CHOLOGRAFIN MEGLUMINE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CHOLOGRAFIN MEGLUMINE (CHOLOGRAFIN MEGLUMINE).

How it works

Cholografin meglumine is an iodinated contrast agent that opacifies the biliary tract. It is actively taken up by hepatocytes and excreted into the bile, allowing radiographic visualization of the bile ducts and gallbladder.

What the body does with it

Metabolism	Primarily excreted unchanged in the bile; minimal hepatic metabolism.
Excretion	Primarily hepatic excretion via bile into feces; renal excretion accounts for <1% of the dose in patients with normal hepatic function.
Half-life	Terminal elimination half-life is approximately 1-2 hours in patients with normal hepatic function, reflecting rapid biliary excretion; prolonged in hepatic impairment.
Protein binding	Extensive binding to serum albumin, approximately 90-95%.
Volume of Distribution	Approximately 0.2-0.3 L/kg, consistent with distribution primarily in extracellular fluid with minimal tissue penetration.
Bioavailability	100% after intravenous administration; not administered orally.
Onset of Action	Visualization of bile ducts occurs within 10-15 minutes after intravenous administration; maximal opacification at 20-30 minutes.
Duration of Action	Adequate opacification persists for 30-60 minutes; may continue up to 2 hours depending on hepatic function.

Classification & Brands

Dosing & administration

Intravenous: 20 mL (10.3 g) of a 52% solution (meglumine salt) administered by slow IV injection over 3-5 minutes; repeated once after 10-15 minutes if visualization is inadequate, not to exceed 40 mL total.

Dosage form	INJECTABLE
Renal impairment	GFR 30-59 mL/min: Administer 50% of standard dose (maximum 20 mL total). GFR <30 mL/min: Contraindicated due to risk of acute renal failure.
Liver impairment	Child-Pugh Class A: No adjustment required. Child-Pugh Class B: Administer with caution; consider reducing dose by 50% or extending injection interval. Child-Pugh Class C: Contraindicated due to risk of hepatorenal syndrome.
Pediatric use	Not recommended for use in children under 12 years of age; insufficient safety data. For adolescents (12-18 years): 0.3 mL/kg (maximum 20 mL) by slow IV injection, adjusted for weight, not to exceed adult dose.
Geriatric use	Reduce dose by 50% (maximum 20 mL total) due to age-related decline in renal function and increased risk of contrast-induced nephropathy. 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 CHOLOGRAFIN MEGLUMINE (CHOLOGRAFIN MEGLUMINE).

Breastfeeding	Excreted in breast milk in trace amounts. M/P ratio not established. Discontinue nursing or drug due to potential iodine exposure and adverse effects.
Teratogenic Risk	Category B. No evidence of teratogenicity in animal studies; no adequate human studies. Avoid during pregnancy due to radiation exposure risk. First trimester: unknown risk; second/third trimester: may cause neonatal hypothyroidism if iodine-containing.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Severe, life-threatening adverse reactions including anaphylaxis, cardiac arrest, and respiratory arrest have occurred. Resuscitative equipment and trained personnel must be immediately available.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to iodinated contrast agents","Advanced renal failure (e.g., anuria)","Severe hepatic impairment","Hyperthyroidism","Pregnancy (if risk outweighs benefit)"]

Clinical Precautions

Precautions

["Hypersensitivity reactions including anaphylaxis, bronchospasm, and angioedema may occur.","Acute renal failure, particularly in patients with pre-existing renal impairment, diabetes, or dehydration.","Delayed reactions (e.g., fever, rash, arthralgia) may occur up to 24 hours after administration.","Thyroid storm in patients with hyperthyroidism or thyroid nodules."]

Clinical Tips & Counseling

Drug interactions

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CHOLOGRAFIN MEGLUMINE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CHOLOGRAFIN MEGLUMINE (CHOLOGRAFIN MEGLUMINE).

How it works

What the body does with it

Metabolism	Primarily excreted unchanged in the bile; minimal hepatic metabolism.
Excretion	Primarily hepatic excretion via bile into feces; renal excretion accounts for <1% of the dose in patients with normal hepatic function.
Half-life	Terminal elimination half-life is approximately 1-2 hours in patients with normal hepatic function, reflecting rapid biliary excretion; prolonged in hepatic impairment.
Protein binding	Extensive binding to serum albumin, approximately 90-95%.
Volume of Distribution	Approximately 0.2-0.3 L/kg, consistent with distribution primarily in extracellular fluid with minimal tissue penetration.
Bioavailability	100% after intravenous administration; not administered orally.
Onset of Action	Visualization of bile ducts occurs within 10-15 minutes after intravenous administration; maximal opacification at 20-30 minutes.
Duration of Action	Adequate opacification persists for 30-60 minutes; may continue up to 2 hours depending on hepatic function.

Classification & Brands

Dosing & administration

Dosage form	INJECTABLE
Renal impairment	GFR 30-59 mL/min: Administer 50% of standard dose (maximum 20 mL total). GFR <30 mL/min: Contraindicated due to risk of acute renal failure.
Liver impairment	Child-Pugh Class A: No adjustment required. Child-Pugh Class B: Administer with caution; consider reducing dose by 50% or extending injection interval. Child-Pugh Class C: Contraindicated due to risk of hepatorenal syndrome.
Pediatric use	Not recommended for use in children under 12 years of age; insufficient safety data. For adolescents (12-18 years): 0.3 mL/kg (maximum 20 mL) by slow IV injection, adjusted for weight, not to exceed adult dose.
Geriatric use	Reduce dose by 50% (maximum 20 mL total) due to age-related decline in renal function and increased risk of contrast-induced nephropathy. 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 CHOLOGRAFIN MEGLUMINE (CHOLOGRAFIN MEGLUMINE).

Breastfeeding	Excreted in breast milk in trace amounts. M/P ratio not established. Discontinue nursing or drug due to potential iodine exposure and adverse effects.
Teratogenic Risk	Category B. No evidence of teratogenicity in animal studies; no adequate human studies. Avoid during pregnancy due to radiation exposure risk. First trimester: unknown risk; second/third trimester: may cause neonatal hypothyroidism if iodine-containing.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Severe, life-threatening adverse reactions including anaphylaxis, cardiac arrest, and respiratory arrest have occurred. Resuscitative equipment and trained personnel must be immediately available.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to iodinated contrast agents","Advanced renal failure (e.g., anuria)","Severe hepatic impairment","Hyperthyroidism","Pregnancy (if risk outweighs benefit)"]