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Iopromide

Pronunciation

(eye oh PROE mide)

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

Brand Names: U.S.

  • Ultravist

Pharmacologic Category

  • Iodinated Contrast Media
  • Radiological/Contrast Media, Nonionic (Low Osmolality)

Pharmacology

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

Distribution

Vdss: 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%

Special Populations: Renal Function Impairment

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

Special Populations: Elderly

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

Use: Labeled Indications

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

Intravenous: Enhance imaging in peripheral venography, 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 US labeling): Hypersensitivity to iopromide or any component of the formulation; manifest hyperthyroidism; use in myelography, cerebral ventriculography, and cisternography.

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: 20-50 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

Intra-arterial digital subtraction angiography: Intra-arterial (150 mg iodine/mL): Maximum dose for procedure: 250 mL

Carotid arteries: 6 to 10 mL

Vertebral: 4 to 8 mL

Aorta: 20 to 50 mL

Major branches of the abdominal aorta: 2 to 20 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:

Bolus injection: 50 to 200 mL; maximum dose for procedure: 200 mL

Rapid infusion: 100 to 200 mL; maximum dose for procedure: 200 mL

370 mg iodine/mL:

Head: 41 to 162 mL; maximum dose for procedure: 162 mL

Body:

Bolus injection: 41 to 162 mL; maximum dose for procedure: 162 mL

Rapid infusion: 81 to 162 mL; 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

Peripheral venography: IV (240 mg iodine/mL): Minimum amount to clearly visualize the structure under examination; maximum dose for procedure: 250 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: Children >2 years and Adolescents: IV (300 mg iodine/mL): 1 to 2 mL/kg; maximum dose for procedure: 3 mL/kg

Dosing: Renal Impairment

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.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Administration

Solutions for injection should be as close to body temperature as possible. 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.

Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid infiltration.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; initiate hyaluronidase antidote; elevate extremity.

Hyaluronidase: Intradermal or SubQ: Inject a total of 1 mL (15 units/mL) as five separate 0.2 mL injections (using a 25-gauge needle) into area of extravasation at the leading edge in a clockwise manner (MacCara 1983; 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: Vasodilatation (4%), chest pain (3%), hypertension (1%)

Central nervous system: Headache (6%), pain (2%), dizziness (1%)

Gastrointestinal: Nausea (4%), vomiting (2%), dysgeusia (1%)

Genitourinary: Urinary urgency (3%)

Local: Hematoma at injection site (3%), pain at injection site (1%)

Neuromuscular & skeletal: Back pain (3%)

Ophthalmic: Visual disturbance (2%)

<1% (limited to important or life-threatening): Abdominal pain, abnormal lacrimation, agitation, amnesia, anaphylaxis, angioedema (children), anxiety, aphasia, apnea, arthralgia, asthma, ataxia, bradycardia, bullous rash (delayed), cardiac failure, cerebral edema (children), chills, complete atrioventricular block, confusion, conjunctivitis (children), constipation, coronary thrombosis, cough, depression, diabetes insipidus (children), diaphoresis, diarrhea, drowsiness, dysmenorrhea, dyspepsia, dyspnea, dysuria, emotional lability, epistaxis (children), erythema (delayed), facial edema, fever, fixed drug eruption (children), hematuria, hemopericardium, hypersensitivity reaction, hypertonia, hypoesthesia, hypotension, hypotonia, hypovolemic shock, hypoxemia, hypoxia, injection site reaction (edema, erythema, skin rash, warm feeling), insomnia, joint effusion (children), laryngeal edema, malaise, migraine (children), mucous membrane disease (swelling; children), muscle cramps (children), myasthenia, mydriasis, neck pain, neuropathy, papular rash (delayed), paresthesia, pharyngitis, polydipsia, pruritus, pulmonary hypertension, renal disease, renal failure, renal pain, salivation, seizure, skin discoloration, skin rash (delayed), sneezing (delayed), sore throat, speech disturbance, syncope, tachycardia, tenesmus, thrombosis, thyroid dysfunction (underactive; premature infants and infants with underlying medical conditions are more vulnerable; FDA Safety Alert 2015), tongue paralysis, tremor, urinary retention, urticaria (may be delayed), vascular disease, ventricular fibrillation, ventricular premature contractions, vertigo (children), visual field defect, weakness, xerostomia

ALERT: U.S. Boxed Warning

Appropriate use:

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.

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: Vesicant; ensure proper needle/catheter/line placement prior to and during administration. 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.

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 Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Iopromide crosses the placenta and was detected in a newborn gut and urine at birth (Vanhaesebrouck 2005). Thyroid dysfunction in the neonate has not been reported (ACR 2015; Kochi 2012). In general, use of iodinated contrast media should be avoided unless absolutely required to obtain diagnostic information that will influence the care of the mother or fetus during pregnancy (ACOG 2015; ACR 2015).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flushing, sensation of warmth, headache, or nausea. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), angina, tachycardia, abnormal heartbeat, skin discoloration, signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), severe dizziness, passing out, nail discoloration, vision changes, shortness of breath, excessive weight gain, swelling of arms or legs, seizures, bradycardia, or severe injection site redness, burning, edema, pain, or irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating, and advising patients.

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