HYPAQUE-M,90%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HYPAQUE-M,90% (HYPAQUE-M,90%).
Ionic, high-osmolality iodinated contrast agent that absorbs X-rays, enhancing radiographic contrast by attenuating X-rays in tissues where it distributes.
| Metabolism | Not metabolized; eliminated unchanged by glomerular filtration. |
| Excretion | Renal: >95% unchanged; biliary/fecal: <5% |
| Half-life | Terminal half-life: 1-2 hours (normal renal function); prolonged in renal impairment |
| Protein binding | Minimal (<10%); primarily albumin |
| Volume of Distribution | 0.2-0.3 L/kg (confined to extracellular fluid) |
| Bioavailability | Intravenous: 100%; Oral: not administered orally due to GI irritation |
| Onset of Action | Intravenous: immediate (within seconds to minutes); Oral: not applicable |
| Duration of Action | Intravenous: 15-30 minutes for imaging; excretion complete within 24 hours |
Intra-arterial or intravenous injection: 30-60 mL of 90% solution, administered as a bolus or infusion over 1-2 minutes; repeat dosing not recommended.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with GFR <30 mL/min/1.73 m² (anuric or severely impaired renal function). For GFR 30-60 mL/min/1.73 m²: reduce dose by 50%, ensure adequate hydration, and monitor renal function for 48 hours post-dose. |
| Liver impairment | No specific dose adjustment required for Child-Pugh Class A or B. For Child-Pugh Class C: use lowest effective dose (e.g., 30 mL of 90% solution) and ensure adequate hydration due to potential hepatic encephalopathy risk with high osmolar load. |
| Pediatric use | 0.5-1.5 mL/kg of 90% solution (maximum 30 mL) intra-arterial or intravenous, administered as a slow injection over 1-3 minutes; not recommended for neonates (<1 month) due to high osmolarity. |
| Geriatric use | Initiate with lowest effective dose (e.g., 30 mL of 90% solution) and monitor renal function closely due to age-related GFR decline; ensure adequate hydration before and after procedure. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HYPAQUE-M,90% (HYPAQUE-M,90%).
| Breastfeeding | Minimal excretion into breast milk; estimated infant dose <1% of maternal. M/P ratio not established. Consider pump and discard for 24 hours post-administration to minimize potential exposure. |
| Teratogenic Risk | FDA Pregnancy Category D. Iodinated contrast media, including diatrizoate meglumine and sodium diatrizoate, cross the placenta and can cause transient neonatal hypothyroidism if used during pregnancy. First trimester exposure: potential but undocumented teratogenicity. Second and third trimesters: risk of fetal thyroid suppression. Use only if essential for maternal diagnosis. |
■ FDA Black Box Warning
Risk of fatal anaphylactic reactions; severe adverse reactions (including death) have occurred with intravascular administration. Resuscitative equipment and trained personnel must be immediately available.
| Serious Effects |
["Known hypersensitivity to diatrizoate or any formulation component","Severe oliguria or anuria","Concurrent administration with biguanides (metformin) due to risk of lactic acidosis"]
| Precautions | ["Risk of acute kidney injury in patients with pre-existing renal impairment, diabetes, or dehydration","Hypersensitivity reactions including anaphylaxis","Thyroid storm in patients with hyperthyroidism","Extravasation risk during administration","Lactic acidosis potential in patients with metabolic disorders"] |
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| Fetal Monitoring | Monitor maternal renal function, thyroid function tests (TSH, free T4) before and after administration. Assess fetal heart rate and thyroid function if exposure occurs in second/third trimester. Monitor for signs of contrast-induced nephropathy. |
| Fertility Effects | No direct effects on fertility reported. Theoretical risk of ovarian damage due to free radical formation, but clinical significance is minimal. No recommended fertility precautions. |