ULTRAVIST (PHARMACY BULK)

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ULTRAVIST (PHARMACY BULK) (ULTRAVIST (PHARMACY BULK)).

How it works

Iodinated nonionic radiographic contrast agent that attenuates X-rays due to its iodine content, providing vascular and tissue opacification during imaging.

What the body does with it

Metabolism	Not metabolized; eliminated unchanged via glomerular filtration.
Excretion	Primarily renal by glomerular filtration; approximately 60-70% eliminated unchanged in urine within 6 hours, with >90% excreted within 24 hours. Less than 1% biliary or fecal.
Half-life	Terminal elimination half-life is approximately 1.5-2 hours in patients with normal renal function. Prolonged in renal impairment (up to 10-30 hours) or severe disease.
Protein binding	Low; approximately 10-15% bound to plasma proteins, mainly albumin.
Volume of Distribution	Approximately 0.2-0.3 L/kg, indicating distribution primarily in extracellular fluid.
Bioavailability	Not applicable for oral route; administered intravenously, bioavailability is 100%.
Onset of Action	Intravenous administration: immediate opacification occurs within seconds to minutes after injection, peaking at 1-2 minutes for angiographic studies.
Duration of Action	Duration of contrast enhancement is typically short (minutes) for angiography; for excretory urography, maximal contrast in renal collecting system occurs within 5-15 minutes, fading by 30-60 minutes.

Classification & Brands

Dosing & administration

300 mg iodine/mL, 370 mg iodine/mL: 0.6-1.5 mL/kg IV for CT; 100-300 mL IV for angiography. Repeat doses allowed up to maximum total dose of 500 mL.

Dosage form	INJECTABLE
Renal impairment	eGFR <30 mL/min/1.73 m²: Administer with caution, ensure adequate hydration, consider lowest possible dose. eGFR <15 mL/min: Avoid use unless dialysis immediately available.
Liver impairment	No specific dose adjustment recommended based on Child-Pugh class; use caution in severe hepatic impairment due to potential coagulation abnormalities.
Pediatric use	CT: 1-2 mL/kg (300 mg I/mL) IV; Angiography: 1-2 mL/kg (300 mg I/mL) IV. Maximum single dose: 4 mL/kg. Adjust for age and clinical condition.
Geriatric use	Start with lower end of dosing range; monitor renal function (eGFR) and hydration status; increased risk of nephrotoxicity and volume overload.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for ULTRAVIST (PHARMACY BULK) (ULTRAVIST (PHARMACY BULK)).

Breastfeeding	Iopromide is excreted into breast milk in very small amounts. The M/P ratio is approximately 1.0. The systemic dose to the infant is negligible (<0.01% of maternal dose). Breastfeeding can continue without interruption, but the infant should be monitored for rare hypersensitivity or gastrointestinal effects.
Teratogenic Risk	ULTRAVIST (iopromide) is an iodinated contrast agent. In pregnancy, it crosses the placenta. First trimester: Inadvertent exposure is not associated with teratogenicity based on limited human data; animal studies show no evidence of fetal harm. Second and third trimesters: Fetal thyroid exposure can cause transient neonatal hypothyroidism; risk is dose-dependent.

Warnings & precautions

■ FDA Black Box Warning

Risk of contrast-induced acute kidney injury (CI-AKI), especially in patients with pre-existing renal impairment, diabetes, dehydration, or concurrent use of nephrotoxic drugs. Not for intrathecal use.

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of severe hypersensitivity to iodinated contrast media","Manifest hyperthyroidism","Decompensated heart failure","Intrathecal administration (not indicated)","Anuria or severe renal impairment (relative, with caution)"]

Clinical Precautions

Precautions

["Hypersensitivity reactions (anaphylaxis, bronchospasm, angioedema)","Contrast-induced nephropathy","Thyroid storm in patients with hyperthyroidism","Cardiovascular effects (arrhythmias, hypotension, pulmonary edema)","Extravasation risk","Hematologic abnormalities (coagulopathy)","Interference with thyroid function tests","Sickle cell disease exacerbation"]

Clinical Tips & Counseling

Drug interactions

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ULTRAVIST (PHARMACY BULK)

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ULTRAVIST (PHARMACY BULK) (ULTRAVIST (PHARMACY BULK)).

How it works

Iodinated nonionic radiographic contrast agent that attenuates X-rays due to its iodine content, providing vascular and tissue opacification during imaging.

What the body does with it

Metabolism	Not metabolized; eliminated unchanged via glomerular filtration.
Excretion	Primarily renal by glomerular filtration; approximately 60-70% eliminated unchanged in urine within 6 hours, with >90% excreted within 24 hours. Less than 1% biliary or fecal.
Half-life	Terminal elimination half-life is approximately 1.5-2 hours in patients with normal renal function. Prolonged in renal impairment (up to 10-30 hours) or severe disease.
Protein binding	Low; approximately 10-15% bound to plasma proteins, mainly albumin.
Volume of Distribution	Approximately 0.2-0.3 L/kg, indicating distribution primarily in extracellular fluid.
Bioavailability	Not applicable for oral route; administered intravenously, bioavailability is 100%.
Onset of Action	Intravenous administration: immediate opacification occurs within seconds to minutes after injection, peaking at 1-2 minutes for angiographic studies.
Duration of Action	Duration of contrast enhancement is typically short (minutes) for angiography; for excretory urography, maximal contrast in renal collecting system occurs within 5-15 minutes, fading by 30-60 minutes.

Classification & Brands

Dosing & administration

300 mg iodine/mL, 370 mg iodine/mL: 0.6-1.5 mL/kg IV for CT; 100-300 mL IV for angiography. Repeat doses allowed up to maximum total dose of 500 mL.

Dosage form	INJECTABLE
Renal impairment	eGFR <30 mL/min/1.73 m²: Administer with caution, ensure adequate hydration, consider lowest possible dose. eGFR <15 mL/min: Avoid use unless dialysis immediately available.
Liver impairment	No specific dose adjustment recommended based on Child-Pugh class; use caution in severe hepatic impairment due to potential coagulation abnormalities.
Pediatric use	CT: 1-2 mL/kg (300 mg I/mL) IV; Angiography: 1-2 mL/kg (300 mg I/mL) IV. Maximum single dose: 4 mL/kg. Adjust for age and clinical condition.
Geriatric use	Start with lower end of dosing range; monitor renal function (eGFR) and hydration status; increased risk of nephrotoxicity and volume overload.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for ULTRAVIST (PHARMACY BULK) (ULTRAVIST (PHARMACY BULK)).

Breastfeeding	Iopromide is excreted into breast milk in very small amounts. The M/P ratio is approximately 1.0. The systemic dose to the infant is negligible (<0.01% of maternal dose). Breastfeeding can continue without interruption, but the infant should be monitored for rare hypersensitivity or gastrointestinal effects.
Teratogenic Risk	ULTRAVIST (iopromide) is an iodinated contrast agent. In pregnancy, it crosses the placenta. First trimester: Inadvertent exposure is not associated with teratogenicity based on limited human data; animal studies show no evidence of fetal harm. Second and third trimesters: Fetal thyroid exposure can cause transient neonatal hypothyroidism; risk is dose-dependent.