OPTIRAY 350

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OPTIRAY 350 (OPTIRAY 350).

How it works

Iodinated radiocontrast agent that attenuates X-rays and enhances visualization of vascular structures and organs during imaging procedures.

What the body does with it

Metabolism	Primarily excreted unchanged by the kidneys via glomerular filtration; no significant hepatic metabolism.
Excretion	Renal: 90-95% as unchanged drug via glomerular filtration within 24 hours; biliary/fecal: <5%
Half-life	2.0 ± 0.4 hours in patients with normal renal function (creatinine clearance >90 mL/min); prolonged to 10-40 hours in severe renal impairment (CrCl <30 mL/min)
Protein binding	~10% bound primarily to serum albumin; negligible binding at clinical concentrations
Volume of Distribution	0.15-0.3 L/kg, consistent with distribution primarily in extracellular space; does not cross intact blood-brain barrier
Bioavailability	Intravenous: 100% (by definition); oral: negligible (<1%) due to poor gastrointestinal absorption (not used orally)
Onset of Action	Intravenous: immediate (within seconds) for opacification of vasculature; intra-arterial: immediate upon injection
Duration of Action	Diagnostic opacification lasts 15-30 minutes for CT imaging; complete elimination requires 24 hours in normal renal function

Classification & Brands

Dosing & administration

Intravenous administration: 50-150 mL of 350 mgI/mL solution for contrast-enhanced CT; dose determined by procedure, body weight, and clinical indication. Intra-arterial: Varies per procedure, typically 30-60 mL total. Maximum single dose not established; avoid exceeding 5 mL/kg body weight.

Dosage form	INJECTABLE
Renal impairment	eGFR >=30 mL/min/1.73m²: No adjustment necessary. eGFR <30 mL/min/1.73m²: Use lowest diagnostic dose; consider alternative imaging if possible. Hemodialysis: Administer before dialysis session; can be removed by dialysis. Avoid in acute kidney injury with eGFR <15 unless absolutely necessary.
Liver impairment	No specific dose adjustments for hepatic impairment. Caution in severe hepatic disease with coagulopathy or encephalopathy; monitor for contrast-induced nephropathy and delayed elimination.
Pediatric use	Based on weight: For body CT, 1.5-2.0 mL/kg (525-700 mgI/kg) intravenously; not to exceed 150 mL total. For head CT, 1.0-1.5 mL/kg (350-525 mgI/kg). For angiographic procedures, individualize per protocol. Use lowest dose necessary for diagnostic image quality.
Geriatric use	Use lowest diagnostic dose due to age-related renal impairment. Assess renal function prior to administration. Hydrate adequately (0.9% NaCl or 1.4% sodium bicarbonate) unless contraindicated. Monitor for adverse reactions, especially in patients with cardiovascular disease.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for OPTIRAY 350 (OPTIRAY 350).

Breastfeeding	Iodinated contrast media are excreted into breast milk in very small amounts (M/P ratio <0.1). Oral bioavailability in infants is low. The American College of Radiology states breastfeeding can continue without interruption. Minimal risk.
Teratogenic Risk	Iodinated contrast media cross the placenta. No teratogenic effects reported in humans; theoretical risk of neonatal hypothyroidism if high doses used near term. Limited data: avoid in pregnancy unless essential.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Risk of acute kidney injury in patients with pre-existing renal impairment, diabetes, dehydration, or advanced age. Avoid concomitant use of nephrotoxic drugs and ensure adequate hydration.

Side Effect Profile

Serious Effects

Absolute Contraindications

Absolute: Known hypersensitivity to ioversol or any component of the formulation. Relative: History of severe allergic reactions to iodinated contrast, anuria, acute renal failure, or severe renal impairment (eGFR <30 mL/min/1.73 m²) unless dialysis is available.

Clinical Precautions

Precautions

Serious hypersensitivity reactions (including anaphylaxis) can occur; contraindicated in patients with known hypersensitivity. Thyroid storm may be precipitated in patients with hyperthyroidism. Use caution in patients with congestive heart failure, severe hypertension, multiple myeloma, pheochromocytoma, or sickle cell disease.

Clinical Tips & Counseling

Drug interactions

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OPTIRAY 350

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OPTIRAY 350 (OPTIRAY 350).

How it works

Iodinated radiocontrast agent that attenuates X-rays and enhances visualization of vascular structures and organs during imaging procedures.

What the body does with it

Metabolism	Primarily excreted unchanged by the kidneys via glomerular filtration; no significant hepatic metabolism.
Excretion	Renal: 90-95% as unchanged drug via glomerular filtration within 24 hours; biliary/fecal: <5%
Half-life	2.0 ± 0.4 hours in patients with normal renal function (creatinine clearance >90 mL/min); prolonged to 10-40 hours in severe renal impairment (CrCl <30 mL/min)
Protein binding	~10% bound primarily to serum albumin; negligible binding at clinical concentrations
Volume of Distribution	0.15-0.3 L/kg, consistent with distribution primarily in extracellular space; does not cross intact blood-brain barrier
Bioavailability	Intravenous: 100% (by definition); oral: negligible (<1%) due to poor gastrointestinal absorption (not used orally)
Onset of Action	Intravenous: immediate (within seconds) for opacification of vasculature; intra-arterial: immediate upon injection
Duration of Action	Diagnostic opacification lasts 15-30 minutes for CT imaging; complete elimination requires 24 hours in normal renal function

Classification & Brands

Dosing & administration

Dosage form	INJECTABLE
Renal impairment	eGFR >=30 mL/min/1.73m²: No adjustment necessary. eGFR <30 mL/min/1.73m²: Use lowest diagnostic dose; consider alternative imaging if possible. Hemodialysis: Administer before dialysis session; can be removed by dialysis. Avoid in acute kidney injury with eGFR <15 unless absolutely necessary.
Liver impairment	No specific dose adjustments for hepatic impairment. Caution in severe hepatic disease with coagulopathy or encephalopathy; monitor for contrast-induced nephropathy and delayed elimination.
Pediatric use	Based on weight: For body CT, 1.5-2.0 mL/kg (525-700 mgI/kg) intravenously; not to exceed 150 mL total. For head CT, 1.0-1.5 mL/kg (350-525 mgI/kg). For angiographic procedures, individualize per protocol. Use lowest dose necessary for diagnostic image quality.
Geriatric use	Use lowest diagnostic dose due to age-related renal impairment. Assess renal function prior to administration. Hydrate adequately (0.9% NaCl or 1.4% sodium bicarbonate) unless contraindicated. Monitor for adverse reactions, especially in patients with cardiovascular disease.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for OPTIRAY 350 (OPTIRAY 350).

Breastfeeding	Iodinated contrast media are excreted into breast milk in very small amounts (M/P ratio <0.1). Oral bioavailability in infants is low. The American College of Radiology states breastfeeding can continue without interruption. Minimal risk.
Teratogenic Risk	Iodinated contrast media cross the placenta. No teratogenic effects reported in humans; theoretical risk of neonatal hypothyroidism if high doses used near term. Limited data: avoid in pregnancy unless essential.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Risk of acute kidney injury in patients with pre-existing renal impairment, diabetes, dehydration, or advanced age. Avoid concomitant use of nephrotoxic drugs and ensure adequate hydration.