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 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 of head and body and excretory urography (270 and 320 mg Iodine/mL)
• CT imaging 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)

Pediatric patients less than 12 years of age:

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

In concentrations of 270 and 320 mg of organically bound iodine per mL (550 mg and 642 mg of Iodixanol per mL).

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.

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. 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.

Not indicated for intrathecal use.

Most common adverse reactions (incidence greater than 0.5%) in adult patients after Iodixanol injection:Discomfort, warmth, pain

• Cardiovascular: angina
• Gastrointestinal: diarrhea, nausea, vomiting
• Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning
• Skin: itchy rash, severe itching, hives
• Special Senses: smell, taste, and vision alteration Pediatric patients experienced similar adverse reactions.

Pregnancy: There are no data with iodixanol use in pregnant women to inform any drug-associated risks.

Lactation: A lactating woman may pump and discard breast milk for 10 hours after Iodixanol administration.

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 reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration.

Geriatrics: Exercise caution in dose selection for elderly patients.

Pediatric Use: The safety and efficacy of Iodixanol have been established in pediatric patients down to birth for angiocardiography, cerebral arteriography, visceral arteriography, CT imaging of the head and body, and excretory urography. The safety and efficacy of Iodixanol have also been established in pediatric patients 12 years and older for intra-arterial digital subtraction angiography, peripheral arteriography, CT imaging peripheral venography, and CCTA.

The adverse effects of overdosage of any contrast agent may be life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Iodixanol Injection does not bind to plasma or serum protein and can be dialyzed.

Contrast medium for diagnostic procedures

Store Iodixanol at controlled room temperature, 20°C-25°C; excursions permitted to 15°C-30°C.