RENOGRAFIN-60

Clinical safety rating: caution

Comprehensive clinical and safety monograph for RENOGRAFIN-60 (RENOGRAFIN-60).

How it works

RENOGRAFIN-60 (diatrizoate meglumine and diatrizoate sodium) is an ionic, high-osmolality, iodinated contrast agent. It enhances radiographic contrast by absorbing X-rays due to the high atomic number of iodine. It distributes into the intravascular space and is excreted primarily by the kidneys via glomerular filtration without significant tubular reabsorption or secretion.

What the body does with it

Metabolism	The drug is not metabolized; it is eliminated unchanged via the kidneys by glomerular filtration.
Excretion	Renal: 95-100% (glomerular filtration, no tubular reabsorption). Biliary/Fecal: negligible.
Half-life	Terminal elimination half-life: 1-2 hours in normal renal function. Prolonged in renal impairment: up to 50 hours. Clinically significant for timing of contrast imaging and risk of contrast-induced nephropathy.
Protein binding	Low (5-10%). Loosely bound to serum albumin.
Volume of Distribution	0.2-0.3 L/kg. Distributes primarily in extracellular fluid; no significant intracellular penetration. Higher in neonates and children relative to body weight.
Bioavailability	Intravenous/Intra-arterial: 100%. Oral: essentially 0% (not absorbed; used for gastrointestinal opacification).
Onset of Action	Intravenous: immediate (seconds to minutes). Intra-arterial: immediate. Oral: not applicable (gastrointestinal opacification requires ingestion; radiographic visualization within 15-30 minutes).
Duration of Action	Intravenous: diagnostic imaging window of 15-30 minutes for angiography/CT. Renal excretion complete within 24 hours in normal renal function. Prolonged in renal impairment.

Classification & Brands

Dosing & administration

Intravenous: 50-100 mL of a 60% solution as a single dose for CT or angiography. Intra-arterial: 5-50 mL depending on vessel size. Maximum total dose: 3 mL/kg.

Dosage form	INJECTABLE
Renal impairment	GFR >30 mL/min: No adjustment needed. GFR 15-30 mL/min: Use with caution, reduce dose to minimal required volume. GFR <15 mL/min: Contraindicated due to risk of contrast-induced nephropathy.
Liver impairment	No dose adjustment required for hepatic impairment. Use caution in severe hepatic impairment due to altered hemodynamics.
Pediatric use	Intravenous: 1-2 mL/kg (max 3 mL/kg total). Intra-arterial: 0.5-1 mL/kg adjusted for vessel size. Not recommended for neonates due to high osmolality.
Geriatric use	Use lowest effective dose (typically 50% of standard dose). Assess renal function (Cockcroft-Gault) prior to administration; reduce dose if GFR <30 mL/min.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for RENOGRAFIN-60 (RENOGRAFIN-60).

Breastfeeding	Contraindicated in breastfeeding; iodine is excreted in milk and may cause infant hypothyroidism. M/P ratio not available.
Teratogenic Risk	First trimester: Avoid; iodine exposure may cause fetal thyroid suppression. Second and third trimesters: Use only if clearly needed; fetal thyroid blockade risk; neonatal hypothyroidism reported.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Not for intrathecal use. Severe adverse reactions, including death, anaphylaxis, cardiovascular events, and nephrotoxicity, have occurred. Patients with pre-existing renal insufficiency, diabetes, or dehydration are at increased risk. Resuscitative equipment and trained personnel must be readily available.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to diatrizoate or any component of the formulation","Anuria or severe oliguria due to renal failure","Concurrent administration with metformin in patients with renal impairment (risk of lactic acidosis)","Intrathecal administration (risk of severe neurotoxicity)"]

Clinical Precautions

Precautions

["Risk of contrast-induced nephropathy (CIN), especially in patients with pre-existing renal impairment, diabetes, dehydration, or concurrent nephrotoxic drugs","Risk of anaphylactoid reactions, including anaphylaxis, bronchospasm, and hypotension","Patients with asthma, allergies, or prior contrast reactions are at increased risk","Avoid in patients with sickle cell disease (risk of sickling)","Pheochromocytoma: risk of hypertensive crisis","Hyperthyroidism or thyroid storm: risk of thyroid dysfunction","Pregnancy and lactation: use only if clearly needed"]

Clinical Tips & Counseling

Drug interactions

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RENOGRAFIN-60

Clinical safety rating: caution

Comprehensive clinical and safety monograph for RENOGRAFIN-60 (RENOGRAFIN-60).

How it works

What the body does with it

Metabolism	The drug is not metabolized; it is eliminated unchanged via the kidneys by glomerular filtration.
Excretion	Renal: 95-100% (glomerular filtration, no tubular reabsorption). Biliary/Fecal: negligible.
Half-life	Terminal elimination half-life: 1-2 hours in normal renal function. Prolonged in renal impairment: up to 50 hours. Clinically significant for timing of contrast imaging and risk of contrast-induced nephropathy.
Protein binding	Low (5-10%). Loosely bound to serum albumin.
Volume of Distribution	0.2-0.3 L/kg. Distributes primarily in extracellular fluid; no significant intracellular penetration. Higher in neonates and children relative to body weight.
Bioavailability	Intravenous/Intra-arterial: 100%. Oral: essentially 0% (not absorbed; used for gastrointestinal opacification).
Onset of Action	Intravenous: immediate (seconds to minutes). Intra-arterial: immediate. Oral: not applicable (gastrointestinal opacification requires ingestion; radiographic visualization within 15-30 minutes).
Duration of Action	Intravenous: diagnostic imaging window of 15-30 minutes for angiography/CT. Renal excretion complete within 24 hours in normal renal function. Prolonged in renal impairment.

Classification & Brands

Dosing & administration

Intravenous: 50-100 mL of a 60% solution as a single dose for CT or angiography. Intra-arterial: 5-50 mL depending on vessel size. Maximum total dose: 3 mL/kg.

Dosage form	INJECTABLE
Renal impairment	GFR >30 mL/min: No adjustment needed. GFR 15-30 mL/min: Use with caution, reduce dose to minimal required volume. GFR <15 mL/min: Contraindicated due to risk of contrast-induced nephropathy.
Liver impairment	No dose adjustment required for hepatic impairment. Use caution in severe hepatic impairment due to altered hemodynamics.
Pediatric use	Intravenous: 1-2 mL/kg (max 3 mL/kg total). Intra-arterial: 0.5-1 mL/kg adjusted for vessel size. Not recommended for neonates due to high osmolality.
Geriatric use	Use lowest effective dose (typically 50% of standard dose). Assess renal function (Cockcroft-Gault) prior to administration; reduce dose if GFR <30 mL/min.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for RENOGRAFIN-60 (RENOGRAFIN-60).

Breastfeeding	Contraindicated in breastfeeding; iodine is excreted in milk and may cause infant hypothyroidism. M/P ratio not available.
Teratogenic Risk	First trimester: Avoid; iodine exposure may cause fetal thyroid suppression. Second and third trimesters: Use only if clearly needed; fetal thyroid blockade risk; neonatal hypothyroidism reported.
Fetal Monitoring