Iopromide

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

Ultravist: 31% (50 mL [DSC]); 50% (50 mL [DSC], 100 mL, 200 mL); 62% (50 mL, 75 mL [DSC], 100 mL, 125 mL [DSC], 150 mL [DSC], 200 mL, 500 mL); 77% (50 mL, 75 mL [DSC], 100 mL, 125 mL [DSC], 150 mL, 200 mL, 250 mL [DSC], 500 mL)

Pharmacology

Mechanism of Action

Iopromide opacifies vessels in its path of flow, permitting radiographic visualization of internal structures.

Pharmacokinetics/Pharmacodynamics

Distribution

V_dss: 16 L

Excretion

Urine 97% (as unchanged drug)

Time to Peak

Intravascular: Contrast enhancement: 15 to 120 seconds after bolus injection

Intravenous: Contrast enhancement: Kidneys: 5 to 15 minutes

Half-Life Elimination

Main elimination phase: 2 hours; Terminal phase: 6.2 hours

Protein Binding

1%

Use in Specific Populations

Special Populations: Renal Function Impairment

Plasma AUC is increased approximately 2-fold in moderate and 6-fold in severe renal impairment.

Special Populations: Elderly

V_dss is 30 to 40 L; Terminal elimination half-life is 40 hours.

Use: Labeled Indications

Intra-arterial: Enhance imaging in cerebral arteriography and peripheral arteriography, coronary arteriography and left ventriculography, visceral angiography and aortography.

IV: Enhance imaging in excretory urography and contrast-enhanced computed tomographic imaging of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and nonneoplastic lesions.

Contraindications

Intrathecal use; use in children with preparatory dehydration (eg, prolonged fasting and the administration of a laxative) before iopromide injection.

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to iopromide or any component of the formulation; manifest hyperthyroidism; use in myelography, cerebral ventriculography, and cisternography.

Dosage and Administration

Dosing: Adult

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

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

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

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

Excretory urography: IV (300 mg iodine/mL): 1 mL/kg in patients with normal renal function; maximum dose for procedure: 100 mL

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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

Administration

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).

Storage

Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light.

Drug Interactions

Aldesleukin: May enhance the potential for allergic or hypersensitivity reactions to Iodinated Contrast Agents. 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. Consider therapy modification

Test Interactions

Thyroid function tests (which depend on estimates of iodine) will not accurately assess function for at least 16 days following administration of iodinated contrast agents. Iopromide may affect PTT, calcium thromboplastin time, and thrombin activity. It may activate the complement alternate pathway. No effects on Factor XIIa have been demonstrated.

Adverse Reactions

1% to 10%:

Cardiovascular: Vasodilation (3%), chest pain (2%), bradycardia (≤1%), complete atrioventricular block (≤1%), coronary thrombosis (≤1%), facial edema (≤1%), flushing (≤1%), hypertension (≤1%), peripheral edema (≤1%), peripheral vascular disease (≤1%), syncope (≤1%), vascular disease (≤1%; vascular anomaly), ventricular premature contractions (≤1%)

Central nervous system: Headache (4%), agitation (≤1%), anxiety (≤1%), ataxia (≤1%), chest discomfort (≤1%), chills (≤1%), confusion (≤1%), dizziness (≤1%), drowsiness (≤1%), feeling hot (≤1%), hypertonia (≤1%), hypoesthesia (≤1%), hypotension (≤1%), malaise (≤1%), myasthenia (≤1%), neuropathy (≤1%), paresthesia (≤1%), seizure (≤1%), speech disturbance (≤1%)

Dermatologic: Erythema (≤1%), hyperhidrosis (≤1%), pruritus (≤1%), skin rash (≤1%), urticaria (≤1%)

Endocrine & metabolic: Increased lactate dehydrogenase (≤1%), polydipsia (≤1%)

Gastrointestinal: Nausea (4%), vomiting (2%), dysgeusia (1%), abdominal distress (≤1%), abdominal pain (≤1%), constipation (≤1%), diarrhea (≤1%), dyspepsia (≤1%), gastrointestinal pain (≤1%), salivation (≤1%), sore throat (≤1%), stomach discomfort (≤1%), tenesmus (≤1%), upper abdominal pain (≤1%), xerostomia (≤1%)

Genitourinary: Urinary urgency (2%), dysuria (≤1%), urinary retention (≤1%)

Hematologic & oncologic: Increased hemoglobin (≤1%), leukocytosis (≤1%)

Local: Injection site reaction (4%; edema, erythema, hematoma, hemorrhage, pain, skin rash, warm feeling)

Neuromuscular & skeletal: Back pain (2%), arthralgia (≤1%), limb pain (≤1%), musculoskeletal pain (≤1%), neck pain (≤1%), tremor (≤1%), weakness (≤1%)

Ophthalmic: Visual disturbance (1%), visual field defect (≤1%)

Renal: Increased blood urea nitrogen (≤1%), renal pain (≤1%)

Respiratory: Apnea (≤1%), asthma (≤1%), increased cough (≤1%), dyspnea (≤1%), hypoxia (≤1%), pharyngeal edema (≤1%), pharyngitis (≤1%), pleural effusion (≤1%), pulmonary hypertension (≤1%), respiratory tract disease (≤1%)

