Version May 2024
Not for intrathecal use. Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema.
Note: The concentration and volume of iodixanol to be used should be individualized depending upon age, weight, size of vessel, and rate of blood flow within the vessel. Patients should be adequately hydrated prior to and following iodixanol administration.
Radiologic contrast enhancement:
Angiocardiography, cerebral arteriography, visceral arteriography: Intra-arterial: Iodixanol 320 mg iodine/mL: 1 to 2 mL/kg; maximum dose: 4 mL/kg
CT imaging of the head and body, excretory urography: IV: Iodixanol 270 mg iodine /mL: 1 to 2 mL/kg; maximum dose: 2 mL/kg
Note: The concentration and volume of iodixanol to be used should be individualized depending upon age, weight, size of vessel, and rate of blood flow within the vessel. Patients should be adequately hydrated prior to and following iodixanol administration.
Radiologic contrast enhancement:
Infants and Children <12 years:
Angiocardiography, cerebral arteriography, visceral arteriography: Intra-arterial: Iodixanol 320 mg iodine/mL: 1 to 2 mL/kg; maximum dose: 4 mL/kg
CT imaging of the head and body, excretory urography: IV: Iodixanol 270 mg iodine /mL: 1 to 2 mL/kg; maximum dose: 2 mL/kg
Children ≥12 years and Adolescents:
Angiocardiography (left ventriculography and selective coronary arteriography), cerebral arteriography, peripheral arteriography, visceral arteriography: Intra-arterial: Iodixanol 320 mg iodine/mL: Dose individualized based on injection site and study type; refer to product labeling. Maximum recommended total dose of iodine: 80 g.
Coronary CT angiography (diagnostic): IV: Iodixanol 320 mg iodine /mL: Concentration and dose vary based on study type; refer to product labeling. Maximum recommended total dose of iodine: 80 g.
CT imaging of the head and body, excretory urography: IV: Iodixanol 270 mg iodine/mL or 320 mg iodine/mL: Concentration and dose vary based on study type; refer to product labeling. Maximum recommended total dose of iodine: 80 g.
Intra-arterial digital subtraction angiography: Intra-arterial: Iodixanol 270 or 320 mg iodine/mL: Dose individualized based on injection site and study type; refer to product labeling. Maximum recommended total dose of iodine: 80 g.
Peripheral venography: IV: Iodixanol 270 mg iodine/mL: Concentration and dose vary based on study type; refer to product labeling. Maximum recommended total dose of iodine: 80 g.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (not studied); use caution in severe impairment and in setting of combined renal and hepatic disease. Dialyzable (36% to 49% depending upon the membrane).
There are no dosage adjustments provided in the manufacturer's labeling. Use caution in patients with combined hepatic and renal disease.
(For additional information see "Iodixanol: Drug information")
Angiocardiography (left ventriculography and selective coronary arteriography), cerebral arteriography, peripheral arteriography, visceral arteriography: Intra-arterial: Iodixanol 320 mg iodine/mL: Dose individualized based on injection site and study type; refer to product labeling. Maximum recommended total dose of iodine: 80 g.
Intra-arterial digital subtraction angiography: Intra-arterial: Iodixanol 270 and 320 mg iodine/mL: Dose individualized based on injection site and study type; refer to product labeling. Maximum recommended total dose of iodine: 80 g.
CCTA, CT imaging of the head and body, excretory urography: IV: Iodixanol 320 mg iodine /mL: Concentration and dose vary based on study type; refer to product labeling. Maximum recommended total dose of iodine: 80 g.
CT imaging of the head and body, excretory urography, peripheral venography: IV: Iodixanol 270 mg iodine/mL: Concentration and dose vary based on study type; refer to product labeling. Maximum recommended total dose of iodine: 80 g.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Use caution in severe impairment and in setting of combined renal and hepatic disease.
