OMNIPAQUE 9
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMNIPAQUE 9 (OMNIPAQUE 9).
Iodinated nonionic contrast agent that attenuates X-rays, enhancing vascular and tissue contrast. Its iodine content (350 mg/mL) provides radiopacity, while low osmolality reduces adverse hemodynamic effects.
| Metabolism | Primarily eliminated unchanged by renal glomerular filtration. No significant hepatic metabolism. Minimal protein binding (<5%). |
| Excretion | Renal: >95% unchanged via glomerular filtration; fecal: <1%. |
| Half-life | Terminal elimination half-life: 1–2 hours in patients with normal renal function; prolonged to >24 hours in severe renal impairment (CrCl <30 mL/min), necessitating dose adjustment. |
| Protein binding | Negligible (<1%); does not bind significantly to plasma proteins. |
| Volume of Distribution | 0.2–0.3 L/kg; distributes primarily in extracellular fluid, with minimal intracellular penetration. |
| Bioavailability | Oral: negligible (<1%) due to poor gastrointestinal absorption; intravenous: 100%. |
| Onset of Action | Intravenous: within 1–2 minutes for contrast enhancement; oral: for CT of GI tract, onset ~30 minutes; rectal: onset ~15 minutes. |
| Duration of Action | Intravenous: contrast effect lasts 1–2 hours for CT; oral/rectal: GI opacification persists 30–90 minutes depending on transit time. |
Omnipaque 9 (iohexol 9 mg I/mL) is administered intravenously. For CT enhancement, typical adult dose is 50-100 mL (450-900 mg I) by slow IV injection.
| Dosage form | SOLUTION |
| Renal impairment | In patients with GFR 30-59 mL/min: reduce dose by 50% and ensure adequate hydration. With GFR <30 mL/min: avoid use or use only if essential with minimum dose (e.g., 10-20 mL) and nephrology consult. |
| Liver impairment | No specific dose adjustment for Child-Pugh class; however, monitor for contrast-induced nephropathy in ascites (volume status). Use lowest effective dose with hydration. |
| Pediatric use | Children: 1-2 mL/kg (9-18 mg I/kg) IV; maximum 50 mL total. For neonates: 0.5-1 mL/kg IV slowly. |
| Geriatric use | Elderly: use minimum dose (e.g., 25-50 mL) to achieve diagnostic result; pre-hydrate and monitor renal function closely due to age-related GFR decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMNIPAQUE 9 (OMNIPAQUE 9).
| Breastfeeding | Iohexol (active component) is excreted in breast milk in minimal amounts; estimated infant dose <1% of maternal. M/P ratio not established. Discontinue breastfeeding for 24 hours post-administration as precaution. |
| Teratogenic Risk | FDA Category C. No adequate studies in pregnant women. Iodinated contrast crosses placenta. First trimester: theoretical risk of fetal hypothyroidism if administered; third trimester: transient neonatal hypothyroidism reported. Benefits must outweigh risks. |
| Fetal Monitoring |
■ FDA Black Box Warning
Not to be used for intrathecal administration unless specifically indicated for myelography. Risk of severe adverse reactions including anaphylaxis, cardiac arrest, and seizures. Must have emergency resuscitation equipment available.
| Serious Effects |
["Absolute: History of anaphylaxis to iodinated contrast media.","Absolute: Known or suspected pregnancy (unless benefit outweighs risk).","Relative: Severe renal impairment (eGFR <30 mL/min/1.73 m²) without dialysis.","Relative: Untreated hyperthyroidism."]
| Precautions | ["Risk of contrast-induced acute kidney injury (CI-AKI), especially in patients with pre-existing renal impairment, diabetes, or dehydration.","Serious hypersensitivity/anaphylactoid reactions, including bronchospasm, laryngeal edema, and hypotension.","Thyroid dysfunction: Iodine exposure may induce hyperthyroidism in predisposed patients.","Cardiovascular: Avoid in patients with severe heart failure or pulmonary hypertension due to risk of hemodynamic decompensation.","Neurologic: Intrathecal use may cause seizures, arachnoiditis, or meningitis."] |
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| Monitor maternal renal function (serum creatinine, eGFR) before and after administration. Fetal monitoring: ultrasound if concern for fetal hypothyroidism; neonatal thyroid function tests if contrast given near delivery. |
| Fertility Effects | No evidence of impaired fertility in animal studies. No human data on ovarian or testicular function. |