ISOVUE-300

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ISOVUE-300 (ISOVUE-300).

How it works

Iodinated radiocontrast agent that attenuates X-rays, providing enhanced visualization of vascular structures and body cavities during imaging procedures.

What the body does with it

Metabolism	Not metabolized; excreted unchanged by glomerular filtration.
Excretion	Primarily renal (glomerular filtration), with >95% of administered dose excreted unchanged in urine within 24 hours. Less than 1% is excreted via bile/fecal route.
Half-life	Terminal elimination half-life in patients with normal renal function is approximately 2 hours. In patients with moderate to severe renal impairment (creatinine clearance <30 mL/min), the half-life can be prolonged up to 20–40 hours, requiring dose adjustment.
Protein binding	Iopamidol (active ingredient) is minimally protein bound (<5%), primarily to albumin.
Volume of Distribution	Approximately 0.20–0.30 L/kg, indicating distribution primarily within extracellular fluid space; low tissue binding.
Bioavailability	Not applicable for oral route as it is used only intravascularly or intrathecally; bioavailability is 100% for IV injection and near 100% for intra-arterial and intrathecal administration.
Onset of Action	Intravenous administration: opacification begins almost immediately during injection. Intra-arterial: begins within seconds to minutes depending on injection site and catheter placement.
Duration of Action	Intravenous: adequate contrast enhancement persists for 30–60 minutes following bolus injection due to rapid redistribution and excretion. Intrathecal: diagnostic visualization up to 1 hour but may last longer; caution in patients with impaired renal function.

Classification & Brands

Dosing & administration

Intravenous: 50-150 mL (up to 300 mg iodine/kg) as a bolus or infusion; intra-arterial: 5-40 mL depending on procedure; intrathecal: 8-15 mL. Maximum total iodine dose: 300 mg iodine/kg.

Dosage form	INJECTABLE
Renal impairment	GFR <30 mL/min: Use with caution; consider lower dose and ensure adequate hydration. GFR <15 mL/min: Avoid use unless essential; post-procedure hemodialysis may be considered. No specific dose reduction formula; clinical judgment advised.
Liver impairment	No specific Child-Pugh based dose adjustments; use cautiously in severe hepatic impairment due to altered pharmacokinetics.
Pediatric use	Weight-based: 1-2 mL/kg (300 mg iodine/mL) intravenously; maximum total dose 300 mg iodine/kg. Adjust for body habitus and procedure.
Geriatric use	Elderly patients may have reduced renal function; assess GFR and adjust dose accordingly. Ensure adequate hydration before and after procedure. Monitor for nephrotoxicity and hypersensitivity.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for ISOVUE-300 (ISOVUE-300).

Breastfeeding	Iopamidol is excreted into breast milk in small amounts (<1% of maternal dose). M/P ratio not established. Discontinue breastfeeding for 12-24 hours after administration, or pump and discard. Use only if clearly needed.
Teratogenic Risk	Iodinated contrast agents like Isovue-300 (iopamidol) cross the placenta. First trimester: Avoid unless essential; theoretical risk of fetal hypothyroidism from free iodide. Second/third trimester: Risk of transient neonatal hypothyroidism if high doses used; fetal goiter reported. No teratogenic effects at clinical doses in animal studies.

Warnings & precautions

■ FDA Black Box Warning

No FDA boxed warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to iopamidol or any components of the formulation","History of severe adverse reaction to iodinated contrast agents"]

Clinical Precautions

Precautions

["Risk of serious hypersensitivity reactions (including anaphylaxis)","Acute kidney injury in patients with pre-existing renal impairment or other risk factors","Thyroid dysfunction (especially in neonates) due to iodine load","Pregnancy and lactation considerations"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

ISOVUE-300

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ISOVUE-300 (ISOVUE-300).

How it works

Iodinated radiocontrast agent that attenuates X-rays, providing enhanced visualization of vascular structures and body cavities during imaging procedures.

What the body does with it

Metabolism	Not metabolized; excreted unchanged by glomerular filtration.
Excretion	Primarily renal (glomerular filtration), with >95% of administered dose excreted unchanged in urine within 24 hours. Less than 1% is excreted via bile/fecal route.
Half-life	Terminal elimination half-life in patients with normal renal function is approximately 2 hours. In patients with moderate to severe renal impairment (creatinine clearance <30 mL/min), the half-life can be prolonged up to 20–40 hours, requiring dose adjustment.
Protein binding	Iopamidol (active ingredient) is minimally protein bound (<5%), primarily to albumin.
Volume of Distribution	Approximately 0.20–0.30 L/kg, indicating distribution primarily within extracellular fluid space; low tissue binding.
Bioavailability	Not applicable for oral route as it is used only intravascularly or intrathecally; bioavailability is 100% for IV injection and near 100% for intra-arterial and intrathecal administration.
Onset of Action	Intravenous administration: opacification begins almost immediately during injection. Intra-arterial: begins within seconds to minutes depending on injection site and catheter placement.
Duration of Action	Intravenous: adequate contrast enhancement persists for 30–60 minutes following bolus injection due to rapid redistribution and excretion. Intrathecal: diagnostic visualization up to 1 hour but may last longer; caution in patients with impaired renal function.

Classification & Brands

Dosing & administration

Intravenous: 50-150 mL (up to 300 mg iodine/kg) as a bolus or infusion; intra-arterial: 5-40 mL depending on procedure; intrathecal: 8-15 mL. Maximum total iodine dose: 300 mg iodine/kg.

Dosage form	INJECTABLE
Renal impairment	GFR <30 mL/min: Use with caution; consider lower dose and ensure adequate hydration. GFR <15 mL/min: Avoid use unless essential; post-procedure hemodialysis may be considered. No specific dose reduction formula; clinical judgment advised.
Liver impairment	No specific Child-Pugh based dose adjustments; use cautiously in severe hepatic impairment due to altered pharmacokinetics.
Pediatric use	Weight-based: 1-2 mL/kg (300 mg iodine/mL) intravenously; maximum total dose 300 mg iodine/kg. Adjust for body habitus and procedure.
Geriatric use	Elderly patients may have reduced renal function; assess GFR and adjust dose accordingly. Ensure adequate hydration before and after procedure. Monitor for nephrotoxicity and hypersensitivity.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for ISOVUE-300 (ISOVUE-300).

Breastfeeding	Iopamidol is excreted into breast milk in small amounts (<1% of maternal dose). M/P ratio not established. Discontinue breastfeeding for 12-24 hours after administration, or pump and discard. Use only if clearly needed.
Teratogenic Risk	Iodinated contrast agents like Isovue-300 (iopamidol) cross the placenta. First trimester: Avoid unless essential; theoretical risk of fetal hypothyroidism from free iodide. Second/third trimester: Risk of transient neonatal hypothyroidism if high doses used; fetal goiter reported. No teratogenic effects at clinical doses in animal studies.

Warnings & precautions

■ FDA Black Box Warning

No FDA boxed warning.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to iopamidol or any components of the formulation","History of severe adverse reaction to iodinated contrast agents"]