Iothalamate (Systemic)


VA CLASSIFICATION
Primary: DX102

Commonly used brand name(s): Angio-Conray; Conray; Conray-30; Conray-325; Conray-400; Conray-43; Conray-60; Vascoray.

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



Category:

Note: Iothalamate is an ionic radiopaque contrast agent.



Diagnostic aid, radiopaque (cardiac disease)—Iothalamate Meglumine and Iothalamate Sodium Injection; Iothalamate Sodium Injection;

Diagnostic aid, radiopaque (vascular disease)—Iothalamate Meglumine Injection; Iothalamate Meglumine and Iothalamate Sodium Injection; Iothalamate Sodium Injection;

Diagnostic aid, radiopaque (biliary tract disorders)—Iothalamate Meglumine Injection;

Diagnostic aid, radiopaque (pancreas disease)—Iothalamate Meglumine Injection;

Diagnostic aid, radiopaque (brain disorders)—Iothalamate Meglumine Injection; Iothalamate Meglumine and Iothalamate Sodium Injection; Iothalamate Sodium Injection;

Diagnostic aid, radiopaque contrast enhancer in computed tomography (CT)—Iothalamate Meglumine Injection; Iothalamate Meglumine and Iothalamate Sodium Injection; Iothalamate Sodium Injection;

Diagnostic aid, radiopaque (urinary tract disorders)—Iothalamate Meglumine Injection; Iothalamate Meglumine and Iothalamate Sodium Injection; Iothalamate Sodium Injection;

Diagnostic aid, radiopaque (joint disease)—Iothalamate Meglumine Injection;

Indications

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

Accepted

Intravascular
Angiocardiography—Iothalamate meglumine and iothalamate sodium injection and iothalamate sodium injection are indicated to visualize lesions or malformations of the heart and obstructions or anomalies of the major thoracic blood vessels. {01} {02} {06} {33} {63} {68} {69}

Angiography
Arteriography or
Venography—Iothalamate is indicated to visualize specific regions of the vascular system and blood flow in these 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. Iothalamate meglumine injection is indicated for use in cerebral angiography, peripheral arteriography or venography, arterial digital subtraction angiography1 , and intravenous digital subtraction angiography. Iothalamate meglumine and iothalamate sodium injection is indicated for use in selective coronary arteriography, selective renal arteriography, and in intravenous digital subtraction angiography. {01} {06} {33} {64} {65} {66} {69}
—The iothalamate meglumine and iothalamate sodium injection is not indicated for cerebral angiography by direct injection into the carotid or vertebral arteries because of its high concentration and viscosity. {69}

Aortography—Iothalamate meglumine and iothalamate sodium injection and iothalamate sodium injection are indicated to visualize the aorta and its major branches. However, the injection of iothalamate meglumine and iothalamate sodium is preferred because it generally causes less severe hemodynamic, neurotoxic, and cardiotoxic effects than the individual injection of iothalamate sodium. {06} {63} {68} {69}

Body imaging, computed tomographic—Iothalamate meglumine injection and iothalamate sodium injection are indicated for enhancement of computed tomographic scans of the body (CT of the body) performed for the detection and evaluation of lesions in the liver, pancreas, kidneys, abdominal aorta, mediastinum, abdominal cavity, and retroperitoneal space. {04} {66} {68}

Brain imaging, computed tomographic—Iothalamate meglumine injection, iothalamate meglumine and iothalamate sodium injection, and iothalamate sodium injection are indicated for enhancement of computed tomographic scans of the brain (CT of the brain) to determine the presence and extent of neoplasms or other lesions such as cerebral infarction or infection. {01} {02} {06} {33} {64} {65} {68} {69}

Urography, excretory—Iothalamate meglumine injection, iothalamate meglumine and iothalamate sodium injection, and iothalamate sodium injection are indicated in excretion urography to evaluate abnormalities of the urinary tract such as urinary tract obstructions. {06} {64} {65} {66} {67} {68} {69}

[Splenoportography]1—Iothalamate is used for splenoportography to determine the site of the portal obstruction or to visualize collateral pathways of blood flow or esophageal varices in patients with portal hypertension or portal venous obstruction. It should be noted that splenoportography is being replaced by other procedures in which the portal system may be evaluated by late films of the celiac and superior mesenteric arterial systems (their venous phases). In other cases, it is being replaced by direct portography via the transhepatic route. {32}

Intraductal
Cholangiography, direct, operative—Iothalamate meglumine injection is indicated during surgery to visualize the biliary ducts and to evaluate the cause and location of biliary obstructions such as calculi or strictures, and after surgery to rule out the presence of retained calculi. {01} {02} {06} {33} {64}

Cholangiography, direct, postoperative T-tube—Iothalamate meglumine injection is indicated to visualize, and thus ensure the patency of, the biliary ducts before removal of a surgically placed T-tube. {01} {02} {06} {33} {64}

Cholangiography, percutaneous transhepatic—Iothalamate meglumine injection is indicated for percutaneous transhepatic cholangiography, which is used in some patients to determine the cause and site of biliary obstruction when other diagnostic examinations of the biliary system have not provided the needed information. {06}

Cholangiopancreatography, endoscopic retrograde—Iothalamate meglumine injection is indicated in some patients with known or suspected pancreatic or biliary disease to visualize the pancreatic duct and/or common bile duct. {06} {64}

Intrasynovial
Arthrography—Iothalamate meglumine injection is indicated for use in arthrography in the diagnosis of post-traumatic or degenerative joint disease or synovial rupture, for visualization of communicating bursae or cysts, and meniscography. {06} {20} {64}

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Iothalamate meglumine: 809.13 {56}
    Iothalamate sodium; 635.90


Osmolality
    High. The osmolality of iothalamate injections ranges from 600 to 2400 mOsmol per kg of water {06} {32} {63} {64} {65} {66} {67} {68} {69}

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. 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. Iothalamate's distribution in and elimination from the body as iodinated ion allow the visualization of the internal structures in the path of its flow. {02} {03} {05} {19} {32} {39}


Other actions/effects:

Anticoagulant activity (inhibitory effect on platelet aggregation and blood clotting); vasodilating effects. {26} {33} {40}

Distribution:

Intravascular—Rapidly distributed throughout extracellular fluid following intravascular administration. {03} {06} {63} {64} {65} {66} {67} {68} {69}

Protein binding:

Low. {01} {64} {65} {66} {67} {68} {69}

Iothalamate meglumine—1 to 4%.

Iothalamate sodium—8 to 27%.

Half-life:

Distribution (alpha phase)—10 minutes {06} {63} {64}.

Elimination (beta phase)—90 minutes.