Miscellaneous: Fever (≤1%)

Frequency not defined:

Cardiovascular: Cardiac arrhythmia, cerebrovascular accident, ischemic heart disease

Central nervous system: Cerebral edema (children)

Endocrine & metabolic: Diabetes insipidus (children)

Gastrointestinal: Mucous membrane disease (swelling; children)

Hypersensitivity: Fixed drug eruption (children)

Neuromuscular & skeletal: Joint effusion (children), muscle cramps (children)

Ophthalmic: Conjunctivitis (children)

Renal: Acute renal failure

Respiratory: Aspiration, cyanosis, epistaxis (children), respiratory insufficiency

<1%, postmarketing and/or case reports: Abnormal lacrimation, acute generalized exanthematous pustulosis, acute respiratory distress, amnesia, anaphylactic shock, anaphylactoid reaction, angina pectoris, angioedema, aphasia, atrial fibrillation, bronchospasm, cardiac failure, cerebral infarction, cerebral ischemia, coma, cortical blindness (transient), DRESS syndrome, dysphagia, enlargement of salivary glands, exacerbation of myasthenia gravis, hematuria, hypersensitivity reaction, hypotonia, laryngeal edema, laryngospasm, loss of consciousness, migraine (children), mydriasis, myocardial infarction, palpitations, paralysis, paresis, pulmonary edema, renal failure, shock, skin discoloration, Stevens-Johnson syndrome, tachycardia, tinnitus, toxic epidermal necrolysis, vasospasm, ventricular fibrillation, vertigo

Warnings/Precautions

Concerns related to adverse effects:

• Contrast media reactions: Serious and life-threatening reactions have occurred. Use extreme caution in patients with a history of previous reaction to contrast dye or iodine and patients with a known allergic disorder (eg, bronchial asthma, hay fever, food allergies) or other hypersensitivities. Monitor closely during and for 30 to 60 minutes after administration (delayed reactions have occurred).
• Contrast-induced acute kidney injury: Acute kidney injury, including renal failure, may occur following intravascular administration of iodinated contrast media. Risk factors include patients with preexisting renal disease, advanced age, advanced vascular disease, heart failure, dehydration, diabetes mellitus, concomitant use of nephrotoxic agents or diuretics, multiple myeloma/paraproteinemia, or large doses or multiple doses of iodinated contrast media. Adequately hydrate patients prior to and following administration to minimize the risk.
• 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 iothalamate.
• 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.
• Thromboembolic events: Serious thromboembolic events have been reported during angiographic procedures with both ionic and nonionic contrast agents. Clotting may occur when blood remains in contact with syringes containing iodinated contrast media. Therefore, meticulous intravascular administration technique is necessary.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease or heart failure. Iodinated contrast media may result in an increased circulatory osmotic load and subsequent acute or delayed hemodynamic changes, especially following the use of large doses or repeated doses. Observe patients with cardiovascular disease for several hours after procedure for the development of delayed hemodynamic changes. Preparatory dehydration may contribute to acute renal failure in patients with heart failure or advanced vascular disease; avoid fluid restriction and maintain normal hydration in these patients.
• Diabetes: Use with caution in patients with diabetes mellitus; these patients may have altered renal blood flow, increasing risk of nephrotoxicity. 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, especially those with concomitant renal impairment or when using both oral and IV contrast agents in close proximity.
• Homocystinuria: Avoid angiography in patients with homocystinuria; may be at risk for thrombosis and embolism.
• Hyperthyroidism: Use with caution in patients with thyroid disease; thyroid storm has been reported in patients with history of hyperthyroidism or with an autonomously functioning thyroid nodule.
• Hypothyroidism: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been reported (uncommon) in adult and pediatric patients (including infants); some patients were treated for hypothyroidism.
• Multiple myeloma: Use with caution in patients with multiple myeloma; use of intravascular contrast agents may lead to renal impairment, especially with concurrent dehydration.
• Pheochromocytoma: Use with extreme caution in patients with pheochromocytoma (known or suspected). Minimize the amount of contrast agent used (for intravascular administration) and monitor blood pressure closely throughout procedure. Therapy for treatment of 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 patients with sickle cell disease; may promote sickling.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Appropriate use: For IV or intra-arterial use only. [US Boxed Warning]: Not for intrathecal use. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. 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).

Monitoring Parameters

Renal function, blood pressure, hydration; monitor for extravasation during IV administration; monitor for hypersensitivity reactions for ≥30 to 60 minutes.

Coronary arteriography: ECG (coronary arteriography); vital signs; signs and symptoms of hypersensitivity; renal function

Pregnancy

Pregnancy Considerations

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).

Patient Education

What is this drug used for?

• It is used before a CT scan or other test.

Frequently reported side effects of this drug

• Flushing
• Sensation of warmth
• Headache
• Nausea
• Vomiting
• Back pain
• Change in taste

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain
• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes
• Severe cerebrovascular disease like change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes
• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood
• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes
• Fast heartbeat
• Abnormal heartbeat
• Slow heartbeat
• Severe dizziness
• Passing out
• Nail discoloration
• Vision changes
• Seizures
• Severe injection site redness, burning, edema, pain, or irritation
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.