Iodixanol
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema [see Contraindications (4) and Warnings and Precautions (5.1) ] . WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning Inadvertent intrathecal administration may cause death, convulsions/seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia, and brain edema. ( 4 , 5.1 )
Radiographic Contrast Agent
Dosing in kidney impairment
The time between VISIPAQUE injection and peak arterial concentration varies between patients. Selected dosing for different indications in adults and pediatric patients over 12 years of age are shown in Table 2. [See table below.] 100 to 150 mL 75 to 150 mL 100 to 150 mL 150 mL Excretory Urography Normal Renal Function 1 mL/kg 1 mL/kg 100 mL Venography Per lower extremity 50 to 150 mL 250 mL CCTA For pediatric patients aged 12 to 17, recommended dose is 1 to 2 mL/kg.
| ARTERIOGRAPHY | IA-DSAIA-DSA = Intra-Arterial Digital Subtraction Angiography | |||
|---|---|---|---|---|
| Intra-Arterial Injection Sites | 320 mg Iodine/mL | 270 mg Iodine/mL | 320 mg Iodine/mL | Maximum Total Dose |
| Carotid Arteries | 10 to 14 mL | 5 to 8 mL | Usually Not to Exceed 175 mL | |
| Vertebral Arteries | 10 to 12 mL | 5 to 8 mL | ||
| Right Coronary Artery | 3 to 8 mL | Usually Not to Exceed 200 mL | ||
| Left Coronary Artery | 3 to 10 mL | |||
| Left Ventricle | 20 to 45 mL | |||
| Renal Arteries | 8 to 18 mL | 10 to 25 mL | -- | Usually Not to Exceed 250 mL |
| Aortography | 30 to 70 mL | 20 to 50 mL | 10 to 50 mL | |
| Major Branches of Aorta | 10 to 70 mL | 5 to 30 mL | 2 to 10 mL | |
| Aortofemoral Runoffs | 20 to 90 mL | -- | 6 to 15 mL | |
| Peripheral Arteries | 15 to 30 mL | -- | 3 to 15 mL | |
| Study Type | Comment | 270 mg Iodine/mL | 320 mg Iodine/mL | Maximum Total Volume |
|---|---|---|---|---|
| CT of Head or Body | Bolus Infusion | 75 to 150 mL 100 to 150 mL | 75 to 150 mL 100 to 150 mL | 150 mL |
| Excretory Urography | Normal Renal Function | 1 mL/kg | 1 mL/kg | 100 mL |
| Venography | Per lower extremity | 50 to 150 mL | 250 mL | |
| CCTAFor pediatric patients aged 12 to 17, recommended dose is 1 to 2 mL/kg. | Bolus injection with test bolusThe main VISIPAQUE volume may be preceded by a test bolus consisting of 20 mL VISIPAQUE, immediately followed by a 20 mL saline flush, both injected at rate of 4 to 7 mL/sec. or bolus tracking | 50 to 150 mLInjection of VISIPAQUE with saline can be either biphasic (without dilution phase) or triphasic (with dilution phase). Alternatively, a dose of 1 mL/kg may be used to calculate total VISIPAQUE dose (excluding any test bolus). For CCTA acquired at < 120 kVp, the dose of VISIPAQUE may be reduced by up to 15% in patients < 85 kg and BMI < 30 kg/m2. For CCTA acquired on a scanner with more than 64 detector rows, the dose of VISIPAQUE may be reduced in proportion to the scan duration. (4 to 7 mL per second) | 150 mL |
Preparation and administration
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Important Dosage and Administration Instructions VISIPAQUE is for intravascular use only [see Boxed Warning , Contraindications , and Warnings and Precautions ] Use sterile technique for all handling and administration of VISIPAQUE. Do not use if tamper-evident ring is broken or missing. Warm VISIPAQUE and administer at body or room temperature.
Inspect VISIPAQUE for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if VISIPAQUE contains particulate matter or is discolored. Do not mix VISIPAQUE with, or inject in intravenous lines containing, other drugs or total nutritional admixtures. Use the lowest dose necessary to obtain adequate visualization.
Individualize the volume, strength, and rate of administration of VISIPAQUE. Consider factors such as age, bodyweight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.
The maximum recommended total dose of iodine for adults is 80 grams. Avoid extravasation when injecting VISIPAQUE; especially in patients with severe arterial or venous disease [see Warnings and Precautions ]. Hydrate patients before and after VISIPAQUE administration [see Warnings and Precautions ].
Intra-Arterial Dosage and Administration Intra-arterial digital subtraction angiography (IA-DSA) (270 and 320 mg Iodine/mL) Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL) Use Injection rates approximately equal to the flow rate in the vessel being injected.
The usual single injection volumes or total dose per patient (mL/kg) for adults and adolescents over 12 years of age are listed in Table 1. [See table below.]
Intravenous Dosage and Administration Computed Tomography of the Head or Body (270 mg Iodine/mL and 320 mg Iodine/mL) Excretory Urography (270 mg Iodine/mL and 320 mg Iodine/mL) Peripheral Venography (270 mg Iodine/mL) Coronary Computed Tomography Angiography (CCTA) (320 mg Iodine/mL) Recommended dosage of VISIPAQUE is dependent on: the administration procedure, patient weight, and CT device factors, as detailed in Table 2.Calibrate the intravenous injection rate so that image acquisition coincides with peak arterial concentration.
