ISOVUE-128
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | 809.11 |
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 | Limited human data; animal studies not available; use only if clearly needed. Iodinated contrast crosses placenta; theoretical risk of thyroid suppression in fetus. |
| 2nd trimester | Use only if diagnostic benefit outweighs potential risk; fetal thyroid maturation begins at 12 weeks; avoid if possible due to iodine exposure. |
| 3rd trimester | Use only if clearly needed; iodine exposure may cause neonatal hypothyroidism; assess thyroid function in neonate post-exposure. |
Clinical note
Comprehensive clinical and safety monograph for ISOVUE-128 (ISOVUE-128).
| Placental transfer | Crosses placenta; degree varies with gestational age, but iodinated contrast agents are known to reach fetal circulation. |
| Breastfeeding | Minimal excretion into breast milk; iodinated contrast has low oral bioavailability (<1%); theoretical risk of direct toxicity or hypersensitivity; consider pumping and discarding milk for 24 hours post-administration if concern. |
| Lactation Rating | L2 (Safer, compatible with breastfeeding) |
| 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. |
| 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. |
■ 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 |
known anaphylactoid reaction to iopamidol or any contrast mediumsevere acute renal failure or chronic kidney disease stage 4-5 without dialysis
| 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. |
| Food/Dietary | No specific food interactions. However, patients are often advised to maintain adequate hydration. Avoid alcohol consumption for 24 hours before and after the procedure as it may increase risk of dehydration. No dietary restrictions required. |
| Clinical Pearls | ISOVUE-128 (iopamidol) is a nonionic, low-osmolality contrast medium. Pre-warming to body temperature reduces viscosity and improves patient tolerance. Risk of contrast-induced nephropathy (CIN) increases with pre-existing renal impairment; assess renal function (eGFR) prior to administration. Adequate hydration is critical. Monitor for delayed hypersensitivity reactions (up to 7 days). Metformin should be withheld for 48 hours post procedure if renal function is compromised. Have emergency equipment available for anaphylactoid reactions. |
| Patient Advice | Inform your healthcare provider if you have any allergies, especially to contrast media or iodine. · Tell your provider about all medications you take, particularly metformin or any kidney-affecting drugs. · You may be asked to drink extra fluids before and after the procedure to protect your kidneys. · Report any symptoms like hives, itching, difficulty breathing, or swelling of the face/throat immediately. · If you have diabetes and take metformin, your doctor may advise stopping it for 48 hours after the scan. · Sensation of warmth, a metallic taste, or nausea during injection is common and usually resolves quickly. · After the procedure, you can resume normal diet unless directed otherwise. |
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