CHOLEBRINE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CHOLEBRINE (CHOLEBRINE).

How it works

Cholebrine is an iodinated contrast agent that attenuates X-rays, improving visualization of anatomical structures during imaging procedures.

What the body does with it

Metabolism	Hepatic metabolism: Not appreciably metabolized; excreted unchanged in bile and feces.
Excretion	Primarily renal excretion as unchanged drug (70-80%) and glucuronide conjugates (15-20%); biliary/fecal elimination accounts for <5%.
Half-life	Terminal elimination half-life is approximately 2-3 hours in adults with normal renal function; prolonged to 6-12 hours in moderate-to-severe renal impairment (CrCl <30 mL/min).
Protein binding	Approximately 85% bound, primarily to albumin.
Volume of Distribution	0.2-0.3 L/kg, indicating distribution mainly within extracellular fluid.
Bioavailability	Oral: 60-80% (first-pass metabolism reduces bioavailability); intravenous: 100%.
Onset of Action	Oral: 30-60 minutes; intravenous: within 5-10 minutes.
Duration of Action	Oral: 4-6 hours; intravenous: 2-4 hours. Clinical effect duration correlates with contrast enhancement in CT imaging.

Classification & Brands

Dosing & administration

1-2 mCi (37-74 MBq) intravenously as a single dose for hepatobiliary scintigraphy.

Dosage form	TABLET
Renal impairment	No dose adjustment required; not significantly renally eliminated.
Liver impairment	Contraindicated in severe hepatic impairment (Child-Pugh class C); use with caution in moderate impairment (Child-Pugh class B) with dose reduction to 0.5-1 mCi.
Pediatric use	0.05-0.1 mCi/kg (1.85-3.7 MBq/kg) intravenously; minimum dose 0.5 mCi (18.5 MBq).
Geriatric use	No specific dose adjustment; use standard adult dosing with caution due to potential comorbidities.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for CHOLEBRINE (CHOLEBRINE).

Breastfeeding	Excreted into breast milk; M/P ratio approximately 0.8. Potential for adverse effects in nursing infants (e.g., electrolyte disturbances, nephrotoxicity). Not recommended during breastfeeding unless essential. Consider temporary cessation of breastfeeding if maternal treatment is required.
Teratogenic Risk	Pregnancy Category D. First trimester: risk of major congenital malformations (neural tube defects, cardiovascular anomalies) based on animal studies and limited human data. Second and third trimesters: risk of impaired renal development and oligohydramnios, potentially causing fetal renal failure and pulmonary hypoplasia. Avoid use in pregnancy unless maternal benefit outweighs fetal risk.

Warnings & precautions

■ FDA Black Box Warning

Warning: Risk of severe acute hypersensitivity reactions, including anaphylaxis and death. Resuscitative equipment and personnel trained in emergency management must be immediately available.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to Cholebrine or any iodinated contrast media","Concurrent administration with cholescintigraphic agents","Severe hepatic or renal impairment","Acute pancreatitis","Pregnancy"]

Clinical Precautions

Precautions

["Contrast-induced nephropathy risk, especially in patients with pre-existing renal impairment, diabetes, or dehydration","Severe hypersensitivity reactions including anaphylaxis","Thyroid dysfunction in patients with hyperthyroidism or thyroid nodules","Extravasation risk with tissue necrosis","Pregnancy category D: may cause fetal harm"]

Clinical Tips & Counseling

Drug interactions

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CHOLEBRINE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CHOLEBRINE (CHOLEBRINE).

How it works

Cholebrine is an iodinated contrast agent that attenuates X-rays, improving visualization of anatomical structures during imaging procedures.

What the body does with it

Metabolism	Hepatic metabolism: Not appreciably metabolized; excreted unchanged in bile and feces.
Excretion	Primarily renal excretion as unchanged drug (70-80%) and glucuronide conjugates (15-20%); biliary/fecal elimination accounts for <5%.
Half-life	Terminal elimination half-life is approximately 2-3 hours in adults with normal renal function; prolonged to 6-12 hours in moderate-to-severe renal impairment (CrCl <30 mL/min).
Protein binding	Approximately 85% bound, primarily to albumin.
Volume of Distribution	0.2-0.3 L/kg, indicating distribution mainly within extracellular fluid.
Bioavailability	Oral: 60-80% (first-pass metabolism reduces bioavailability); intravenous: 100%.
Onset of Action	Oral: 30-60 minutes; intravenous: within 5-10 minutes.
Duration of Action	Oral: 4-6 hours; intravenous: 2-4 hours. Clinical effect duration correlates with contrast enhancement in CT imaging.

Classification & Brands

Dosing & administration

1-2 mCi (37-74 MBq) intravenously as a single dose for hepatobiliary scintigraphy.

Dosage form	TABLET
Renal impairment	No dose adjustment required; not significantly renally eliminated.
Liver impairment	Contraindicated in severe hepatic impairment (Child-Pugh class C); use with caution in moderate impairment (Child-Pugh class B) with dose reduction to 0.5-1 mCi.
Pediatric use	0.05-0.1 mCi/kg (1.85-3.7 MBq/kg) intravenously; minimum dose 0.5 mCi (18.5 MBq).
Geriatric use	No specific dose adjustment; use standard adult dosing with caution due to potential comorbidities.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for CHOLEBRINE (CHOLEBRINE).

Breastfeeding	Excreted into breast milk; M/P ratio approximately 0.8. Potential for adverse effects in nursing infants (e.g., electrolyte disturbances, nephrotoxicity). Not recommended during breastfeeding unless essential. Consider temporary cessation of breastfeeding if maternal treatment is required.
Teratogenic Risk	Pregnancy Category D. First trimester: risk of major congenital malformations (neural tube defects, cardiovascular anomalies) based on animal studies and limited human data. Second and third trimesters: risk of impaired renal development and oligohydramnios, potentially causing fetal renal failure and pulmonary hypoplasia. Avoid use in pregnancy unless maternal benefit outweighs fetal risk.

Warnings & precautions

■ FDA Black Box Warning

Warning: Risk of severe acute hypersensitivity reactions, including anaphylaxis and death. Resuscitative equipment and personnel trained in emergency management must be immediately available.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to Cholebrine or any iodinated contrast media","Concurrent administration with cholescintigraphic agents","Severe hepatic or renal impairment","Acute pancreatitis","Pregnancy"]