Time to peak concentration:

Immediate, after intravascular administration. Concentration falls rapidly as a result of flow-induced dilution within the vascular compartment. {03} {33}


Time to peak opacification


Angiography:

Immediate, after intravascular administration. {06} {33} {65}



Urography:

Renal parenchyma including the renal cortex: 1 minute following rapid injection of contrast media. Peak opacification is directly dependent on the peak plasma iodine concentration and the glomerular filtration rate of the patient's kidney. {33} {64}

Calyces, pelves, and ureters: 10 to 15 minutes after bolus injection of contrast media. Peak opacification is dependent on both the final urinary iodine concentration and the volume of urine within the respective regions of the urinary tract. {33} {64}


Elimination:


Renal—
        Normal renal function: > 90% of intravascular dose eliminated within 24 hours via glomerular filtration. {01} {03} {32} {35} {64}



Fecal—
        Normal renal function: < 2% of intravascular dose. {01} {03}
        Severe renal function impairment: Elimination in the feces via biliary tract may become a primary route. {01} {03} {64}



In dialysis—
        Removed by peritoneal dialysis or hemodialysis. {03}



Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to iodine or other iodinated contrast media may be sensitive to iothalamate also. {01} {02} {03} {21}

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of iothalamate have not been performed. {63} {64} {65} {66} {67} {68} {69}

Pregnancy/Reproduction

Pregnancy—
Iothalamate crosses the placenta and is evenly distributed in fetal tissue. Adequate and well-controlled studies in humans have not been done. However, risk-benefit must be considered since other organically bound–iodine containing preparations administered near term by intra-amniotic injection have caused hypothyroidism in some newborns. {10}

Also, elective contrast radiography of the abdomen is usually not recommended during pregnancy because of the risks to the fetus from radiation exposure. {01} {02} {03}

Studies in animals have not shown that iothalamate causes teratogenic effects in the fetus. {58} {63} {64} {65} {66} {67} {68} {69}

FDA Pregnancy Category B. {06} {63} {64} {65} {66} {67} {68} {69}

Breast-feeding

Although problems in humans have not been documented, temporary discontinuation of breast-feeding is recommended for at least 24 hours following iothalamate administration since iothalamate is distributed unchanged into breast milk. {06} {58} {63} {64} {65} {66} {67} {68} {69}

Pediatrics

Convulsions are more likely to occur in infants than in other age groups with administration of iothalamate meglumine and iothalamate sodium injection, and iothalamate sodium injection for angiocardiography, especially after repeated administration. {06} {69}

Difficulty in breathing, unusually slow or irregular heartbeat, and unusual feeling of tiredness and depression are more likely to occur in cyanotic infants during angiocardiography with administration of iothalamate meglumine and iothalamate sodium injection and iothalamate sodium injection. {01} {02} {06} {69}

Dehydration and/or the risk of renal failure may be exacerbated by iothalamate in infants and young children, especially those with polyuria, oliguria, diabetes, or pre-existing dehydration; adequate hydration is recommended before and following intravascular administration of iothalamate. {01} {02} {06} {32} {39} {63} {64} {65} {66} {67} {68} {69}


Geriatrics


Although overall prevalence of adverse effects has been reported to be less in patients 50 years of age and older, the severity of the reactions may be greater in this age group than in younger patients. {05} {32} {34}

Dehydration and/or the risk of renal failure may be exacerbated by iothalamate in geriatric patients, especially those with polyuria, oliguria, diabetes, or pre-existing dehydration; adequate hydration is recommended before and following intravascular administration of iothalamate. {01} {06} {32} {63} {64} {65} {66} {67} {68} {69}

The elderly may be more sensitive to the effects of iothalamate on thyroid function. Iodine-induced thyrotoxicosis may occur 4 to 12 weeks following contrast radiography. Thyroid function monitoring may be needed in geriatric patients. {71}

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 iothalamate with beta-adrenergic blocking agents may increase the risk of moderate to severe anaphylactoid reaction; hypotensive effects may be exacerbated; discontinuation of the beta-adrenergic blocking agent may be advisable before administration of contrast media in patients with other risk factors {22} {33} {41} {42} {43})


Cholecystographic agents, oral    (may increase the risk of renal toxicity when followed by intravenous iothalamate, especially in patients with hepatic function impairment {01} {03} {68})


Hypotension-producing medications, other (See Appendix II )    (the risk of severe hypotension may be increased if iothalamate is given concurrently with other medications that produce hypotension {33})


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; there is some evidence that incidence is reduced if contrast media administration is delayed until 6 weeks after interleukin-2 administration {44} {45} {46} {47} {48} {49})


Nephrotoxic medications, other (See Appendix II )    (concurrent intravascular administration of iothalamate with other nephrotoxic medications may increase the potential for nephrotoxicity {33})


Platelet aggregation inhibitors, other (See Appendix II )    (increased risk of bleeding may occur when these medications are used concurrently with iothalamate {33})


Vasopressors (See Appendix II )    (neurologic effects, including paraplegia, of iothalamate may be increased during aortography when iothalamate is administered after hypertensive agents used to increase contrast, due to contraction of vessels in the splanchnic circulation forcing more of the contrast material into the vessels leading to the spine and spinal cord {03} {23} {68})


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    (imaging of blood pool may be impaired because of decreased technetium Tc 99m-labeling of red blood cells caused by the intravascular administration of iothalamate {33} {57} {59})


Leukocyte counts and
Red cell counts    (may be decreased {31} {33})


Phenolsulfonphthalein (PSP) excretion test    (test results may be affected, especially in patients with severely impaired renal function who are also given intravascular iothalamate; although iothalamate is excreted by glomerular filtration, in patients with impaired renal function iothalamate may be secreted by the renal tubules, thus resulting in decreased tubular excretion of PSP; therefore, concurrent use of intravascular iothalamate is not recommended in patients receiving a PSP excretion test {01} {03} {35})


Prothrombin time (PT) and
Thromboplastin time    (may be increased since ionic contrast media have been shown to inhibit all stages of coagulation {26} {33})


Skeletal imaging    (possible renal and hepatic uptake of technetium Tc 99m medronate, technetium Tc 99m oxidronate, technetium Tc 99m pyrophosphate, and technetium Tc 99m [pyro- and trimeta-] phosphates if iothalamate is administered intravenously immediately after one of these technetium Tc 99m-labeled agents {33} {46})


Thyroid function determinations and
Thyroid imaging    (administration of iothalamate, especially for excretory urography or angiography, may cause an increase of serum protein–bound iodine [PBI] and a decrease in radioactive iodine or pertechnetate ion uptake for up to 16 days {01} {03} {10}; thyroid test should be performed prior to administration of iothalamate. Other thyroid function tests not based on measurement of iodine, such as resin triiodothyronine uptake, are not affected {01} {03} {06})


Urinalysis    (may produce abnormal results; urine should be collected prior to or at least 2 days after intravenous administration of iothalamate {01} {03})

With physiology/laboratory test values
Blood urea nitrogen (BUN)
Creatinine, serum
Glucose, plasma    (concentrations may be increased transiently following selective renal arteriography)

