IOPAMIDOL-200 IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IOPAMIDOL-200 IN PLASTIC CONTAINER (IOPAMIDOL-200 IN PLASTIC CONTAINER).
Iopamidol is a nonionic, water-soluble iodinated radiographic contrast agent that attenuates X-rays by increasing the density of tissues, thereby enhancing vascular and tissue contrast during imaging procedures.
| Metabolism | Iopamidol is not significantly metabolized; it undergoes renal elimination via glomerular filtration with minimal tubular reabsorption. The drug is excreted unchanged in the urine. |
| Excretion | Primarily renal (99% unchanged in urine within 24 hours). Biliary/fecal excretion <1%. |
| Half-life | Terminal elimination half-life approximately 2 hours (range 1.5-2.5 hours) in patients with normal renal function; prolonged in renal impairment. |
| Protein binding | Negligible (<3%), primarily to serum proteins (albumin). |
| Volume of Distribution | Approximately 0.2-0.3 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | 100% when administered via intravascular routes (IV, IA). Not applicable for oral or other routes. |
| Onset of Action | Immediate upon intravascular injection (contrast enhancement within seconds). Not applicable for other routes. |
| Duration of Action | Rapid redistribution and elimination; contrast enhancement lasts for minutes to a few hours. Imaging typically performed within 5-60 minutes post-injection. |
Intravascular administration: 1-2 mL/kg (200 mg I/mL) intravenously, up to a maximum of 150 mL per diagnostic procedure. Intraarterial administration: varies by procedure; typical 5-60 mL per injection.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with GFR <30 mL/min/1.73m². For GFR 30-45, consider using lowest effective dose with adequate hydration. For GFR 45-60, use with caution. |
| Liver impairment | No specific Child-Pugh based dose adjustments recommended; use with caution in severe hepatic impairment due to potential osmotic effects. |
| Pediatric use | Neonates (0-1 month): 0.5-1 mL/kg IV. Infants/Children: 1-2 mL/kg IV up to maximum 3 mL/kg. Adjust for total iodine load not to exceed 600 mg I/kg. |
| Geriatric use | Elderly: Use lowest effective dose due to reduced renal function and increased risk of contrast-induced nephropathy; ensure adequate hydration pre- and post-procedure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IOPAMIDOL-200 IN PLASTIC CONTAINER (IOPAMIDOL-200 IN PLASTIC CONTAINER).
| Breastfeeding | Iopamidol is excreted into breast milk in very low amounts; the milk-to-plasma ratio is approximately 0.04. The half-life in breast milk is about 1.5 hours. Based on limited data, the estimated infant dose is less than 1% of the maternal dose, which is considered clinically insignificant. The American College of Radiology recommends that breastfeeding may be continued without interruption after administration of iopamidol. |
| Teratogenic Risk | Iopamidol is a nonionic iodinated contrast agent. In pregnant women, iodinated contrast crosses the placenta and can enter fetal circulation. Animal studies have not shown teratogenic effects, but there are no adequate human studies. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. First trimester exposure may theoretically increase risk of neonatal hypothyroidism due to fetal iodine exposure, though reported cases are rare. |
■ FDA Black Box Warning
None
| Serious Effects |
["Absolute: Known hypersensitivity to iopamidol or any component of the formulation","Intrathecal administration in patients with suspected intracranial hemorrhage, obstructive hydrocephalus, or history of seizures","Relative: Severe renal impairment (eGFR <30 mL/min/1.73m²) without adequate hydration; concomitant use of nephrotoxic drugs; multiple myeloma; sickle cell disease; severe heart failure; pulmonary hypertension; uncontrolled hyperthyroidism"]
| Precautions | ["Risk of contrast-induced nephropathy (especially in patients with pre-existing renal impairment, diabetes, or dehydration)","Severe hypersensitivity reactions (e.g., anaphylaxis, bronchospasm, laryngeal edema) — require emergency resuscitation equipment","Thyroid storm in patients with hyperthyroidism or autonomous thyroid nodules","Intrathecal use: risk of neurotoxicity including seizures, arachnoiditis, and meningitis","Avoid extravasation due to risk of tissue necrosis","Pregnancy: only if clearly needed (Category B)","Lactation: discontinue breastfeeding for 12-24 hours after administration"] |
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| Fetal Monitoring | Monitor maternal vital signs (blood pressure, heart rate) during and after injection due to risk of hypotension or allergic reactions. For the fetus, no specific monitoring is required. However, if there is concern for fetal hypothyroidism, neonatal thyroid function tests may be considered after exposure in the third trimester. |
| Fertility Effects | No adverse effects on fertility have been reported in animal studies. There are no human data regarding fertility effects from iopamidol. |