RENO-30
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENO-30 (RENO-30).
Iodinated contrast agent that attenuates X-rays, enhancing vascular and tissue contrast during radiographic procedures.
| Metabolism | Not metabolized; excreted unchanged by glomerular filtration. |
| Excretion | Renal: >95% unchanged via glomerular filtration; biliary/fecal: <5%. |
| Half-life | Terminal half-life: 1-2 hours (normal renal function); prolonged to 20-40 hours in severe renal impairment (CrCl <30 mL/min), requiring dose adjustment. |
| Protein binding | Negligible (<10%), primarily to albumin. |
| Volume of Distribution | 0.2-0.3 L/kg, indicating distribution primarily within extracellular fluid. |
| Bioavailability | Intravenous/intra-arterial: 100%; oral: negligible (not administered orally). |
| Onset of Action | Intravenous: Immediate (within minutes). Intra-arterial: Almost immediate. Oral: Not applicable (administered only via intravascular routes). |
| Duration of Action | Intravenous: 15-30 minutes for contrast enhancement imaging; longer in renal impairment due to delayed clearance. |
Adults: 30 mL (30 g iodine) intravenously as a single dose for imaging procedures; may repeat once if needed.
| Dosage form | SOLUTION |
| Renal impairment | For GFR 30-59 mL/min: reduce dose to 15 mL; for GFR <30 mL/min: contraindicated. |
| Liver impairment | No specific adjustment required for Child-Pugh A or B; use with caution in Child-Pugh C due to potential hepatorenal syndrome. |
| Pediatric use | 0.5-1 mL/kg (max 30 mL) intravenously as a single dose based on body weight and imaging indication. |
| Geriatric use | Use lowest effective dose; monitor renal function as age-related GFR decline may require renal adjustment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENO-30 (RENO-30).
| Breastfeeding | Diatrizoate is excreted into breast milk in very small quantities; M/P ratio approximately 0.1–0.3. The low oral bioavailability (<1%) in infants and small amount ingested make clinically relevant effects unlikely. Therefore, breastfeeding can continue without interruption after maternal administration. To minimize exposure, mothers may pump and discard milk for 24 hours, though not strictly necessary. |
| Teratogenic Risk | RENO-30 is diatrizoate meglumine 30% (ionic monomeric contrast medium). Teratogenic risk is low; no malformations are reported in animal studies or human data. However, since iodine can affect fetal thyroid, the second and third trimesters risk neonatal hypothyroidism if substantial free iodide is released. First-trimester exposure: theoretical risk from free iodide but no confirmed teratogenicity. Avoid unnecessary use throughout pregnancy. |
■ FDA Black Box Warning
Not for intrathecal administration; severe adverse reactions including death have occurred with inadvertent intrathecal injection.
| Serious Effects |
["Known hypersensitivity to iodinated contrast media.","Concurrent intrathecal administration.","Oliguric anuria due to renal shutdown."]
| Precautions | ["Risk of acute kidney injury, especially in patients with pre-existing renal impairment, diabetes, or dehydration.","Anaphylactic reactions may occur; have resuscitation equipment available.","Thyroid storm in patients with hyperthyroidism."] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine, eGFR) before administration due to potential contrast-induced nephropathy. Assess hydration status. For fetal monitoring: no specific fetal monitoring is required after RENO-30 exposure. However, if used near term, consider neonatal thyroid function test if high doses or multiple procedures occurred due to free iodide release. |
| Fertility Effects | No specific studies on human fertility; animal studies show no impairment of fertility at therapeutic doses. Transient changes in menstrual cycle or sperm parameters are not reported. No effects on conception or implantation are expected with standard radiographic doses. |