Version May 2024
Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Iopromide is not approved for intrathecal use.
Note: Maximum recommended total dose of iodine is 86 g. Individualize dose taking into account patient's age, body weight, size of the vessel, and the rate of blood flow within the vessel. Consideration should also be made for the extent of opacification required, structure or area to be examined, disease processes, and equipment and technique used.
Aortography and visceral angiography: Intra-arterial (370 mg iodine/mL): Volume and rate of administration based on blood flow and specific characteristics of vessels being studied; maximum dose for procedure: 225 mL
Cerebral arteriography: Intra-arterial (300 mg iodine/mL): Maximum dose for procedure: 150 mL
Carotid artery visualization: 3 to 12 mL
Vertebral artery visualization: 4 to 12 mL
Aortic arch injection: 20 to 50 mL
Contrast-enhanced CT: IV:
300 mg iodine/mL:
Head: 50 to 200 mL; maximum dose for procedure: 200 mL
Body:
Single phase:
Bolus injection: 50 to 200 mL; maximum dose for procedure: 200 mL
Rapid infusion: 100 to 200 mL; maximum dose for procedure: 200 mL
Multiple phase: 50 to 200 mL; use power injector for simultaneous administration of contrast and saline (100% contrast administered in phase 1; 20% to 60% contrast administered in phase 2); maximum dose for procedure: 200 mL
370 mg iodine/mL:
Head: 41 to 162 mL; maximum dose for procedure: 162 mL
Body:
Single phase:
Bolus injection: 41 to 162 mL; maximum dose for procedure: 162 mL
Rapid infusion: 81 to 162 mL; maximum dose for procedure: 162 mL
Multiple phase: 41 to 162 mL; use power injector for simultaneous administration of contrast and saline (100% contrast administered in phase 1; 20% to 60% contrast administered in phase 2); maximum dose for procedure: 162 mL
Contrast mammography: IV: (300 or 370 mg iodine/mL): 1.5 mL/kg; use power injector at 2 to 4 mL/second; maximum dose for procedure: 150 mL.
Coronary arteriography and left ventriculography: Intra-arterial (370 mg iodine/mL): Maximum dose for procedure: 225 mL
Left coronary: 3 to 14 mL
Right coronary: 3 to 14 mL
Left ventricle: 30 to 60 mL
Excretory urography: IV (300 mg iodine/mL): 1 mL/kg in patients with normal renal function; maximum dose for procedure: 100 mL
Peripheral arteriography: Intra-arterial (300 mg iodine/mL): Maximum dose for procedure: 250 mL
Subclavian or femoral artery: 5 to 40 mL
Aortic bifurcation for distal runoff: 25 to 50 mL
Excretory urography: IV (300 mg iodine/mL): 1 mL/kg in patients with normal renal function; maximum dose for procedure: 100 mL
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; use caution in renal impairment and in setting of combined renal and hepatic disease. Manufacturer recommends using lowest necessary dose.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Cardiac chambers and related arteries: Children >2 years and Adolescents: Intra-arterial (370 mg iodine/mL): 1 to 2 mL/kg; maximum dose for procedure: 4 mL/kg
Contrast-enhanced CT or excretory urography: Children >2 years and Adolescents: IV (300 mg iodine/mL): 1 to 2 mL/kg; maximum dose for procedure: 3 mL/kg
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; use caution in renal impairment and in setting of combined renal and hepatic disease. Manufacturer recommends using lowest necessary dose.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Cardiovascular: Bradycardia (≤1%), chest discomfort (≤1%), chest pain (2%), complete atrioventricular block (≤1%), coronary thrombosis (≤1%), facial edema (≤1%), flushing (≤1%), hypertension (≤1%), hypotension (≤1%), peripheral edema (≤1%), peripheral vascular disease (≤1%), syncope (≤1%), vascular disease (≤1%; vascular anomaly), vasodilation (3%), ventricular premature contractions (≤1%)