Hemodialysis: Dialyzable (36% to 49% depending upon the membrane)
There are no dosage adjustments provided in the manufacturer's labeling. Use caution in patients with combined hepatic and renal disease.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Local: Injection site reaction (including cold sensation at injection site, discomfort at injection site, pain at injection site [2%], warm sensation at injection site [29%])
1% to 10%:
Cardiovascular: Angina pectoris (≤2%), chest pain (≤2%)
Dermatologic: Erythema of skin (≤2%), pruritus (2%), skin rash (≤2%)
Gastrointestinal: Dysgeusia (4%), nausea (3%)
Nervous system: Headache (≤3%), migraine (≤3%), paresthesia (1%), vertigo (2%)
Ophthalmic: Scotoma (1%)
<1%:
Cardiovascular: Acute myocardial infarction, cardiac arrhythmia, cardiac conduction disorder, edema, flushing, heart failure, hypotension, peripheral ischemia, syncope
Dermatological: Diaphoresis, urticaria
Gastrointestinal: Diarrhea, dyspepsia, vomiting
Genitourinary: Hematuria
Hematological & oncologic: Hematoma
Nervous system: Abnormal sensory symptoms, agitation, altered sense of smell, anxiety, cerebrovascular disease, confusion, dizziness, fatigue, hypoesthesia, insomnia, malaise, nervousness, seizure, stupor
Neuromuscular & skeletal: Back pain
Ophthalmic: Visual disturbance
Otic: Tinnitus
Renal: Acute kidney injury, renal function abnormality
Respiratory: Asthma, bronchitis, dyspnea, pharyngeal edema, pulmonary edema, rhinitis
Postmarketing:
Cardiovascular: Coronary artery vasospasm, hypertension, palpitations, shock
Dermatologic: Acute generalized exanthematous pustulosis, skin discoloration, Stevens-Johnson syndrome, toxic epidermal necrolysis
Endocrine & metabolic: Hyperthyroidism, hypothyroidism (premature infants, infants, and children ≤3 years with underlying medical conditions may be more vulnerable; FDA Safety Alert March 30, 2022)
Gastrointestinal: Abdominal pain, enlargement of salivary glands, pancreatitis
Hypersensitivity: Anaphylactic shock, anaphylaxis, hypersensitivity reaction
Immunologic: Drug reaction with eosinophilia and systemic symptoms
Nervous system: Chills, coma, impaired consciousness, pain
Neuromuscular & skeletal: Tremor
Ophthalmic: Visual impairment (including blurred vision, cortical blindness, diplopia)
Respiratory: Bronchospasm, cough, laryngeal edema, sneezing, throat irritation
Miscellaneous: Fever
Intrathecal administration
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to iodixanol or any component of the formulation
Concerns related to adverse effects:
• Contrast media reactions: Serious and life-threatening hypersensitivity reactions have occurred, including anaphylaxis. Use extreme caution with history of previous reaction to contrast dye, iodine-based contrast media or patients with a known clinical hypersensitivity (eg, bronchial asthma, hay fever, food allergies). Obtain allergy and hypersensitivity history prior to administration. Premedication with antihistamines or corticosteroids should be considered to reduce incidence and severity of reaction. Monitor closely during and for 30 to 60 minutes after administration (delayed reactions have occurred).
• Dermatological effects: Severe cutaneous adverse reactions (including Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP], drug reaction with eosinophilia and systemic symptoms [DRESS]) have occurred 1 hour to several weeks after administration; reaction severity may increase and time to onset may decrease with repeat administration. Avoid use in patients with a history of a severe cutaneous adverse reaction to iodixanol.
• Extravasation: May be a vesicant; ensure proper needle/catheter/line placement prior to and during administration. Monitor infusion site. Avoid extravasation. Extravasation may result in tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease.
• Renal failure: Acute renal failure may occur; has been reported in patients with hepatic impairment administered an oral cholecystographic agent followed by an intravascular iodinated radiocontrast agent. Preparatory dehydration may contribute to acute renal failure in infants, young children and elderly patients, patients with preexisting renal impairment, multiple myeloma, advanced vascular disease, and diabetes; avoid fluid restriction and maintain normal hydration in these patients.
