Iopromide

What it is and how it works

Mechanism of Action Intravascular injection of iopromide opacifies those vessels where the contrast agent is present, permitting radiographic visualization of the internal structures through attenuation of photons. In imaging of the body, iodinated contrast agents diffuse from the vessels into the extravascular space. In 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 extravascular space in the region of disruption.

Mechanism class: X-Ray Contrast Activity

Indications

® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older Intravenous Procedures † • Excretory urography in adults and pediatric patients aged 2 years and older • Contrast computed tomography (CT) of head and body in adults and pediatric patients aged 2 years and older • Contrast mammography in adults as an adjunct following mammography and/or ultrasound † Specific concentrations and presentations are recommended for each type of imaging procedure.

Dosage and administration (summary)

• Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. ( 2.2 , 2.3 , 2.4 ) • For contrast mammography, use ULTRAVIST with a device that is cleared for dual-energy full field digital mammography. • See full prescribing information for important dosage and administration instructions and directions for use of pharmacy bulk packages and imaging bulk packages. ( 2.1 , 2.6 , 2.7 ) Important Dosage and Administration Information • ULTRAVIST is for intra-arterial or intravenous use only and must not be administered intrathecally .

Contraindications

None None

Warnings and precautions

• Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. • Acute Kidney Injury : Acute injury including renal failure can occur. Dose minimization and hydration may decrease risk. • Cardiovascular Reactions : Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration.

Pregnancy

Pregnancy Risk Summary There are no data on ULTRAVIST use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts (see Data) .

Storage and supply

How Supplied ULTRAVIST injection is a sterile, clear, colorless to slightly yellow, odorless, pyrogen-free aqueous solution available in the following presentations: ULTRAVIST 300 mg Iodine per mL Package Type Volume Sale Unit NDC Single-Dose Vials 50 mL Carton of 10 50419-344-05 100 mL Carton of 10 50419-344-10 125 mL Carton of 10 50419-344-12 150…

Source: Iopromide (Ultravist) — US FDA prescribing information, 2026-03-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.