Dermatologic: Erythema of skin (≤1%), hyperhidrosis (≤1%), pruritus (≤1%), skin rash (≤1%), urticaria (≤1%)
Endocrine & metabolic: Increased lactate dehydrogenase (≤1%), increased thirst (≤1%)
Gastrointestinal: Abdominal distress (≤1%), abdominal pain (≤1%; including upper abdominal pain), constipation (≤1%), diarrhea (≤1%), dysgeusia (1%), dyspepsia (≤1%), gastrointestinal pain (≤1%), nausea (4%), rectal tenesmus (≤1%), sialorrhea (≤1%), sore throat (≤1%), vomiting (2%), xerostomia (≤1%)
Genitourinary: Dysuria (≤1%), urinary retention (≤1%), urinary urgency (2%)
Hematologic & oncologic: Increased hemoglobin (≤1%), leukocytosis (≤1%)
Local: Injection site reaction (4%; including bleeding at injection site, erythema at injection site, hematoma at injection site, pain at injection site, rash at injection site, swelling at injection site, warm sensation at injection site)
Nervous system: Agitation (≤1%), anxiety (≤1%), ataxia (≤1%), chills (≤1%), confusion (≤1%), dizziness (≤1%), drowsiness (≤1%), feeling hot (≤1%), headache (4%), hypertonia (≤1%), hypoesthesia (≤1%), malaise (≤1%), myasthenia (≤1%), neuropathy (≤1%), pain (1%), paresthesia (≤1%), seizure (≤1%), speech disturbance (≤1%)
Neuromuscular & skeletal: Arthralgia (≤1%), asthenia (≤1%), back pain (2%), limb pain (≤1%), musculoskeletal pain (≤1%), neck pain (≤1%), tremor (≤1%)
Ophthalmic: Visual disturbance (1%), visual field defect (≤1%)
Renal: Increased blood urea nitrogen (≤1%), renal pain (≤1%)
Respiratory: Apnea (≤1%), asthma (≤1%), dyspnea (≤1%), hypoxia (≤1%), increased cough (≤1%), pharyngeal edema (≤1%), pharyngitis (≤1%), pleural effusion (≤1%), pulmonary hypertension (≤1%)
Miscellaneous: Fever (≤1%)
Frequency not defined:
Cardiovascular: Cardiac arrhythmia, cerebrovascular accident, ischemic heart disease, shock
Nervous system: Brain edema
Renal: Acute kidney injury
Respiratory: Cyanosis, pulmonary aspiration
Postmarketing:
Cardiovascular: Acute myocardial infarction, angina pectoris, atrial fibrillation, cerebral infarction, cerebral ischemia, heart failure, palpitations, tachycardia, vasospasm, ventricular fibrillation
Dermatologic: Acute generalized exanthematous pustulosis, skin discoloration, Stevens-Johnson syndrome, toxic epidermal necrolysis
Endocrine & metabolic: Hyperthyroidism, hypothyroidism, thyrotoxicosis
Gastrointestinal: Dysphagia, enlargement of salivary glands
Genitourinary: Hematuria
Hypersensitivity: Anaphylactic shock, angioedema, hypersensitivity reaction, nonimmune anaphylaxis
Immunologic: Drug reaction with eosinophilia and systemic symptoms
Nervous system: Amnesia, aphasia, coma, exacerbation of myasthenia gravis, hypotonia, loss of consciousness, paralysis, paresis, vertigo
Neuromuscular & skeletal: Laryngospasm
Ophthalmic: Abnormal lacrimation, cortical blindness (transient), mydriasis
Otic: Tinnitus
Renal: Renal failure syndrome
Respiratory: Acute respiratory distress syndrome, bronchospasm, laryngeal edema, pulmonary edema
There are no contraindications listed within the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to iopromide or any component of the formulation; manifest hyperthyroidism; use in myelography, cerebral ventriculography, and cisternography, intrathecal use; preparatory dehydration (eg, prolonged fasting, restriction of fluids, administration of a laxative) in pediatric patients.
