HYPAQUE-M,75%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HYPAQUE-M,75% (HYPAQUE-M,75%).
Iodinated contrast agent that attenuates X-rays, providing radiographic contrast due to high iodine content. It increases the density of vascular structures and tissues, allowing visualization of anatomical structures during imaging procedures.
| Metabolism | Not metabolized; excreted unchanged by the kidneys via glomerular filtration with minimal tubular reabsorption. |
| Excretion | Renal excretion: >95% unchanged via glomerular filtration; biliary/fecal: <5%. |
| Half-life | Terminal elimination half-life: 1.5-2 hours in normal renal function; prolonged in renal impairment (up to 24-48 hours in anuria). |
| Protein binding | Minimal (<10%); primarily albumin. |
| Volume of Distribution | 0.2-0.3 L/kg; approximates extracellular fluid volume. |
| Bioavailability | Intravenous: 100%; Oral: not administered orally due to high osmolarity and GI intolerance. |
| Onset of Action | Intravenous: immediate (seconds to minutes); Oral: not applicable; Intraarterial: immediate. |
| Duration of Action | Intravenous: imaging adequate for 15-30 minutes post-injection; complete plasma clearance within 2-4 hours. |
1.2-1.5 mL/kg IV as a single dose for CT enhancement; maximum 150 mL per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73m2: contraindicated; eGFR 30-60: use minimum diagnostic dose, ensure adequate hydration; eGFR >60: no adjustment. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: use with caution; Child-Pugh C: contraindicated due to risk of hepatorenal syndrome. |
| Pediatric use | 1-2 mL/kg IV not to exceed 3 mL/kg or 125 mL total, based on body weight. |
| Geriatric use | Reduce dose to 0.8-1.2 mL/kg IV; ensure adequate hydration; monitor renal function before and after administration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HYPAQUE-M,75% (HYPAQUE-M,75%).
| Breastfeeding | Excreted into breast milk in minimal amounts (M/P ratio not established; estimated <1% of maternal dose). Breastfeeding is considered safe; however, theoretical risk of iodine-induced hypothyroidism in neonates. The American College of Radiology recommends no interruption of breastfeeding after contrast administration. |
| Teratogenic Risk | HYPAQUE-M,75% (diatrizoate meglumine and diatrizoate sodium) is an iodinated radiocontrast agent. Teratogenic risk: FDA Category B. No evidence of fetal harm in animal studies; no adequate human studies. First trimester: Theoretical risk of fetal hypothyroidism due to free iodide. Second and third trimesters: Risk of neonatal hypothyroidism if administered near term; transient effects possible. Direct fetal exposure via intra-amniotic use may cause goiter. |
■ FDA Black Box Warning
Not recommended for intrathecal use. Injection into the subarachnoid space may cause death, convulsions, brain damage, and other severe neurologic complications. Accidental intrathecal administration must be avoided.
| Serious Effects |
["Known hypersensitivity to diatrizoate meglumine or any component","Intrathecal administration (black box warning)","Anuria or severe oliguria","Concurrent administration with other contrast agents that may cause anuria"]
| Precautions | ["Risk of serious adverse reactions including anaphylaxis, arrhythmias, myocardial infarction, and renal failure","Pre-existing renal insufficiency increases risk of contrast-induced nephropathy","Use with caution in patients with known hypersensitivity to iodine or contrast media","Patients with pheochromocytoma may develop hypertensive crisis","May exacerbate symptoms in patients with sickle cell disease","In patients with hyperthyroidism, thyroid storm may be precipitated","Test dose is not recommended to predict severe reactions"] |
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| Fetal Monitoring | Monitor maternal renal function (serum creatinine, BUN) before and after procedure due to risk of contrast-induced nephropathy. Assess fetal heart rate if intrauterine exposure occurs. In neonates, monitor thyroid function tests (TSH, T4) if contrast was administered near delivery or via intra-amniotic route. |
| Fertility Effects | No known effects on fertility in animal or human studies. Single exposure used for diagnostic imaging is unlikely to impact reproductive function. |