DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM).
Radiopaque contrast agent that attenuates X-rays, providing visualization of vascular and urinary structures. It is a high-osmolality ionic dimer that distributes in extracellular fluid and is excreted renally.
| Metabolism | Not metabolized; excreted unchanged by glomerular filtration. |
| Excretion | Renal: >95% unchanged via glomerular filtration; biliary/fecal: <5% |
| Half-life | 1-2 hours in normal renal function; prolonged in renal impairment (up to 20-30 hours in severe impairment) |
| Protein binding | ~10% bound to plasma proteins (albumin) |
| Volume of Distribution | 0.2-0.3 L/kg; primarily extracellular |
| Bioavailability | Oral: <5%; rectal: ~30% |
| Onset of Action | IV: immediate (within seconds); oral: 15-30 minutes; rectal: 30-60 minutes |
| Duration of Action | IV: 30-60 minutes for contrast enhancement; oral/rectal: 1-3 hours for visualization |
Intra-arterial or intravenous administration; adult dose varies by procedure: for intravenous urography, 50-100 mL of 60% solution; for CT enhancement, 100-150 mL of 60% solution; maximum total dose 4.2 g iodine/kg body weight.
| Dosage form | SOLUTION |
| Renal impairment | Contraindicated in anuria or severe renal impairment (eGFR <30 mL/min/1.73 m²); for moderate impairment (eGFR 30-59 mL/min/1.73 m²), use with caution, ensure adequate hydration, and consider lowest diagnostic dose. |
| Liver impairment | No specific dose adjustment for hepatic impairment; use caution in severe hepatic disease due to potential for adverse effects. |
| Pediatric use | Weight-based: 0.5-2 mL/kg of 60% solution for intravenous urography or CT; maximum 4.2 g iodine/kg body weight. |
| Geriatric use | Elderly patients may have reduced renal function; assess renal function before administration and use lowest effective dose; ensure adequate hydration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM).
| Breastfeeding | Diatrizoate is excreted into breast milk in minimal amounts, with an M/P ratio of approximately 0.1. Oral bioavailability in infants is low (<1%). The American College of Radiology considers it compatible with breastfeeding; no interruption required. |
| Teratogenic Risk | Diatrizoate is an ionic iodinated contrast agent. Animal studies have not shown teratogenic effects. In humans, therapeutic doses during pregnancy are considered low risk, but elective use should be avoided. First trimester: theoretical risk of fetal hypothyroidism from free iodide; second and third trimesters: minimal risk with standard doses. No malformations attributed to diatrizoate. |
■ FDA Black Box Warning
Not recommended for intrathecal use; severe adverse reactions including death have occurred.
| Serious Effects |
Absolute: History of hypersensitivity reaction to diatrizoate; intrathecal administration. Relative: Anuria or severe renal impairment; concurrent use of metformin in patients with renal impairment; multiple myeloma; pheochromocytoma; hyperthyroidism; pregnancy.
| Precautions | Risk of contrast-induced nephropathy, especially in patients with pre-existing renal impairment, diabetes, dehydration. Hypersensitivity/anaphylactoid reactions possible. Severe cardiovascular reactions including arrhythmias, hypotension, cardiac arrest. Thyroid storm in patients with hyperthyroidism. Sickle cell disease patients may experience vaso-occlusive crises. |
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| Fetal Monitoring | Monitor maternal vital signs, renal function, and signs of hypersensitivity. Fetal monitoring not routinely required unless high-dose or repeated exposure. In neonates, thyroid function tests may be considered if high maternal doses used close to delivery. |
| Fertility Effects | No evidence of impaired fertility in animal studies. In humans, no known adverse effects on reproductive function. |