IOPAMIDOL-300
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IOPAMIDOL-300 (IOPAMIDOL-300).
Iopamidol is a nonionic, water-soluble iodinated contrast agent that attenuates X-rays, thereby enhancing radiographic visualization of vascular structures and organs. It does not bind to receptors and has no significant pharmacological activity.
| Metabolism | Iopamidol is not metabolized and is excreted unchanged by the kidneys via glomerular filtration. No significant hepatic metabolism. |
| Excretion | Primarily renal excretion of intact drug via glomerular filtration; >90% excreted unchanged in urine within 24 hours. Less than 1% fecal or biliary elimination. |
| Half-life | Terminal elimination half-life is approximately 2 hours in patients with normal renal function (creatinine clearance >90 mL/min). In moderate renal impairment it extends to 3-5 hours; in severe renal impairment (CrCl <30 mL/min) it can exceed 30 hours, prolonging diagnostic window. |
| Protein binding | Negligible protein binding (<5%), primarily α- and β-globulins and albumin. |
| Volume of Distribution | Approximately 0.24 L/kg (range 0.2–0.3 L/kg), indicating distribution primarily within extracellular fluid space. |
| Bioavailability | Not applicable for oral route; only for intravenous or intra-arterial administration (100% bioavailability). |
| Onset of Action | Intravenous injection: Enhancement effect seen within 1 minute, optimal opacification within 1–5 minutes. Intra-arterial: immediate. |
| Duration of Action | Radiographic opacification lasts 30–60 minutes after intravenous injection, sufficient for typical CT or angiography studies. Duration may be prolonged with renal impairment or slow injection. |
Intravenous or intra-arterial administration; dose varies by procedure (e.g., 1-2 mL/kg for CT, up to 50-100 mL for angiography) up to a maximum of 200 mL per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR ≥30 mL/min/1.73m²: no adjustment; eGFR <30 mL/min: use minimum necessary dose and ensure adequate hydration; hemodialysis: consider removal after procedure. |
| Liver impairment | No specific Child-Pugh based adjustment; use caution due to potential hepato-renal syndrome; no dose reduction required for hepatic impairment alone. |
| Pediatric use | 0.5-2.0 mL/kg intravenously, not to exceed 3 mL/kg total; adjust based on age, weight, and indication; maximum 125 mL per procedure. |
| Geriatric use | Consider reduced renal function; use lowest effective dose; ensure adequate hydration prior to and after administration; monitor for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IOPAMIDOL-300 (IOPAMIDOL-300).
| Breastfeeding | Iopamidol is excreted into breast milk in small amounts. The M/P ratio is not established for iopamidol specifically, but for iodinated contrast agents in general, the amount transferred is <1% of maternal dose. Breastfeeding can be continued without interruption, though some guidelines suggest discarding milk for 24 hours post-exposure. No adverse effects in infants have been reported. |
| Teratogenic Risk | Iopamidol-300 is a nonionic iodinated contrast agent. In pregnant animals, no teratogenic effects were observed at clinically relevant doses. In humans, there is limited data; however, exposure during first trimester is not associated with a significant increase in major congenital malformations. Fetal risk cannot be excluded, but the agent is considered category B. Transient neonatal hypothyroidism may occur if exposure occurs near term due to iodine load. |
■ FDA Black Box Warning
Not for intrathecal use (except for iopamidol formulations specifically approved for myelography). Risk of serious adverse reactions including anaphylaxis, cardiac arrest, and renal failure. Use with caution in patients with multiple myeloma, pheochromocytoma, sickle cell disease, or known hypersensitivity to iodinated contrast media.
| Serious Effects |
["Known hypersensitivity to iopamidol or any other iodinated contrast agent.","Anuria or severe oliguria due to renal impairment (absolute contraindication).","Intrathecal administration (unless specifically approved for that route)."]
| Precautions | ["Risk of contrast-induced acute kidney injury (CI-AKI) especially in patients with pre-existing renal impairment, diabetes, dehydration, or advanced age.","Anaphylactic and anaphylactoid reactions can occur; appropriate resuscitation equipment and trained personnel should be available.","Severe cutaneous adverse reactions (e.g., SJS, TEN) have been reported.","Thyroid iodine uptake may be decreased for up to several weeks following administration.","Caution in patients with heart failure, coronary artery disease, or unstable angina due to risk of hemodynamic instability.","Posterior reversible encephalopathy syndrome (PRES) has been reported rarely.","Patients on beta-blockers may have diminished signs of acute hypersensitivity reactions."] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine, BUN) prior to and after administration due to potential nephrotoxicity. Assess fetal heart rate and uterine activity during and after procedure, especially in later pregnancy. In neonates exposed near term, monitor thyroid function (TSH, T4) within first week of life for hypothyroidism. |
| Fertility Effects | No evidence of impaired fertility or reproductive function in animal studies at clinically relevant doses. No human data suggest negative effects on fertility. |