    (peak rise in serum creatinine is usually delayed, occurring 3 to 5 days following contrast media administration and generally returning to baseline values in 7 to 10 days {33} {39} {50})


Platelet aggregation    (may be decreased {33} {40})


Protein, urine    (may be increased; false positive results may occur with Lowry's and sulphosalicylic assays, or with protein reagent strips {51} {52})


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

For all procedures requiring intravascular administration of iothalamate:
» Allergic reaction (anaphylaxis) to penicillins or to skin allergens, previous    (increased risk of anaphylactoid reaction {43})


» Allergies or asthma, history of    (increased risk of idiosyncratic response or anaphylactoid reaction {06} {22} {63} {64} {65} {66} {67} {68} {69})


» Cardiovascular disease, severe    (increased risk of cardiac arrest; increased risk of anaphylactoid reaction {43} {55})


» Dehydration, especially associated with diabetes mellitus, azotemia, or multiple myeloma    (osmotic diuretic action of iothalamate may exacerbate dehydration and increase risk of acute renal failure {24} {25} {26} {55})


Hyperthyroidism    (intravascular administration of iothalamate may precipitate thyroid storm {01} {57} {68})


» Pheochromocytoma    (intravascular administration of iothalamate may precipitate severe hypertension; amount of medium 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 {06} {33} {34} {57} {68})


» Renal function impairment    (intravascular administration of iothalamate may increase risk of acute renal failure in the presence of renal insufficiency [serum creatinine ³ 132.6 micromoles/L]; preventive measures recommended to prevent contrast-associated nephropathy include reducing the dose or volume of contrast medium administered, lengthening the time between radiologic procedures, volume expansion with 0.9% sodium chloride, using drug therapy such as furosemide or mannitol or calcium antagonists, and administering low osmolality contrast media; however, validity of some of these recommendations remains controversial {06} {25} {27} {33} {50} {53} {68})


» Seizures, recent    (increased risk for reoccurrence {33} {34} {55})


» Sensitivity to iodinated contrast media    (increased risk of anaphylactoid reaction in patients with history of prior reactions to contrast media {22} {33} {34} {43} {58} {63} {64} {65} {66} {67} {68} {69})


Sickle cell disease    (intravascular administration of iothalamate may promote sickling in patients who are homozygous for sickle cell disease {01} {06} {57} {58} {68})


For angiocardiography:
Angina, unstable    (increased risk of severe cardiac reaction {54})


Aortic stenosis    (use of iothalamate may cause decreased coronary artery perfusion due to the systemic hypotension produced {26})


Cardiac failure, incipient    (fluid overload, pressure changes, and expansion of blood volume may aggravate condition {06} {26} {69})


Cyanosis, in infants    (use of iothalamate may increase risk of apnea, bradycardia, arrhythmias, acidosis, and central nervous system [CNS] effects in cyanotic infants {06} {28} {68})


Mitral stenosis    (increased blood flow may produce an increase in the mitral diastolic pressure gradient {03})


Myocardial ischemia    (systemic hypotension and resultant diminished cardiac perfusion may aggravate condition and precipitate heart failure {03})


» Pulmonary hypertension, severe    (hypervolemic effect of iothalamate 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 {19} {32} {33} {68})


For cerebral angiography:
Arteriosclerosis, advanced or
Cardiac decompensation or
Cerebral embolism, recent or
Hemorrhage, subarachnoid or
Hypertension, severe or
Migraine or
Senility or
Thrombosis    (hemodynamic changes produced may result in decreased cerebral perfusion, which may cause CNS damage {03} {60} {64})


» Homocystinuria    (procedure may increase risk of thrombosis and embolism {03} {69})


For coronary arteriography:
» Myocardial infarction    (procedure done within 4 weeks may increase risk of cardiac complications; administration of iothalamate or manipulation of catheter may cause ventricular fibrillation {03} {06} {69})


For peripheral arteriography:
» Buerger's disease or
» Ischemia, severe, associated with ascending infection    (procedure may induce severe arterial or venous spasm {03} {28} {58})


For percutaneous transhepatic cholangiography:
» Coagulation disorders, such as prolonged prothrombin times    (procedure may increase risk of internal bleeding {03} {06} {58} {64})


For CT of the brain:
» Cerebral neoplasms, primary or metastatic    (use of iothalamate may precipitate convulsions {03} {06} {30} {32} {68})


Hemorrhage, cranial subarachnoid    (intravascular administration of contrast media has been associated with death in some patients; however, a causal relationship has not been established {03} {06} {65})


For excretory urography:
» Anuria or
» Diabetes    (increased risk of acute renal failure {06} {33} {64})


» Congestive heart failure    (intravenous infusion may produce an increased osmotic load and may aggravate condition {06} {33} {58})


For peripheral venography:
Infection, local or
Ischemia, severe or
Phlebitis or
Thrombosis or
Venous stasis or
Venous system obstruction    (procedure may increase risk of thrombophlebitis, syncope, and ischemic changes {28} {39} {64})


For endoscopic retrograde cholangiopancreatography:
» Cholangitis, severe, or
» Pancreatitis, acute    (increased risk of adverse effects {03} {06} {58})


For splenoportography:
» Coagulation defects, such as prolonged prothrombin times and significant thrombocytopenia or
Inflammation of spleen    (procedure may increase risk of rupture of the spleen {60})


For arthrography:
» Infection in or near joint to be examined    (procedure may increase risk of complications {06} {58})



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 examination, especially in patients with known or suspected pheochromocytoma or hemodynamic compromise or instability; also recommended for approximately 10 minutes following intra-arterial administration of iothalamate {03} {06} {39})


Electrocardiogram (ECG)    (recommended for early detection of arrhythmias during coronary arteriography and angiocardiography {01} {06} {69})


Thyroid function determinations    (iodine-induced thyrotoxicosis may occur 4 to 12 weeks following contrast radiography in geriatric patients; thyroid function monitoring may be needed {71})




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 tend to increase the incidence and severity of adverse effects. {03} {33}
Most of the adverse effects appear during or within a few minutes after intravascular administration of iothalamate. {01}
Thromboembolic events causing myocardial infarction and stroke have been reported rarely during angiographic procedures with ionic contrast media. {07} {63} {64} {65} {66} {67} {68} {69}
Acute renal failure has been reported following intravascular administration of iothalamate, especially in patients with diabetic nephropathy and in susceptible nondiabetic patients. Also, a higher incidence of contrast-induced renal failure has been associated with severe congestive heart failure, in patients who have had multiple contrast studies within 72 hours, those receiving large volumes of contrast agent, and those with elevated uric acid levels. Renal function may also be slightly and temporarily impaired following intravascular administration of iothalamate during selective renal arteriography. {03} {24} {25} {26} {29} {32} {33} {64}
Convulsions are more likely to occur in infants than in other age groups with the administration of iothalamate meglumine and iothalamate sodium injection and iothalamate sodium injection, especially after repeated administration. {19} {69}
Difficulty in breathing, unusually slow or irregular heartbeat, unusual feeling of tiredness, and mental depression are more likely to occur in cyanotic infants during angiocardiography with the administration of iothalamate meglumine and iothalamate sodium injection or iothalamate sodium injection. {01} {02} {06} {69}
Dehydration and/or the risk of renal failure may be exacerbated by iothalamate and in some cases may cause a shock-like state in infants and young children, and in geriatric, azotemic, and dehydrated or debilitated patients. {01} {03} {32} {63} {64} {65} {66} {67} {68} {69}
Cortical blindness has been reported rarely after cardiac angiography; vision has returned within 24 to 48 hours. {62}
Death has occurred rarely during injection or 5 to 10 minutes after, mainly due to cardiac arrest, especially in patients with cardiovascular disease. {01} {69}

