OMNIPAQUE 210
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMNIPAQUE 210 (OMNIPAQUE 210).
Radiopaque contrast agent that contains iodine, which attenuates X-rays and provides radiographic visualization of vascular structures and organs. It does not have a pharmacological mechanism of action.
| Metabolism | Not metabolized; remains as an intact molecule in the body and is excreted unchanged via the kidneys. |
| Excretion | Renal: ~95% unchanged within 24 hours via glomerular filtration; biliary/fecal: <5% |
| Half-life | Terminal elimination half-life: 1-2 hours in patients with normal renal function; prolonged in renal impairment (up to 30 hours in severe cases). In neonates, half-life is 6-12 hours due to immature renal function. |
| Protein binding | Negligible (<2%); no significant binding to plasma proteins (primarily albumin). |
| Volume of Distribution | Vd: ~0.25 L/kg (total extracellular fluid volume); reflects distribution primarily in extracellular space, minimal intracellular penetration. |
| Bioavailability | Intravascular: 100% (IV); oral/rectal: <5% (negligible systemic absorption due to poor gastrointestinal uptake). |
| Onset of Action | Intravascular: immediate (seconds to minutes); intrathecal: rapid (minutes) with visualization within 15-30 minutes; oral/rectal: 15-30 minutes for GI opacification. |
| Duration of Action | Intravascular: 15-30 minutes for contrast enhancement; intrathecal: 1-2 hours; oral/rectal: 1-2 hours. Clinical duration may be shorter due to rapid redistribution and excretion. |
Intravascular administration: 50-150 mL (10-30 g iodine) as bolus or infusion, based on procedure (CT, angiography, urography). Intravenous infusion for CT: 100-200 mL at 1-3 mL/sec.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-59 mL/min: reduce dose by 50% or extend interval. GFR <30 mL/min: use only if essential, with minimum dose and adequate hydration. Not studied in dialysis. |
| Liver impairment | No specific adjustment for Child-Pugh class A, B, or C. Use caution in severe liver disease due to risk of contrast-induced nephropathy. |
| Pediatric use | 0.5-2 mL/kg (100-400 mg iodine/kg) IV, not to exceed adult dose. Individualize based on age, weight, and procedure. |
| Geriatric use | Reduce dose by 10-20% due to decreased renal function. Ensure adequate hydration. Monitor renal function pre- and post-contrast. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMNIPAQUE 210 (OMNIPAQUE 210).
| Breastfeeding | Iohexol is excreted into breast milk in very small amounts; estimated infant dose <1% of maternal dose. M/P ratio not established. A 12-24 hour interruption of breastfeeding after administration is considered prudent to reduce any theoretical risk. |
| Teratogenic Risk | Iodinated contrast agents cross the placenta. No teratogenic effects have been reported in animal studies or human case series. Risk in first trimester is theoretical due to potential fetal thyroid suppression; second and third trimester exposure may transiently suppress fetal thyroid function. Use only if clearly needed. |
■ FDA Black Box Warning
Not available for OMNIPAQUE 210.
| Serious Effects |
["History of severe hypersensitivity reaction to iodinated contrast media","Acute or chronic renal failure when renal function is severely impaired"]
| Precautions | ["Risk of serious or fatal adverse reactions including anaphylaxis, renal failure, and cardiovascular complications","Patients with a history of allergy, asthma, or previous reaction to contrast media should be premedicated","Renal function should be assessed prior to administration in patients at risk for contrast-induced acute kidney injury","Hydration should be maintained before and after administration","Thyroid storm may occur in patients with hyperthyroidism","Extravasation may cause tissue necrosis"] |
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| Fetal Monitoring | Monitor maternal renal function prior to administration. In pregnant patients, assess fetal heart rate if possible during procedure. Post-exposure, monitor neonatal thyroid function (TSH, T4) at birth if exposure occurred during pregnancy. |
| Fertility Effects | No evidence of impaired fertility in animal studies. No human data available; effects on fertility are unlikely at diagnostic doses. |