IOPAMIDOL-300 IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IOPAMIDOL-300 IN PLASTIC CONTAINER (IOPAMIDOL-300 IN PLASTIC CONTAINER).
Iopamidol is a non-ionic, low-osmolality iodinated contrast agent that increases the radiopacity of vascular structures and tissues by attenuating X-rays. It distributes into the extracellular fluid compartment and is excreted unchanged by glomerular filtration.
| Metabolism | Iopamidol is not metabolized; it is excreted unchanged by the kidneys via glomerular filtration. |
| Excretion | Primarily renal via glomerular filtration; >95% eliminated unchanged in urine within 24 hours. Biliary/fecal elimination is negligible (<1%). |
| Half-life | Approximately 2 hours in patients with normal renal function (GFR >90 mL/min). Prolonged in renal impairment (up to 30 hours or more in severe disease). |
| Protein binding | Minimal (<5% bound), primarily to albumin. |
| Volume of Distribution | 0.2–0.3 L/kg, approximating extracellular fluid volume. |
| Bioavailability | 100% by intravascular (intravenous or intra-arterial) routes as it is not absorbed orally. |
| Onset of Action | Immediate upon intravascular injection; opacification occurs within seconds during angiography or CT. |
| Duration of Action | Radiographic enhancement persists for 30–60 minutes following injection due to rapid redistribution and renal clearance. In imaging, peak enhancement occurs immediately and declines rapidly. |
Intravenous administration: 1-2 mL/kg (300-600 mg iodine/kg) for contrast imaging; maximum 200 mL per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR 30-59 mL/min: reduce dose to 0.5-1 mL/kg; eGFR <30 mL/min: contraindicated or use only if benefit outweighs risk, consider lowest possible dose and ensure hydration. |
| Liver impairment | No specific adjustment for Child-Pugh class A or B; use with caution in Child-Pugh class C due to increased risk of nephrotoxicity. |
| Pediatric use | Neonates and infants: 1-2 mL/kg (300-600 mg iodine/kg); children: 1-2 mL/kg (maximum 100-150 mL total). |
| Geriatric use | Use lowest effective dose; ensure adequate hydration; monitor renal function before and after administration; consider dose reduction if eGFR <60 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IOPAMIDOL-300 IN PLASTIC CONTAINER (IOPAMIDOL-300 IN PLASTIC CONTAINER).
| Breastfeeding | Iopamidol is excreted into breast milk in very small amounts (M/P ratio not established). The estimated infant dose is <1% of maternal dose. Because of low bioavailability and rapid elimination, adverse effects in nursing infants are unlikely. The American College of Radiology recommends no interruption of breastfeeding after contrast administration; however, some sources suggest discarding milk for 12-24 hours. |
| Teratogenic Risk | Iodinated contrast agents, including iopamidol, cross the placenta and have been associated with transient neonatal hypothyroidism when used during pregnancy. First trimester exposure: theoretical risk of radiation exposure if combined with X-ray; contrast alone is not known to be teratogenic based on limited human data. Second and third trimesters: risk of fetal hypothyroidism (transient); no consistent evidence of structural malformations. FDA Pregnancy Category B (before 2015); current labeling advises use only if clearly needed. |
■ FDA Black Box Warning
Not for intrathecal use with IOPAMIDOL-300; higher concentrations (e.g., IOPAMIDOL-200) are indicated for myelography. Risk of severe adverse reactions including anaphylaxis, renal failure, and cardiovascular collapse.
| Serious Effects |
["History of hypersensitivity to iopamidol or any iodinated contrast agent.","Intrathecal administration of IOPAMIDOL-300 (use lower concentration formulations for myelography).","Oliguric renal failure (relative contraindication; use only if benefit outweighs risk).","Concomitant administration of metformin in patients with renal impairment (risk of lactic acidosis)."]
| Precautions | ["Risk of contrast-induced acute kidney injury (CI-AKI), especially in patients with pre-existing renal impairment, diabetes, dehydration, or concurrent nephrotoxic drugs.","Hypersensitivity reactions ranging from mild skin reactions to severe anaphylaxis.","Contrast-induced encephalopathy following intrathecal administration (with appropriate formulations).","Thyroid storm in patients with hyperthyroidism or autonomously functioning thyroid tissue.","Extravasation causing tissue damage.","Sickle cell disease patients are at risk of vaso-occlusive crises."] |
| Food/Dietary |
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| Fetal Monitoring | Obtain maternal renal function (serum creatinine, eGFR) prior to administration. Monitor for acute allergic reactions (urticaria, bronchospasm, hypotension). In pregnant patients, assess fetal heart rate and uterine activity if pre-term. In neonates, consider thyroid function testing (TSH, free T4) 1-2 weeks after in utero exposure. Monitor for contrast-induced nephropathy in high-risk mothers. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not shown impaired fertility at clinically relevant doses. Transient effects on sperm or ovulation not reported. |
| No specific food interactions; maintain adequate hydration before and after administration. Avoid alcohol prior to procedure as it may increase dehydration risk. |
| Clinical Pearls | Iopamidol is a low-osmolar nonionic iodinated contrast medium used for angiography, urography, and CT enhancement. Monitor renal function pre- and post-procedure due to risk of contrast-induced nephropathy (CIN). Prehydrate with isotonic saline (e.g., 1 mL/kg/h for 6-12 hours) in high-risk patients (eGFR < 30 mL/min). Have emergency equipment available for anaphylactoid reactions. Use with caution in patients with pheochromocytoma (may provoke hypertensive crisis; pre-treat with alpha-blockers). For myelography, use only formulations labeled for intrathecal use; Iopamidol-300 is not approved for intrathecal administration. |
| Patient Advice | Inform your doctor if you have a history of kidney disease, diabetes, or are taking metformin (may need to stop temporarily). · Report any prior allergic reactions to contrast media or iodine. · You may experience a warm sensation or metallic taste during injection; this is normal. · Stay well hydrated before and after the procedure unless instructed otherwise. · Seek immediate medical attention if you develop hives, difficulty breathing, swelling, or irregular heartbeat after the scan. |