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 less frequent or rare
For all procedures
    
Pseudo-allergic reaction {02}{03}{05}{18}{36}{37}{38}{63}{64}{65}{66}{67}{68}{69}(skin rash or hives; swelling of face or skin; swelling of the larynx; wheezing, tightness in chest, or troubled breathing)
Note: Pseudo-allergic reactions are usually transient. However, they may be initial manifestations of more severe anaphylactoid reactions. The anaphylactoid reaction may progress to respiratory arrest and vasomotor collapse if appropriate treatment is not administered. {43}



With intravascular administration
    
Bronchospasm or pulmonary edema (severe wheezing or troubled breathing{18}{33}{34}{36}{37}{38}{63}{64}{65}{66}{67}{68}{69})
    
cardiotoxic effects, with decreased contractile force and ventricular fibrillation (irregular heartbeat{19}{26}{33})
    
convulsions, especially in patients with convulsive disorders{19}{30}{63}{64}{65}{66}{67}{68}{69}
    
swelling of the larynx{18}{36}{37} {38}{63}{64}{65}{66}{67}{68}{69}
    
severe swelling of salivary glands{18}{36}{37}{38}{63}{64}{65}{66}{67}{68}{69}
    
vasovagal effects, with bradycardia and hypotension {19}{26}(slow heartbeat; severe unusual tiredness or weakness)




Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
With intravascular administration
    
Redness, swelling, or pain at injection site{03}{04}{05}{63}{64}{65}{66}{67}{68}{69}
    
vasodilation, arteriolar (unusual warmth and flushing of skin{19}{63}{64}{65}{66}{67}{68}{69})

With intrasynovial administration
    
Joint pain or exacerbation of existing pain{20}{64}


Incidence less frequent or rare
With all procedures
    
Psychosomatic reaction (changes in vision, chills, CNS effects [numbness, tingling, pain, or weakness in hands or feet], confusion, dizziness or lightheadedness, headache, increased sweating, increased watering of the mouth, nausea or vomiting, unusual tiredness or weakness{63}{64}{65}{66}{67}{68}{69})
Note: Psychosomatic reactions are associated with patient anxiety, fatigue, inadequate hydration, and poor nutrition; usually self-limited and of short duration; may also be initial manifestations of more severe reaction. {09} {26}








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: Concentrates in particular area of the body; visualization of radiopacity possible with x-rays

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

Pregnancy—Iothalamate crosses the placenta; risk to the fetus from radiation exposure; possibility of causing hypothyroidism in the newborn





Breast-feeding—Distributed into breast milk; temporary discontinuation of breast-feeding for at least 24 hours is recommended





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 severe adverse effects; possible exacerbation of dehydration; increased risk of thyrotoxicosis
Other medical problems, especially allergies or asthma (history of), anuria, cardiovascular disease, dehydration, diabetes mellitus, pheochromocytoma, previous allergic reaction to penicillins or to skin allergens, renal function impairment, and seizures

Preparation for this test
Adequate intake of fluids to prevent dehydration

Special diet, use of laxative, and/or other preparatory instructions may apply (for excretory urography); patient should inquire in advance

Omitting any food for several hours before examination to prevent possible aspiration of gastric contents; moderate amounts of clear liquids may be permitted

Precautions after having this test
Possible interference with future thyroid tests


Side/adverse effects
Signs of possible side effects, especially pseudo-allergic reaction, convulsions, and cardiac or pulmonary problems that may occur within minutes of administration


General Dosing Information
The 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. {03} {04} {33} {43}

Pretreatment with corticosteroids or antihistamines has been used to minimize the incidence and severity of reactions in patients with a history of severe reactions to contrast media or with other high-risk conditions (e.g., asthma or history of allergies, positive allergy history to skin allergens or penicillin, dehydration, history of seizures, pheochromocytoma). {04} {08} In some studies, the additional use of ephedrine has been shown to be beneficial in preventing anaphylactoid reactions. When considering the use of a contrast agent, the following protocols are recommended: {11} {12} {13} {14} {15} {16} {17} {18} {32} {39} {43} {54} {55} {63} {64} {65} {66} {67} {68} {69} 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 before 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 especially important in infants, young children, and geriatric or azotemic patients receiving intravascular iothalamate since dehydration may be further increased by the contrast medium. {63} {64} {65} {66} {67} {68} {69}

Preparatory partial dehydration has been used to increase the urinary concentration of, and contrast produced by, iothalamate. However, in general, dehydration is no longer recommended because, with modern contrast media and recommended doses, it is no longer necessary and may do harm. Dehydration is particularly contraindicated in patients with multiple myeloma since it may predispose to irreversible precipitation of myeloma protein in the renal tubules. In these patients fluids should be administered and urine should be made alkaline. {32} {39} {63} {64} {65} {66} {67} {68} {69}

Dosage and concentration of iothalamate for intravascular administration should be individualized and are usually in proportion to the size of the specific region of the vascular system to be visualized and the anticipated degree of hemodilution in the region. {02} {33}

No food should be ingested for several hours before an examination to prevent aspiration of gastric contents if vomiting occurs. However, moderate amounts of clear liquids are permissible and even recommended by some clinicians to prevent dehydration. {02} {33} {63} {64} {65} {66} {67} {68} {69}

During and for at least 30 to 60 minutes after administration of contrast medium, the patient should be observed for possible severe reactions; competent personnel and emergency facilities should be available during this period. {03} {63} {64} {65} {66} {67} {68} {69}

Thromboembolic events causing myocardial infarction and stroke, reported rarely during angiographic procedures, may have resulted from atherosclerotic lesions rather than from coagulation of blood that has come in contact with the contrast agent outside the body. Nonetheless, it is recommended that risk factors for blood cell 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. {07} {32} {39}

For excretory urography

Administration of a laxative at bedtime the evening before the examination is recommended to eliminate gas from the intestine. {06} {64}

For splenoportography

Fasting is recommended for several hours before the examination, in case the patient may require surgery on an emergency basis. Also, a local anesthetic and a sedative may be given before the procedure. {60}

For treatment of adverse effects
Recommended treatment consists of the following: {06} {39} {55}

   • 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).For mild to moderate bronchospasm—0.1 to 0.2 mg of epinephrine (1:1000) may be administered subcutaneously, except in 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.Patients on beta-adrenergic blocking agents should not receive epinephrine since they are at risk of excessive 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 intravenously or intramuscularly at a rate not to exceed 30 to 60 mg per minute may be given.



