OXILAN-350
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OXILAN-350 (OXILAN-350).
Iodinated contrast medium that attenuates X-rays due to its iodine content, enhancing vascular and tissue contrast during imaging. It distributes in extracellular fluid and is freely filtered by glomeruli.
| Metabolism | Primarily eliminated renally via glomerular filtration with minimal hepatic metabolism or biliary excretion. Over 95% excreted unchanged in urine. |
| Excretion | Renal: >90% unchanged drug within 24 hours; Biliary/fecal: <2% |
| Half-life | Terminal elimination half-life: 2 hours (normal renal function); prolonged in renal impairment (up to 24 hours in severe impairment). |
| Protein binding | Negligible (<2%), primarily to albumin. |
| Volume of Distribution | 0.2 L/kg (extracellular fluid space; limited distribution into cells). |
| Bioavailability | IV/IA: 100%; Oral: not applicable (not administered orally). |
| Onset of Action | Intravascular (IV): immediate upon injection (seconds to minutes); Intra-arterial: immediate; Oral: not applicable. |
| Duration of Action | Intravascular: 15–30 minutes for contrast enhancement; peak enhancement at 30–90 seconds post-injection; imaging window depends on study (e.g., CT angiography). |
Intravenous: 0.5–2 mL/kg (350 mg I/mL) for CT imaging; maximum 200 mL total. Intra-arterial: 0.3–1.5 mL/kg per injection; maximum 200 mL per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR ≥30 mL/min/1.73m²: no adjustment. eGFR <30: avoid use unless dialysis anticipated; consider alternative imaging. eGFR <15: contraindicated (risk of nephrogenic systemic fibrosis with gadolinium? but this is iodinated contrast; actually for iodinated contrast, eGFR <30: use lowest dose, hydrate, consider N-acetylcysteine; hemodialysis post-procedure if on dialysis). |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: use caution, monitor renal function. Child-Pugh C: limited data; use lowest diagnostic dose, ensure adequate hydration. |
| Pediatric use | Intravenous: 1–2 mL/kg (350 mg I/mL) for CT; maximum 100 mL (based on weight). Intra-arterial: 0.5–1.5 mL/kg per injection; maximum 100 mL. Adjust for neonates: 0.5–1 mL/kg; monitor fluid balance. |
| Geriatric use | Use lowest effective dose; assess renal function (eGFR); ensure pre-hydration; monitor for contrast-induced nephropathy. No specific dose adjustment based on age alone. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OXILAN-350 (OXILAN-350).
| Breastfeeding | Ioxilan is excreted into breast milk in very small amounts (estimated M/P ratio ~0.01-0.02). The low oral bioavailability (<1%) makes systemic absorption by the infant negligible. Guidelines suggest no need to interrupt breastfeeding, but some recommend pumping and discarding milk for 24 hours to minimize theoretical risk. |
| Teratogenic Risk | Oxilan-350 (ioxilan) is an iodinated contrast agent. In pregnancy, there is no evidence of teratogenicity from human data; however, iodinated contrast crosses the placenta. First trimester: theoretical risk from free iodide, but no documented malformations. Second/third trimester: can cause transient neonatal hypothyroidism if high doses are used; risk is low but may require neonatal thyroid screening. |
■ FDA Black Box Warning
Risk of contrast-induced acute kidney injury (CI-AKI) especially in patients with pre-existing renal impairment, diabetes, dehydration, or those taking nephrotoxic drugs. Inadvertent intrathecal administration of formulations not labeled for intrathecal use can cause severe neurotoxicity.
| Serious Effects |
["Known hypersensitivity to iodinated contrast media","Severe renal impairment (eGFR <30 mL/min/1.73 m²) unless benefits outweigh risks","Concurrent administration of metformin in patients with moderate to severe renal impairment due to risk of lactic acidosis","Untreated hyperthyroidism or thyroid storm"]
| Precautions | ["Serious hypersensitivity reactions including anaphylaxis; premedication may be considered in high-risk patients","Nephrotoxicity risk: assess renal function before administration; hydrate patients appropriately","Thyroid dysfunction: iodine-containing contrast can induce hyperthyroidism, especially in patients with latent hyperthyroidism or multinodular goiter","Extravasation injury: ensure proper vascular access to prevent tissue damage","Interference with lab tests: may affect coagulation, thyroid function, and serum creatinine measurements"] |
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| Fetal Monitoring | No specific fetal monitoring required during administration. However, for pregnant patients, assess maternal renal function to minimize contrast-induced nephropathy. Postpartum, if large doses were used, monitor neonatal thyroid function (TSH, T4) within 48-72 hours to rule out transient hypothyroidism. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies did not show impairment of fertility at clinically relevant doses. |