38}{63})
    
CNS effects (confusion, hallucinations{38})
    
hypertension{38}
    
hypotension (severe and unusual tiredness or weakness{38})
    
infarct, cerebral (severe headache, blurred vision{38})




Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent or rare
With intravascular administration
    
Blurred vision or other changes in vision{38}
    
dizziness or lightheadedness
    
headache, mild to moderate{38}
    
nausea and vomiting, mild to moderate{38}
    
respiratory problems (coughing, sneezing, stuffy nose)
    
unusual feeling of warmth{38}

With intrasynovial administration
    
Joint pain or exacerbation of existing pain{61}
    
swelling at joint{61}






Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopaque Agents (Diagnostic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use

Action in the body:
Injection into vein or artery; visualization of radiopacity in brain, heart, blood vessels, and urinary tract possible with x-rays

Direct injection into region to be studied; visualization of joint spaces, pancreatic and bile ducts

Before having this test
»   Conditions affecting use, especially:
Sensitivity to iodine or other iodinated contrast media

Pregnancy—Risk to the fetus from radiation exposure; may cause hypothyroidism in neonate





Breast-feeding—Temporary discontinuation of breast-feeding for at least 24 hours





Use in children—Increased risk of severe adverse reactions, especially in children with other medical problems; possible exacerbation of dehydration






Use in the elderly—Increased risk of side effects; possible exacerbation of dehydration; increased risk of thyrotoxicosis
Other medical problems, especially anuria, dehydration, diabetes mellitus, and pheochromocytoma

Preparation for this test
Adequate intake of fluids to prevent dehydration

Special preparatory instructions may be given; patient should inquire in advance

Precautions after having this test
Possible interference with future thyroid tests


Side/adverse effects
Signs of possible side effects, especially pseudo-allergic reaction, cardiovascular problems, and CNS effects


General Dosing Information
Manufacturer's package insert or other appropriate literature should be consulted for specific techniques and procedures for the administration of contrast media.

Sensitivity test doses are not usually recommended since severe or fatal reactions to contrast media are not predictable from a patient's history or a sensitivity test. On some occasions, severe or fatal reactions have occurred with a test dose or with a full dose in patients who did not react to the test dose. {01}

Pretreatment with corticosteroids and/or antihistamines may minimize the incidence and severity of reactions in patients with a history of severe reactions to contrast media or other high-risk conditions (e.g., asthma or history of allergies, positive allergy history to skin allergens or penicillins, dehydration, history of seizures, pheochromocytoma). {01} In some studies, the additional use of ephedrine has been shown to be beneficial in preventing anaphylactoid reactions (except in patients with a history of hypertension or cardiovascular disease). When the use of a contrast agent is being considered, the following protocols are recommended: {01} {12} {13} {14} {15} {16} {17} {18} {19} {20} {21} {22} For high-risk patients

   • Use of a high-osmolality contrast agent plus pretreatment with a corticosteroid (oral prednisone 50 mg administered 13 hours, 7 hours, and 1 hour before procedure) and an antihistamine (intramuscular, intravenous, or oral diphenhydramine, 50 mg administered one hour prior to procedure) or
   • Use of a low-osmolality contrast agent if pretreatment is not feasible or
   • Use of a low-osmolality contrast agent plus corticosteroid pretreatment.
For low-risk patients

   • Use of a high-osmolality contrast agent or
   • Use of a high-osmolality contrast agent and corticosteroid pretreatment.


Adequate hydration is recommended for all patients before and after the procedure. Intravenous or oral intake of fluids may continue up to time of administration of ioversol. {01}

During and for at least 30 to 60 minutes after intravascular injection of ioversol, the patient should be observed for possible severe reactions; competent personnel and emergency facilities should be available during this period. {01} {38}

Nonionic contrast media, such as ioversol, inhibit blood coagulation in vitro less than ionic contrast media. Blood cell aggregation has been reported when blood remains in contact with syringes containing nonionic contrast media. Thus, thromboembolic events causing myocardial infarction and stroke, reported during angiographic procedures, may have resulted from aggregation of blood that had come in contact with the contrast agent outside the body. It is recommended that risk factors for aggregation be minimized by performing the procedure in the shortest time possible, using plastic rather than glass syringes, and flushing catheters with heparinized saline solutions. {01} {09}

Dosage and concentration of iodine (as ioversol injection) are dependent upon the degree and extent of contrast needed in the areas under examination and on the equipment and technique used.

