HYPAQUE SODIUM 20%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HYPAQUE SODIUM 20% (HYPAQUE SODIUM 20%).
Hypaque sodium is an ionic monomeric iodinated contrast medium that absorbs X-rays due to its iodine content, providing radiographic contrast. It increases the density of vascular structures and organ parenchyma, allowing visualization during imaging procedures.
| Metabolism | Hypaque sodium is not significantly metabolized and is excreted unchanged primarily by glomerular filtration. |
| Excretion | Renal: >95% unchanged via glomerular filtration within 24 hours; <5% biliary/fecal. |
| Half-life | Terminal elimination half-life: 1-2 hours in normal renal function; prolonged in renal impairment. |
| Protein binding | Minimal, <10%; primarily albumin. |
| Volume of Distribution | 0.2-0.3 L/kg; limited to extracellular fluid. |
| Bioavailability | Oral: <1% (poor absorption, used for GI opacification); not applicable for IV. |
| Onset of Action | Intravenous: immediate; oral: 15-30 minutes; rectal: 30-60 minutes. |
| Duration of Action | Intravascular: 30-60 minutes for contrast enhancement; systemic effects resolve within 24 hours. |
Intravenous: 30-60 mL (6-12 g iodine) administered as a bolus or infusion for excretory urography; may be repeated up to a total of 125 mL (25 g iodine). Intra-arterial: Variable based on procedure, typically 8-30 mL for selective angiography.
| Dosage form | SOLUTION |
| Renal impairment | GFR < 30 mL/min: Avoid use; if necessary, reduce dose by 50% and ensure adequate hydration. GFR 30-60 mL/min: Use with caution, consider lower doses and monitor renal function. GFR > 60 mL/min: No adjustment required. |
| Liver impairment | No specific adjustment for mild to moderate impairment (Child-Pugh A or B). Severe impairment (Child-Pugh C): Use with caution due to potential for delayed excretion; monitor for adverse effects. |
| Pediatric use | Intravenous: 1-2 mL/kg (0.2-0.4 g iodine/kg) for excretory urography, not to exceed 30 mL. Intra-arterial: 0.5-1 mL/kg per injection, adjusted based on procedure. |
| Geriatric use | Start with lower doses (e.g., 50% of adult dose) and titrate upward as needed. Monitor renal function closely due to age-related decline; ensure adequate hydration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HYPAQUE SODIUM 20% (HYPAQUE SODIUM 20%).
| Breastfeeding | Minimal excretion into breast milk; M/P ratio is not available. The amount ingested by a nursing infant is likely negligible. However, due to potential hypersensitivity or iodine effects, caution is advised. The manufacturer recommends discontinuing breastfeeding for 24 hours after administration, but this may be excessive. Discuss with patient. |
| Teratogenic Risk | Hypaque Sodium 20% (diatrizoate sodium) is a radiocontrast agent. It is not known to be teratogenic in humans. However, because it contains iodine, fetal thyroid function may be affected, particularly if exposure occurs during the second or third trimester. The risk of fetal hypothyroidism is theoretical and low with single exposure. Use only if clearly needed. |
■ FDA Black Box Warning
Not for intrathecal use. Intrathecal administration may cause severe adverse reactions including convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, and death.
| Serious Effects |
["Known hypersensitivity to Hypaque sodium or any of its components","History of anaphylactoid reaction to iodinated contrast media","Intrathecal administration (contraindicated due to risk of neurotoxicity)","Severe renal impairment (e.g., estimated glomerular filtration rate <30 mL/min/1.73 m²)","Concurrent administration of metformin in patients with acute kidney injury or severe renal impairment (risk of lactic acidosis)"]
| Precautions | ["Risk of acute kidney injury, particularly in patients with pre-existing renal impairment, diabetes mellitus, or volume depletion","Anaphylactoid reactions, including anaphylaxis, bronchospasm, and hypotension","Thyroid storm in patients with hyperthyroidism or thyroid nodules","Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome","Cardiovascular adverse events including arrhythmias and cardiac arrest","Vasovagal reactions","Extravasation leading to tissue injury"] |
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| Fetal Monitoring | Monitor for allergic reactions, including anaphylaxis. In pregnancy, fetal heart rate monitoring may be considered if there is any maternal hemodynamic instability. Thyroid function tests (TSH, free T4) in the neonate if exposure occurred in late pregnancy. |
| Fertility Effects | No known adverse effects on fertility in humans. Animal studies have not shown impaired fertility. No specific data for Hypaque Sodium 20%. |