ISOVUE-M 300
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ISOVUE-M 300 (ISOVUE-M 300).
Iopamidol is a nonionic, low-osmolality iodinated contrast agent that attenuates X-rays by increasing the density of tissues, thereby enhancing the visibility of vascular structures and organs during imaging procedures. It acts by absorbing X-rays due to the high atomic number of iodine.
| Metabolism | Iopamidol is not metabolized and is excreted unchanged primarily by the kidneys via glomerular filtration. In patients with renal impairment, excretion is prolonged. |
| Excretion | Primarily renal excretion via glomerular filtration; unchanged drug: >95% excreted in urine within 24 hours. Biliary/fecal excretion: negligible (<1%). |
| Half-life | Terminal elimination half-life: approximately 2 hours (range 1.5–2.5 hours). Normal renal function; prolonged in renal impairment. |
| Protein binding | Less than 5% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | 0.2–0.3 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Not applicable; administered intravenously (100% bioavailability). No oral absorption. |
| Onset of Action | Iodinated contrast agent; immediate visualization upon intravascular injection (seconds to minutes). |
| Duration of Action | Intravascular contrast enhancement persists for minutes; imaging window typically 5–30 minutes post-injection. |
1.0-2.0 mL/kg intravenous bolus for CT imaging up to a total of 150 mL per procedure; intra-arterial dosing varies by procedure, typical adult dose 30-60 mL per injection.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73m2: use lowest possible dose and consider alternative imaging; no formal dose reduction calculated; ensure adequate hydration before and after administration. |
| Liver impairment | No specific Child-Pugh based modifications; caution in severe hepatic impairment due to potential volume overload and altered clearance; monitor renal function. |
| Pediatric use | Intravenous: 1.0-2.0 mL/kg (max 150 mL total) administered as a bolus; intra-arterial: 1.0-1.5 mL/kg per injection adjusted for body weight and clinical indication. |
| Geriatric use | Use lowest effective dose to minimize risk of contrast-induced nephropathy; ensure adequate hydration; monitor renal function closely; dose not adjusted solely based on age. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ISOVUE-M 300 (ISOVUE-M 300).
| Breastfeeding | Iopamidol is excreted in human milk in trace amounts (M/P ratio not reported). It is poorly absorbed orally; risk to nursing infant likely negligible. Manufacturer advises caution: consider temporary cessation of breastfeeding for 24-48 hours post-administration. |
| Teratogenic Risk | Iopamidol, the active ingredient, crosses the placenta. No well-controlled studies in pregnant women; animal studies show no teratogenic effects at clinically relevant doses. Risk cannot be excluded. First trimester: theoretical risk from ionizing radiation if used in X-ray procedures; weigh benefit vs risk. Second/third trimester: exposure to iodinated contrast may cause transient neonatal hypothyroidism; thyroid function screening recommended postnatally. |
■ FDA Black Box Warning
Not for intrathecal use with other contrast agents. Risk of severe neurologic adverse reactions including seizures, meningitis, and arachnoiditis. Use only when necessary and follow recommended dosing.
| Serious Effects |
["Hypersensitivity to iopamidol or any of its components","Severe renal impairment (eGFR < 30 mL/min/1.73 m²)","Active meningitis or subarachnoid hemorrhage","Concurrent intrathecal administration of corticosteroids or other contrast agents"]
| Precautions | ["Risk of serious adverse reactions including anaphylaxis, renal toxicity, seizures, and central nervous system disturbances.","Use with caution in patients with renal impairment, diabetes mellitus, multiple myeloma, pheochromocytoma, sickle cell disease, and those on nephrotoxic drugs.","Ensure adequate hydration before and after administration.","Monitor for delayed reactions.","Have resuscitation equipment available."] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine, eGFR) prior to administration to assess risk of contrast-induced nephropathy. In pregnancy, monitor fetal heart rate if MRI with contrast is used. Postnatal: check neonatal thyroid function (TSH, T4) within 1-3 weeks if exposure occurred in third trimester. |
| Fertility Effects | No human studies on fertility. In animal studies, no impairment of fertility observed at doses up to 200 mg iodine/kg. Theoretical risk of ovarian damage from radiation if used in fluoroscopic procedures, but this is not due to the drug itself. |