IOPAMIDOL-200
Clinical safety rating: caution
Comprehensive clinical and safety monograph for IOPAMIDOL-200 (IOPAMIDOL-200).
Iopamidol is a nonionic iodinated contrast agent that attenuates X-rays, enhancing vascular and tissue contrast. It does not have a pharmacological effect but provides radiographic opacity.
| Metabolism | Iopamidol is not metabolized. It is eliminated unchanged via glomerular filtration. No hepatic metabolism. |
| Excretion | Renal: >95% unchanged via glomerular filtration within 24 hours; biliary/fecal: <1%. |
| Half-life | Terminal half-life: 2 hours (normal renal function); prolonged to 8-48 hours in severe renal impairment (CrCl <30 mL/min). |
| Protein binding | Less than 10% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | 0.2-0.3 L/kg; reflects distribution primarily in extracellular fluid, minimal tissue penetration. |
| Bioavailability | Intravenous/intra-arterial: 100% (not bioavailable orally due to lack of absorption). |
| Onset of Action | Intravenous: immediate (within seconds) as contrast appears in vessels; intra-arterial: immediate. |
| Duration of Action | I.V. or I.A.: 15-30 minutes for contrast enhancement; imaging window due to rapid renal clearance. |
Intravascular: 50-150 mL (75-225 mg iodine/kg) IV; frequency depends on procedure, usually single dose. Intrathecal: 5-15 mL (200 mg iodine/mL) injected into subarachnoid space.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <30 mL/min: use lowest effective dose; consider alternative contrast agent. GFR 30-60 mL/min: reduce dose; ensure adequate hydration. No specific formula, clinical judgment. |
| Liver impairment | No dose adjustment recommended for Child-Pugh A-C. Use caution in severe hepatic impairment due to potential delayed excretion. |
| Pediatric use | Intravascular: 1-2 mL/kg (200-400 mg iodine/kg) IV; maximum 3 mL/kg. Intrathecal: weight-based, typical 0.3-0.5 mL/kg, not to exceed adult dose. |
| Geriatric use | Consider reduced initial dose and slower injection; monitor renal function; ensure hydration. No fixed dose reduction, use lowest effective dose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for IOPAMIDOL-200 (IOPAMIDOL-200).
| Breastfeeding | Iopamidol is excreted in breast milk in very low amounts. The M/P ratio is not established. Because of low oral bioavailability, it is considered compatible with breastfeeding. The manufacturer advises discontinuing breastfeeding for 24-48 hours after administration as a precaution. |
| Teratogenic Risk | Iopamidol is an iodinated contrast agent. In animal studies, no teratogenic effects were observed at clinically relevant doses. Human data are limited; however, iodine exposure in utero can potentially cause fetal hypothyroidism, especially during the late second and third trimesters. Use only if clearly needed. |
■ FDA Black Box Warning
Risk of serious adverse reactions including fatal anaphylaxis, cardiovascular collapse, and seizures, particularly in patients with history of prior reaction to contrast media, asthma, or other allergies. Intrathecal administration may cause severe neurological reactions including coma, seizures, and paralysis. Resuscitative equipment and trained personnel must be immediately available.
| Serious Effects |
["Absolute: Known hypersensitivity to iopamidol or any component; anuria","Relative: Severe renal impairment (eGFR <30), severe hepatic impairment, decompensated heart failure, uncontrolled hyperthyroidism, pregnancy (use only if clearly needed)"]
| Precautions | ["Hypersensitivity: Risk of anaphylaxis, require pretreatment in high-risk patients","Renal impairment: Acute kidney injury risk, especially in preexisting renal disease, dehydration, or concurrent nephrotoxic drugs","Cardiovascular: Can precipitate CHF, arrhythmias, or aortic dissection in unstable patients","CNS effects: With intrathecal use, risk of seizures, especially in patients with seizure history or medications lowering seizure threshold","Thyroid dysfunction: Can induce hyperthyroidism in patients with autonomous thyroid nodules or Graves' disease","Sickle cell disease: May promote sickling","Pheochromocytoma: Hypertensive crisis risk, premedicate with alpha-blockers"] |
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| Fetal Monitoring | Monitor for allergic reactions, thyroid function in the neonate if exposure occurs near term, and renal function in the mother. |
| Fertility Effects | No specific human data on fertility effects. Animal studies did not indicate impaired fertility at relevant doses. |
| Food/Dietary | No specific food interactions. Patients should maintain adequate hydration with water or clear liquids before and after contrast administration. Avoid alcohol for 24 hours before and after the procedure due to potential dehydration and additive renal effects. |
| Clinical Pearls | Iopamidol-200 is a nonionic, low-osmolar contrast agent with lower chemotoxicity and fewer adverse reactions than high-osmolar agents. Prehydration with normal saline (1-2 mL/kg/hr for 4-6 hours before and after procedure) reduces risk of contrast-induced acute kidney injury (CI-AKI). For patients with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², consider alternative imaging or prophylactic N-acetylcysteine (600 mg twice daily day before and day of procedure). Always screen for prior contrast reaction; premedicate with corticosteroids (prednisone 50 mg PO q6h for 3 doses before procedure) and diphenhydramine (50 mg IV/PO 1 hour before) if history of mild reaction. Metformin should be withheld for 48 hours after contrast administration in patients with renal impairment or eGFR <30. Iopamidol-200 (200 mg iodine/mL) is suitable for CT angiography and venography where lower iodine concentration is acceptable; however, for optimal opacification in larger patients, higher concentration (e.g., iopamidol-300) may be required. Extravasation risk is minimal due to low osmolality, but if occurs, elevate extremity and apply cold compresses. |
| Patient Advice | You will receive a contrast dye through an IV line before your imaging test to help visualize blood vessels and organs. · Inform your doctor if you have any allergies, especially to contrast material, iodine, or shellfish. · Tell your doctor if you have kidney problems, diabetes, are taking metformin, or are pregnant or breastfeeding. · Drink plenty of water before and after the procedure as directed by your healthcare provider to help protect your kidneys. · You may experience a warm feeling or metallic taste in your mouth when the contrast is injected; this is normal and will pass quickly. · After the test, monitor for any delayed symptoms like rash, itching, difficulty breathing, or swelling; seek immediate medical attention if these occur. · Do not stop taking any prescription medications without consulting your doctor. |