DIATRIZOATE-60
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DIATRIZOATE-60 (DIATRIZOATE-60).
Diatrizoate is an ionic, monomeric, high-osmolar iodinated contrast agent that absorbs X-rays due to its iodine content, enhancing radiographic imaging by attenuating X-ray beams. It distributes in the extracellular fluid and is excreted unchanged by glomerular filtration.
| Metabolism | Not metabolized; excreted unchanged by the kidneys via glomerular filtration. |
| Excretion | Primarily renal (glomerular filtration); >95% excreted unchanged in urine within 24 hours. Negligible biliary or fecal elimination. |
| Half-life | Terminal half-life approximately 1-2 hours in patients with normal renal function. Prolonged in renal impairment (up to 20-30 hours in anuria). |
| Protein binding | Very low; less than 5% bound, primarily to albumin. |
| Volume of Distribution | Approximately 0.2-0.3 L/kg, confined to extracellular fluid; no significant tissue penetration. |
| Bioavailability | Bioavailability is 100% for intravenous and intra-arterial routes; oral bioavailability near 0% (not absorbed). |
| Onset of Action | Intravenous: immediate (within seconds). Intra-arterial: immediate. Oral: not absorbed (used for GI opacification, no systemic effect). |
| Duration of Action | For IV urography: opacification persists 30-60 minutes; for angiography: seconds to minutes. Limited by rapid renal excretion. |
1-2 mL/kg IV bolus up to 150 mL total for contrast-enhanced CT; repeat doses may be given based on imaging needs.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR >60 mL/min: no adjustment. eGFR 30-60: reduce dose by 50% or use alternative if possible. eGFR <30: avoid use; if essential, use minimum dose (0.5 mL/kg) with pre-hydration and N-acetylcysteine. |
| Liver impairment | No specific dose adjustment for Child-Pugh class; use cautiously in severe hepatic impairment due to risk of nephrotoxicity. |
| Pediatric use | 0.5-2 mL/kg IV based on imaging protocol; maximum 150 mL. Adjust for weight: infants: 1-2 mL/kg, children: 1-1.5 mL/kg. |
| Geriatric use | Lower initial doses (0.5-1 mL/kg) with careful monitoring of renal function; avoid in eGFR <30 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DIATRIZOATE-60 (DIATRIZOATE-60).
| Breastfeeding | Diatrizoate is excreted into breast milk in very low quantities (<0.01% of maternal dose). The M/P ratio is not well defined but is low. The American College of Radiology suggests no special precautions are needed, and breastfeeding can be continued normally after contrast exposure. |
| Teratogenic Risk | Diatrizoate is an iodinated contrast agent. There is no evidence of teratogenicity in humans based on limited data; however, as a precaution, avoid use in the first trimester when organogenesis occurs. Inadvertent exposure during pregnancy has not been associated with an increased risk of major birth defects. Use only if clearly needed and risk-benefit justifies exposure. |
■ FDA Black Box Warning
Not recommended for intrathecal use; severe neurological complications including seizures, paralysis, and death can occur if administered into the subarachnoid space.
| Serious Effects |
["Known hypersensitivity to diatrizoate or any component","Intrathecal administration (absolute)","Severe renal impairment (relative, use with caution)"]
| Precautions | ["Risk of acute kidney injury (AKI) in patients with pre-existing renal impairment, diabetes, or dehydration","Anaphylactoid reactions, including hypotension, bronchospasm, and angioedema","Contrast-induced nephropathy (CIN)","Hypersensitivity reactions"] |
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| Fetal Monitoring | Monitor for allergic reactions, nephrotoxicity (serum creatinine, urine output), and thyroid dysfunction (thyroid function tests) in the mother. Fetal monitoring is not routinely required except for assessing fetal thyroid function if repeated or high-dose exposure occurs, due to potential for transient neonatal hypothyroidism. |
| Fertility Effects | No known adverse effects on human fertility. Animal studies have not shown impaired fertility at clinically relevant doses. |