Parenteral Dosage Forms

IOTHALAMATE MEGLUMINE INJECTION USP

Usual adult and adolescent dose
Intravascular


Angiography, cerebral {32} {64}:


For carotid angiography—
Percutaneous or via catheter, 5 to 12 mL of a solution containing the equivalent of 282 mg of iodine per mL, repeated as needed.



For vertebral angiography—
Percutaneous or via catheter, 4 to 10 mL of a solution containing the equivalent of 282 mg of iodine per mL, repeated as needed.



For retrograde brachial cerebral angiography—
Percutaneous, 35 to 50 mL of a solution containing the equivalent of 282 mg of iodine per mL as a single dose, administered rapidly into the brachial artery.




Angiography, by digital subtraction:


Arterial1


Via catheter, as a solution containing the equivalent of 141 mg of iodine per mL, repeated as needed, but not to exceed a total dose of 250 mL, into the following {65}
Abdominal aorta: 10 to 30 mL.

Aortic arch: 15 to 30 mL.

Carotid or vertebral arteries: 3 to 10 mL.

Major branches of the aorta: 5 to 30 mL.

Subclavian and brachial arteries: 5 to 15 mL.




Intravenous—
Via catheter, 20 to 40 mL of a solution containing the equivalent of 282 mg of iodine per mL, repeated as needed. {58} {64}




Arteriography, peripheral:
Percutaneous or operative methods, 20 to 40 mL of a solution containing the equivalent of 282 mg of iodine per mL as a single dose, administered rapidly into the brachial artery in the arm or the femoral artery in the leg. {64}



Venography, peripheral:


Upper or lower extremity—
Percutaneous, 20 to 40 mL of a solution containing the equivalent of 282 mg of iodine per mL per extremity, administered rapidly into a superficial vein of the forearm or hand or lateral side of the foot. {64}



Lower extremity—
Percutaneous, 30 to 125 mL of a solution containing the equivalent of 202 mg of iodine per mL administered rapidly into a superficial vein on the lateral side of the foot. {66}




Body imaging, computed tomographic:
Intravenous, rapid intravenous infusion, or combination of bolus injection and infusion, 200 to 250 mL of a solution containing the equivalent of 202 mg of iodine per mL; or a bolus injection of 25 to 50 mL of a solution containing the equivalent of 282 mg of iodine per mL. {64} {66}

Note: When the combination bolus injection and infusion technique is used, 50 to 100 mL bolus injection is followed by a rapid infusion of 100 to 150 mL. {66}




Brain imaging, computed tomographic:
Intravenous, 2 mL per kg of body weight of a solution containing the equivalent of 282 mg of iodine per mL, not to exceed 150 mL. {64}

Intravenous infusion, 200 to 300 mL of a solution containing the equivalent of 141 mg of iodine per mL administered rapidly; or 3 mL per kg of body weight of a solution containing the equivalent of 202 mg of iodine per mL, not to exceed 200 mL. {65}



Urography, excretory:
Intravenous infusion, 2 to 3 mL per kg of body weight of a solution containing the equivalent of 202 mg of iodine per mL, not to exceed 200 mL, administered at a rate of 40 to 50 mL per minute; or 2 to 4 mL of a solution containing the equivalent of 141 mg of iodine per mL per kg of body weight, not to exceed 300 mL, administered at a rate of 50 mL per minute. {66}

Note: Geriatric patients or patients with cardiac disease may require a slower infusion rate.


Intravenous, rapid, 30 to 60 mL of a solution containing the equivalent of 282 mg of iodine per mL administered within 30 to 90 seconds. {32}


Intraductal


Cholangiography, direct:
Operative and postoperative—Intraductal, 10 to 25 mL of a solution containing the equivalent of 141 mg or 282 mg of iodine per mL into the cystic duct or common bile duct. {64}

Pancreatitis, acute—Intraductal, 5 to 10 mL of a solution containing the equivalent of 282 mg of iodine per mL.

Percutaneous transhepatic cholangiography—Percutaneous, 20 to 40 mL of a solution containing the equivalent of 282 mg of iodine per mL administered slowly into the biliary ducts. {64}



Cholangiopancreatography, endoscopic retrograde:


Via catheter, as a solution containing the equivalent of 282 mg of iodine per mL {64}
For visualization of the common bile duct: 10 to 100 mL.

For visualization of the pancreatic duct: 2 to 10 mL.



Intrasynovial


Arthrography:
Intrasynovial, as a solution containing the equivalent of 282 mg of iodine per mL— {64}Knee, shoulder, or hip joint: 5 to 15 mL.

Shoulder, ankle: 5 to 10 mL.

Other joints: 1 to 4 mL.



Usual pediatric dose
Intravascular {64}


Angiography, cerebral:
Dosage must be individualized by physician in proportion to body weight.


Arteriography, peripheral—
Dosage must be individualized by physician in proportion to body weight.



Venography, peripheral—
Dosage must be individualized by physician in proportion to body weight.



Cholangiography, direct—
Dosage must be individualized by physician in proportion to body weight.



Cholangiography, percutaneous transhepatic—
Dosage must be individualized by physician in proportion to body weight.



Body imaging, computed tomographic—
Dosage must be individualized by physician in proportion to body weight.



Brain imaging, computed tomographic—
Intravenous infusion, 4 mL per kg of body weight of a solution containing the equivalent of 141 mg of iodine per mL, administered rapidly.



Urography, excretory—


Intravenous, as a solution containing the equivalent of 282 mg of iodine per mL—
Children up to 14 years of age: 0.5 to 1 mL per kg of body weight.

Children 14 years of age and over: See Usual adult and adolescent dose.



Intravenous infusion, as a solution containing the equivalent of 202 mg of iodine per mL—
Children up to 12 years of age: See Usual adult and adolescent dose.




Intrasynovial


Arthrography:
Dosage must be individualized by physician in proportion to body weight {64}.



Usual geriatric dose
See Usual adult and adolescent dose .

