Iodixanol

Iodixanol is used for intra-arterial digital subtraction angiography, angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography. Iodixanol intravenous is indicated for CECT imaging of the head and body, excretory urography, and peripheral venography.

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

Dosages of Iodixanol:

Adult and Pediatric Dosage Forms and Strengths

Injectable Solution

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

Dosage Considerations – Should be Given as Follows:

Visipaque 320

Intra-arterial administration (arteriography), Adults and Children over 12 years

• 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
• Aorto-femoral runoffs: 20-90 mL

Intra-arterial administration, Children 1-12 years

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

Intra-arterial administration (IA-DSA), Adults and Children over 12 years

• Carotid or vertebral arteries: 5-8 mL
• Aortography: 10-50 mL
• Major aorta branch: 2-10 mL
• Aorto-femoral runoffs: 6-15 mL
• Peripheral arteries: 3-15 mL

Intravenous (IV) administration, Adults and Children over 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

Intra-arterial administration (IA-DSA), Adults and Children over 12 years

• Renal arteries: 10-25 mL
• Aortography: 20-50 mL
• Major aorta branches: 5-30 mL

Intra-arterial administration (IA-DSA), Children 1-12 years

• CECT or excretory urography: 1-2 mL/kg; not to exceed 2 mL/kg

IV administration, Adults and Children over 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 for normal renal function
• Venography (per lower extremity): 50-150 mL; not to exceed 250 mL

Side effects of Iodixanol may include:

• Discomfort at the injection site
• Chest pain (angina)
• Headache
• Migraine
• Spinning sensation (vertigo)
• Numbness and tingling
• Itching
• Skin rash
• Redness
• Changes in taste

Postmarketing side effects of iodixanol reported include:

• Cardiovascular Disorders: Cardiac arrest, palpitations, spasms of coronary arteries, high blood pressure (hypertension), and flushing
• Endocrine Disorders: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants; some patients were treated for hypothyroidism; low blood sugar (hypoglycemia), hyperthyroidism
• Eye Disorders: Transient visual impairment including cortical blindness, double vision, and blurred vision
• Gastrointestinal Disorders: Abdominal pain, pancreatitis, salivary gland enlargement
• General Disorders and Administration Site Conditions: Chills, fever, pain and discomfort, administration site reactions including fluid leakage
• Immune System Disorders: Hypersensitivity reactions, anaphylactic shock including, life-threatening or fatal anaphylaxis
• Nervous System Disorders: Tremor (transient), coma, disturbance in consciousness, transient contrast-induced encephalopathy caused by extravasation of contrast media (including amnesia, hallucination, paralysis, paresis, transient speech disorder, aphasia, difficulty speaking)
• Psychiatric Disorders: Anxiety, agitation
• Respiratory, Thoracic, and Mediastinal Disorders: Cough, sneezing, throat irritation or tightness, laryngeal swelling, pharyngeal swelling, bronchospasm
• Skin and subcutaneous tissue disorders: Reactions range from mild (e.g. rash, redness, itching hives, and skin discoloration) to severe: [e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS)]

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

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 of 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.

Warnings

• This medication contains iodixanol. Do not take Visipaque if you are allergic to iodixanol or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Black Box Warnings

• Not for intrathecal (IT) use
• Inadvertent IT administration of iodinated contrast media has resulted in serious adverse reactions including death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, muscle wasting (rhabdomyolysis), hyperthermia, and brain edema

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

• No information is available.

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 reported; use 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 hr 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

Coadministration with P-gp inhibitors

• Iodixanol is a P-gp substrate; avoid coadministration with P-gp inducers (e.g., rifampin)
• NVAF: No dose reduction recommended when coadministered with P-gp inhibitors; based on clinical experience from the ENGAGE AF-TIMI 48 study, dose reduction in patients concomitantly receiving P-gp inhibitors resulted in iodixanol blood levels that were lower than in patients who were given the full dose
• DVT/PE treatment: Dose reduction recommended when coadministered with P-gp inhibitors

Reversal of anticoagulant effects

• There is no established way to reverse the anticoagulant effects of iodixanol
• Effects may persist for 24 hours after the last dose
• Anticoagulant effects cannot be reliably monitored with standard laboratory testing
• Agent for iodixanol is not available; hemodialysis does not significantly contribute to iodixanol clearance
• Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse the anticoagulant activity of iodixanol; the use of prothrombin complex concentrates, or other procoagulant reversal agents such as activated prothrombin complex concentrate or recombinant factor VIIa (rFVIIa) may be considered but has not been evaluated in clinical outcome studies; when PCCs are used, monitoring for the anticoagulation effect of iodixanol using clotting test or anti-FXa activity is not useful and not recommended

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. Consult your doctor.
• There are no data on the presence of iodixanol in human milk, the effects on breastfed infants, or its 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. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for iodixanol and any potential adverse effects on a 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.
• Source: https://reference.medscape.com/drug/visipaque-iodixanol-3437