IOPAMIDOL-250
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IOPAMIDOL-250 (IOPAMIDOL-250).
Iopamidol is a non-ionic, water-soluble, iodinated radiographic contrast agent that attenuates X-rays, thereby enhancing vascular and tissue contrast during imaging procedures. It acts by increasing the radiodensity of blood vessels and organs.
| Metabolism | Iopamidol is not metabolized; it is excreted unchanged by the kidneys via glomerular filtration. |
| Excretion | Renal: >90% unchanged via glomerular filtration; biliary/fecal: <2% |
| Half-life | Terminal half-life 1.5-2 hours in normal renal function; may extend to 5-10 hours in severe renal impairment (CrCl <30 mL/min) |
| Protein binding | <5% bound to plasma proteins (albumin negligible) |
| Volume of Distribution | 0.2-0.3 L/kg; confined to extracellular fluid space, no significant tissue binding |
| Bioavailability | Not applicable; only administered parenterally (IV, IA, intrathecal); oral bioavailability negligible |
| Onset of Action | Intravenous: immediate (within seconds); intra-arterial: immediate; intrathecal: within 1-2 minutes |
| Duration of Action | Intravenous: 15-30 minutes for contrast enhancement; intrathecal: 1-2 hours for myelography |
1-2 mL/kg intravenously for contrast imaging, not to exceed 200 mL total; dose and rate vary by procedure and patient weight.
| Dosage form | INJECTABLE |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59 mL/min: reduce dose by 50%; GFR <30 mL/min: contraindicated or use minimum necessary dose with hemodialysis availability; no specific GFR-based calculator recommended. |
| Liver impairment | No specific Child-Pugh based dose adjustment; use with caution in severe hepatic impairment due to potential nephrotoxicity. |
| Pediatric use | 0.5-2 mL/kg intravenously, not exceeding 3 mL/kg; maximum single dose 4 mL/kg; dose based on procedure, age, and weight. |
| Geriatric use | Reduce initial dose by 50% and increase infusion time; monitor renal function closely due to age-related GFR decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IOPAMIDOL-250 (IOPAMIDOL-250).
| Breastfeeding | Iopamidol is excreted into human breast milk in very small amounts (M/P ratio not established; estimated less than 1% of maternal dose). Oral bioavailability is negligible, therefore risk to nursing infant is minimal. The American College of Radiology recommends no interruption of breastfeeding after receiving iodine-based contrast media. However, if concern exists, pumping and discarding milk for 12–24 hours is an option. |
| Teratogenic Risk | Iopamidol is an iodinated contrast agent that crosses the placenta. No adequate and well-controlled studies in pregnant women. Animal studies have not reported teratogenic effects; however, thyroid dysfunction (transient neonatal hypothyroidism) has been reported postnatally after in utero exposure to iodinated contrast media, particularly when administered near term. Risk is considered low when used at standard diagnostic doses. The drug is listed as FDA Pregnancy Category B (for non-ionic agents), but this classification may be outdated. |
■ FDA Black Box Warning
Risk of serious hypersensitivity reactions, including anaphylaxis, and acute kidney injury. Non-ionic contrast media may cause severe, life-threatening adverse events, especially in patients with pre-existing renal impairment, diabetes mellitus, or those receiving nephrotoxic drugs.
| Serious Effects |
["Known hypersensitivity to iopamidol or any of its components","Anuria or severe renal impairment (e.g., dialysis-dependent)","Acute or chronic renal insufficiency with creatinine clearance <30 mL/min","Concurrent administration of metformin (risk of lactic acidosis)","Active thyrotoxicosis"]
| Precautions | ["Hypersensitivity reactions (rash, urticaria, bronchospasm, anaphylaxis)","Acute kidney injury (risk increased in renal impairment, diabetes, dehydration, advanced age)","Cardiovascular adverse effects (arrhythmias, hypotension, heart failure)","Thyroid dysfunction (induction of hyperthyroidism in susceptible patients)","Extravasation risk (tissue necrosis)","Sickle cell disease (risk of sickling)","Pheochromocytoma (hypertensive crisis)"] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine, eGFR) before administration as contrast-induced nephropathy risk exists. Assess thyroid function in neonate if contrast was given during late pregnancy (especially third trimester) due to risk of transient hypothyroidism. Monitor fetal heart rate if administered during labor. Standard precautions for allergic reactions (have resuscitation equipment available). |
| Fertility Effects | No known adverse effects on fertility based on animal studies and clinical experience. No evidence of reproductive toxicity or impairment of fertility in males or females. |