OMNIPAQUE 12
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMNIPAQUE 12 (OMNIPAQUE 12).
Radiopaque agent that attenuates X-rays, providing contrast in imaging. Iodine atoms absorb X-rays, enhancing visualization of blood vessels and tissues.
| Metabolism | Primarily excreted unchanged by the kidneys via glomerular filtration. Not metabolized. |
| Excretion | Renal: >95% unchanged; biliary/fecal: <5% |
| Half-life | 1-2 hours (normal renal function); prolonged to >20 hours in severe renal impairment (CrCl <30 mL/min) |
| Protein binding | Negligible (<1%); does not bind significantly to plasma proteins |
| Volume of Distribution | 0.2-0.3 L/kg (mainly extracellular fluid; does not cross intact blood-brain barrier) |
| Bioavailability | IV: 100%; oral: <5% (not absorbed from GI tract); intra-arterial: 100% |
| Onset of Action | IV: immediate (within 1 minute for CT enhancement); intra-arterial: within seconds; oral/rectal: 15-60 minutes for GI opacification |
| Duration of Action | IV: 1-2 hours for contrast enhancement (renal excretion-dependent); oral/rectal: up to 4 hours for GI tract imaging |
Adult dose: 12 g iodine (e.g., 200 mL of Omnipaque 12) administered intravenously, intra-arterially, or into body cavities. Typical contrast study dose: 1-2 mL/kg (max 150 mL) for CT; 40-60 mL for angiographic procedures.
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-59 mL/min: reduce dose by 50% or use lowest effective dose; GFR <30 mL/min or on dialysis: contraindicated or use only if necessary with minimal dose and ensure hydration. |
| Liver impairment | No specific Child-Pugh based adjustments; use with caution in severe hepatic impairment due to decreased clearance of contrast media; monitor renal function. |
| Pediatric use | Intravenous dose: 1-2 mL/kg (max 150 mL) of Omnipaque 12 (12 g iodine/100 mL). For neonates and infants (<1 year): 1-1.5 mL/kg. Intrathecal use not recommended. |
| Geriatric use | Elderly patients: use lowest effective dose (e.g., 0.5-1 mL/kg) due to age-related renal impairment; ensure adequate hydration before and after procedure; monitor renal function for 48 hours. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMNIPAQUE 12 (OMNIPAQUE 12).
| Breastfeeding | Excreted in breast milk in minimal amounts (less than 1% of maternal dose); M/P ratio not established. Oral bioavailability from breast milk is low. Consider pumping and discarding milk for 24 hours post-administration to minimize exposure. |
| Teratogenic Risk | Iodinated contrast agents cross the placenta. First trimester: No evidence of teratogenicity in humans, but theoretical risk from direct fetal exposure; use only if essential. Second and third trimesters: Fetal thyroid function begins at 10-12 weeks; exposure may cause transient neonatal hypothyroidism. Postmarketing data show no increased risk of congenital anomalies. |
■ FDA Black Box Warning
Risk of serious adverse reactions including anaphylaxis, cardiac arrest, and death. Not for intrathecal use in patients with elevated intracranial pressure or CNS disorders.
| Serious Effects |
["Known hypersensitivity to iohexol or other iodinated contrast media","Anuria or severe renal impairment (eGFR < 30 mL/min/1.73m²) for intrathecal use","Concurrent administration of oral cholecystographic agents","Intrathecal use in patients with elevated intracranial pressure or CNS disorders"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Renal toxicity in patients with pre-existing renal impairment","Thyroid dysfunction in predisposed patients","CNS toxicity with intrathecal use","Serious cardiovascular reactions"] |
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| Fetal Monitoring | Monitor maternal renal function (creatinine) and hydration status during pregnancy. Fetal heart rate monitoring is not routine unless clinically indicated. Evaluate neonatal thyroid function (TSH) at birth if exposure occurs after 24 weeks gestation. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies show no impairment of reproductive function at clinically relevant doses. |