ISOVUE-200

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ISOVUE-200 (ISOVUE-200).

How it works

Iodinated contrast medium that attenuates X-rays, providing radiographic contrast by increasing the density of blood vessels and tissues.

What the body does with it

Metabolism	Iopamidol is not metabolized; eliminated unchanged via glomerular filtration.
Excretion	Renal: 100% unchanged as iohexol; glomerular filtration with no tubular reabsorption. No biliary/fecal elimination.
Half-life	2 hours in normal renal function; prolongs up to 30 hours in severe renal impairment. Closely correlates with creatinine clearance.
Protein binding	<2% bound; negligible binding to plasma proteins.
Volume of Distribution	0.24 L/kg; restricted to extracellular fluid, no intracellular penetration.
Bioavailability	Oral: 0% (not absorbed); IV/IA/Intrathecal: 100% (administered directly into blood/CSF).
Onset of Action	IV injection: immediate opacification (within seconds); intra-arterial: immediate during injection; intrathecal: within minutes.
Duration of Action	IV: 15-30 minutes for contrast enhancement; CT scanning optimal 5-10 min post-bolus. Intrathecal: up to 1-2 hours for CSF imaging.

Classification & Brands

Dosing & administration

Intravenous administration of 1.0-2.0 mL/kg (200 mg iodine/mL) for computed tomography; intra-arterial doses vary by procedure, typically 5-80 mL total. Maximum recommended dose: 2.0 mL/kg.

Dosage form	INJECTABLE
Renal impairment	eGFR <30 mL/min/1.73m²: Administer with caution, consider prophylaxis with hydration and N-acetylcysteine. eGFR <15: Use only if diagnostic benefit outweighs risk of contrast-induced nephropathy. No specific dose reduction established; consider using lowest feasible volume.
Liver impairment	No specific adjustments recommended for Child-Pugh class A, B, or C. Monitor renal function in patients with severe liver disease due to risk of hepatorenal syndrome.
Pediatric use	Neonates and infants: 1.5-2.0 mL/kg intravenously. Children: 1.0-2.0 mL/kg intravenously; maximum 2.0 mL/kg. For intra-arterial use, consult weight-based dosing guidelines.
Geriatric use	No specific dose adjustment required based on age alone. Assess renal function (eGFR) in elderly patients as age-related decline is common; follow renal adjustment guidelines. Ensure adequate hydration before and after administration.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for ISOVUE-200 (ISOVUE-200).

Breastfeeding	Minimal excretion into breast milk; M/P ratio not established. Iodinated contrast is poorly absorbed orally and poses negligible risk to nursing infant. Interruption of breastfeeding not required.
Teratogenic Risk	Iodinated contrast agents cross the placenta but have not been associated with teratogenic effects in humans. First trimester: theoretical risk from free iodide; avoid unless essential. Second and third trimesters: no known teratogenicity; neonatal thyroid function monitoring recommended after exposure.

Warnings & precautions

■ FDA Black Box Warning

Not for intrathecal use with ISOVUE-200 (iopamidol injection 41%) due to risk of severe adverse reactions including seizures, paralysis, and death.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Absolute: Hypersensitivity to iopamidol or any component; history of severe adverse reaction to iodinated contrast media; anuria or severe renal impairment (for intravascular use).","Relative: Pregnancy (only if clearly needed); lactation; multiple myeloma; pheochromocytoma; sickle cell disease."]

Clinical Precautions

Precautions

Risk of severe hypersensitivity reactions including anaphylaxis; acute kidney injury in patients with pre-existing renal impairment; CNS adverse effects including seizures with intrathecal administration; thyroid dysfunction in patients with hyperthyroidism; contrast-induced nephropathy.

Clinical Tips & Counseling

Drug interactions

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ISOVUE-200

Clinical safety rating: caution

Comprehensive clinical and safety monograph for ISOVUE-200 (ISOVUE-200).

How it works

Iodinated contrast medium that attenuates X-rays, providing radiographic contrast by increasing the density of blood vessels and tissues.

What the body does with it

Metabolism	Iopamidol is not metabolized; eliminated unchanged via glomerular filtration.
Excretion	Renal: 100% unchanged as iohexol; glomerular filtration with no tubular reabsorption. No biliary/fecal elimination.
Half-life	2 hours in normal renal function; prolongs up to 30 hours in severe renal impairment. Closely correlates with creatinine clearance.
Protein binding	<2% bound; negligible binding to plasma proteins.
Volume of Distribution	0.24 L/kg; restricted to extracellular fluid, no intracellular penetration.
Bioavailability	Oral: 0% (not absorbed); IV/IA/Intrathecal: 100% (administered directly into blood/CSF).
Onset of Action	IV injection: immediate opacification (within seconds); intra-arterial: immediate during injection; intrathecal: within minutes.
Duration of Action	IV: 15-30 minutes for contrast enhancement; CT scanning optimal 5-10 min post-bolus. Intrathecal: up to 1-2 hours for CSF imaging.

Classification & Brands

Dosing & administration

Intravenous administration of 1.0-2.0 mL/kg (200 mg iodine/mL) for computed tomography; intra-arterial doses vary by procedure, typically 5-80 mL total. Maximum recommended dose: 2.0 mL/kg.

Dosage form	INJECTABLE
Renal impairment	eGFR <30 mL/min/1.73m²: Administer with caution, consider prophylaxis with hydration and N-acetylcysteine. eGFR <15: Use only if diagnostic benefit outweighs risk of contrast-induced nephropathy. No specific dose reduction established; consider using lowest feasible volume.
Liver impairment	No specific adjustments recommended for Child-Pugh class A, B, or C. Monitor renal function in patients with severe liver disease due to risk of hepatorenal syndrome.
Pediatric use	Neonates and infants: 1.5-2.0 mL/kg intravenously. Children: 1.0-2.0 mL/kg intravenously; maximum 2.0 mL/kg. For intra-arterial use, consult weight-based dosing guidelines.
Geriatric use	No specific dose adjustment required based on age alone. Assess renal function (eGFR) in elderly patients as age-related decline is common; follow renal adjustment guidelines. Ensure adequate hydration before and after administration.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for ISOVUE-200 (ISOVUE-200).

Breastfeeding	Minimal excretion into breast milk; M/P ratio not established. Iodinated contrast is poorly absorbed orally and poses negligible risk to nursing infant. Interruption of breastfeeding not required.
Teratogenic Risk	Iodinated contrast agents cross the placenta but have not been associated with teratogenic effects in humans. First trimester: theoretical risk from free iodide; avoid unless essential. Second and third trimesters: no known teratogenicity; neonatal thyroid function monitoring recommended after exposure.

Warnings & precautions

■ FDA Black Box Warning

Not for intrathecal use with ISOVUE-200 (iopamidol injection 41%) due to risk of severe adverse reactions including seizures, paralysis, and death.