The time between VISIPAQUE injection and peak arterial concentration varies between patients. Selected dosing for different indications in adults and pediatric patients over 12 years of age are shown in Table 2. [See table below.] 100 to 150 mL 75 to 150 mL 100 to 150 mL 150 mL Excretory Urography Normal Renal Function 1 mL/kg 1 mL/kg 100 mL Venography Per lower extremity 50 to 150 mL 250 mL CCTA For pediatric patients aged 12 to 17, recommended dose is 1 to 2 mL/kg.
Bolus injection with test bolus The main VISIPAQUE volume may be preceded by a test bolus consisting of 20 mL VISIPAQUE, immediately followed by a 20 mL saline flush, both injected at rate of 4 to 7 mL/sec. or bolus tracking 50 to 150 mL Injection of VISIPAQUE with saline can be either biphasic (without dilution phase) or triphasic (with dilution phase).
Alternatively, a dose of 1 mL/kg may be used to calculate total VISIPAQUE dose (excluding any test bolus). For CCTA acquired at < 120 kVp, the dose of VISIPAQUE may be reduced by up to 15% in patients < 85 kg and BMI < 30 kg/m 2 . For CCTA acquired on a scanner with more than 64 detector rows, the dose of VISIPAQUE may be reduced in proportion to the scan duration. (4 to 7 mL per second) 150 mL
Dosage in Pediatric Patients Less Than 12 Years of Age Intra-arterial Dosage and Administration Angiocardiography, cerebral arteriography, or visceral arteriography (320 mg Iodine/mL) : The recommended dosage is 1 to 2 mL/kg. The maximum dose should not exceed 4 mL/kg. Intravenous Dosage and Administration Computerized Tomography or Excretory Urography (270 mg Iodine/mL) : The recommended dosage is 1 to 2 mL/kg.
The maximum dose should not exceed 2 mL/kg.
| Study Type | Comment | 270 mg Iodine/mL | 320 mg Iodine/mL | Maximum Total Volume |
|---|---|---|---|---|
| CT of Head or Body | Bolus Infusion | 75 to 150 mL 100 to 150 mL | 75 to 150 mL 100 to 150 mL | 150 mL |
| Excretory Urography | Normal Renal Function | 1 mL/kg | 1 mL/kg | 100 mL |
| Venography | Per lower extremity | 50 to 150 mL | 250 mL | |
| CCTAFor pediatric patients aged 12 to 17, recommended dose is 1 to 2 mL/kg. | Bolus injection with test bolusThe main VISIPAQUE volume may be preceded by a test bolus consisting of 20 mL VISIPAQUE, immediately followed by a 20 mL saline flush, both injected at rate of 4 to 7 mL/sec. or bolus tracking | 50 to 150 mLInjection of VISIPAQUE with saline can be either biphasic (without dilution phase) or triphasic (with dilution phase). Alternatively, a dose of 1 mL/kg may be used to calculate total VISIPAQUE dose (excluding any test bolus). For CCTA acquired at < 120 kVp, the dose of VISIPAQUE may be reduced by up to 15% in patients < 85 kg and BMI < 30 kg/m2. For CCTA acquired on a scanner with more than 64 detector rows, the dose of VISIPAQUE may be reduced in proportion to the scan duration. (4 to 7 mL per second) | 150 mL |
Drug interactions
Check iodixanol against a medication listLabel text (6 paragraphs)
7 DRUG INTERACTIONS
7.1 Drug-Drug Interactions Metformin In patients with renal impairment, metformin 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, VISIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable.
Radioactive Iodine Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy in patients with carcinoma of the thyroid. The decrease in efficacy lasts for 6 to 8 weeks. Beta-adrenergic Blocking Agents The use of beta-adrenergic blocking agents lowers the threshold for and increases the severity of contrast reactions, and reduces the responsiveness of treatment of hypersensitivity reactions with epinephrine. Because of the risk of hypersensitivity reactions, use caution when administering VISIPAQUE to patients taking beta-blockers.
Oral Cholecystographic Contrast Agents Renal toxicity has been reported in patients with liver dysfunction who were given an oral cholecystographic agent followed by intravascular iodinated contrast agents. Postpone the administration of VISIPAQUE in patients who have recently received an oral cholecystographic contrast agent.
7.2 Drug-Laboratory Test Interactions Effect on Thyroid Tests The results of protein bound iodine and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for at least 16 days following administration of iodinated contrast agents. However, thyroid function tests which do not depend on iodine estimations (e.g., T3 resin uptake and total or free thyroxine T4 assays) are not affected. Effect on Urine Tests As reported with other contrast agents, VISIPAQUE may produce a false-positive result for protein in the urine using urine dip tests.
However, the Coomassie blue method has been shown to give accurate results for the measurement of urine protein in the presence of VISIPAQUE. In addition, care should be used in interpreting the results of urine specific gravity measurements in the presence of high levels of VISIPAQUE and other contrast agents in the urine. Refractometry or urine osmolality may be substituted.
Contraindications
4 CONTRAINDICATIONS VISIPAQUE is contraindicated for Intrathecal use [see Warnings and Precautions (5.1) ] . Not indicated for intrathecal use. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data with iodixanol use in pregnant women to inform any drug-associated risks. In animal reproduction studies, no developmental toxicity occurred with intravenous iodixanol administration to rats and rabbits at doses up to 0.24 (rat) or 0.48 (rabbit) times the maximum recommended human intravenous dose ( see Data ). 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 Animal Data Reproduction studies were performed in rats and rabbits with intravenous administration of iodixanol at doses up to 2 g Iodine/kg, daily, from implantation of the embryo (gestation day 7 in rat; 6 in rabbit) through closure of the hard palate (gestation day 17 in rats; 18 in rabbits). No maternal toxicity occurred, and no adverse effects occurred on fetal survival, embryo-fetal development, or the ability of dams to rear a litter.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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