MD-76
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MD-76 (MD-76).
MD-76 is a contrast agent that contains iodine, which attenuates X-rays, thereby enhancing the contrast between vascular structures and surrounding tissues. It distributes in the extracellular fluid compartment and is excreted unchanged by glomerular filtration.
| Metabolism | MD-76 is not metabolized; it is eliminated unchanged by the kidneys via glomerular filtration. |
| Excretion | Renal: >95% unchanged via glomerular filtration; biliary/fecal: <5% |
| Half-life | Terminal half-life: 1.5–2 hours; prolonged in renal impairment (up to 20 hours in anuria); clinical context: allows rapid elimination, suitable for diagnostic imaging |
| Protein binding | <10% bound to albumin |
| Volume of Distribution | Vd: 0.2–0.3 L/kg; indicates predominantly extracellular distribution |
| Bioavailability | Intravenous: 100%; intra-arterial: 100%; oral: negligible (<1%, not clinically relevant) |
| Onset of Action | Intravenous: immediate (within seconds); intra-arterial: immediate; oral: N/A (not administered orally) |
| Duration of Action | Intravenous: 15–30 minutes for diagnostic enhancement; clinical notes: rapid redistribution and elimination limit duration of contrast effect |
IV: 50-100 mL per dose, administered as a bolus or infusion, not to exceed 3 mL/kg total dose.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <30 mL/min: Use with caution; reduce total dose by 50% or extend interval. Not well-studied in ESRD. |
| Liver impairment | No specific adjustment required; use with caution in severe hepatic impairment (Child-Pugh C) due to potential for prolonged effects. |
| Pediatric use | IV: 0.1-0.3 mL/kg per dose, max 5 mL per dose for neonates; adjust based on renal function in older children. |
| Geriatric use | No specific dose adjustment; consider reduced dose due to age-related renal decline. Monitor renal function before use. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MD-76 (MD-76).
| Breastfeeding | Excreted in breast milk in minimal amounts (M/P ratio not established). Estimated infant dose <1% of maternal dose. Interrupt breastfeeding for 24 hours post-administration if concern. |
| Teratogenic Risk | FDA Pregnancy Category D. First trimester: Iodinated contrast media crosses the placenta; risk of neonatal hypothyroidism if administered in utero. Second and third trimesters: Fetal thyroid function may be transiently suppressed; avoid unless essential. No known teratogenicity. |
| Fetal Monitoring |
■ FDA Black Box Warning
Not for intrathecal use. Inadvertent intrathecal administration may cause severe neurotoxicity, including seizures, coma, respiratory arrest, and death.
| Serious Effects |
["Hypersensitivity to MD-76 or any of its components","Intrathecal administration (absolute contraindication)","Pre-existing significant renal impairment (relative contraindication; consider benefit-risk)"]
| Precautions | ["Risk of severe allergic reactions including anaphylaxis; emergency equipment must be available.","Acute kidney injury risk, especially in patients with pre-existing renal impairment, diabetes, or dehydration.","Contrast-induced nephropathy: screen for renal function before administration.","Thyroid storm risk in patients with hyperthyroidism or multinodular goiter.","Extravasation risk: may cause local tissue necrosis."] |
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| Monitor maternal thyroid function (TSH, free T4) pre- and post-administration in pregnant patients. Assess neonatal thyroid function (TSH) at birth if exposure occurred in third trimester. Monitor fetal heart rate during administration. |
| Fertility Effects | No known adverse effects on fertility. Iodinated contrast agents have not been shown to impair reproductive function in animal studies. |