For treatment of adverse effects
Recommended treatment consists of the following: {01} {30} {31}

   • For major or life-threatening reactions, careful monitoring of vital signs and emergency therapy, including artificial respiration with oxygen, if needed for respiratory depression, and cardiac massage in the event of cardiac arrest.
   • To restore blood pressure, administration of intravenous fluids and/or vasopressors. If hypotension necessitates the use of vasopressors, slow infusion of 0.008 to 0.012 mg per minute of norepinephrine or 0.1 to 0.18 mg per minute of phenylephrine, appropriately diluted. If hypotension is due to increased vagal activity (vasovagal reaction), intravenous administration of 1 mg of atropine, repeated in one to two hours if needed.
   • Other specific treatment may include— {55}

• Diphenhydramine: For minor allergic-like reactions—An antihistamine such as diphenhydramine hydrochloride (except in epileptic patients) may be administered intravenously.


• Epinephrine: For acute allergic-like or anaphylactoid reactions—Slow intravenous infusion of 0.1 mg of epinephrine (1:10,000). {62}For mild to moderate bronchospasm—0.1 to 0.2 mg of epinephrine (1:1000) may be administered subcutaneously, except in patients with hypotension. In extreme emergency, 0.1 mg of epinephrine (1:10,000) may be given slowly by intravenous route, followed by a continuous intravenous infusion at an initial rate of 0.001 mg per minute; the rate may be increased to 0.004 mg per minute if necessary. (Note: Patients on beta-adrenergic blocking agents should not receive epinephrine since they are at risk of unopposed alpha-adrenergic stimulation, which may result in hypertension, reflex bradycardia, and heart-block. In these patients, isoproterenol and norepinephrine are used instead of epinephrine to overcome bronchospasm and hypotension, respectively.)For cardiac arrest—0.1 to 1 mg of epinephrine may be administered by the intravenous route.


• Diazepam or phenobarbital: To control convulsions—5 to 10 mg of diazepam by slow, intravenous administration or phenobarbital sodium may be given intravenously or intramuscularly at a rate not to exceed 30 to 60 mg per minute.



Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

IOVERSOL INJECTION

Usual adult and adolescent dose
Angiography


Intra-arterial, by digital subtraction:
Intra-arterial, as a solution containing the equivalent of 160 mg of iodine per mL, injected at a rate approximately equal to the flow rate of the blood vessel and repeated, as necessary, into the following vessels {38}:

Carotid arteries, 6 to 10 mL.

Vertebral arteries, 4 to 8 mL.

Aorta, 20 to 50 mL.

Subclavian or brachial arteries, 2 to 10 mL.

Major branches of the abdominal aorta, 2 to 20 mL.




Intravenous, by digital subtraction:
Via catheter, 30 to 50 mL of a solution containing the equivalent of 350 mg of iodine per mL, repeated as needed. {38}


Arteriography, cerebral
Via catheter, as a solution containing the equivalent of 240 mg, 300 mg, or 320 mg of iodine per mL, into the following vessels {37} {38}:

Carotid or vertebral arteries, 2 to 12 mL, repeated as necessary.

Aortic arch, 20 to 50 mL for simultaneous four-vessel study. {38}


Venography, peripheral
Percutaneous, 50 to 100 mL per extremity of a solution containing the equivalent of 240 mg or 350 mg of iodine per mL. {38}

Note: Following venography, the venous system should be flushed with 0.9% sodium chloride injection or 5% dextrose in water. Massage and elevation of the extremities are also recommended to help clear the contrast medium from the extremities. {01} {38}


Aortography and
Arteriography, visceral and renal
Via catheter, as a solution containing the equivalent of 320 mg of iodine per mL, repeated as necessary, into the following arteries {38}:

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).


Arteriography, coronary and
Ventriculography, left
Via catheter, as a solution containing the equivalent of 320 mg or 350 mg of iodine per mL, repeated as necessary, into the following vessels {38}:

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).


Arteriography, peripheral
Percutaneous or operative methods, as a solution containing the equivalent of 300 mg or 320 mg of iodine per mL, repeated as necessary, into the following arteries {38}:

Aortoiliac runoff, 60 mL (range, 20 to 90 mL).

Common iliac and femoral, 40 mL (range, 10 to 50 mL).

Subclavian, brachial, 20 mL (range, 15 to 30 mL).


