ISOVUE-M 200
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ISOVUE-M 200 (ISOVUE-M 200).
Iodinated radiocontrast agent that attenuates X-rays, allowing visualization of vascular structures and organs during imaging procedures.
| Metabolism | Not metabolized; excreted unchanged by the kidneys. Undergoes passive resorption from cerebrospinal fluid into plasma. |
| Excretion | Primarily renal: >90% of the administered dose is excreted unchanged in urine within 24 hours. Less than 1% is excreted via biliary/fecal routes. |
| Half-life | Terminal elimination half-life is approximately 1.5–2 hours in patients with normal renal function. Prolonged in renal impairment, which may necessitate dose adjustment. |
| Protein binding | Negligible, <2% bound to plasma proteins. |
| Volume of Distribution | Approximately 0.3–0.4 L/kg, consistent with distribution into extracellular fluid space. |
| Bioavailability | Not applicable; administered intravenously or intra-arterially, with 100% bioavailability by these routes. |
| Onset of Action | Immediate following intravascular injection; contrast enhancement begins within seconds. |
| Duration of Action | Enhancement lasts for 15–30 minutes after intravenous injection; rapid renal clearance limits prolonged exposure. |
Intrathecal: 8-12 mL (200 mg Iodine/mL) for lumbar myelography. Intravenous: 50-200 mL for contrast enhancement, administered as a bolus or infusion per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR ≥30 mL/min: No adjustment. eGFR <30 mL/min: Contraindicated due to risk of nephrogenic systemic fibrosis (NSF) with gadolinium-based agents; however, for iopamidol-based Isovue-M 200, renal impairment requires dose reduction and careful monitoring. In severe renal impairment (eGFR <30 mL/min), use lowest effective dose and ensure adequate hydration; consider alternative imaging. |
| Liver impairment | No specific Child-Pugh based adjustments recommended; use with caution in severe hepatic impairment due to potential for contrast-induced nephropathy and systemic effects. |
| Pediatric use | Intrathecal: 0.2-0.4 mL/kg (up to 12 mL total) for myelography. Intravenous: 1.5-2.5 mL/kg (max 200 mL) for CT or angiography, adjusted per procedure. |
| Geriatric use | Use with caution due to increased prevalence of renal impairment, cardiovascular disease, and dehydration. Assess renal function before use; ensure adequate hydration; consider lower doses and longer intervals between procedures. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ISOVUE-M 200 (ISOVUE-M 200).
| Breastfeeding | Iopamidol is excreted into human breast milk in very small amounts. The milk-to-plasma ratio (M/P) is approximately 0.01. After IV administration, the amount ingested by a nursing infant is minimal (<0.1% of the maternal dose). Because of the low bioavailability of oral iodinated contrast agents, adverse effects in the infant are unlikely. The American College of Radiology considers it safe to continue breastfeeding after use of iodinated contrast agents. However, some guidelines suggest discarding breast milk for 12-24 hours after administration if desired. |
| Teratogenic Risk | Iopamidol (ISOVUE-M 200) is a nonionic iodinated contrast agent. Animal reproduction studies have not been conducted. It is not known whether iopamidol can cause fetal harm when administered to a pregnant woman. However, iodinated contrast agents cross the placenta and accumulate in the fetal thyroid, potentially causing hypothyroidism. Use during pregnancy should be limited to situations where the diagnostic benefit clearly outweighs the risk. First trimester exposure is not advised due to organogenesis. Second and third trimester use may be considered with caution, but neonatal thyroid function should be assessed after birth. |
■ FDA Black Box Warning
Risk of serious adverse reactions including anaphylaxis, seizures, and neurological complications when administered intrathecally. Use only by physicians trained in myelography and familiar with the procedure. Resuscitative equipment and trained personnel must be immediately available.
| Serious Effects |
["Known hypersensitivity to iopamidol or any component of the formulation","Concurrent intrathecal administration of corticosteroids or other contrast agents","Blood in CSF (hemorrhagic puncture) due to increased risk of neurotoxicity","History of seizures or epilepsy (relative contraindication depending on benefit-risk)","Severe renal impairment (relative, may be used after dialysis if necessary)"]
| Precautions | ["Risk of anaphylactoid reactions, especially in patients with history of allergy or bronchial asthma","Seizures may occur, particularly in patients with epilepsy or when concurrent medications lower seizure threshold","Renal impairment delays elimination and increases risk of adverse effects","Adequate hydration before and after procedure is essential","Neurotoxicity: avoid hemorrhage or infection at puncture site, do not use in patients with increased intracranial pressure"] |
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| Fetal Monitoring | Monitor maternal vital signs (blood pressure, heart rate, oxygen saturation) during and after administration due to potential allergic or idiosyncratic reactions. Assess fetal heart rate if pregnancy is advanced and the procedure allows. In third trimester, monitor for uterine contractions or fetal distress. After exposure, neonatal thyroid function tests (TSH, free T4) should be performed at birth or within the first week of life to detect potential hypothyroidism. |
| Fertility Effects | No human data on the effects of iopamidol on fertility. Animal studies have not been conducted. Based on the low systemic absorption and transient nature of contrast agents, clinically significant effects on fertility are unlikely. However, the use of diagnostic iodinated contrast is not associated with long-term reproductive impairment. |