ULTRAVIST (PHARMACY BULK)
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULTRAVIST (PHARMACY BULK) (ULTRAVIST (PHARMACY BULK)).
Iodinated nonionic radiographic contrast agent that attenuates X-rays due to its iodine content, providing vascular and tissue opacification during imaging.
| Metabolism | Not metabolized; eliminated unchanged via glomerular filtration. |
| Excretion | Primarily renal by glomerular filtration; approximately 60-70% eliminated unchanged in urine within 6 hours, with >90% excreted within 24 hours. Less than 1% biliary or fecal. |
| Half-life | Terminal elimination half-life is approximately 1.5-2 hours in patients with normal renal function. Prolonged in renal impairment (up to 10-30 hours) or severe disease. |
| Protein binding | Low; approximately 10-15% bound to plasma proteins, mainly albumin. |
| Volume of Distribution | Approximately 0.2-0.3 L/kg, indicating distribution primarily in extracellular fluid. |
| Bioavailability | Not applicable for oral route; administered intravenously, bioavailability is 100%. |
| Onset of Action | Intravenous administration: immediate opacification occurs within seconds to minutes after injection, peaking at 1-2 minutes for angiographic studies. |
| Duration of Action | Duration of contrast enhancement is typically short (minutes) for angiography; for excretory urography, maximal contrast in renal collecting system occurs within 5-15 minutes, fading by 30-60 minutes. |
| Molecular Weight | 769.1 |
300 mg iodine/mL, 370 mg iodine/mL: 0.6-1.5 mL/kg IV for CT; 100-300 mL IV for angiography. Repeat doses allowed up to maximum total dose of 500 mL.
| Dosage form | INJECTABLE |
| Renal impairment | eGFR <30 mL/min/1.73 m²: Administer with caution, ensure adequate hydration, consider lowest possible dose. eGFR <15 mL/min: Avoid use unless dialysis immediately available. |
| Liver impairment | No specific dose adjustment recommended based on Child-Pugh class; use caution in severe hepatic impairment due to potential coagulation abnormalities. |
| Pediatric use | CT: 1-2 mL/kg (300 mg I/mL) IV; Angiography: 1-2 mL/kg (300 mg I/mL) IV. Maximum single dose: 4 mL/kg. Adjust for age and clinical condition. |
| Geriatric use | Start with lower end of dosing range; monitor renal function (eGFR) and hydration status; increased risk of nephrotoxicity and volume overload. |
| 1st trimester | Iodinated contrast agents are generally avoided in the first trimester due to theoretical risk of fetal thyroid suppression. Use only if essential and benefits outweigh risks. |
| 2nd trimester | Use with caution; may be used if diagnostic information is necessary and cannot be obtained by alternative methods. No known teratogenic risk in humans. |
| 3rd trimester | Use with caution; may cause transient neonatal hypothyroidism. Monitor neonatal thyroid function if administered near term. |
Clinical note
Comprehensive clinical and safety monograph for ULTRAVIST (PHARMACY BULK) (ULTRAVIST (PHARMACY BULK)).
| Placental transfer | Crosses the placenta freely. Animal studies indicate no teratogenic effects, but human data are limited. Free iodine can affect fetal thyroid function. |
| Breastfeeding | Excreted in breast milk in minimal amounts. The very small quantity of contrast agent absorbed by the infant is unlikely to cause adverse effects. Breastfeeding can be continued without interruption, although some sources suggest discontinuing for 12-24 hours if mother is concerned. |
■ FDA Black Box Warning
Risk of contrast-induced acute kidney injury (CI-AKI), especially in patients with pre-existing renal impairment, diabetes, dehydration, or concurrent use of nephrotoxic drugs. Not for intrathecal use.
| Serious Effects |
Known hypersensitivity to iodinated contrast mediaSignificant thyrotoxicosisAnuria or severe renal impairment (if not on dialysis)Concomitant administration of oral cholecystographic agents
| Precautions | Hypersensitivity reactions (anaphylaxis, bronchospasm, angioedema), Contrast-induced nephropathy, Thyroid storm in patients with hyperthyroidism, Cardiovascular effects (arrhythmias, hypotension, pulmonary edema), Extravasation risk, Hematologic abnormalities (coagulopathy), Interference with thyroid function tests, Sickle cell disease exacerbation |
| Food/Dietary | No specific food interactions; however, patients should maintain adequate hydration. Solid foods are generally not restricted, but some procedures may require fasting (e.g., 4-6 hours) per institutional protocol. |
Loading safety data…
| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | ULTRAVIST (iopromide) is an iodinated contrast agent. In pregnancy, it crosses the placenta. First trimester: Inadvertent exposure is not associated with teratogenicity based on limited human data; animal studies show no evidence of fetal harm. Second and third trimesters: Fetal thyroid exposure can cause transient neonatal hypothyroidism; risk is dose-dependent. |
| Fetal Monitoring | Assess renal function before administration. Monitor for signs of hypersensitivity, including urticaria, bronchospasm, and hypotension. In neonates exposed in utero, monitor thyroid function (TSH, fT4) at birth and at 2-3 weeks postnatally. |
| Fertility Effects | No human data on fertility effects. Animal studies have not demonstrated impaired fertility at clinically relevant doses. |
| Clinical Pearls | Pre-warm contrast to body temperature to reduce viscosity and patient discomfort. Ensure adequate hydration (e.g., 100 mL/hour oral or IV fluids for 4-6 hours pre- and post-scan) to lower nephrotoxicity risk. Monitor serum creatinine and eGFR in patients with renal impairment; consider holding metformin for 48 hours post-contrast if eGFR <30 mL/min. Have resuscitation equipment available due to risk of anaphylactoid reactions, especially in patients with asthma or prior contrast allergy. Use lowest iodine dose necessary for diagnostic image quality. |
| Patient Advice | Inform your healthcare provider if you have ever had an allergic reaction to contrast dye, iodine, or any medications. · Drink plenty of water before and after the procedure unless instructed otherwise by your doctor. · Tell your doctor if you are pregnant, breastfeeding, or have kidney disease, diabetes, or asthma. · You may feel a warm sensation or metallic taste during injection; this is normal and usually temporary. · Report any symptoms like hives, itching, difficulty breathing, or swelling of the face/throat immediately. |