ISOVUE-128
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ISOVUE-128 (ISOVUE-128).
Isovue-128 (iopamidol) is a nonionic, water-soluble, radiographic contrast medium that enhances imaging by attenuating X-rays, thereby increasing contrast between vascular structures and surrounding tissues. Its mechanism is based on the high iodine content which absorbs X-rays, allowing visualization of blood vessels and organs during angiography, urography, and CT scans.
| Metabolism | Iopamidol is not metabolized and is excreted unchanged almost entirely by the kidneys via glomerular filtration. No hepatic metabolism or significant protein binding occurs. |
| Excretion | Renal: >95% excreted unchanged in urine via glomerular filtration; fecal/biliary: <5%. |
| Half-life | Terminal elimination half-life is approximately 1.5-2 hours in patients with normal renal function; prolonged in renal impairment (up to 8-10 hours with GFR <30 mL/min). |
| Protein binding | Minimal protein binding (<5%), primarily to albumin. |
| Volume of Distribution | Approximately 0.2-0.3 L/kg, reflecting distribution into extracellular fluid. |
| Bioavailability | Not applicable for oral route (no oral formulation); 100% bioavailability via intravenous or intra-arterial administration. |
| Onset of Action | Intravenous: Immediate, with opacification of vasculature within 30-60 seconds; intra-arterial: 1-2 seconds for cerebral arteriography. |
| Duration of Action | Rapid redistribution and renal elimination provide adequate opacification for 10-30 minutes for angiographic procedures; contrast enhancement in CT persists for up to 2 hours. |
Adult: 50-200 mL (0.5-2.0 mL/kg) intravenously, single dose for contrast-enhanced CT; for angiography, dose and rate vary by procedure.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <30 mL/min: use lowest feasible dose; GFR <15 mL/min: avoid use unless essential; consider hydration and N-acetylcysteine. |
| Liver impairment | No specific Child-Pugh based adjustments; use with caution in severe hepatic impairment due to risk of contrast-induced nephropathy. |
| Pediatric use | Neonates: 0.5-1 mL/kg IV; Infants/Children: 1-2 mL/kg IV (max 125 mL per dose) for contrast-enhanced CT. |
| Geriatric use | Reduce dose to lowest effective (e.g., 50-100 mL); ensure adequate hydration; monitor renal function pre and post administration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ISOVUE-128 (ISOVUE-128).
| Breastfeeding | Iopamidol is excreted into breast milk in very small amounts. The milk-to-plasma (M/P) ratio is approximately 0.04–0.08 based on limited studies. The absolute dose received by a nursing infant is estimated to be less than 0.01% of the maternal dose, which is clinically insignificant. Therefore, breastfeeding can be continued without interruption, although some experts suggest discarding milk for 24 hours post-administration as a precaution. No adverse effects on the infant have been reported. |
| Teratogenic Risk | Iodinated contrast agents, including iopamidol (ISOVUE-128), are generally considered low risk for teratogenicity in humans based on limited data. In the first trimester, there is a theoretical risk of fetal hypothyroidism due to free iodide, but clinical evidence does not show a significant increase in congenital anomalies. Second and third trimester exposure is associated with transient neonatal hypothyroidism if the agent crosses the placenta, but no structural teratogenic effects are documented. The FDA assigns a Pregnancy Category B for iodinated contrast agents. |
■ FDA Black Box Warning
Iodinated contrast media including iopamidol are associated with an increased risk of contrast-induced acute kidney injury (CI-AKI) in patients with pre-existing renal impairment, particularly those with diabetes, volume depletion, or concurrent use of nephrotoxic drugs. Strict adherence to hydration protocols and renal monitoring is required.
| Serious Effects |
["Absolute: Known hypersensitivity to iopamidol, other iodine-containing contrast media, or any component of the formulation.","Absolute: Intrathecal administration in patients with significant thrombophlebitis or infection at the injection site.","Relative: Pre-existing renal impairment (eGFR <30 mL/min/1.73m²) unless benefits outweigh risks; consider alternative imaging.","Relative: Multiple myeloma, pheochromocytoma, sickle cell disease (due to risk of vaso-occlusive events).","Relative: Pregnancy (especially first trimester) unless essential for diagnosis."]
| Precautions | ["Risk of contrast-induced nephropathy (CIN): Monitor renal function before and after administration, ensure adequate hydration, and avoid concurrent nephrotoxic agents.","Severe hypersensitivity reactions (e.g., anaphylaxis, bronchospasm): Have resuscitation equipment available; premedication may be considered for patients with known contrast allergy.","Thyroid dysfunction: Iodinated contrast may induce hyperthyroidism or hypothyroidism; caution in patients with thyroid disease.","Cardiovascular events: In patients with heart failure, coronary artery disease, or pulmonary hypertension, contrast media can cause hemodynamic instability, arrhythmias, or myocardial ischemia.","Neurologic effects: Intrathecal administration may cause seizures, arachnoiditis, or aseptic meningitis; use lowest possible dose and monitor for neurotoxicity.","Extravasation: Risk of tissue necrosis; administer through a secure IV line and monitor injection site."] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine) before administration to assess risk of contrast-induced nephropathy. During pregnancy, fetal heart rate and uterine activity should be monitored if the procedure involves radiation exposure. In case of inadvertent high-dose or repeated exposure, consider neonatal thyroid function tests (TSH, T4) at birth to screen for transient hypothyroidism. |
| Fertility Effects | No human studies indicate that iopamidol adversely affects fertility. Animal studies have not demonstrated impaired fertility or reproductive function at clinically relevant doses. There is no known impact on spermatogenesis or oogenesis. Fertility effects are not expected with standard diagnostic use. |