RENOCAL-76
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENOCAL-76 (RENOCAL-76).
Contains iothalamate meglumine, an ionic high-osmolar contrast medium that absorbs X-rays, thereby enhancing vascular and tissue contrast during radiographic procedures. It functions by increasing the attenuation of X-rays in blood and tissues where it distributes.
| Metabolism | Not metabolized; eliminated unchanged by glomerular filtration via the kidneys. |
| Excretion | Primarily renal excretion via glomerular filtration. Approximately 95% of administered dose is excreted unchanged in urine within 24 hours. Less than 5% undergoes biliary/fecal elimination. |
| Half-life | Terminal elimination half-life ranges from 1.2 to 2.5 hours in patients with normal renal function. In patients with severe renal impairment, half-life may be prolonged up to 20 hours. |
| Protein binding | Minimal protein binding; less than 5% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 0.2–0.3 L/kg, indicating distribution primarily in extracellular fluid. Does not cross the blood-brain barrier significantly. |
| Bioavailability | Bioavailability not applicable; administered exclusively via intravascular routes (intravenous or intra-arterial). Not absorbed orally. |
| Onset of Action | Intravenous administration: immediate enhancement of radiographic contrast within seconds to minutes. Intra-arterial: within seconds. Oral/rectal: not applicable; not administered via these routes. |
| Duration of Action | Intravenous: adequate contrast for imaging lasting 30–60 minutes. Prolonged in patients with renal impairment due to delayed clearance. |
Intravenous: 50-100 mL of a 37% iodine-containing solution (approximately 14-28 g iodine) administered as a slow intravenous injection over 1-2 minutes, or as an intravenous infusion over 10-30 minutes, typically not exceeding 4.5 mL/kg body weight.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-59 mL/min: Reduce dose by 50% and increase interval to 48 hours. For GFR <30 mL/min or dialysis: Contraindicated; risk of nephrotoxicity. |
| Liver impairment | Child-Pugh Class A: No adjustment. Class B: Administer with caution; consider 50% dose reduction. Class C: Avoid use; insufficient data. |
| Pediatric use | Intravenous: 1-2 mL/kg of a 37% iodine-containing solution (approximately 0.37-0.74 g iodine/kg), not to exceed 4.5 mL/kg total; maximum single dose 100 mL. Administer slow IV over 2-3 minutes. |
| Geriatric use | No specific dose adjustment; use with caution due to increased risk of nephrotoxicity. Monitor renal function before and after administration. Consider hydration and lowest effective dose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENOCAL-76 (RENOCAL-76).
| Breastfeeding | Minimal excretion into breast milk; M/P ratio approximately 0.01-0.1. Considered compatible with breastfeeding; however, time breastfeeding to coincide with trough levels or discard milk for 24 hours after administration to minimize infant exposure. |
| Teratogenic Risk | First trimester: Iodinated contrast media may cause fetal hypothyroidism due to iodine exposure. Second and third trimesters: Risk of neonatal hypothyroidism; transient and usually reversible. No known teratogenic effects in humans; animal studies show no evidence of teratogenicity at clinical doses. |
■ FDA Black Box Warning
Risk of acute renal failure, particularly in patients with pre-existing renal impairment, diabetes, or dehydration.
| Serious Effects |
Absolute: Anuria or known hypersensitivity to iothalamate or other iodinated contrast media. Relative: Renal impairment, diabetes, dehydration, multiple myeloma, concurrent use of nephrotoxic drugs or metformin (risk of lactic acidosis).
| Precautions | Use with caution in patients with renal impairment, diabetes, dehydration, multiple myeloma, or those on nephrotoxic drugs. Monitor renal function before and after administration. Contraindicated in patients with known hypersensitivity to iodinated contrast media. |
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| Fetal Monitoring |
| Monitor maternal thyroid function (TSH, free T4) before and after exposure in pregnancy. Assess neonatal thyroid function (TSH) at birth if significant exposure occurred. Also monitor maternal renal function, hydration status, and for allergic reactions. |
| Fertility Effects | No known adverse effects on fertility in animal studies. No human data available; iodinated contrast media are not expected to impair fertility at clinical doses. |