HYPAQUE-76
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HYPAQUE-76 (HYPAQUE-76).
HYPAQUE-76 (diatrizoate meglumine and diatrizoate sodium) is an ionic iodinated contrast agent that attenuates X-rays, providing radiographic contrast. Its mechanism involves high iodine content (76%) that absorbs X-rays, distinguishing anatomical structures in imaging procedures.
| Metabolism | Not metabolized; excreted unchanged primarily via glomerular filtration in the kidneys. |
| Excretion | Primarily renal; >95% excreted unchanged in urine within 24 hours via glomerular filtration. Fecal excretion minimal (<5%). Biliary excretion negligible. |
| Half-life | Terminal elimination half-life of 1.5-2 hours in normal renal function. Prolonged to >10 hours in moderate renal impairment (CrCl 30-50 mL/min). Closely correlates with creatinine clearance. |
| Protein binding | <5% bound to plasma proteins (primarily albumin). Minimal binding due to high water solubility. |
| Volume of Distribution | Vd of 0.2-0.3 L/kg, approximates extracellular fluid volume. Does not enter cells or cross blood-brain barrier under normal conditions. |
| Bioavailability | Intravenous: 100%. Intra-arterial: 100%. No oral bioavailability due to lack of absorption (not administered orally). |
| Onset of Action | Intravenous: Immediate (seconds to minutes) for vascular opacification. Intra-arterial: Immediate upon injection. Oral/rectal: not applicable due to intravascular use. |
| Duration of Action | Intravenous: Imaging peak at 1-2 minutes post-injection; adequate opacification persists 5-10 minutes for standard CT. Renal excretion leads to rapid decline in plasma concentration. |
Intravenous: 50-100 mL (as a 76% solution, 370 mg iodine/mL) for contrast imaging, administered as a bolus or infusion; maximum 300 mL per procedure.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73 m²: avoid use unless essential; consider alternative agent. eGFR 30-59 mL/min/1.73 m²: ensure adequate hydration, monitor renal function. No specific dose reduction recommended; use minimal volume. |
| Liver impairment | Child-Pugh Class A/B: no adjustment required. Class C: use with caution due to increased risk of contrast-induced nephropathy; monitor renal function. |
| Pediatric use | Intravenous: 1-2 mL/kg (up to 100 mL) of 76% solution; maximum 3 mL/kg. Adjust based on indication and imaging modality. |
| Geriatric use | Use lowest effective volume; ensure adequate hydration; monitor renal function due to age-related decline in glomerular filtration rate. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HYPAQUE-76 (HYPAQUE-76).
| Breastfeeding | Diatrizoate is excreted into breast milk in very small amounts (<1% of maternal dose). The M/P ratio is unknown. The theoretical risk of direct toxicity or allergic reaction to the infant is negligible. The American College of Radiology recommends that breastfeeding can be continued without interruption after contrast administration, although some sources suggest discarding milk for 12-24 hours post-exposure out of caution. |
| Teratogenic Risk | HYPAQUE-76 (diatrizoate meglumine) is an iodinated contrast agent. In animal studies, no teratogenic effects were observed at clinically relevant doses. However, iodine-containing contrast agents can cross the placenta and may have potential to affect fetal thyroid function, particularly during the second and third trimester when fetal thyroid is active. Transient neonatal hypothyroidism has been reported after in utero exposure. The risk is considered low with single diagnostic exposure, but caution is warranted. |
■ FDA Black Box Warning
Not recommended for intrathecal use due to risk of severe neurological adverse reactions including seizure, coma, and death.
| Serious Effects |
["Absolute: Known hypersensitivity to diatrizoate or any component; intrathecal administration.","Relative: Renal impairment (eGFR <30 mL/min/1.73m²), unstable congestive heart failure, multiple myeloma, pheochromocytoma, sickle cell disease, active hyperthyroidism."]
| Precautions | ["Risk of anaphylactic or anaphylactoid reactions; premedication may be considered in high-risk patients.","Contrast-induced nephropathy (CIN) risk, especially in patients with pre-existing renal impairment, diabetes, or dehydration.","Thyroid storm in patients with hyperthyroidism or autonomously functioning thyroid tissue.","Extravasation risk leading to tissue necrosis.","Acute severe adverse reactions including cardiovascular collapse, bronchospasm, and seizures."] |
| Food/Dietary | No specific food interactions. Maintain adequate hydration with water before and after the procedure unless contraindicated (e.g., heart failure). |
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| Fetal Monitoring | Monitor maternal renal function before administration due to risk of contrast-induced nephropathy. Assess for allergic reactions (urticaria, bronchospasm, hypotension). In pregnant patients, consider fetal heart rate monitoring if clinically indicated. For neonates exposed in utero, thyroid function tests (TSH, T4) may be considered, especially if exposure occurred in the second or third trimester. |
| Fertility Effects | No specific studies exist on diatrizoate affecting human fertility. In animal studies, no adverse effects on fertility were observed at clinically relevant doses. The single diagnostic exposure is unlikely to impair fertility. |
| Clinical Pearls | Hypaque-76 (diatrizoate meglumine and diatrizoate sodium) is a high-osmolar ionic contrast agent used for CT, angiography, and urography. Pre-hydrate patients to reduce nephrotoxicity. Use with caution in patients with multiple myeloma, pheochromocytoma, or sickle cell disease due to risk of adverse reactions. Have emergency equipment and drugs (e.g., epinephrine, antihistamines) available. Consider premedication with corticosteroids and antihistamines in high-risk patients (e.g., previous contrast reaction, asthma). |
| Patient Advice | Inform your doctor if you have any allergies, especially to contrast agents or iodine. · Tell your doctor about all medications you take, especially metformin (may need to stop temporarily). · You may experience warmth, flushing, or a metallic taste during injection. · Drink plenty of fluids before and after the procedure unless instructed otherwise. · Report any difficulty breathing, hives, or swelling immediately to the healthcare team. |