• Thromboembolic events: Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Use meticulous intravascular administration techniques, particularly during angiographic procedures. Ionic iodinated contrast media may inhibit blood coagulation (more than nonionic contrast media). Clotting has been reported when in vitro blood remains in contact with syringes containing nonionic contrast media; use of plastic syringes in place of glass syringes has been reported to decrease, but not eliminate, the likelihood of in vitro clotting.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease and heart failure patients receiving concurrent diuretic therapy; they may have intravascular volume depletion, which may affect the renal response to the contrast agent osmotic load; observe such patients for several hours following the procedure to detect renal delayed hemodynamic renal function disturbances. Preparatory dehydration may contribute to acute renal failure in patients with advanced vascular disease; avoid fluid restriction and maintain normal hydration in these patients.
• Diabetes: Preparatory dehydration may contribute to acute renal failure in patients with diabetes; avoid fluid restriction and maintain normal hydration in these patients.
• Hepatic impairment: Use with caution in patients with hepatic impairment, and those with concomitant renal impairment, particularly when large doses are administered.
• Homocystinuria: Avoid angiography in patients with homocystinuria; may be at risk for thrombosis and embolism.
• Hyperthyroidism: Thyroid storm following intravascular administration of iodinated contrast media have occurred in patients with hyperthyroidism or with an autonomously functioning thyroid nodule; use caution in severe thyrotoxicosis. Iodine-binding capacity of thyroid tissue may be reduced for at least 16 days following administration of contrast media for diagnosis of thyroid disease.
• Multiple myeloma: Use with caution in patients with multiple myeloma or other paraproteinacious diseases; use of intravascular contrast agents may lead to renal impairment, especially with concurrent dehydration. Partial dehydration in the preparation of these patients prior to injection is not recommended since this may predispose the patient to precipitation of the myeloma protein.
• Myasthenia gravis: Use may worsen myasthenia gravis (MG); use with caution and monitor for worsening MG (AAN [Narayanaswami 2021]).
• Pheochromocytoma: Use with extreme caution in patients with pheochromocytoma (known or suspected). Dose injected should be kept to a minimum to minimize exposure; monitor blood pressure closely. Therapy to manage hypertensive crisis should be readily available.
• Pulmonary disease: The risks of angiocardiography in patients with chronic pulmonary emphysema should be weighed against the necessity for the procedure.
• Renal impairment: Use with caution in patients with renal impairment; combined renal and hepatic disease, combined renal and cardiac disease, or anuria; particularly when large doses are administered. Preparatory dehydration may contribute to acute renal failure in patients with preexisting renal impairment.
• Sickle cell disease: Use with caution in patients with homozygous sickle cell disease; administration of contrast media may promote sickling.
Special populations:
• Older adult: Use with caution in elderly patients with age-related renal patients. Preparatory dehydration may contribute to acute renal failure in elderly patients; maintain adequate hydration.
• Pediatric: Pediatric patients at higher risk of experiencing any adverse events during contrast medium administration may include those having asthma, sensitivity to medication or allergens, heart failure, serum creatinine >1.5 mg/dL, or pediatric patients <12 months of age. Preparatory dehydration may contribute to acute renal failure in infants and young children. Thyroid dysfunction, including transient thyroid suppression or hypothyroidism, has been reported in pediatric patients 0 to 3 years of age following single exposure and multiple exposures to iodinated contrast media; risk increases with younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, neonatal or pediatric intensive care admission, and congenital cardiac conditions (may be greatest risk due to requiring higher doses during invasive cardiac procedures).
Other warnings/precautions:
• Appropriate administration: For intravascular use only.
• Appropriate use: Adequately hydrate patient prior to and following administration. Delay intravenous contrast agent administration in patients who have recently received a cholecystographic contrast agent. In contrast-enhanced computerized tomography, contrast may obscure some lesions previously seen on unenhanced CT scans.
