RENO-60
Clinical safety rating: caution
Comprehensive clinical and safety monograph for RENO-60 (RENO-60).
RENO-60 (diatrizoate meglumine and diatrizoate sodium) is an ionic, high-osmolality iodinated contrast agent. It attenuates X-rays by blocking photons due to the high atomic number of iodine, thereby enhancing vascular and tissue contrast. It distributes in extracellular fluid and is excreted unchanged by glomerular filtration.
| Metabolism | RENO-60 is not metabolized; it is excreted unchanged primarily by glomerular filtration. Approximately 95% of the administered dose is eliminated unchanged in urine within 24 hours. No hepatic metabolism occurs. |
| Excretion | Primarily renal excretion via glomerular filtration; up to 20% excreted unchanged in urine within 24 hours; minor biliary/fecal (<5%). |
| Half-life | Terminal elimination half-life approximately 30-60 minutes in patients with normal renal function; prolonged in renal impairment (up to 24 hours in anuria). |
| Protein binding | Approximately 10% bound to serum proteins (mainly albumin). |
| Volume of Distribution | Approximately 0.2-0.3 L/kg, reflecting distribution primarily in extracellular fluid. |
| Bioavailability | Intravenous: 100%; oral: negligible (<1%) due to poor absorption; not used orally. |
| Onset of Action | Intravenous: immediate (within seconds) opacification; intra-arterial: immediate; oral: not applicable (diagnostic agent). |
| Duration of Action | Intravascular contrast enhancement persists for 30-60 minutes; complete excretion within 24 hours; may be prolonged in renal impairment. |
Intravenous administration of 0.5-1.0 mL/kg (up to 150 mL total) per radiographic procedure. Dose may be repeated once if needed.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min: Use lowest effective dose and consider alternative imaging. Hemodialysis: No specific dose adjustment required as contrast is dialyzable. |
| Liver impairment | No specific Child-Pugh based dose modifications recommended. Use with caution in severe hepatic impairment due to increased risk of contrast-induced nephropathy. |
| Pediatric use | 0.5-1.0 mL/kg intravenously, not to exceed 4 mL/kg total for the procedure. Adjust based on patient size and imaging need. |
| Geriatric use | Use lowest effective dose. Monitor renal function closely; consider hydration protocols to reduce nephrotoxicity. Avoid doses exceeding 150 mL total. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for RENO-60 (RENO-60).
| Breastfeeding | Excreted in breast milk in small amounts; estimated M/P ratio 0.1-0.5 (not well defined). Oral bioavailability in infant is low. Consider pumping and discarding milk for 24 hours post-administration to reduce exposure. Not known to cause adverse effects in breastfed infants. |
| Teratogenic Risk | RENO-60 (diatrizoate meglumine and diatrizoate sodium) is an iodinated radiographic contrast agent. Teratogenic risk: First trimester: Theoretical risk from radiation exposure, but contrast alone not known to be teratogenic. Second and third trimesters: Fetal hypothyroidism risk from free iodide; transient neonatal hypothyroidism reported. Use only if essential. |
■ FDA Black Box Warning
WARNING: SEVERE ADVERSE REACTIONS TO IODINATED CONTRAST MEDIA. Intravascular administration of iodinated contrast media can cause serious, life-threatening reactions including anaphylaxis, hemodynamic instability, and death. Resuscitative equipment and trained personnel must be immediately available. Patients with a history of prior reaction to contrast media, known allergies, or bronchial asthma are at increased risk. Premedication may be considered but does not eliminate risk. Additionally, RENO-60 is contraindicated in patients with known hypersensitivity to diatrizoate or any component.
| Serious Effects |
["Absolute: Known hypersensitivity to diatrizoate or any component; anuria (due to impaired renal excretion)","Relative (risk-benefit assessment needed): Preexisting renal insufficiency; diabetes; multiple myeloma; pregnancy (use only if clearly needed); concurrent administration of nephrotoxic drugs; history of asthma or allergic disorders; severe cardiac disease (e.g., congestive heart failure, pulmonary hypertension); hyperthyroidism; pheochromocytoma; sickle cell disease"]
| Precautions | ["Risk of contrast-induced nephropathy (CIN) in patients with pre-existing renal impairment, diabetes, dehydration, or concurrent nephrotoxic drugs; hydration is recommended","Serum creatinine should be assessed prior to administration; acute renal failure may occur","Anaphylactoid reactions (including urticaria, bronchospasm, laryngeal edema, hypotension); have emergency medications and airway support available","Thyrotoxicosis: Iodinated contrast may precipitate thyroid storm in patients with hyperthyroidism or multinodular goiter","Severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome) have been reported","Interference with thyroid function tests for up to several weeks","Extravasation risk: May cause local tissue necrosis; administer via secure intravenous line","Use caution in patients with pheochromocytoma (may provoke hypertensive crisis) and sickle cell disease (may induce sickling)","Hemodynamic effects: High osmolality can cause fluid shifts, hypotension, or bradycardia; monitor during injection"] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine, eGFR) and thyroid function (TSH, free T4) before and after administration. Fetal monitoring: thyroid function in neonate if exposed in third trimester. Assess for hypersensitivity reactions (urticaria, anaphylaxis). |
| Fertility Effects | No known effect on fertility. Iodinated contrast agents do not alter reproductive function based on available data. |