IOPAMIDOL-250 IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IOPAMIDOL-250 IN PLASTIC CONTAINER (IOPAMIDOL-250 IN PLASTIC CONTAINER).
Iodinated radiographic contrast medium that attenuates X-rays and provides radiopacity in vascular and body cavities. It does not undergo significant pharmacological activity.
| Metabolism | Iopamidol is not metabolized. It is excreted unchanged primarily by glomerular filtration in the kidneys. |
| Excretion | Renal: 95% unchanged via glomerular filtration; biliary/fecal: <5% |
| Half-life | Terminal elimination half-life: 2 hours (normal renal function); prolonged in renal impairment (up to 30+ hours in severe impairment), dictating contrast dosing intervals |
| Protein binding | Negligible (<1%); no specific binding proteins |
| Volume of Distribution | 0.2–0.3 L/kg; distributes mainly in extracellular fluid; minimal intracellular penetration |
| Bioavailability | IV: 100% (only route); not absorbed orally; no relevant bioavailability for other routes |
| Onset of Action | IV: immediate (within seconds) for vascular opacification; intra-arterial: immediate |
| Duration of Action | IV: 15–30 minutes for diagnostic imaging (parenchymal phase); reduces rapidly due to renal clearance; effective for CT scanning within 1–2 minutes post-injection |
250 mg iodine/mL; 1.5 mL/kg (up to 100 mL) IV bolus or infusion for CT imaging.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73m2: avoid use; if necessary, lowest dose possible and ensure adequate hydration. eGFR 30-60: use lowest dose, hold metformin, monitor renal function. |
| Liver impairment | No specific Child-Pugh adjustment; caution in severe hepatic impairment due to risk of contrast-induced nephropathy. |
| Pediatric use | Neonates: 1.5 mL/kg IV; Children: 1-2 mL/kg IV (max 100 mL); adjust for renal function. |
| Geriatric use | Use lowest effective dose; assess renal function (eGFR) prior; ensure hydration; risk of contrast-induced nephropathy increased. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IOPAMIDOL-250 IN PLASTIC CONTAINER (IOPAMIDOL-250 IN PLASTIC CONTAINER).
| Breastfeeding | Limited data; iopamidol is excreted into breast milk in low amounts. M/P ratio not established. Minimal oral bioavailability in infant; risk of direct toxicity negligible. The American College of Radiology (ACR) states breastfeeding can continue without interruption after iodinated contrast media; alternative: discard milk for 12-24 hours post-exposure if concerned. |
| Teratogenic Risk | Iopamidol-250 crosses the placenta. First trimester exposure: No established teratogenic risk; limited human data, animal studies show no consistent malformations. Second and third trimesters: Transient neonatal hypothyroidism (due to free iodine) has been reported post-iodinated contrast exposure; risk likely low with iopamidol (nonionic, low osmolar). Avoid unnecessary exposure; balance diagnostic need. |
■ FDA Black Box Warning
Not for intrathecal use. Severe adverse reactions (e.g., anaphylaxis, cardiac arrest) can occur. Patients with history of prior reaction, known allergies, or bronchial asthma are at increased risk.
| Serious Effects |
["Hypersensitivity to iopamidol or any component of the formulation","Anuria or severe renal impairment (off-label use in some protocols)","Intrathecal administration (not for myelography)"]
| Precautions | ["Risk of acute kidney injury, especially in patients with pre-existing renal impairment, diabetes, or volume depletion.","Risk of severe hypersensitivity reactions (e.g., anaphylaxis) requiring emergency treatment.","Thyroid storm in patients with hyperthyroidism or thyroid nodules.","Sickle cell crisis in patients with sickle cell disease.","Extravasation risk leading to tissue necrosis."] |
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| Fetal Monitoring | Monitor fetal thyroid function (TSH, free T4) in neonates after in utero exposure; assess for signs of hypothyroidism. For mother: renal function (serum creatinine, eGFR) pre-dose due to risk of contrast-induced nephropathy; monitor for allergic reactions (urticaria, anaphylaxis) and treat promptly. No fetal heart rate monitoring required for contrast alone. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies: No impairment of fertility observed. Iopamidol is not expected to affect reproductive organs; standard risk category. |