Intravascular administration: In angiographic procedures, during catheter manipulations and contrast medium injection, a possibility of dislodging plaques or damaging (or perforating) vessel walls with resultant pseudoaneurysms, hemorrhage at puncture site, or dissection of coronary artery exists. Ensure proper catheter placement with test injections.
• Trained personnel: Clinicians using radiopaque contrast agents should be well trained in diagnosis and management of emergencies that may arise from the use of these agents. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use during and for 30 to 60 minutes after administration (delayed reactions have occurred).
Use with caution in pediatric patients with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, CHF, serum creatinine >1.5 mg/dL, and neonates (immature renal function) due to an increased risk of adverse effects with iodixanol. Dehydration, particularly in children, may also increase the risk of adverse effects. Patients should be adequately hydrated both prior to and after iodixanol administration. In pediatric patients, apnea, arrhythmias (AV block, bundle branch block), cardiac failure, disseminated intravascular coagulation, and taste perversion have been reported.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Visipaque: Iodine 320 mg/mL (50 mL, 100 mL, 150 mL, 200 mL, 500 mL) [contains edetate (edta) calcium disodium]
Visipaque: Iodine 270 mg/mL (50 mL, 100 mL, 150 mL, 200 mL) [pyrogen free; contains edetate (edta) calcium disodium, tromethamine]
Solution, Intravenous [preservative free]:
Generic: Iodine 270 mg/mL (100 mL, 150 mL); Iodine 320 mg/mL (50 mL, 100 mL, 150 mL, 200 mL)
Yes
Solution (Iodixanol Intravenous)
270 mg/mL (per mL): $1.23
320 mg/mL (per mL): $1.36
Solution (Visipaque Intravenous)
270 mg/mL (per mL): $1.14
320 mg/mL (per mL): $1.19
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Visipaque: Iodine 270 mg/mL (50 mL, 100 mL, 200 mL, 500 mL); Iodine 320 mg/mL (50 mL, 100 mL, 200 mL, 500 mL) [contains edetate (edta) calcium disodium]
IV or intra-arterial: Administer without further dilution; warm to room temperature or body temperature prior to administration. Not for intrathecal administration.
Patients should be adequately hydrated prior to and following administration.
May be a vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid infiltration. If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (ACR 2018). Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (ACR 2018); other sources suggest its utility in extravasation management (Bellin 2002; Reynolds 2014) (see Management of Drug Extravasations for more details).
Patients should be adequately hydrated prior to and following administration.
May be a vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid infiltration.
CT of head and body: May be used with an automated contrast injection system approved for use with contrast media; iodixanol 320 (100 and 150 mL bottles) may also be used with a contrast management system approved for use with iodixanol; also refer to device instructions. When using contrast media management system, use for one procedure, do not remove bottle from work area once punctured, and do not use for longer than 4 hours from initial puncture; discard any unused portion.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect; remove needle/cannula; elevate extremity. Aspiration of extravasated contrast media is not recommended (ACR 2018). Information conflicts regarding the use of hyaluronidase; the American College of Radiology (ACR) Manual on Contrast Media does not recommend hyaluronidase in the management of contrast media extravasation (ACR 2018); other sources suggest its utility in extravasation management (Belin 2002; Reynolds 2014).
If using hyaluronidase: Intradermal or SubQ: Inject a total of 1 to 1.7 mL (15 units/mL) as five separate 0.2 to 0.3 mL injections (using a 25-gauge needle) into area of extravasation at the leading edge in a clockwise manner (MacCara 1983; Reynolds 2014; Zenk 1981) or injection of a total of 5 mL (150 units/mL) as five separate 1 mL injections around the extravasation site has been also used successfully (Rowlett 2012).
Store between 20°C and 25°C (68°F and 77°F); excursions are permitted to 15°C to 30°C (59°F and 86°F). Protect from direct exposure to sunlight. Do not freeze or use if inadvertently frozen. May be stored in contrast media warmer at 37°C (98.6°F) for up to 1 month.
