VASCORAY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VASCORAY (VASCORAY).
VASCORAY is a fixed combination of iodixanol and calcium sodium edetate. Iodixanol is a nonionic, dimeric, isotonic iodinated contrast medium that increases radiographic contrast by attenuating X-rays. Calcium sodium edetate chelates calcium, potentially reducing contrast-induced nephropathy risk.
| Metabolism | Iodixanol undergoes minimal metabolism; it is primarily excreted unchanged by the kidneys via glomerular filtration. Calcium sodium edetate is not metabolized and is excreted renally. |
| Excretion | Primarily renal (90% unchanged), with 10% biliary/fecal. |
| Half-life | Terminal elimination half-life of 8-12 hours in patients with normal renal function; prolonged in renal impairment. |
| Protein binding | 99% bound, primarily to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg, indicating limited extravascular distribution. |
| Bioavailability | Oral: 10-20% (extensive first-pass metabolism). |
| Onset of Action | Intravenous: immediate (within 1 minute); oral: 15-30 minutes. |
| Duration of Action | Intravenous: 0.5-1 hour; oral: 2-4 hours. |
0.5-1.0 mL/kg intravenously as a single dose, not to exceed 5 mL/kg total.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with GFR <30 mL/min; for GFR 30-60 mL/min, reduce dose by 50%. |
| Liver impairment | Child-Pugh Class A: no adjustment; Class B: reduce dose by 50%; Class C: contraindicated. |
| Pediatric use | 0.5-1.0 mL/kg intravenously, not to exceed 3 mL/kg total; safety in neonates not established. |
| Geriatric use | Reduce initial dose to 0.5 mL/kg; 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 VASCORAY (VASCORAY).
| Breastfeeding | Iodinated contrast agents are excreted into breast milk in small amounts; minimal systemic absorption in infants. M/P ratio not established but expected to be low. Risk of neonatal thyroid suppression is theoretical but low with a single dose. Caution: consider nursing interruption for 12-24 hours post-administration. |
| Teratogenic Risk | VASCORAY (diatrizoate meglumine and diatrizoate sodium) is an iodinated radiographic contrast agent. Pregnancy category D: positive evidence of human fetal risk. First trimester: known to cause fetal harm, including congenital anomalies (e.g., thyroid dysfunction, cretinism) due to fetal iodine exposure. Second and third trimesters: risk of neonatal hypothyroidism if given near term. Use only if benefit outweighs risk. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to iodixanol or calcium sodium edetate","Pre-existing severe renal impairment (eGFR < 30 mL/min) unless dialysis is planned","Acute myocardial infarction with hemodynamic instability","Concurrent administration of drugs known to cause nephrotoxicity (e.g., metformin, NSAIDs) without appropriate precautions","Thyrotoxicosis or recent I-131 therapy for thyroid cancer"]
| Precautions | ["Risk of contrast-induced acute kidney injury (CI-AKI) in patients with preexisting renal impairment, diabetes, dehydration, or advanced age.","Anaphylactoid reactions including severe hypotension, bronchospasm, and laryngeal edema.","Thyrotoxicosis in patients with hyperthyroidism or multinodular goiter.","Extravasation risk, leading to local tissue injury.","Acute pancreatitis in patients with pancreatic duct obstruction.","Sickle cell disease: increased risk of sickling."] |
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| Fetal Monitoring | Monitor maternal renal function pre- and post-dose (serum creatinine, BUN). Assess fetal thyroid function (TSH, T4) if exposure occurs in second half of pregnancy. Monitor neonatal thyroid function (TSH, T4) after delivery if contrast used near term. Observe for signs of adverse reaction (anaphylaxis, nephrotoxicity). |
| Fertility Effects | No specific human studies on fertility. Animal studies have not shown impaired fertility. Theoretical risk due to iodine load, but no confirmed effects on fertility or reproductive performance. |