OMNIPAQUE 350
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMNIPAQUE 350 (OMNIPAQUE 350).
Radiopaque agent: iodine-containing contrast medium that attenuates X-rays, enhancing vascular and tissue contrast during imaging. Non-ionic, low-osmolar agent.
| Metabolism | Not metabolized; excreted unchanged by glomerular filtration with renal clearance; negligible hepatic metabolism. |
| Excretion | Primarily renal excretion via glomerular filtration; >95% eliminated unchanged in urine within 24 hours. Biliary/fecal excretion is negligible (<1%). |
| Half-life | Terminal elimination half-life is approximately 1.5–2 hours in patients with normal renal function. May be prolonged in renal impairment. |
| Protein binding | Negligible (<5%). Iohexol does not bind significantly to plasma proteins. |
| Volume of Distribution | Approximately 0.26 L/kg, indicating distribution primarily within extracellular fluid. |
| Bioavailability | Not applicable for intravenous administration; bioavailability is 100% intravenously. |
| Onset of Action | Intravenous administration: immediate (within minutes) for contrast enhancement. |
| Duration of Action | Duration of diagnostic enhancement is approximately 30 minutes to 1 hour for CT imaging; the contrast agent is rapidly cleared from the vascular compartment. |
1-2 mL/kg IV up to 150 mL for CT; 30-50 mL IV for DSA; max 350 mL per procedure.
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-59 mL/min: reduce dose by 50% or use alternative; GFR <30 mL/min: contraindicated. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B/C: consider risk/benefit; no formal dose guidelines. |
| Pediatric use | 0.5-2 mL/kg IV (max 3 mL/kg) based on age and indication. |
| Geriatric use | Use lowest effective dose; monitor renal function; dose adjustment based on GFR as for adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMNIPAQUE 350 (OMNIPAQUE 350).
| Breastfeeding | Iohexol is excreted into breast milk in minimal amounts (less than 0.1% of maternal dose). M/P ratio not established. Estimated infant dose less than 1% of maternal weight-adjusted dose. American College of Radiology states breastfeeding can continue without interruption, but some experts suggest discarding milk for 12-24 hours post-administration. No adverse effects reported in nursing infants. |
| Teratogenic Risk | FDA Pregnancy Category B. Animal studies have not demonstrated fetal risk, but no adequate human studies in pregnant women. Iodinated contrast crosses the placenta. Potential fetal hypothyroidism if high doses administered near term, particularly in premature infants. First trimester: theoretical risk from free iodide; second trimester: no known teratogenicity; third trimester: risk of neonatal hypothyroidism if maternal thyroid function compromised. Use only if clearly needed. |
■ FDA Black Box Warning
Risk of fatal anaphylactoid reactions, especially in patients with history of allergic reaction, asthma, or sensitivity to iodine. Emergency resuscitation equipment and trained personnel must be immediately available.
| Serious Effects |
["Absolute: known hypersensitivity to iohexol or any iodine-based contrast","Absolute: anuria or severe oliguria (CIN risk)","Relative: multiple myeloma, pheochromocytoma, hyperthyroidism"]
| Precautions | ["Contrast-induced nephropathy (CIN): risk increased with pre-existing renal impairment, diabetes, dehydration, concurrent nephrotoxic drugs","Anaphylactoid reactions: severe, life-threatening reactions can occur","Thyroid storm: in patients with hyperthyroidism or thyroid nodules","Extravasation: local tissue injury; ensure proper catheter placement","Sickle cell disease: may promote sickling"] |
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| Fetal Monitoring | Monitor maternal thyroid function tests in patients with pre-existing thyroid disease or when repeated doses are given. In neonates exposed in utero, perform thyroid function screening at birth if contrast was administered near term. Monitor renal function in at-risk pregnant women (preeclampsia, diabetes). Assess fetal heart rate and uterine activity during intrauterine procedures. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not shown impairment of fertility or reproductive performance. No data on long-term reproductive outcomes after exposure. |