MD-76R
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MD-76R (MD-76R).
MD-76R is a radiopaque contrast agent that contains iodine, which attenuates X-rays, thereby enhancing the contrast of blood vessels and tissues during radiographic procedures. It functions by increasing the absorption of X-rays in areas where it is present, allowing for visualization of vascular structures and organ perfusion.
| Metabolism | MD-76R is not metabolized; it is excreted unchanged by the kidneys via glomerular filtration. |
| Excretion | Primarily renal; 95% eliminated unchanged in urine within 24 hours; <1% fecal. |
| Half-life | Terminal half-life 1-2 hours; prolonged in renal impairment. |
| Protein binding | <10% bound to plasma proteins. |
| Volume of Distribution | Vd 0.2-0.3 L/kg; primarily extracellular fluid. |
| Bioavailability | IV only; oral bioavailability negligible. |
| Onset of Action | IV: Immediate (within seconds). |
| Duration of Action | IV: 30-60 minutes for contrast enhancement; longer in renal impairment. |
2–4 mL/kg intravenously, maximum 150 mL per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | GFR ≥30 mL/min: no adjustment; GFR <30 mL/min: avoid use or use minimum necessary dose with adequate hydration. |
| Liver impairment | No specific Child-Pugh based guidelines; use with caution in severe hepatic impairment due to risk of nephrotoxicity. |
| Pediatric use | 0.5–2 mL/kg intravenously, maximum 3 mL/kg per procedure depending on weight and age. |
| Geriatric use | Use minimum effective dose; monitor renal function closely due to age-related decline in GFR. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MD-76R (MD-76R).
| Breastfeeding | Limited excretion into breast milk; M/P ratio unknown. Small amounts likely not expected to cause adverse effects in nursing infants. Caution recommended, especially with repeated exposure due to potential thyroid effects. Consider temporary cessation of breastfeeding for 12-24 hours post-administration if feasible. |
| Teratogenic Risk | FDA Category C. First trimester: Risk of fetal harm cannot be ruled out; iodine-containing contrast agents may affect fetal thyroid function leading to transient hypothyroidism. Second and third trimesters: Potential for neonatal hypothyroidism if administered near term; avoid if possible. No well-controlled studies in pregnant women. |
■ FDA Black Box Warning
Risk of serious adverse reactions, including anaphylaxis, cardiovascular collapse, and death, especially in patients with history of prior reaction to contrast media, asthma, or other allergies.
| Serious Effects |
["Hypersensitivity to MD-76R or any of its components","Severe oliguria or anuria due to renal failure","Concurrent administration of metformin in patients with renal impairment (risk of lactic acidosis)"]
| Precautions | ["Risk of acute kidney injury, particularly in patients with pre-existing renal impairment, diabetes, or dehydration","Hypersensitivity reactions including anaphylaxis require immediate treatment","Thyroid dysfunction in patients with hyperthyroidism or thyroid tumors","Extravasation risk causing tissue necrosis","Avoid in pregnancy unless absolutely necessary"] |
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| Fetal Monitoring | Monitor fetal heart rate during and after procedure. Assess neonatal thyroid function (TSH, free T4) at birth if contrast was administered in third trimester. Monitor for maternal adverse reactions (hypotension, anaphylactoid reactions). |
| Fertility Effects | No known effects on fertility in animal studies; human data lacking. Iodinated contrast agents have not been reported to impair fertility or reproductive function. |