Iopromide
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. 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. ULTRAVIST is not approved for intrathecal use. (5.1)
Radiographic Contrast Agent
Dosing in kidney impairment
Renal Impairment The clearance of iopromide decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system [see Clinical Pharmacology] . In addition, preexisting renal impairment increases the risk for acute kidney injury [see Warnings and Precautions] . Iopromide can be removed by dialysis.
Preparation and administration
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Important Dosage and Administration Information
ULTRAVIST is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions] .
Specific concentrations and presentations of ULTRAVIST are recommended for each type of imaging procedure [see Dosage and Administrations ( 2.2 , 2.3 , 2.4 )] .
Hydrate patients, as appropriate, prior to and following the administration of ULTRAVIST [see Warnings and Precautions] .
Individualize the volume, concentration, and injection rate of ULTRAVIST according to the specific dosing tables [see Dosage and Administration ( 2.2 , 2.3 , 2.4 )] . Consider factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel; also consider extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
Visually inspect ULTRAVIST for particulate matter and/or discoloration, whenever solution and container permit. Do not administer ULTRAVIST if particulate matter (including crystals) and/or discoloration is observed or if containers are defective.
Use aseptic technique for all handling and administration of ULTRAVIST.
Warm ULTRAVIST to body temperature before administration.
ULTRAVIST can be used with 0.9% Sodium Chloride Injection in a power injector suitable for simultaneous injection of contrast [see Dosage and Administration] . However, do not mix or inject ULTRAVIST in intravenous administration lines containing other drugs or total nutritional admixtures.
Discard any unused portion remaining in the single-dose container following initial use.
| Imaging Procedure | Cerebral Arteriography | Peripheral Arteriography | Coronary Arteriographyand Left Ventriculography | Visceral AngiographyandAortography | |
| Concentration(mg Iodine per mL) | 300* | 300* | 370* | 370* | |
| Intra-Arterial Injection Sites | Carotid Arteries | 3 mL to 12 mL | - | - | - |
| Vertebral Arteries | 4 mL to 12 mL | ||||
| Aortic Arch Injection (four vessel study) | 20 mL to 50 mL | ||||
| Subclavian or Femoral Artery | - | 5 mL to 40 mL | - | - | |
| Aortic Bifurcation (distal runoff) | 25 mL to 50 mL | ||||
| Right Coronary Artery | - | - | 3 mL to 14 mL | - | |
| Left Coronary Artery | 3 mL to 14 mL | ||||
| Left Ventricle | 30 mL to 60 mL | ||||
| Aorta and Major Abdominal Branches | - | - | - | Individualize a volume approximately equal to the blood flow and related to the vascular and pathological characteristics of the specific vessels being studied. | |
| Maximum Total Dose | 150 mL | 250 mL | 225 mL | 225 mL | |
| Imaging Procedure | Excretory Urography | Contrast Computed Tomography | Contrast Mammography | |
| Concentration (mg Iodine per mL) | 300* | 300‡ | 370‡ | 300‡ or 370‡ |
| Excretory Urography | 1 mL/kg body weight | - | - | - |
| CT of Head | - | 50 mL to 200 mL | 41 mL to 162 mL | - |
| CT of Body - Single Phase ContrastBolus InjectionRapid Infusion | - | 50 mL to 200 mL100 mL to 200 mL | 41 mL to 162 mL81 mL to 162 mL | - |
| CT of Body – Multiple Phase Contrast | - | 50 mL to 200 mL total volumePhase 1: 100% contrast,Phase 2: 20% to 60% contrast,using a power injector suitable for simultaneous injection of contrast and 0.9% Sodium Chloride Injection | 41 mL to 162 mL total volumePhase 1: 100% contrast,Phase 2: 20% to 60% contrast,using a power injector suitable for simultaneous injection of contrast and 0.9% Sodium Chloride Injection | - |
| Contrast Mammography | - | - | - | 1.5 mL/kg body weight using a power injector at 2 mL/second to 4 mL/second |
| Maximum Total Dose | 100 mL | 200 mL | 162 mL | 150 mL |
| Imaging Procedure | Intra-arterial | Intravenous | |
| Cardiac Chambers and Related Arteries | Excretory Urography | Contrast Computerized Tomography | |
| Concentration (mg Iodine/mL) | 370* | 300* | 300‡ |
| Volume (mL/kg body weight) | 1 to 2 | 1 to 2 | 1 to 2 |
| Maximum Total Dose (mL/kg) | 4 | 3 | 3 |
Drug interactions
Check iopromide against a medication listLabel text (4 paragraphs)
7 DRUG INTERACTIONS
7.1 Drug-Drug Interactions Metformin In patients with renal impairment, biguanides can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, ULTRAVIST administration in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast agents. Re-evaluate eGFR 48 hours after the imaging procedure and reinstitute only after renal function is stable.
Radioactive Iodine ULTRAVIST may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post ULTRAVIST.
7.2 Drug-Laboratory Test Interactions Protein-Bound Iodine Test Iodinated contrast agents, including ULTRAVIST, will temporarily increase protein-bound iodine in blood. Do not perform protein-bound iodine test for at least 16 days following administration of ULTRAVIST. However, thyroid function tests which do not depend on iodine estimations, for example, T 3 resin uptake and total or free thyroxine (T 4 ) assays are not affected.
Contraindications
None None
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for iopromide. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data on ULTRAVIST use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts (see Data) . In animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Limited case reports demonstrate that intravenously administered iodinated contrast agents, including iopromide, cross the placenta and are visualized in the digestive tract of exposed infants after birth.
Animal Data Reproduction studies were performed with intravenous iopromide in rats (day 6 to 15 of gestation) and rabbits (day 6 to 18 of gestation) at dose levels of 0, 0.37, 1.11, and 3.7 g iodine per kg, corresponding to doses up to 0.35 times (rats) and 0.7 times (rabbits) the maximum human recommended dose based on body surface area. Iopromide was not teratogenic at any dose level in rats and rabbits and embryolethality was observed in rabbits that received 3.7 g iodine per kg, but this was considered to have been secondary to maternal toxicity.
Breastfeeding (LactMed)
Intravenous iodinated contrast media are poorly excreted into breastmilk and poorly absorbed orally so they are not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants. Guidelines developed by several professional organizations state that breastfeeding need not be disrupted after a nursing mother receives an iodine-containing contrast medium.- However, because there is no published experience with iopromide during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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