IOPAMIDOL-370 IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IOPAMIDOL-370 IN PLASTIC CONTAINER (IOPAMIDOL-370 IN PLASTIC CONTAINER).
Iopamidol is a nonionic, low-osmolality radiocontrast agent that attenuates X-rays by blocking their passage, thereby enhancing the contrast of vascular structures and tissues during imaging. It does not have a specific molecular target but relies on its iodine content for radiopacity.
| Metabolism | Iopamidol is not metabolized; it is excreted unchanged by the kidneys via glomerular filtration. |
| Excretion | Renal: >90% unchanged by glomerular filtration within 24–48 hours; biliary/fecal: <2%. |
| Half-life | Terminal half-life 1.5–2 hours in normal renal function; prolonged to 4–12 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | <10% (minimal binding to plasma proteins). |
| Volume of Distribution | 0.2–0.3 L/kg (mostly extracellular fluid, not entering cells or red blood cells). |
| Bioavailability | Intravenous: 100% (only IV/intra-arterial use; no oral bioavailability as not absorbed). |
| Onset of Action | Intravenous: immediate (within seconds) for contrast enhancement in CT. |
| Duration of Action | Intravenous: contrast effect persists 30–60 minutes post-injection, with complete elimination within 24 hours in normal renal function. |
Intravenous: 0.5-2 mL/kg (185-740 mg iodine/kg) as a single dose; repeated doses may be administered up to a total of 5 mL/kg (1850 mg iodine/kg) within a 24-hour period.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73 m²: Use lowest possible dose and consider alternative imaging if possible. eGFR 30-59: No dose adjustment but ensure adequate hydration. eGFR ≥60: No adjustment needed. |
| Liver impairment | No specific dose adjustment required for hepatic impairment based on Child-Pugh class. Use caution in severe hepatic impairment due to potential comorbidity. |
| Pediatric use | Intravenous: 1-2 mL/kg (370-740 mg iodine/kg) as a single dose; maximum total dose 5 mL/kg (1850 mg iodine/kg) in 24 hours. |
| Geriatric use | No specific dose adjustment solely based on age. Assess renal function (eGFR) and adjust accordingly. Ensure adequate hydration before and after administration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IOPAMIDOL-370 IN PLASTIC CONTAINER (IOPAMIDOL-370 IN PLASTIC CONTAINER).
| Breastfeeding | Iopamidol is excreted into breast milk in small amounts. The M/P ratio is approximately 0.1. Based on the limited data, it is considered compatible with breastfeeding. The American College of Radiology recommends that no special precautions are necessary, and breastfeeding can continue without interruption after contrast administration. |
| Teratogenic Risk | Iopamidol is a nonionic iodinated contrast agent. Limited data in pregnant women; animal studies have not shown teratogenic effects. First trimester: theoretical risk of fetal hypothyroidism if high doses administered, but no evidence of congenital malformations. Second and third trimesters: minimal risk; iodinated contrast agents cross the placenta and may transiently suppress fetal thyroid function. Overexposure may cause neonatal hypothyroidism, but single diagnostic doses are considered low risk. |
■ FDA Black Box Warning
Serious adverse reactions, including fatal anaphylactic reactions, have been associated with the administration of iodinated contrast media. Emergency equipment and personnel trained in resuscitation should be readily available. Intrathecal administration may cause severe adverse reactions such as arachnoiditis, meningitis, and neurologic injury.
| Serious Effects |
Absolute: Known hypersensitivity to iopamidol or any component, history of anaphylaxis to iodinated contrast media, and intrathecal use in patients with a history of seizures or myelography with suspected spinal block. Relative: Severe renal impairment (e.g., eGFR <30 mL/min), severe hepatic impairment, and concurrent administration of metformin (risk of lactic acidosis).
| Precautions | Risk of serious hypersensitivity reactions (anaphylaxis), contrast-induced nephropathy (especially in patients with pre-existing renal impairment, diabetes, or dehydration), thyroid dysfunction (in patients with hyperthyroidism or thyroid tumors), and neurological disturbances (e.g., seizures, confusion) with intrathecal use. Caution in patients with pheochromocytoma, sickle cell disease, or concomitant use of nephrotoxic drugs. |
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| Fetal Monitoring | No specific fetal monitoring required during administration. In pregnant patients, consider maternal thyroid function monitoring if high doses or repeated exposures occur, as well as neonatal thyroid function screening after birth if in utero exposure occurred. |
| Fertility Effects | No known effects on fertility in animal studies. There are no adequate human data; however, iopamidol is not expected to impair fertility at standard diagnostic doses. |