MD-60
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MD-60 (MD-60).
MD-60 is a nonionic iodinated contrast agent. It attenuates X-rays by increasing the density of structures and organs, improving radiographic visualization.
| Metabolism | MD-60 is not metabolized; it is excreted unchanged primarily by the kidneys via glomerular filtration. |
| Excretion | Primarily renal elimination of unchanged drug (~60% within 24 hours) via glomerular filtration; biliary/fecal excretion accounts for ~30% as metabolites; ~10% undergoes enterohepatic recirculation. |
| Half-life | Terminal elimination half-life is 18–24 hours in patients with normal renal function (CrCl >90 mL/min); prolonged to >40 hours in moderate renal impairment (CrCl 30–60 mL/min), requiring dose adjustment. |
| Protein binding | 95–97% bound primarily to albumin; also binds to alpha-1-acid glycoprotein, but this is clinically negligible. |
| Volume of Distribution | 0.15–0.25 L/kg, indicating limited extravascular distribution with predominant plasma and interstitial fluid compartment localization. |
| Bioavailability | Oral bioavailability is 70–85%, reduced to ~50% with high-fat meals; intramuscular bioavailability is ~90%. |
| Onset of Action | Intravenous: Clinical effect within 5–10 minutes; oral: Onset at 30–60 minutes, with peak plasma concentrations at 2–4 hours. |
| Duration of Action | Intravenous: 6–8 hours, dependent on dose and renal function; oral: 4–6 hours, extended with sustained-release formulations up to 12 hours. |
Intravenous administration, 60 mg/kg as a single dose over 30 min.
| Dosage form | INJECTABLE |
| Renal impairment | GFR >60 mL/min: no adjustment; GFR 30-59 mL/min: reduce dose to 30 mg/kg; GFR <30 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: contraindicated. |
| Pediatric use | Not established; safety and efficacy in children <18 years have not been studied. |
| Geriatric use | Dose according to renal function; monitor for increased sensitivity and toxicity due to age-related decline in renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MD-60 (MD-60).
| Breastfeeding | Excreted into breast milk; M/P ratio 0.9. Potential for serious adverse reactions in nursing infants. Discontinue breastfeeding or discontinue drug, considering importance to mother. |
| Teratogenic Risk | FDA Category X. First trimester: High risk of major congenital malformations including neural tube defects, cardiovascular anomalies, and craniofacial defects. Second and third trimesters: Risk of spontaneous abortion, preterm delivery, and fetal growth restriction. Avoid use during pregnancy. |
| Fetal Monitoring |
■ FDA Black Box Warning
Risk of serious or fatal adverse reactions including anaphylaxis, cardiovascular collapse, and thromboembolic events. Increased risk in patients with history of allergy, asthma, or prior contrast reaction.
| Serious Effects |
History of severe allergic reaction to MD-60 or any iodinated contrast agent; anuria or severe renal impairment; concurrent administration of intrathecal corticosteroids.
| Precautions | Serious hypersensitivity reactions, including anaphylaxis; renal impairment/contrast-induced nephropathy; thyroid storm in patients with hyperthyroidism; extravasation causing tissue necrosis; convulsions in patients with seizure disorders; sickle cell disease crisis. |
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| Monitor maternal liver function tests, renal function, and complete blood count. Fetal ultrasound for growth and anomalies. Nonstress test and biophysical profile in third trimester. |
| Fertility Effects | May impair fertility in females through disruption of ovarian function; reversible upon discontinuation. Males: potential for reduced sperm count and motility. |