Iodixanol

Iodixanol is a prescription medication used as a contrast agent for scans or other radiologic (x-ray) examinations.

• Iodixanol is available under the following different brand names: Visipaque.

Common side effects of iodixanol include:

• pain or warm feeling e at the injection site,
• dizziness,
• spinning sensation,
• numbness or tingly feeling,
• vision changes,
• sleep problems (insomnia),
• headache,
• migraine,
• chest pain,
• nausea,
• vomiting,
• diarrhea,
• agitation,
• anxiety,
• nervousness,
• skin rash,
• itching, and
• changes in the sense of taste or smell

Serious side effects of iodixanol include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• swollen glands,
• flu-like symptoms,
• muscle aches,
• severe weakness,
• unusual bruising,
• yellowing of the skin or eyes,
• light-headedness,
• swelling,
• rapid weight gain,
• little or no urination,
• wheezing,
• seizure,
• extreme tired feeling,
• dry skin,
• joint pain or stiffness,
• muscle pain or weakness,
• hoarse voice,
• increased sensitivity to cold temperatures,
• weight gain,
• chest pain or pressure,
• pain spreading to the jaw or shoulder,
• nausea,
• sweating,
• sudden numbness or weakness (especially on side of the body),
• sudden severe headache,
• slurred speech,
• problems with vision or balance,
• sudden cough,
• rapid breathing and
• coughing up blood

Rare side effects of iodixanol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 270 mg/mL organically bound iodine (.e, iodixanol 550 mg/mL)
• 320 mg/mL organically bound iodine (.e, iodixanol 652 mg/mL)
• Visipaque 320

Adult dosage

• Intra-arterial administration (arteriography)
  • Carotid arteries: 10-14 mL
  • Vertebral arteries: 10-12 mL
  • Right coronary artery: 3-8 mL
  • Left coronary artery: 3-10 mL
  • Left ventricle: 20-45 mL
  • Renal arteries: 8-18 mL
  • Aortography: 30-70 mL
  • Major aorta branch: 10-70 mL
  • Peripheral arteries: 15-30 mL
  • Aortofermoral runoffs: 20-90 mL

Pediatric dosage

Children1-12 years

• Cerebral, cardiac chambers and related major arteries, and visceral studies: 1-2 mL/kg; not to exceed 4 mL/kg

Children above12 years

• Carotid arteries: 10-14 mL
• Verterbral arteries: 10-12 mL
• Right coronary artery: 3-8 mL
• Left coronary artery: 3-10 mL
• Left ventricle: 20-45 mL
• Renal arteries: 8-18 mL
• Aortography: 30-70 mL
• Major aorta branch: 10-70 mL
• Peripheral arteries: 15-30 mL
• Aortofermoral runoffs: 20-90 mL

Intra-arterial administration (IA-DSA)

• Adult dosage
• Carotid or vertebral arteries: 5-8 mL
• Aortography: 10-50 mL
• Major aorta branch: 2-10 mL
• Aortofemoral runoffs: 6-15 mL
• Peripheral arteries: 3-15 mL
• Pediatric dosage
• Visipaque 320
• Children above12 years
• Carotid or vertebral arteries: 5-8 mL
• Aortography: 10-50 mL
• Major aorta branch: 2-10 mL
• Aortofemoral runoffs: 6-15 mL
• Peripheral arteries: 3-15 mL

IV administration

Adult dosage

• CECT of head or body: 75-150 mL bolus, then 100-150 mL infusion not to exceed 150 mL
• Excretory urography: 1 mL/kg, not to exceed 100 mL
• Venography: 50-150 mL per lower extremity

Pediatric dosage

• Visipaque 320
• Children above 12 years
  • CECT of head or body: 75-150 mL bolus, then 100-150 mL infusion not to exceed 150 mL
  • Excretory urography: 1 mL/kg, not to exceed 100 mL
  • Venography: 50-150 mL per lower extremity
• Visipaque 270
• Adult dosage
  • Intra-arterial administration (IA-DSA
  • Renal arteries: 10-25 mL
  • Aortography: 20-50 mL
  • Major aorta branches: 5-30 mL

Pediatric dosage

• Children1-12 years
  • CECT or excretory urography: 1-2 mL/kg; not to exceed 2 mL/kg
• Children above 12 years
  • Renal arteries: 10-25 mL
  • Aortography: 20-50 mL
  • Major aorta branches: 5-30 mL

