Iodixanol

IODIXANOL- iodixanol injection, solution
FRESENIUS KABI USA, LLC

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 Adverse Reactions (5.1)].

1 INDICATIONS AND USAGE

Iodixanol injection is indicated in for:

1.1 Intra-arterial Procedures

Adult and pediatric patients 12 years of age and older

  • (270 mg Iodine/mL and 320 mg Iodine/mL) intra-arterial digital subtraction angiography (IA-DSA).
  • (320 mg Iodine/mL) angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography.

Pediatric patients less than 12 years of age

  • (320 mg Iodine/mL) angiocardiography, cerebral arteriography, and visceral arteriography.

1.2 Intravenous Procedures

Adult and pediatric patients 12 years of age and older

  • (270 mg Iodine/mL and 320 mg Iodine/mL) CT imaging of the head and body.
  • (270 mg Iodine/mL and 320 mg Iodine/mL) excretory urography.
  • (270 mg Iodine/mL) peripheral venography.
  • (320 mg Iodine/mL) coronary computed tomography angiography (CCTA) to assist in the diagnostic evaluation of patients with suspected coronary artery disease.

Pediatric patients less than 12 years of age

  • (270 mg Iodine/mL) CT imaging of the head and body.
  • (270 mg Iodine/mL) excretory urography.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

  • Iodixanol injection is for intravascular use only [see Boxed Warning, Contraindications (4), and Warnings and Precautions (5.1)]
  • Use sterile technique for all handling and administration of iodixanol injection.
  • Do not use if tamper-evident ring is broken or missing.
  • Warm iodixanol injection and administer at body or room temperature.
  • Inspect iodixanol injection for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if iodixanol injection contains particulate matter or is discolored.
  • Do not mix iodixanol injection 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 iodixanol injection. 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 iodixanol injection; especially in patients with severe arterial or venous disease [see Warnings and Precautions (5.6)].
  • Hydrate patients before and after iodixanol injection administration [see Warnings and Precautions (5.3)] .

2.2 Intra-arterial Dosage and Administration

  • Intra-arterial digital subtraction angiography (IA-DSA) (270 mg Iodine/mL 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:

TABLE 1

ADULTS and PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

IODIXANOL INJECTION SINGLE DOSE RECOMMENDATIONS FOR INJECTION INTO SELECTED ARTERIES

ARTERIOGRAPHY IA-DSA1 Maximum Total Dose
Intra-arterial Injection Sites 320 mg Iodine/mL 270 mgIodine/mL 320 mg Iodine/mL
Carotid Arteries 10 mL to 14 mL 5 mL to 8 mL Usually Not to Exceed 175 mL
Vertebral Arteries 10 mL to 12 mL 5 mL to 8 mL
Right Coronary Artery 3 mL to 8 mL Usually Not to Exceed 200 mL
Left Coronary Artery 3 mL to 10 mL
Left Ventricle 20 mL to 45 mL
Renal Arteries 8 mL to 18 mL 10 mL to 25 mL Usually Not to Exceed 250 mL
Aortography 30 mL to 70 mL 20 mL to 50 mL 10 mL to 50 mL
Major Branches of Aorta 10 mL to 70 mL 5 mL to 30 mL 2 mL to 10 mL
Aortofemoral Runoffs 20 mL to 90 mL 6 mL to 15 mL
Peripheral Arteries 15 mL to 30 mL 3 mL to 15 mL

1 IA-DSA = Intra-arterial Digital Subtraction Angiography

2.3 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 iodixanol injection 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 iodixanol 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.

TABLE 2

ADULTS and PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER IODIXANOL INJECTION DOSING RECOMMENDATIONS FOR INTRAVENOUS CONTRAST ADMINISTRATION
Study Type Comment 270 mg Iodine/mL 320 mg Iodine/mL Maximum Total Volume
CT of Head or Body1

Bolus

75 mL to 150 mL 75 mL to 150 mL 150 mL
Infusion 100 mL to 150 mL 100 mL to 150 mL
Excretory Urography Normal Renal Function 1 mL/kg 1 mL/kg 100 mL
Venography Per lower extremity 50 mL to 150 mL 250 mL
CCTA1,2 Bolus injection with test bolus3 or bolus tracking 50 mL to 150 mL4 (4 mL to 7 mL per second) 150 mL

1 For CT of the head and body, iodixanol injection may be used with an automated contrast injection system or contrast media management system cleared for use with iodixanol injection.

2 For pediatric patients aged 12 to 17, recommended dose is 1 mL/kg to 2 mL/kg.
3 The main iodixanol injection volume may be preceded by a test bolus consisting of 20 mL iodixanol injection, immediately followed by a 20 mL saline flush, both injected at rate of 4 mL/sec to 7 mL/sec.
4 Injection of iodixanol injection 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 iodixanol injection dose (excluding any test bolus). For CCTA acquired at < 120 kVp, the dose of iodixanol injection 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 iodixanol injection may be reduced in proportion to the scan duration.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.