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. {01}
In excretory urography, geriatric patients may require a slower infusion rate. {02}


Strength(s) usually available
U.S.—


30% (300 mg per mL) of iothalamate meglumine with 14.1% (141 mg per mL) of iodine (Rx) [Conray-30 (0.11 mg of edetate calcium disodium per mL)]


43% (430 mg per mL) of iothalamate meglumine with 20.2% (202 mg per mL) of iodine (Rx) [Conray-43 (0.11 mg of edetate calcium disodium per mL)]


60% (600 mg per mL) of iothalamate meglumine with 28.2% (282 mg per mL) of iodine (Rx) [Conray (0.09 mg of edetate calcium disodium per mL)]

Canada—


30% (300 mg per mL) of iothalamate meglumine with 14.1% (141 mg per mL) of iodine (Rx) [Conray-30 (0.11 mg of edetate calcium disodium per mL)]


43% (430 mg per mL) of iothalamate meglumine with 20.2% (202 mg per mL) of iodine (Rx) [Conray-43 (0.11 mg of edetate calcium disodium per mL)]


60% (600 mg per mL) of iothalamate meglumine with 28.2% (282 mg per mL) of iodine (Rx) [Conray-60 (0.09 mg of edetate calcium disodium per mL)]

Packaging and storage:
Store below 30 °C (86 °F), unless otherwise specified by manufacturer. Protect from light. Protect from freezing. {64} {70}

Preparation of dosage form:
A 30% solution (containing the equivalent of 141 mg of iodine per mL) may be prepared from a 60% solution (containing the equivalent of 282 mg of iodine per mL) by dilution with 0.9% sodium chloride injection. {02} {64} {65} {66}

Stability:
Crystals may form in the solution at very cold temperatures but are readily redissolved by bringing the container of solution to room temperature and gently shaking it. {58} {64} {65} {66}

Any unused portion remaining in the container should be discarded.

Incompatibilities:
Iothalamate meglumine injection is physically incompatible with promethazine hydrochloride injection. {03} {64} {65} {66}


IOTHALAMATE MEGLUMINE AND IOTHALAMATE SODIUM INJECTION USP

Usual adult and adolescent dose
Intravascular


Angiocardiography:
Via catheter, 40 to 50 mL as a single dose, administered rapidly, within one to two seconds, into the chambers of the heart or associated blood vessels. {69}

Intravenous, 50 to 100 mL administered rapidly into a large peripheral vein. Dose may be divided and administered bilaterally into the antecubital veins by simultaneous pressure injection. {69}



Angiography, by digital subtraction:


Intravenous—
Via catheter, 20 to 60 mL, may be repeated as necessary. {69}

Note: For central catheter injections, a power injector with an injection rate between 10 and 30 mL per second is usually used. {69}
For peripheral injections, rates of 12 to 20 mL per second should be used, depending on size of vein. {69}
Flushing of arm vein is recommended immediately following injection using 20 to 25 mL of 5% dextrose in water or normal saline. {69}





Arteriography:


Nonselective coronary arteriography—
Via catheter, 30 to 50 mL. One-half of the usual dose may be administered at the sinus of Valsalva on either side. {69}



Selective coronary arteriography—
Via catheter, 4 to 7 mL injected into a coronary artery; may be administered into each coronary artery and repeated. {69}



Renal arteriography—
Selective: Via catheter, 4 to 8 mL administered into the renal artery; may be repeated. {69}

By aortography: Via catheter, 10 to 25 mL administered into the aorta above the renal arteries. {69}




Aortography:
Retrograde or antegrade catheter method, 20 to 50 mL. {69}

Intravenous, 1 mL per kg of body weight. Dose may be divided equally for simultaneous bilateral injection. {69}

Translumbar, 15 to 30 mL. {69}



Brain imaging, computed tomographic:
Intravenous, 1.5 mL per kg of body weight, not to exceed 100 mL, administered rapidly.



Urography, excretory:
Intravenous, 25 to 50 mL administered rapidly over a period of 30 to 90 seconds. {69}

Note: In patients with reduced renal function, repeat urography is not recommended for at least 48 hours because of the possibility of temporary oliguria or anuria.




Usual pediatric dose
Intravascular


Angiocardiography:
Children up to 14 years of age: Via catheter, 0.5 to 1 mL per kg of body weight as a single dose, administered rapidly, within one to two seconds, into a large peripheral vein or into the chambers of the heart or associated blood vessels. {69}

Note: In infants up to 2 months of age, the total dose administered should not exceed 3 mL per kg of body weight. {69}
In infants weighing less than 7 kg, especially in those with right-heart strain or failure and with decreased or nonfunctional pulmonary vascular beds, repeated injections are not recommended.




Arteriography:
Dosage must be individualized by physician in proportion to body weight. {69}



Aortography {69}:
Retrograde or antegrade catheter method—See Usual adult and adolescent dose .

Intravenous—See Usual adult and adolescent dose .

Translumbar—Dosage must be individualized by physician in proportion to body weight.



Brain imaging, computed tomographic:
See Usual adult and adolescent dose. {69}



Urography, excretory:
Intravenous, 0.5 mL per kg of body weight administered rapidly. {69}



Usual geriatric dose
See Usual adult and adolescent dose .

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. {05} {32} {34}


Strength(s) usually available
U.S.—


52% (520 mg per mL) of iothalamate meglumine and 26% (260 mg per mL) of iothalamate sodium with 40% (400 mg per mL) of iodine (Rx) [Vascoray (0.11 mg of edetate calcium disodium per mL)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from light. Protect from freezing. {69} {70}

Stability:
Crystals may form in the solution at very cold temperatures but are readily redissolved by bringing the container of solution to room temperature and gently shaking it. {69}

Any unused portion remaining in the container should be discarded.

Incompatibilities:
Iothalamate meglumine and iothalamate sodium injection is physically incompatible with promethazine hydrochloride injection. {03} {69}


IOTHALAMATE SODIUM INJECTION USP

Usual adult and adolescent dose
Intravascular


Angiocardiography:
Via catheter, 40 to 50 mL of a solution containing the equivalent of 400 mg or 480 mg of iodine per mL as a single dose, administered rapidly, within one to two seconds, into the chambers of the heart or associated blood vessels. {63} {68}

Intravenous, 50 to 100 mL of a solution containing the equivalent of 400 mg or 480 mg of iodine per mL administered rapidly, within one to two seconds, into a large peripheral vein. Dose may be divided and administered bilaterally into the antecubital veins by simultaneous pressure injection. {03} {63} {68}



Arteriography, renal, by aortography:
Via catheter, 10 to 25 mL of the solution containing the equivalent of 400 mg or 480 mg of iodine per mL. {02} {03} {63} {68}



Aortography: As a solution containing the equivalent of 400 mg or 480 mg of iodine per mL:
Retrograde or antegrade catheter method, 20 to 50 mL as a single dose. {63} {68}

Intravenous, 1 mL per kg of body weight. Dose may be divided equally for simultaneous bilateral injection. {63} {68}

Translumbar, 20 mL. {63} {68}



Body imaging, computed tomographic:
Intravenous, rapid bolus injection, 25 to 60 mL of a solution containing the equivalent of 400 mg of iodine per mL. {68}



Brain imaging, computed tomographic:
Intravenous, 1.5 mL per kg of body weight of a solution containing the equivalent of 400 mg of iodine per mL, not to exceed 100 mL, administered rapidly. {68}



Urography, excretory:
Intravenous, 30 to 60 mL of a solution containing the equivalent of 325 mg of iodine per mL or 25 to 50 mL of a solution containing the equivalent of 400 mg of iodine per mL, administered rapidly. {58} {67} {68}

Note: In patients with reduced renal function, repeat urography is not recommended for at least 48 hours because of the possibility of temporary oliguria or anuria.




