OXILAN-300
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OXILAN-300 (OXILAN-300).
Iodinated contrast agent that attenuates X-rays and enhances vascular and tissue visualization during imaging procedures.
| Metabolism | Primarily eliminated renally; negligible hepatic metabolism. |
| Excretion | Renal elimination: 100% unchanged via glomerular filtration; biliary/fecal excretion negligible (<1%). |
| Half-life | Terminal half-life: 1.5–2.5 hours (normal renal function); prolonged in renal impairment (up to 30 hours in severe impairment). |
| Protein binding | Negligible (<1%); no significant protein binding. |
| Volume of Distribution | Vd: 0.2–0.3 L/kg (confined to extracellular fluid; minimal tissue penetration). |
| Bioavailability | Intravenous: 100%; oral: not administered (not absorbed). |
| Onset of Action | Intravenous: immediate (within seconds); intra-arterial: 5–10 seconds; oral: not applicable. |
| Duration of Action | Intravenous: imaging window 15–60 minutes (first-pass renal phase); prolonged in renal impairment. Total body clearance within 24 hours. |
Intravenous: 1-2 mL/kg (300 mg iodine/mL) for contrast imaging; maximum dose 2 mL/kg per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR ≥30 mL/min: no adjustment; eGFR <30 mL/min: contraindicated or use with extreme caution, consider alternative imaging. |
| Liver impairment | No specific adjustment required; use standard dosing as hepatic metabolism is minimal. |
| Pediatric use | Intravenous: 1-2 mL/kg (300 mg iodine/mL) based on body weight; not to exceed 2 mL/kg. |
| Geriatric use | No specific dose adjustment; monitor renal function (eGFR) and hydration status due to increased risk of contrast-induced nephropathy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OXILAN-300 (OXILAN-300).
| Breastfeeding | Ioxilan is excreted into human breast milk in minimal amounts (M/P ratio not established). The American College of Radiology states that breastfeeding can be continued without interruption after administration of iodinated contrast media. Theoretical risk of direct toxicity or allergic reaction to infant is extremely low. |
| Teratogenic Risk | Oxilan-300 (ioxilan) is an iodinated contrast agent. No adequate and well-controlled studies in pregnant women. Animal studies have not shown teratogenic effects. Potential fetal hypothyroidism if administered during pregnancy. Use only if clearly needed. Risks in first trimester are theoretical; second and third trimester use may transiently affect fetal thyroid function. |
■ FDA Black Box Warning
Risk of acute kidney injury in patients with preexisting renal impairment, particularly those receiving high doses or with conditions such as diabetes mellitus.
| Serious Effects |
["History of severe hypersensitivity reaction to ioxilan or other iodinated contrast agents","Anuria or severe renal impairment (eGFR < 30 mL/min/1.73 m²) if dose cannot be adjusted"]
| Precautions | ["Contrast-induced acute kidney injury (CI-AKI)","Severe hypersensitivity reactions (anaphylaxis)","Thyroid dysfunction in susceptible patients","Extravasation may cause local tissue damage"] |
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| Fetal Monitoring | Monitor maternal renal function before administration (serum creatinine, eGFR). Assess for signs of allergic or anaphylactoid reactions. For neonates, monitor thyroid function (TSH, free T4) if exposure occurred in utero, particularly in the third trimester. |
| Fertility Effects | No known effects on fertility in animal studies. No human data available. Likely no significant impact given single diagnostic use. |