OMNIPAQUE 140
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMNIPAQUE 140 (OMNIPAQUE 140).
Radiopaque contrast agent that attenuates X-rays due to iodine content, enhancing vascular and tissue visualization.
| Metabolism | Not metabolized; excreted unchanged via glomerular filtration in urine. |
| Excretion | Renal: >95% unchanged via glomerular filtration; biliary/fecal: negligible (<1%). |
| Half-life | Terminal elimination half-life: 1–2 hours; prolonged in renal impairment (up to 30–40 hours in severe dysfunction). |
| Protein binding | < 2% bound; negligible binding to plasma proteins. |
| Volume of Distribution | Vd: 0.2–0.3 L/kg; limited to extracellular space, minimal intracellular penetration. |
| Bioavailability | Intravenous: 100% (only route used); not absorbed orally due to high osmolality and radiocontrast nature. |
| Onset of Action | Intravenous: immediate (seconds to minutes) for contrast enhancement; intrathecal: 2–5 minutes for myelography. |
| Duration of Action | Intravenous: 30–60 minutes for diagnostic imaging; intrathecal: 1–2 hours due to slower clearance from CSF. |
Intravascular: 50-200 mL (containing 7.0-28.0 g iodine) per procedure, administered intravenously as a bolus or infusion; dose depends on imaging modality and body region. Intrathecal: 6-15 mL (containing 0.84-2.1 g iodine) administered via lumbar puncture for myelography.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR 30-59 mL/min/1.73m2: No routine dose adjustment, ensure adequate hydration. eGFR <30 mL/min/1.73m2: Use lowest feasible dose, consider alternative imaging if possible; post-procedure monitoring for contrast-induced nephropathy recommended. Hemodialysis: Administer after dialysis if possible; no supplemental dose needed. |
| Liver impairment | No specific hepatic adjustment required; metabolism is minimal. Use caution in severe hepatic impairment due to potential renal co-morbidity. |
| Pediatric use | Intravascular: 1.0-2.0 mL/kg (140-280 mg I/kg) per injection, maximum total dose 4.0 mL/kg (560 mg I/kg) per procedure. Intrathecal: 0.5-1.0 mL (70-140 mg I) for children weighing <15 kg; 1.5-3.0 mL (210-420 mg I) for 15-40 kg; 3.0-6.0 mL (420-840 mg I) for >40 kg. |
| Geriatric use | No specific dose adjustment; increased risk of adverse reactions due to age-related renal impairment and dehydration. Ensure adequate hydration and use minimum necessary dose. Monitor renal function pre- and post-procedure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMNIPAQUE 140 (OMNIPAQUE 140).
| Breastfeeding | Excreted into breast milk in very low amounts (M/P ratio ~0.07). Oral bioavailability in infant is negligible; risk of adverse effects is low. American College of Radiology advises no need to interrupt breastfeeding. |
| Teratogenic Risk | Category B. Iodinated contrast agents cross the placenta. First trimester: theoretical risk of fetal hypothyroidism, but no definitive teratogenicity in humans. Second/third trimester: risk of transient neonatal hypothyroidism; no structural anomalies reported. |
■ FDA Black Box Warning
Risk of severe, life-threatening adverse reactions including anaphylaxis, cardiac arrest, and hypotension; especial caution in patients with history of reaction to contrast media, bronchial asthma, or allergies.
| Serious Effects |
["Absolute: Known hypersensitivity to iodinated contrast media","Absolute: Anuria due to contrast-induced nephropathy history","Relative: Decompensated heart failure, severe hypertension, or unstable angina","Relative: Pregnancy (use only if clearly needed)","Relative: Concurrent administration of nephrotoxic drugs"]
| Precautions | ["Risk of contrast-induced nephropathy (CIN) in patients with pre-existing renal impairment, diabetes, or dehydration","Serious anaphylactic/hypersensitivity reactions may occur; have emergency equipment available","Increased risk in patients with multiple myeloma, pheochromocytoma, sickle cell disease, or hyperthyroidism","Intrathecal use may cause neurotoxicity including seizures, arachnoiditis, and meningitis","Avoid in patients with severe hepatic impairment due to risk of delayed clearance"] |
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| Fetal Monitoring |
| Monitor maternal renal function (serum creatinine, eGFR) and hydration status before administration. Assess for signs of hypersensitivity. Fetal monitoring not typically required; consider neonatal thyroid function testing if used near delivery. |
| Fertility Effects | No known adverse effects on fertility or reproduction in animal studies. No human data suggesting impairment of fertility. |