Usual pediatric dose
Intravascular


Angiocardiography:
Via catheter, 0.5 to 1 mL per kg of body weight of a solution containing the equivalent of 400 mg or 480 mg of iodine per mL, as a single dose, administered rapidly, within one to two seconds, into a large peripheral vein or into the chambers of the heart or associated blood vessels. {63} {68}

Note: In infants up to 2 months of age, the total dose administered should not exceed 3 mL per kg of body weight. {63} {68}
In infants weighing less than 7 kg, especially in those with right-heart strain or failure and with decreased or nonfunctional pulmonary vascular beds, repeated injections are not recommended. {63} {68}




Arteriography, renal, by aortography:
Dosage must be individualized by physician in proportion to body weight. {63} {68}



Aortography: As a solution containing the equivalent of 400 mg or 480 mg of iodine per mL {63} {68}:
Retrograde or antegrade catheter method: Dosage must be individualized by physician in proportion to body weight.

Intravenous: 1 mL per kg of body weight.

Translumbar: Dosage must be individualized by physician in proportion to body weight.



Body imaging, computed tomographic:
Dosage must be individualized by physician in proportion to body weight. {63} {68}



Brain imaging, computed tomographic:
Intravenous, 1.5 mL per kg of body weight of a solution containing the equivalent of 400 mg of iodine per mL, not to exceed 100 mL, administered rapidly. {03} {68}



Urography, excretory:
Intravenous, 0.5 mL per kg of body weight of a solution containing the equivalent of 325 mg or 400 mg of iodine per mL, administered rapidly. {67} {68}



Usual geriatric dose
See Usual adult and adolescent dose .

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. {05} {32} {34}


Strength(s) usually available
U.S.—


54.3% (543 mg per mL) of iothalamate sodium with 32.5% (325 mg per mL) of iodine (Rx) [Conray-325 (0.135 mg of edetate calcium disodium per mL)]


66.8% (668 mg per mL) of iothalamate sodium with 40% (400 mg per mL) of iodine (Rx) [Conray-400]


80% (800 mg per mL) of iothalamate sodium with 48% (480 mg per mL) of iodine (Rx) [Angio-Conray (0.11 mg of edetate calcium disodium per mL)]

Canada—


54.3% (543 mg per mL) of iothalamate sodium with 32.5% (325 mg per mL) of iodine (Rx) [Conray-325 (0.11 mg of edetate calcium disodium per mL)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from light. Protect from freezing. {70}

Stability:
Crystals may form in the solution at very cold temperatures but are readily redissolved by bringing the container of solution to room temperature and gently shaking it. {63} {67} {68}

Any unused portion remaining in the container should be discarded.

Incompatibilities:
Iothalamate sodium injection is physically incompatible with promethazine hydrochloride injection. {03}



