ISOVUE-300
Clinical safety rating
cautionComprehensive clinical and safety monograph for ISOVUE-300 (ISOVUE-300).
Iodinated radiocontrast agent that attenuates X-rays, providing enhanced visualization of vascular structures and body cavities during imaging procedures.
| Metabolism | Not metabolized; excreted unchanged by glomerular filtration. |
| Excretion | Primarily renal (glomerular filtration), with >95% of administered dose excreted unchanged in urine within 24 hours. Less than 1% is excreted via bile/fecal route. |
| Half-life | Terminal elimination half-life in patients with normal renal function is approximately 2 hours. In patients with moderate to severe renal impairment (creatinine clearance <30 mL/min), the half-life can be prolonged up to 20–40 hours, requiring dose adjustment. |
| Protein binding | Iopamidol (active ingredient) is minimally protein bound (<5%), primarily to albumin. |
| Volume of Distribution | Approximately 0.20–0.30 L/kg, indicating distribution primarily within extracellular fluid space; low tissue binding. |
| Bioavailability | Not applicable for oral route as it is used only intravascularly or intrathecally; bioavailability is 100% for IV injection and near 100% for intra-arterial and intrathecal administration. |
| Onset of Action | Intravenous administration: opacification begins almost immediately during injection. Intra-arterial: begins within seconds to minutes depending on injection site and catheter placement. |
| Duration of Action | Intravenous: adequate contrast enhancement persists for 30–60 minutes following bolus injection due to rapid redistribution and excretion. Intrathecal: diagnostic visualization up to 1 hour but may last longer; caution in patients with impaired renal function. |
| Molecular Weight | 777.09 |
Intravenous: 50-150 mL (up to 300 mg iodine/kg) as a bolus or infusion; intra-arterial: 5-40 mL depending on procedure; intrathecal: 8-15 mL. Maximum total iodine dose: 300 mg iodine/kg.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <30 mL/min: Use with caution; consider lower dose and ensure adequate hydration. GFR <15 mL/min: Avoid use unless essential; post-procedure hemodialysis may be considered. No specific dose reduction formula; clinical judgment advised. |
| Liver impairment | No specific Child-Pugh based dose adjustments; use cautiously in severe hepatic impairment due to altered pharmacokinetics. |
| Pediatric use | Weight-based: 1-2 mL/kg (300 mg iodine/mL) intravenously; maximum total dose 300 mg iodine/kg. Adjust for body habitus and procedure. |
| Geriatric use | Elderly patients may have reduced renal function; assess GFR and adjust dose accordingly. Ensure adequate hydration before and after procedure. Monitor for nephrotoxicity and hypersensitivity. |
| 1st trimester | Iodinated contrast agents cross the placenta; animal studies show no teratogenic effects but there is no adequate data in human pregnancy. Use only if clearly needed. |
| 2nd trimester | Use during the second trimester only if potential benefit justifies potential risk to the fetus. Contrast exposure may transiently affect fetal thyroid function. |
| 3rd trimester | Use during the third trimester may slightly increase risk for neonatal hypothyroidism; avoid unless essential. Thyroid function monitoring recommended after exposure. |
Clinical note
Comprehensive clinical and safety monograph for ISOVUE-300 (ISOVUE-300).
| Placental transfer | Iopamidol crosses the placenta. In animal studies, placental transfer occurs rapidly after intravenous administration. In humans, amniotic fluid levels are low, but significant fetal serum levels have been measured. The degree of transfer is sufficient to opacity the fetal urinary tract on imaging. |
| Breastfeeding | Iopamidol is excreted into human breast milk in very small amounts (less than 1% of maternal dose). The risk to the nursing infant is minimal; however, because of potential for hypersensitivity reaction or direct toxicity, it is recommended to withhold breastfeeding for 12-24 hours after contrast administration and discard expressed milk during that period. |
| Lactation Rating | L2 (Probably Compatible) |
| Teratogenic Risk | Iodinated contrast agents like Isovue-300 (iopamidol) cross the placenta. First trimester: Avoid unless essential; theoretical risk of fetal hypothyroidism from free iodide. Second/third trimester: Risk of transient neonatal hypothyroidism if high doses used; fetal goiter reported. No teratogenic effects at clinical doses in animal studies. |
| Fetal Monitoring | Monitor maternal renal function (serum creatinine) and thyroid function (TSH/FT4) in pregnancy. Fetal: None required unless high dose or repeated exposures, then postnatal thyroid screening in neonate. |
| Fertility Effects | No known effects on fertility in humans. Animal studies show no impairment of fertility at clinically relevant doses. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
Known hypersensitivity to iopamidol or any component of the formulationHistory of severe anaphylactic reaction to iodinated contrast media
| Precautions | Risk of serious hypersensitivity reactions (including anaphylaxis), Acute kidney injury in patients with pre-existing renal impairment or other risk factors, Thyroid dysfunction (especially in neonates) due to iodine load, Pregnancy and lactation considerations |
| Food/Dietary | No specific food interactions. However, patients are typically advised to avoid solid food for a few hours before the procedure (e.g., 4-6 hours NPO prior to injection) to reduce the risk of aspiration if emesis occurs. Also, ensure adequate hydration: recommend clear liquids (water, juice) unless contraindicated (e.g., pre-procedure fasting for other reasons). |
| Clinical Pearls | ISOVUE-300 (iopamidol) is a nonionic, low-osmolality iodinated contrast medium used for intravascular and intrathecal administration. Key pearls: 1) Pre-hydrate patients with normal saline to reduce risk of contrast-induced nephropathy, especially in those with eGFR <30 mL/min/1.73m². 2) Screen for prior allergic-like reactions; consider premedication with corticosteroids (e.g., prednisone 50 mg PO q12h for 3 doses prior) and antihistamines (diphenhydramine 50 mg IV/PO 1 hour before) for history of moderate or severe reactions. 3) Avoid intrathecal use if there is suspicion of elevated intracranial pressure or CSF obstruction. 4) Metformin should be held for 48 hours post-procedure and only resumed after renal function recheck. 5) Have emergency equipment (oxygen, epinephrine, IV access) readily available for treatment of anaphylactoid reactions. |
| Patient Advice | This contrast agent may cause a warm sensation or metallic taste during injection; these sensations are temporary. · Notify the technologist immediately if you experience itching, hives, difficulty breathing, or swelling of the face or throat. · You should drink plenty of fluids (water) before and after the procedure to help clear the contrast from your kidneys unless otherwise instructed. · If you take metformin for diabetes, you may need to stop it for 48 hours after the procedure; your doctor will advise when to restart. · Inform your healthcare provider about any allergies (especially to iodine or contrast media), kidney problems, asthma, or if you are pregnant or breastfeeding. |
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