IV administration

Visipaque 270

Adult dosage

• CECT of head or body: 75-150 mL bolus, then 100-150 mL infusion; not to exceed 150 mL
• Excretory urography: 1 mL/kg; not to exceed 100 mL for normal renal function
• Venography (per lower extremity): 50-150 mL; not to exceed 250 mL
• Pediatric dosage
• Children above12 years
  • CECT of head or body: 75-150 mL bolus, then 100-150 mL infusion; not to exceed 150 mL
  • Excretory urography: 1 mL/kg; not to exceed 100 mL for normal renal function
  • Venography (per lower extremity): 50-150 mL; not to exceed 250 below

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Iodixanol has no listed severe interactions with other drugs.
• Iodixanol has no listed serious interactions with other drugs.
• Iodixanol has no listed moderate interactions with other drugs.
• Iodixanol has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity to product or components
• Intrathecal use
• In children, prolonged fasting and use of laxative before administration is contraindicated
• The product label has additional procedure-specific contraindications

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using iodixanol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using iodixanol?”

Cautions

• Maintain adequate hydration
• Use caution in renal/hepatic impairment, cardiovascular disease, multiple myeloma, pheochromocytoma, sickle cell disease, elderly patients, and thyroid dysfunction
• Increased risk of adverse effects including heart disease, asthma patients, and sensitivity to allergens or medications
• Renal failure may occur in patients with diabetes during preparatory dehydration; maintain normal hydration in these patients
• Patients with homocystinuria may be at risk for thrombosis and embolism; avoid angiography in these patients
• Avoid extravasation, especially in patients with severe arterial or venous disease
• Thromboembolic events causing myocardial infarction and stroke were reported; the use of meticulous intravascular administration techniques, especially during angiographic procedures
• Severe cutaneous adverse reactions(SCAR), including Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS), may develop from 1 hour to several weeks after intravascular contrast agent administration; reaction severity may increase and time to onset may decrease with repeat administration of contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions; avoid administering the product to patients with a history of severe cutaneous adverse reaction to the product

Thyroid dysfunction in pediatric patients

• Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression was reported after both single exposure and multiple exposures to iodinated contrast media; among patients 0- 3 years of age exposed to iodinated contrast media, thyroid dysfunction was reported depending on the age of the patient and dose of the iodinated contrast agent
• Younger age, very low birth weight, prematurity, and presence of other conditions, such as admission to neonatal or pediatric intensive care units, and cardiac conditions are associated with an increased risk; pediatric patients with cardiac conditions may be at greatest risk given that they often require high doses of contrast during invasive cardiac procedures, such as catheterization and computed tomography (CT)
• Pediatric patients 0-3 years of age warrant closer monitoring because an underactive thyroid during early life may be harmful to the motor, hearing, and cognitive development and may require transient T4 replacement therapy; evaluate thyroid function in all pediatric patients 0-3 years of age within 3 weeks following exposure to iodinated contrast media, especially in term and preterm neonates; if thyroid dysfunction detected, treat and monitor thyroid function as clinically needed
• The safety and effectiveness of this drug in pediatric patients below 2 years of age have not been established, and the drug is not approved for use in pediatric patients below 2 years of age

FDA MedWatch

• March 30, 2022: FDA recommended newborns and children aged below3 years have follow-up thyroid monitoring within 3 weeks after receiving iodinated contrast media (ICM) for X-rays and other medical imaging procedures
• Published studies found underactive thyroid and temporary decreases in thyroid hormone levels were uncommon; however, if identified and treated early, future complications may be prevented
• Appropriately monitor for signs and symptoms of hypothyroidism and decreased thyroid hormone levels following ICM exposure; consider evaluating thyroid function within 3 weeks, especially in term and preterm neonates and children with some underlying conditions
• If thyroid dysfunction is detected, treat and monitor thyroid function as needed to avoid future complications
• Certain pediatric patients are at increased risk, including newborns or have very low birth weight, prematurity, or presence of cardiac or other conditions (.g, requiring care in neonatal or pediatric ICUs)
• Patients with cardiac conditions may be at the greatest risk since they often require high doses of contrast during invasive cardiac procedures

Pregnancy and Lactation

• There are no data on 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

Lactation

• There are no data on the presence of iodixanol in human milk, the effects on breastfed infants, or effects on milk production. Iodinated contrast agents are poorly excreted into human milk and are poorly absorbed by the gastrointestinal tract of a breastfed infant; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for iodixanol and any potential adverse effects on the breastfed infant from iodixanol or underlying maternal condition
• Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small; however, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after iodixanol administration to minimize drug exposure to a breastfed infant