Iodixanol

What it is and how it works

Mechanism of Action Intravascular injection of iodixanol opacifies vessels in the path of flow of the contrast agent, permitting visualization of internal structures. In imaging of the body, iodinated contrast agents diffuse from the vascular into the extravascular space. In a normal brain with an intact blood-brain barrier, contrast does not diffuse into the extravascular space. In patients with a disrupted blood- brain barrier, contrast agent accumulates in the interstitial space in the region of disruption.

Mechanism class: X-Ray Contrast Activity

Indications

Iodixanol injection is indicated in for: Iodixanol injection is a radiographic contrast agent indicated for the following: Intra-arterial Procedures Adults and pediatric patients 12 years of age and over Intra-arterial digital subtraction angiography (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). Pediatric patients less than 12 years of age Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg Iodine/mL). Intravenous Procedures Adults and pediatric patients 12 years of age and over Computed tomography (CT) imaging head and 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) to assist diagnostic evaluation of patients with suspected coronary artery disease (320 mg Iodine/mL).

Dosage and administration (summary)

Individualize the combination of volume and concentration of iodixanol injection considering age, body weight, size of the vessel, rate of blood flow within the vessel, and other applicable factors. ( 2.1 , 2.2 , 2.3 , 2.4 ) 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. For the adult patients, the maximum recommended total dose of iodine is 80 grams. Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents.

Contraindications

Iodixanol is contraindicated for intrathecal use : Not indicated for intrathecal use.

Warnings and precautions

Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. Contrast-Induced Acute Kidney Injury: Acute injury including renal failure can occur. Minimize dose and maintain adequate hydration to minimize risk. Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.

Pregnancy

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)…

Storage and supply

Storage and Handling Protect iodixanol injection, USP from direct exposure to sunlight. Store iodixanol injection, USP at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Iodixanol injection, USP may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).

Source: Iodixanol (Iodixanol) — US FDA prescribing information, 2023-07-21, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.