Concerns related to adverse effects:
• Cardiovascular events: Life-threatening or fatal cardiovascular reactions (eg, hypotension, shock, cardiac arrest) have occurred with administration; fatal events, while rare, typically occurred within 10 minutes after administration. Cardiovascular disease is the predominant aggravating factor. Cardiac decompensation, serious arrhythmias, myocardial ischemia, or myocardial infarction (MI) may occur during coronary arteriography and ventriculography. Use the lowest necessary dose in patients with heart failure; emergency resuscitation equipment and trained personnel should be available during administration.
• 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 intravascular 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 iopromide.
• Extravasation: May be a vesicant (higher osmolar contrast agents and/or higher volumes are associated with a higher risk); ensure proper needle/catheter/line placement prior to and during administration. Monitor infusion site. Avoid infiltration. Extravasation may result in tissue necrosis and/or compartment syndrome, particularly in patients with severe arterial or venous disease.
• Hypersensitivity reactions: May cause life-threatening or fatal hypersensitivity reactions, including anaphylaxis. Manifestations have included respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (within 3 minutes), although reactions may be delayed until hours later. The risk for hypersensitivity is increased in patients with a prior history of reaction to contrast agents, known allergies (eg, bronchial asthma, medication, food allergies), and/or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions, although it may reduce the incidence and severity of reactions. Obtain allergy and hypersensitivity history prior to administration. Emergency resuscitation equipment and trained personnel should be available prior to administration.
• Nephrotoxicity: Acute kidney injury, including renal failure, may occur after iopromide administration. Risk factors for nephrotoxicity include preexisting renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, older age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma (or paraproteinaceous diseases), and repeated and/or large iodinated contrast agent doses. Use the lowest necessary dose in patients with renal impairment. Adequately hydrate patients prior to and following parenteral iopromide administration. Avoid laxatives, diuretics, or preparatory dehydration prior to iopromide administration.
• Thromboembolic events: Serious, rarely fatal, thromboembolic events causing MI and stroke have been reported with both ionic and nonionic contrast media. Ionic iodinated contrast media may inhibit blood coagulation (more than nonionic contrast media). Use meticulous intravascular administration techniques during angiographic procedures and minimize the length of the procedure to minimize the risk. 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. Due to the risk of thrombosis/embolism, avoid angiocardiography in patients with homocystinuria.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment, especially those with concomitant renal impairment or when using both oral and IV contrast agents in close proximity.
• Hyperthyroidism: Thyroid storm following intravascular administration of iodinated contrast media have occurred in patients with hyperthyroidism or with an autonomously functioning thyroid nodule; evaluate risk.
• Multiple myeloma: Use with caution in patients with multiple myeloma; use of intravascular contrast agents may lead to renal impairment, especially with concurrent dehydration.
• Myasthenia gravis: Use may worsen myasthenia gravis (MG); use with caution and monitor for worsening MG (AAN [Narayanaswami 2021]).
• Pheochromocytoma: Hypertensive crisis has occurred after the use of iodinated contrast agents in patient with pheochromocytoma. Use with extreme caution in patients with pheochromocytoma (known or suspected). Minimize the amount of contrast agent used (for intravascular administration) and monitor BP closely throughout procedure. Therapy to manage hypertensive crisis should be readily available.
• Renal impairment: Use with caution in patients with renal impairment. May be associated with deterioration of renal function and/or increases in serum creatinine, particularly in elderly patients and patients with diabetes, advanced vascular disease, and those who are dehydrated. Use lowest dose possible in patients with renal impairment.
• Sickle cell disease: Use with caution in sickle cell disease; iodinated contrast agents may promote sickling in patients homozygous for sickle cell disease. Hydrate patients prior to and following iopromide administration; use iopromide only if the imaging information needed cannot be obtained with alternative imaging measures.
Special populations:
• Pediatrics: 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, or serum creatinine >1.5 mg/dL. 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). Iopromide is not approved for use in pediatric patients <2 years of age.
Other warnings/precautions:
• Appropriate use: For IV or intra-arterial use only.In contrast-enhanced computerized tomography, contrast may obscure some lesions previously seen on unenhanced CT scans.
