OMNIPAQUE 240
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMNIPAQUE 240 (OMNIPAQUE 240).
Iodinated radiocontrast agent that attenuates X-rays due to high atomic number of iodine, enhancing vascular and tissue contrast during imaging procedures. It distributes in extracellular fluid and is excreted unchanged by glomerular filtration.
| Metabolism | Not metabolized; eliminated unchanged primarily by glomerular filtration. Less than 1% is excreted via bile or other extrarenal routes. |
| Excretion | Primarily renal (glomerular filtration, no tubular reabsorption); >95% excreted unchanged in urine within 24 hours; <5% biliary/fecal |
| Half-life | Terminal half-life approximately 1-2 hours in normal renal function; prolonged to 20-40 hours in severe renal impairment (CrCl <30 mL/min), necessitating dose adjustment |
| Protein binding | Negligible (<5%); does not bind significantly to plasma proteins |
| Volume of Distribution | 0.2-0.3 L/kg (approximately 15-20 L in adults), consistent with extracellular fluid distribution; does not cross intact blood-brain barrier |
| Bioavailability | Not applicable for oral use due to negligible absorption; intravascular administration yields 100% bioavailability |
| Onset of Action | Intravenous: immediate (seconds to minutes) due to rapid vascular distribution; Intra-arterial: within seconds; Intrathecal: immediate for myelography |
| Duration of Action | Intravenous: imaging effect lasts 15-30 minutes (intravascular phase) to 1-2 hours (parenchymal phase); Intrathecal: up to 1 hour; clinical imaging typically completed within 30 minutes of injection |
Intravenous administration: 50-200 mL (12-48 g iodine) of OMNIPAQUE 240 (240 mg iodine/mL) as a single dose, adjusted for procedure and patient size.
| Dosage form | SOLUTION |
| Renal impairment | eGFR 30-59 mL/min: reduce dose by 50% or use lowest effective dose; eGFR <30 mL/min: contraindicated or use with extreme caution, consider alternative imaging. |
| Liver impairment | No specific adjustment for hepatic impairment; use caution in severe hepatic disease due to potential risk of delayed clearance. |
| Pediatric use | Weight-based: 1-2 mL/kg (0.24-0.48 g iodine/kg) intravenously, not to exceed adult dose. |
| Geriatric use | Use lowest effective dose; monitor renal function due to age-related decrease; ensure adequate hydration before and after procedure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMNIPAQUE 240 (OMNIPAQUE 240).
| Breastfeeding | Iohexol is excreted into breast milk in very low amounts (M/P ratio ~0.2-0.4). Predicted infant dose is <0.01% of maternal dose. No adverse effects reported. Breastfeeding can continue without interruption; however, some guidelines suggest discarding milk for 24 hours post-contrast. |
| Teratogenic Risk | Iodinated contrast agents like iohexol (Omnipaque 240) cross the placenta. Limited human data show no clear teratogenic risk, but fetal hypothyroidism is a theoretical concern due to free iodide. Use only if clearly needed. First trimester: avoid if possible. Second and third trimesters: no known structural teratogenicity, but neonatal thyroid function should be monitored if exposure occurs. |
■ FDA Black Box Warning
Risk of acute non-cardiogenic pulmonary edema, particularly in patients with anuria or oliguria with dehydration; use in patients with multiple myeloma or other paraproteinemias may increase risk of renal failure. Also, risk of severe, life-threatening or fatal adverse reactions including anaphylaxis, cardiovascular reactions, and central nervous system reactions.
| Serious Effects |
["Hypersensitivity to iohexol or any component of OMNIPAQUE","Patients with known anuria or oliguria with dehydration","Intrathecal administration in patients with active central nervous system infection, epilepsy, or acute intracranial bleeding"]
| Precautions | ["Risk of serious hypersensitivity reactions, including anaphylaxis, especially in patients with history of allergy to contrast media or asthma","Acute kidney injury risk, particularly in patients with preexisting renal impairment, diabetes, dehydration, or concurrent use of nephrotoxic drugs","Extravasation risk causing tissue damage","Thyroid dysfunction risk in patients with hyperthyroidism or thyroid nodules","Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome) reported"] |
Loading safety data…
| Fetal Monitoring | Monitor for allergic reactions, nephrotoxicity (eGFR, serum creatinine), and thyroid function in the mother if preexisting thyroid disease. In neonates, check thyroid-stimulating hormone (TSH) if substantial exposure occurred in utero. Fetal heart rate monitoring is not routinely required but may be considered in high-risk pregnancies. |
| Fertility Effects | No known impact on fertility in males or females. Animal studies show no adverse reproductive effects. Theoretical transient ovarian exposure to radiation (if used in fluoroscopy) but no direct gonadal toxicity. |