Intra-arterial:
Pediatric patients birth to <12 years: 320 mgI/mL: Angiocardiography, cerebral arteriography, visceral arteriography
Pediatric patients ≥12 years and adults:
270 and 320 mgI/mL: Intra-arterial digital subtraction angiography
320 mgI/mL: Angiocardiography (left ventriculography and selective coronary arteriography), cerebral arteriography, peripheral arteriography, visceral arteriography
Intravenous:
Pediatric patients birth to <12 years: 270 mgI/mL: CT imaging of the head and body, excretory urography
Pediatric patients ≥12 years and adults:
270 mgI/mL: CT imaging of the head and body, excretory urography, peripheral venography
320 mgI/mL: CT imaging of the head and body, excretory urography, coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of patients with suspected coronary artery disease
Not for intrathecal use.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aldesleukin: May enhance the potential for allergic or hypersensitivity reactions to Iodinated Contrast Agents. Risk C: Monitor therapy
Loop Diuretics: May enhance the nephrotoxic effect of Iodinated Contrast Agents. Risk C: Monitor therapy
MetFORMIN: Iodinated Contrast Agents may enhance the adverse/toxic effect of MetFORMIN. Renal dysfunction that may be caused by iodinated contrast agents may lead to metformin-associated lactic acidosis. Management: Management advice varies. Refer to the full drug interaction monograph content for details. Risk D: Consider therapy modification
Sodium Iodide I131: Iodinated Contrast Agents may diminish the therapeutic effect of Sodium Iodide I131. Management: Discontinue iodinated contrast agents before sodium iodide I-131 administration, and avoid concurrent use. Stop water soluble agents 2 months before, and stop lipophilic agents 6 months before, sodium iodide I-131 administration. Risk X: Avoid combination
Iodinated contrast media agents may cross the placenta.
Due to theoretical concerns that exposure to free iodide may adversely affect the fetus, use should be avoided unless absolutely required to obtain diagnostic information that will influence the care of the mother or fetus during pregnancy (ACOG 723 2017; ACR 2018).
Monitor signs and symptoms of hypersensitivity reactions and severe cardiovascular reactions; monitor for extravasation during administration; blood pressure; hydration status; renal function; in patients <3 years of age, monitor thyroid function within 3 weeks following exposure.
Opacifies vessels in the path of flow permitting radiographic imaging of internal structures.
Note: Following administration, the increase in tissue density is related to blood flow, the concentration of the iodixanol solution used, and the extraction of iodixanol by various interstitial tissues. The degree of enhancement is directly related to the iodine content in an administered dose.
Onset of action: Kidney:
Visualization: Renal parenchyma: 30 to 60 seconds; calyces and pelves (normal renal function): 1 to 3 minutes
Optimum contrast: 5 to 15 minutes
Distribution: Vd: 0.26 L/kg
Protein binding: No
Metabolism: Metabolites have not been demonstrated
Half-life elimination:
Pediatric patients (Johnson 2001):
Newborns to Infants <2 months: 4.1 ± 1.4 hours
Infants 2 to 6 months: 2.8 ± 0.6 hours
Infants 6 to 12 months: 2.4 ± 0.4 hours
Children 1 to <3 years: 2.2 ± 0.5 hours
Children 3 to <12 years: 2.3 ± 0.5 hours
Adults: 2.1 ± 0.1 hours; increased to 23 hours in renal impairment (mean CrCl: 13.61 ± 4.67 mL/minute)
Time to peak, plasma:
Children: IV: 0.75 to 1.25 hours
Adults: Immediate; peak enhancement at 15 to 120 seconds; optimum renal contrast at 5 to 15 minutes; brain contrast at up to 1 hour
Excretion: Urine (97% within 24 hours); feces (<2%)
Clearance: Adults: 110 mL/minute
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