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. |
| Molecular Weight | 777.09 |
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 | VASCORAY (iodamide meglumine and iodamide sodium) is an iodinated contrast agent. Safety in first trimester is not well studied; animal studies have not shown teratogenicity, but human data are lacking. Use only if clearly needed and potential benefit justifies potential risk to fetus. |
| 2nd trimester | Limited human data; no evidence of teratogenicity or fetotoxicity in animal studies. Use with caution during second trimester if diagnostic necessity outweighs risks. |
| 3rd trimester | Iodinated contrast agents cross the placenta and may transiently affect fetal thyroid function. Prolonged exposure or high doses may cause neonatal hypothyroidism. Use only if essential and consider neonatal thyroid screening after delivery. |
Clinical note
Comprehensive clinical and safety monograph for VASCORAY (VASCORAY).
| Placental transfer | Placental transfer is known to occur with iodinated contrast agents. VASCORAY, as a dimeric ionic agent, has been shown to cross the placenta in animal studies. The degree is dose-dependent and increases with gestational age, but precise data for this specific agent are limited. |
■ FDA Black Box Warning
None.
| Serious Effects |
Known hypersensitivity to iodamide or any component of VASCORAYPrevious life-threatening reaction to iodinated contrast mediaAnuria due to renal failureAcute renal failure (use may worsen renal function)Thyrotoxicosis (may precipitate thyroid storm)Sickle cell disease (may increase risk of sickling)
| 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. |
| Food/Dietary | No specific food interactions. Maintain adequate hydration with water before and after the procedure. Avoid alcohol, which may increase the risk of dehydration and renal impairment. |
Loading safety data…
| Breastfeeding | Iodinated contrast agents are excreted into breast milk in minimal amounts (<1% of maternal dose). The absolute amount transferred to the infant is low, and adverse effects are unlikely. However, caution is advised in neonates or preterm infants due to potential thyroid effects. Express and discard milk for 24-48 hours after administration if concerned. |
| Lactation Rating | L2 (probably compatible) or 'Safe' |
| 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. |
| 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. |
| Clinical Pearls | VASCORAY (iothalamate meglumine and iothalamate sodium) is a high-osmolality ionic dimeric contrast agent. Monitor serum creatinine and eGFR prior to administration to assess risk of contrast-induced nephropathy. Ensure adequate hydration pre- and post-procedure (IV normal saline 0.9% at 1 mL/kg/h for 6-12 hours). Have emergency equipment available for anaphylactoid reactions. VASCORAY is contraindicated in patients with a history of severe reaction to iodinated contrast. For intrathecal use, only formulations specifically labeled for myelography should be used to avoid neurotoxicity. Premedication with corticosteroids and antihistamines may be considered in patients with prior mild-moderate reactions. |
| Patient Advice | Tell your doctor if you have ever had an allergic reaction to contrast dye or iodine. · Inform your healthcare provider about all medications you take, especially metformin, as it may need to be temporarily stopped. · Drink plenty of fluids before and after the procedure unless instructed otherwise. · You may experience a warm sensation or metallic taste during injection, which is temporary. · Contact your doctor immediately if you experience hives, difficulty breathing, or swelling after the procedure. · If you have kidney problems, diabetes, or are over 60, your risk of kidney injury is higher. |