• 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).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Injection:
Ultravist: 50% (100 mL [DSC], 200 mL [DSC]); 62% (50 mL, 100 mL, 125 mL, 150 mL, 200 mL, 500 mL); 77% (50 mL, 75 mL [DSC], 100 mL, 150 mL, 200 mL, 250 mL [DSC], 500 mL)
Ultravist: 62% (50 mL, 200 mL); 77% (50 mL, 100 mL, 200 mL) [pyrogen free; contains edetate (edta) calcium disodium]
No
Solution (Ultravist Injection)
62% (per mL): $0.50
77% (per mL): $0.56
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, Injection:
Ultravist 300: 62% (50 mL, 100 mL, 150 mL) [contains edetate (edta) calcium disodium]
Ultravist 370: 77% (50 mL, 100 mL, 150 mL, 200 mL) [contains edetate (edta) calcium disodium]
For IV or intra-arterial use only. Solutions for injection should be as close to body temperature as possible. Do not administer through the same line as other medications or parenteral nutrition. May be administered simultaneously with saline when utilizing a power injector system. Hydrate patients prior to and following administration. Injection rates should be about equal to the flow rate in the vessel being injected. Allow sufficient time between each large injection.
May be a vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid infiltration.
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 (Bellin 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).
Parenteral: For IV or intra-arterial use only. Solutions for injection should be as close to body temperature as possible. Hydrate patients prior to and following administration.
IV: Contrast-enhanced CT or excretory urography: 300 mg Iodine/mL: Do not administer through the same line as other medications or parenteral nutrition. May be administered simultaneously with saline when utilizing a power injector system.
Intra-arterial: Cardiac chamber and related arteries: 370 mg Iodine/mL: Injection rates should be about equal to the flow rate in the vessel being injected.
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).
Intra-arterial:
Enhance imaging in cerebral arteriography and peripheral arteriography, coronary arteriography and left ventriculography, visceral angiography and aortography in adults.
Radiographic evaluation of cardiac chambers and related arteries in pediatric patients ≥2 years of age.
IV:
Enhance imaging in excretory urography in adults and pediatric patients ≥2 years of age.
Contrast-enhanced computed tomographic imaging of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and nonneoplastic lesions in adults and pediatric patients ≥2 years of age.
Contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound.
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
Iopromide crosses the placenta and was detected in a newborn's gut and urine at birth (Vanhaesebrouck 2005).
Thyroid dysfunction in the neonate has not been reported (Kochi 2012). However, 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).
Iodinated contrast media may be present in breast milk (ACOG 723 2017; ACR 2018).
Because of the low expected excretion of iodinated contrast agents into breast milk and the low absorption from an infant's GI tract, breastfeeding may be continued without interruption after use (ACOG 723 2017; ACR 2018). Theoretically, the taste of milk could be altered if it contains contrast media. Women who prefer to temporarily withhold breastfeeding may express and discard milk from both breasts during a period of 12 to 24 hours after the administration of contrast media. They can pump and store milk prior to the procedure then bottle feed using the stored milk during this time (ACR 2018). According to the manufacturer, the decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Renal function, BP, hydration; monitor for extravasation during IV administration; monitor for cardiovascular events and hypersensitivity reactions.
Coronary arteriography: ECG (coronary arteriography); vital signs; signs and symptoms of hypersensitivity; renal function.
Pediatric patients ≤3 years of age: Individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates.
Iopromide opacifies vessels in its path of flow, permitting radiographic visualization of internal structures.
Distribution: Vdss: 16 L
Protein binding: 1%
Half-life elimination: Main phase: 2 hours; Terminal phase: 6.2 hours
Time to peak:
Intravascular: Contrast enhancement: 15 to 120 seconds after bolus injection
Intravenous: Contrast enhancement: Kidneys: 5 to 15 minutes
Excretion: Urine 97% (as unchanged drug)
Altered kidney function: Plasma AUC is increased approximately 2-fold in moderate and 6-fold in severe renal impairment.
Older adult: Vdss is 30 to 40 L; Terminal elimination half-life is 40 hours.
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