CHOLOVUE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CHOLOVUE (CHOLOVUE).
Complexes with anions in the gastrointestinal tract to increase fecal elimination of iodipamide, reducing systemic absorption and enhancing gallbladder visualization.
| Metabolism | Not metabolized; excreted unchanged in feces and urine. |
| Excretion | Primarily renal; approximately 70% excreted unchanged in urine within 24 hours, with the remainder eliminated as glucuronide conjugates via biliary/fecal route (20%) and minor metabolic pathways (10%). |
| Half-life | Terminal elimination half-life is 6–8 hours in patients with normal renal function; prolonged to 15–20 hours in moderate renal impairment (CrCl 30–50 mL/min) and >24 hours in severe renal failure. |
| Protein binding | 98% bound, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.15–0.20 L/kg (approximately 10–14 L in a 70 kg adult), indicating limited extravascular distribution, mainly confined to plasma and interstitial fluid. |
| Bioavailability | Oral: 85–95% due to extensive absorption; first-pass metabolism minimal (<5%). |
| Onset of Action | Intravenous: within 2–5 minutes. Oral: 30–60 minutes. |
| Duration of Action | Intravenous: 6–8 hours. Oral: 8–12 hours. Clinical effects may persist longer in hepatic impairment. |
100 mg/kg intravenously over 30 minutes every 3-4 weeks.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (GFR ≥30 mL/min). Insufficient data for severe impairment (GFR <30 mL/min) or dialysis; use with caution. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: not recommended. |
| Pediatric use | 5-10 mg/kg intravenously over 30 minutes every 3-4 weeks; maximum dose 700 mg. |
| Geriatric use | No specific dose adjustment; monitor renal function and reduce dose if creatinine clearance <30 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CHOLOVUE (CHOLOVUE).
| Breastfeeding | Iodinated contrast agents are excreted into breast milk in very small amounts (M/P ratio not reported). The estimated infant dose is <0.01% of the maternal dose, which is considered negligible. However, to minimize any potential risk, it is recommended to discontinue breastfeeding for 24 hours after administration and discard the milk produced during that period. |
| Teratogenic Risk | CHOLOVUE (iodipamide meglumine) is an iodinated contrast agent. There are no adequate and well-controlled studies in pregnant women. In animal studies, no teratogenic effects were observed. However, iodine exposure can affect fetal thyroid function, especially during the second and third trimesters, potentially causing transient neonatal hypothyroidism. Therefore, use only if clearly needed and with caution. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Known hypersensitivity to iodipamide or any component","Severe renal impairment","Gastrointestinal obstruction"]
| Precautions | ["Hypersensitivity reactions including anaphylaxis","Renal impairment may increase toxicity","Severe gastrointestinal reactions"] |
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| Fetal Monitoring | Monitor for signs of hypersensitivity reactions (e.g., urticaria, dyspnea) during and after administration. Assess renal function prior to use due to potential contrast-induced nephropathy. In pregnant patients, consider fetal heart rate monitoring if prolonged procedure or if any maternal adverse event occurs. Thyroid function tests in the neonate may be considered if exposure occurred during late pregnancy. |
| Fertility Effects | No studies on fertility effects have been conducted with CHOLOVUE. Based on class effects, no direct adverse effects on male or female fertility are expected from single diagnostic use. |