Revised: 06/29/1995



References
  1. Class Labeling Guideline: Diagnostic IV Radiopaque Human Prescription Drugs. FDA Register Notice, Sept 1982.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1983 May: 751-4.
  1. McEvoy GK, editor. AHFS Drug information 92. Bethesda, MD: American Society of Hospital Pharmacists, 1992: 1456.
  1. Conray-43 package insert (Mallinckrodt—US), Rev 10/86, Rec 4/87.
  1. Reynolds JEF, editor. Martindale, the extra pharmacopeia. 28th ed. London: The Pharmaceutical Press, 1982: 443.
  1. Conray-30 package insert (Mallinckrodt—US), Rev 6/85, Rec 3/86.
  1. FDA Drug Bulletin 1989, 19: 2.
  1. Lasser EC, Berry CC, Talner LB, et al. Pretreatment with corticosteroids to alleviate reactions to intravenous contrast material. New Eng J Med 1987; 317(14): 845-9.
  1. Prevention and Management of Adverse Reactions to Intravascular Contrast Media; American College of Radiology 7/77.
  1. Briggs GG, Freeman RK, Yaffe SJ. A reference guide to fetal and neonatal risk. Drugs in pregnancy and lactation. 3rd ed. Baltimore: Williams & Wilkins, 1990: 323.
  1. Gluck BS, Mitty HA. Reactions to iodinated radiographic contrast agents. How to identify and manage patients at risk. Postgrad Med 1990 Oct; 88: 187-94.
  1. USP Advisory Nonradioactive Diagnostic Agents Panel meeting on 4/9/91.
  1. Yocum MW, Heller AM, Abels RI. Efficacy of intravenous pretesting and antihistamine prophylaxis in radiocontrast media sensitive patients. J Allergy Clin Immunol 1978; 62: 309-15.
  1. Fisher HW, Doust VL. An evaluation of pretesting in the problem of serious and fatal reactions to excretory urography. Radiology 1972; 103: 497-501.
  1. Yarbrough J, Moffitt J, Brown D, et al. Cimetidine in the treatment of refractory anaphylaxis. Ann Allergy 1989; 63: 235-8.
  1. Mayumi H, Kimura S, Asano M, et al. Intravenous cimetidine as an effective treatment for systemic anaphylaxis and acute allergic skin reactions. Ann Allergy 1987; 58: 447-50.
  1. Marshall GD, Lieberman PL. Comparison of three pretreatment protocols to prevent anaphylactoid reactions to radiocontrast media. Ann Allergy 1991 Jul; 67: 70-3.
  1. Greenberger PA. Contrast media reactions. J Allergy Clin Immunol 1984; 74: 600-5.
  1. Almén T. Contrast media: the relation of chemical structure, animal toxicity and adverse clinical effects. Am J Cardiol 1990; 66: 2F-8F.
  1. Tallroth K, Vankk E. Iohexol and meglumine iothalamate in shoulder arthrography. Acta Radiol Diagn 1985; 26: 757.
  1. Mishkin MM. Contrast media safety: what do we know and how do we know it? Am J Cardiol 1990; 66: 34F-36F.
  1. Lang DM, Alpern MB, Visintainer PF, et al. Increased risk for anaphylactoid reaction from contrast media in patients on B-adrenergic blockers or with asthma. Ann Intern Med 1991; 115: 270-6.
  1. Reviewers' responses to revision of Diatrizoates (Systemic) monograph on 07/88.
  1. Drug-induced nephrotoxicity. Drug Saf 1991; 6(2): 137-8.
  1. Dawson P, Trewhella M. Intravascular contrast agents and renal failure. Clin Radiol 1990; 41: 373-5.
  1. Brinker JA. Selection of a contrast agent in the cardiac catheterization laboratory. Am J Cardiol 1990; 66: 26F-33F.
  1. Porter GA. Experimental contrast-associated nephropathy and its clinical implications. Am J Cardiol 1990; 66: 18F-22F.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 22nd ed. Ottawa: Canadian Pharmaceutical Association, 1987: 387.
  1. Katzberg RW. Renal effects of contrast media. Invest Radiol 1988; 23(suppl 1): S157-S160.
  1. Nelson M, Bartlett RJV, Lamb JT. Seizures after intravenous contrast media for cranial computed tomography. J Neurol Neurosurg Psychiatry 1989; 52: 1170-5.
  1. Diatrizoate meglumine package insert (Hypaque, Winthrop—US), Rev 4/89.
  1. Reviewers' responses to Iothalamate monograph revision of 10/1/91.
  1. Swanson DP, Chilton HM, Threll JH, editors. Pharmaceuticals in medical imaging. New York: MacMillan Publishing Company, 1990: 1-35, 40-2, 48, 58-61, 93-4, 253-77.
  1. Bush WH, Swanson DP. Acute reactions to intravascular contrast media: types, risk factors, recognition, and specific treatment. AJR 1991; 157: 1153-61.
  1. Reynolds JEF, editor. Martindale, the extra pharmacopeia. 29th ed. London: The Pharmaceutical Press, 1989: 944.
  1. Katayma H. Adverse reactions to ionic and nonionic contrast media: a report from the Japanese Committee on the safety of contrast media. Radiol 1990; 175: 621-9.
  1. Wolf GL. A prospective trial of ionic vs nonionic contrast agents in routine clinical practice: comparison of adverse effects. AJR 1989; 152: 939-44.
  1. Palmer FJ. The RACR survey of intravenous contrast media reactions: a preliminary report. Austral Radiol 1988; 32: 8-11.
  1. Reviewers' comments per 10/14/91 revision of Diatrizoates (Systemic).
  1. Granger CB, Gabriel DA, Reece NS, et al. Fibrin modification by ionic and nonionic contrast media during cardiac catheterization. Am J Cardiol 1992 Mar; 69: 821-3.
  1. Togwood JH. Risk of anaphylaxis in patients receiving beta-blocker drugs [editorial]. J Allergy Clin Immunol 1988 Jan; 81(1): 1-5.
  1. Lang D. Elevated risk of anaphylactoid reaction from radiographic contrast media is associated with both beta-blocker exposure and cardiovascular disorders. Arch Intern Med 1993; 153: 2033-40.
  1. Wittbrodt ET, Spinler SA. Prevention of anaphylactoid reactions in high-risk patients receiving radiographic contrast media. Ann Pharmacother 1994; 28: 236-41.
  1. Heinzer H, Huland E, Huland H. Adverse reaction to contrast material in a patient treated with local interleukin-2. Am J Roentgenol 1992 Jun; 158: 1407.
  1. Choyke PL, Miller DL, Lotze MT, et al. Delayed reactions to contrast media after interleukin-2 immunotherapy. Radiology 1992 Apr; 183(1): 111-4.
  1. Hladik WB, Saha GB, Study KT. Essentials of nuclear medicine science. Baltimore: Williams & Wilkins, 1987: 195.
  1. Fishman JE, Aberle DR, Moldawer NP, et al. Atypical contrast reactions associated with systemic interleukin-2 therapy. Am J Roentgenol 1991 Apr; 156: 833-4.
  1. Zukiwski AA, David CL, Coan J, et al. Increased incidence of hypersensitivity to iodine-containing radiographic contrast media after interleukin-2 administration. Cancer 1990 Apr 1; 65(7): 1521-4.
  1. Shulman K, Thompson J, Benyunes M, et al. Adverse reactions to I.V. contrast reagents in patients treated with interleukin-2 (IL-2) (abstract 840). Proc Am Soc Clin Oncol 1992 Mar; 11: 257.
  1. Spinler SA, Goldfarb S. Nephrotoxicity of contrast media following cardiac angiography: pathogenesis, clinical course, and preventive measures, including the role of low-osmolality contrast media. Ann Pharmacother 1992 Jan; 26: 56-64.
  1. Morcos SK, El-Nahas AM, Brown P, et al. Effect of iodinated water soluble contrast media on urinary protein assays. Br Med J 1992 Jul; 305: 29.
  1. Dawson P, Howell M. Misleading urine tests after using contrast media. Br J Radiol 1985; 58: 785.
  1. Katholi RE, Taylor GJ, Woods WT, et al. Nephrotoxicity of nonionic low-osmolality versus ionic high-osmolality contrast media: a prospective double-blind randomized comparison in human beings. Radiology 1993 Jan; 186(1): 183-7.
  1. Steinberg EP, Moore RD, Powe NR, et al. Safety and cost effectiveness of high-osmolality as compared with low-osmolality contrast material in patients undergoing cardiac angiography. N Engl J Med 1992 Feb; 326(7): 425-30.
  1. Bush WH, Swanson DP. Acute reactions to intravascular contrast media: types, risk factors, recognition, and specific treatment. Am J Radiol 1991; 157: 1153-61.
  1. Fleeger CA, editor. USAN 1995. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1995: 357.
  1. Hypaque Meglumine 30% package insert (Winthrop—US), Rev 4/89.
  1. Conray-60 (Mallinckrodt). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 274-82.
  1. Technetium Tc 99m [pyro- and trimeta-] phosphates package insert (Pyrolite, DuPont—US), Rev 10/88.
  1. Hypaque Meglumine 60% package insert (Winthrop—US), Rev 4/89.
  1. Hypaque Sodium 50% package insert (Winthrop—US), Rev 4/89.
  1. Kinn RM, Breisblatt WM. Cortical blindness after coronary angiography: a rare but reversible complication. Cathet Cardiovasc D>Kinn RM, Breisblatt WM. Cortical blindness after coronary angiography: a rare but reversible complication. Cathet Cardiovasc Diagn 1991 Mar; 22(3): 177-9.
  1. Angio-Conray package insert (Mallinckrodt—US), Rev 11/90, Rec 11/94.
  1. Conray package insert (Mallinckrodt—US), Rev 8/93, Rec 11/94.
  1. Conray 30 package insert (Mallinckrodt—US), Rev 8/93, Rec 11/94.
  1. Conray 43 package insert (Mallinckrodt—US), Rev 8/93, Rec 11/94.
  1. Conray 325 package insert (Mallinckrodt—US), Rev 1/92, Rec 11/94.
  1. Conray 400 package insert (Mallinckrodt—US), Rev 1/92, Rec 11/94.
  1. Vascoray package insert (Mallinckrodt—US), Rev 4/94, Rec 11/94.
  1. The United States pharmacopeia. The national formulary. USP 22nd revision (January 1, 1990). NF 17th ed (January 1, 1990). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1990: 714-6.
  1. Martin FIR, Tress BW, Colman PG, et al. Iodine-induced hyperthyroidism due to nonionic contrast radiography in the elderly. Am J Med 1993 Jul; 95: 78-82.
Hide
(web5)