CHOLOGRAFIN SODIUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CHOLOGRAFIN SODIUM (CHOLOGRAFIN SODIUM).
Iodipamide (cholografin sodium) is a radiographic contrast agent that opacifies the biliary ducts and gallbladder by being excreted into bile via the hepatic organic anion transporter (OATP) and then concentrated in the gallbladder. It absorbs X-rays due to its iodine content, allowing visualization of the biliary tree.
| Metabolism | Primarily excreted unchanged in bile via hepatic transporters (OATP); minimal hepatic metabolism. A small fraction undergoes renal excretion. |
| Excretion | Primarily renal excretion via glomerular filtration and tubular secretion. Approximately 70-80% of the dose is excreted unchanged in urine within 24 hours. Biliary excretion accounts for less than 10%, with fecal elimination minimal. |
| Half-life | Terminal elimination half-life is approximately 1-2 hours in patients with normal renal function. In severe renal impairment (CrCl < 30 mL/min), half-life may extend to 10-20 hours, requiring dose adjustment. |
| Protein binding | Approximately 90-95% bound to plasma proteins, primarily albumin. Binding is reversible and independent of drug concentration. |
| Volume of Distribution | Volume of distribution is approximately 0.15-0.3 L/kg, confined mainly to extracellular fluid and plasma. Low Vd reflects limited tissue distribution and high protein binding. |
| Bioavailability | Intravenous administration yields 100% bioavailability as the drug is given as an IV injection. No oral formulation is available; the drug is not absorbed orally due to its ionic nature. |
| Onset of Action | For intravenous cholangiography: radiopacification of bile ducts occurs within 10-15 minutes after injection. Peak opacification is seen at 30-60 minutes. |
| Duration of Action | Diagnostic opacification of biliary tree persists for 30-60 minutes post-injection, sufficient for radiographic examination. Clinically, drug effects are limited to the imaging period. |
2-3 mL of 30% solution intravenously over 1-2 minutes, repeated if necessary up to a total of 10 mL.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in acute renal failure or severe renal impairment (eGFR <30 mL/min/1.73m2). No specific dose adjustment; use with caution in mild-moderate impairment. |
| Liver impairment | No specific Child-Pugh based adjustment; contraindicated in severe hepatic impairment (Child-Pugh C) due to increased risk of toxicity. |
| Pediatric use | 1 mL/kg of 30% solution intravenously, not to exceed 20 mL; dosage based on body weight and diagnostic need. |
| Geriatric use | Use with caution; consider lower doses and slower infusion due to age-related decline in renal function and increased risk of adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CHOLOGRAFIN SODIUM (CHOLOGRAFIN SODIUM).
| Breastfeeding | Iodinated contrast agents are excreted into breast milk in minimal amounts (<1% of maternal dose). M/P ratio not reported for Cholografin Sodium specifically, but for similar agents, M/P ratio is low (e.g., 0.01-0.1). A single exposure is considered safe; advise pumping and discarding milk for 10-24 hours post-administration. |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: Animal studies have shown adverse effects, but no adequate human studies. Second and third trimesters: Iodinated contrast agents cross the placenta; theoretical risk of fetal thyroid suppression with high doses or repeated exposure. No reports of teratogenicity in humans. |
■ FDA Black Box Warning
None
| Serious Effects |
Absolute: Known hypersensitivity to iodinated contrast agents. Severe hepatic impairment (e.g., cirrhosis) with inability to excrete contrast. Severe renal impairment (e.g., anuria) as systemic accumulation may occur. Thyrotoxicosis (iodine-induced hyperthyroidism). Relative: Pregnancy (benefit must outweigh risk); lactation; concurrent administration of cholecystokinin or other biliary stimulants may cause gallbladder contraction and interfere with visualization.
| Precautions | Risk of severe hypersensitivity reactions including anaphylaxis; caution in patients with known allergies to iodinated contrast media. Impaired hepatic or renal function may lead to delayed excretion and increased toxicity. Dehydration may enhance adverse effects. Patients with multiple myeloma or severe cardiovascular disease require careful monitoring. Test dose recommended prior to full administration. |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine, eGFR) before administration due to risk of contrast-induced nephropathy. In pregnancy, monitor fetal heart rate if feasible. Assess for signs of maternal allergic reaction. Thyroid function in neonates if repeated exposure. |
| Fertility Effects | No studies on fertility effects in humans. In animal studies, no impairment of fertility was observed at clinically relevant doses. |