Urography, excretory
Intravenous, 75 to 100 mL of a solution containing the equivalent of 240 mg of iodine per mL; or 50 to 75 mL of a solution containing the equivalent of 300 mg, 320 mg, or 350 mg of iodine per mL. {38}

Note: In patients with impaired renal function, poor visualization is anticipated; therefore, doses of 2 mL per kg of body weight of a solution containing the equivalent of 240 mg of iodine per mL (maximum 200 mL); or 1.6 mL per kg of body weight of a solution containing the equivalent of 300 mg of iodine per mL (maximum 150 mL); or 1.5 to 2 mL per kg of body weight of a solution containing the equivalent of 320 mg of iodine per mL (maximum 150 mL); or 1.4 mL per kg of body weight of a solution containing the equivalent of 350 mg of iodine per mL (maximum 140 mL), may be indicated for urography. {01} {38}


CT of the brain
Intravenous, 100 to 250 mL of a solution containing the equivalent of 240 mg of iodine per mL; or 50 to 150 mL of a solution containing the equivalent of 300 mg or 320 mg of iodine per mL. {38}

CT of the body
Intravenous, 35 to 100 mL by bolus injection, or 70 to 200 mL by infusion of a solution containing the equivalent of 240 mg of iodine per mL; or 25 to 75 mL by bolus injection, or 50 to 150 mL by infusion of a solution containing the equivalent of 300 mg, 320 mg, or 350 mg of iodine per mL. {38}


Usual adult prescribing limits
Angiography, intra-arterial, by digital subtraction and

Aortography and

Arteriography, peripheral and

Arteriography, visceral and renal and

Venography, peripheral—Up to 250 mL. {38}

Arteriography, cerebral—Up to 200 mL. {38}

Arteriography, coronary and

Ventriculography, left—Up to 250 mL for combined procedures. {38}

CT of the brain and

CT of the body—Up to 250 mL of a solution containing the equivalent of 240 mg of iodine per mL; or up to 150 mL of a solution containing the equivalent of 300 mg or 320 mg of iodine per mL. {38}

Usual pediatric dose
Angiocardiography
By single injection, 1.25 mL per kg of body weight, with a range of 1 to 1.5 mL per kg of body weight of a solution containing the equivalent of 320 mg or 350 mg of iodine per mL. {37} {38}

Note: When multiple injections are given, the total administered dose should not exceed 5 mL per kg of body weight, up to a total volume of 250 mL. {38}


[Angiography]
Intra-arterial, by digital subtraction: Intra-arterial 1 to 3 mL per kg of body weight of a solution containing the equivalent of 300 mg of iodine per mL. {37}

[Arteriography, coronary] and
[Ventriculography, left]
Via catheter, 1.25 mL per kg of body weight, with a range of 1 to 1.5 mL per kg of body weight of a solution containing the equivalent of 320 mg of iodine per mL. {37}

Urography, excretory
Intravenous, 0.5 to 3 mL per kg of body weight of a solution containing the equivalent of 300 mg or 320 mg of iodine per mL. {38} {62}

CT of the brain and
CT of the body
Intravenous, 1 to 3 mL per kg of body weight of a solution containing the equivalent of 320 mg of iodine per mL. {38}


Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients with renal function impairment may be more sensitive to the effects of the usual adult dose; lower dosages are recommended.
For excretory urography, poor visualization is anticipated in elderly patients; therefore, doses of 2 mL per kg of body weight of a solution containing the equivalent of 240 mg of iodine per mL (maximum 200 mL); or 1.6 mL per kg of body weight of a solution containing the equivalent of 300 mg of iodine per mL (maximum 150 mL); or 1.5 to 2 mL per kg of body weight of a solution containing the equivalent of 320 mg of iodine per mL (maximum 150 mL); or 1.4 mL per kg of body weight of a solution containing the equivalent of 350 mg of iodine per mL (maximum 140 mL) may be indicated. {01} {38}


Strength(s) usually available
U.S.—


339 mg of ioversol with 160 mg of iodine per mL (Rx) [Optiray 160]


509 mg of ioversol with 240 mg of iodine per mL (Rx) [Optiray 240]


636 mg of ioversol with 300 mg of iodine per mL (Rx) [Optiray 300]


678 mg of ioversol with 320 mg of iodine per mL (Rx) [Optiray 320]


741 mg of ioversol with 350 mg of iodine per mL (Rx) [Optiray 350]

Canada—


339 mg of ioversol with 160 mg of iodine per mL (Rx) [Optiray 160]


509 mg of ioversol with 240 mg of iodine per mL (Rx) [Optiray 240]


636 mg of ioversol with 300 mg of iodine per mL (Rx) [Optiray 300]


678 mg of ioversol with 320 mg of iodine per mL (Rx) [Optiray 320]


741 mg of ioversol with 350 mg of iodine per mL (Rx) [Optiray 350]

Note: All formulations above contain 3.6 mg of tromethamine per mL as a buffer and 0.2 mg of edetate calcium disodium per mL as a stabilizer. {37} {38}


Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), in a light-resistant container, unless otherwise specified by manufacturer. Protect from freezing. {38} {62}

Stability:
Ioversol is a clear, colorless to pale yellow solution. Do not use if turbid or discolored. {01}

Any unused portion remaining in the container should be discarded. {01}



Revised: 08/16/1995



References
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