Iopamidol
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From MedlinePlus, U.S. National Library of Medicine
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WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration of ISOVUE, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1 )]. ISOVUE is for intra-arterial, intravenous, or oral use only [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )] .
WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration of ISOVUE, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ISOVUE is for intra-arterial, intravenous, or oral use only. ( 5.1 )
Radiographic Contrast Agent
Dosing in kidney impairment
Renal Impairment The clearance of iopamidol decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system. In addition, preexisting renal impairment increases the risk for acute kidney injury [see Warnings and Precautions] . Iopamidol can be removed by dialysis.
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer per Single Injection for Selected Injection Sites | Maximum Cumulative Total Dose |
| Cerebral Arteriography | 300 | 8 mL to 12 mL by carotid puncture or transfemoral catheterization | 90 mL |
| Peripheral Arteriography | 300 | 5 mL to 40 mL into the femoral artery or subclavian artery25 mL to 50 mL into the aorta for a distal runoff | 250 mL |
| Selective Visceral Arteriography and Aortography | 370 | Up to 10 mL for the renal arteriesUp to 50 mL into the larger vessels such as the aorta or celiac artery | 225 mL |
| Coronary Arteriography and Cardiac Ventriculography | 370 | 2 mL to 10 mL for selective coronary artery injection25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root | 200 mL |
Preparation and administration
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Important Dosing and Administration Information ISOVUE is for intra-arterial, intravenous, or oral use only. Do not administer intrathecally [see Warnings and Precautions] . Specific concentrations of ISOVUE are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )]. Individualize the volume, concentration, and rate of administration of ISOVUE according to the specific dosing tables [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )] .
Consider factors such as: age, body weight, blood vessel size and blood flow rate, anticipated pathology and degree and extent of opacification required, structures or area to be examined, concomitant medical conditions, imaging equipment, and technique to be employed. Hydrate patients before and after ISOVUE administration [see Warnings and Precautions] .
Use aseptic technique for all handling and administration of ISOVUE for intra-arterial and intravenous procedures. ISOVUE may be administered at either body temperature (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F). Visually inspect ISOVUE for particulate matter or discoloration before administration. Do not administer ISOVUE if particulate matter or discolorations are observed.
Do not mix ISOVUE with other drugs or inject in intravenous lines containing other drugs or total nutritional admixtures. ISOVUE single-dose containers are intended for one procedure only. Discard any unused portion.
Recommended Dosage for Oral Procedures in Pediatric Patients and Adults The recommended concentration of diluted ISOVUE is either 6 mg iodine/mL or 9 mg iodine/mL administered orally as shown in Table 4. See Table 5 for dilution instructions of ISOVUE [see Dosage and Administration] [See table below.] ‡ Prepare diluted ISOVUE solution to a concentration of either 6 mg iodine/mL or 9 mg iodine/mL according to Table 5 [see Dosage and Administration].
Age Volume of Diluted ISOVUE ‡ to Administer Administration Instructions Pediatric patients less than 3 years of age 50 mL to 300 mL Administer the oral dose approximately 60 minutes before beginning the CT procedure. Pediatric patients 3 years to 5 years of age 300 mL to 360 mL Pediatric patients 6 years to 11 years of age 360 mL to 500 mL Pediatric patients 12 years of age and older 500 mL to 1,000 mL Adults
Directions for Dilution of ISOVUE for Oral Administration Dilute ISOVUE to 6 mg iodine/mL or 9 mg iodine/mL in water or clear liquids such as apple juice according to Table 5. Use diluted ISOVUE immediately. Discard any unused portion after the procedure. [See table below.] 300 20 980 370 16 984 9 200 45 955 250 36 964 300 30 970 370 24 976
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer per Single Injection for Selected Injection Sites | Maximum Cumulative Total Dose |
| Cerebral Arteriography | 300 | 8 mL to 12 mL by carotid puncture or transfemoral catheterization | 90 mL |
| Peripheral Arteriography | 300 | 5 mL to 40 mL into the femoral artery or subclavian artery25 mL to 50 mL into the aorta for a distal runoff | 250 mL |
| Selective Visceral Arteriography and Aortography | 370 | Up to 10 mL for the renal arteriesUp to 50 mL into the larger vessels such as the aorta or celiac artery | 225 mL |
| Coronary Arteriography and Cardiac Ventriculography | 370 | 2 mL to 10 mL for selective coronary artery injection25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root | 200 mL |
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume to Administer |
| Excretory Urography | 250 | 50 mL to 100 mL by rapid injection |
| 300 | 50 mL by rapid injection | |
| 370 | 40 mL by rapid injection | |
| CT of the Head | 250 | 130 mL to 240 mL |
| 300 | 100 mL to 200 mL | |
| CT of the Body | 250 | 130 mL to 240 mL by rapid infusion or bolus injection |
| 300 | 100 mL to 200 mL by rapid infusion or bolus injection | |
| 370 | 80 mL to 160 mL by rapid infusion or bolus injection | |
| Peripheral Venography | 200 | 25 mL to 150 mL per lower extremity; the maximum total dose is 350 mL |
| 300 | 15 mL to 100 mL per lower extremity; the maximum total dose is 230 mL |
| Imaging Procedure | Concentration (mg Iodine/mL) | Volume per Body Weight to Administer | Maximum Dose |
| Intra-arterial Procedures | |||
| Angiocardiography | 370 | 0.5 mL/kg to 2 mL/kg per single injection | Maximum Cumulative Dose by WeightNeonates: 5 mL/kgAged 4 weeks and older: 8 mL/kgDo not exceed maximum cumulative doses by age below.Maximum Cumulative Dose by Age<2 years 40 mL2 years to 4 years 50 mL5 years to 9 years 100 mL10 years to 18 years 125 mL |
| Intravenous Procedures | |||
| Excretory Urography | 250 | 1.2 mL/kg to 3.6 mL/kg | 120 mL |
| 300 | 1 mL/kg to 3 mL/kg | 100 mL | |
| CT of the Head and Body | 250 | 1.2 mL/kg to 3.6 mL/kg | 120 mL |
| 300 | 1 mL/kg to 3 mL/kg | 100 mL | |
Contraindications
None. None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data from published literature and postmarketing cases from decades of use with iopamidol during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Iopamidol crosses the placenta and reaches fetal tissues in small amounts ( see Data ). In animal reproduction studies, no adverse developmental outcomes were observed with intravenous administration of iopamidol to pregnant rats and rabbits during organogenesis at doses up to 2.7 and 1.4 times, respectively, the maximum recommended human dose ( see Data ).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, 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 Literature reports show that intravenously administered iopamidol crosses the placenta and is visualized in the digestive tract of exposed infants after birth.
Animal Data Iopamidol did not affect fetal development and did not induce teratogenic changes in the offspring in either rats or rabbits at the following dose levels tested: 600 mg, 1,500 mg, or 4,000 mg iodine/kg in rats, administered intravenously once a day during days 6 through 15 of pregnancy; 300 mg, 800 mg, or 2,000 mg iodine/kg in rabbits, administered intravenously once a day during days 6 through 18 of pregnancy.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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