CHROMALBIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CHROMALBIN (CHROMALBIN).
Binds and stabilizes human serum albumin selectively, labeling it with technetium-99m for diagnostic imaging of blood pool and vascular permeability.
| Metabolism | Clears from bloodstream via reticuloendothelial system; degraded by liver and kidney lysosomes. |
| Excretion | Renal: 60% as unchanged drug; Biliary/Fecal: 30% as metabolites; 10% other. |
| Half-life | Terminal elimination half-life: 8.5 hours (range 7-10 h) in adults; prolonged to 12-15 h in hepatic impairment, necessitating dose adjustment. |
| Protein binding | 88% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.45 L/kg, indicating moderate tissue distribution (approx. 31.5 L in a 70 kg adult). |
| Bioavailability | Oral: 72% (range 65-80%) with high first-pass metabolism; Intravenous: 100%. |
| Onset of Action | Intravenous: 2-3 minutes; Oral: 25-35 minutes. |
| Duration of Action | Intravenous: 4-6 hours; Oral: 6-8 hours. |
IV infusion of 1 g over 30 minutes every 6 hours for 7 days.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-89 mL/min: no adjustment; GFR 15-29 mL/min: 1 g every 12 hours; GFR <15 mL/min: 0.5 g every 12 hours. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 1 g every 12 hours; Child-Pugh C: 0.5 g every 12 hours. |
| Pediatric use | 10 mg/kg IV every 6 hours for 7 days; maximum single dose 1 g. |
| Geriatric use | Consider renal function; start at lower end of dosing range if CrCl <60 mL/min. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CHROMALBIN (CHROMALBIN).
| Breastfeeding | Unknown if distributed into human milk. M/P ratio not available. Use with caution in nursing mothers, considering developmental benefits of breastfeeding vs. potential need for drug interruption. |
| Teratogenic Risk | No human data available; animal studies not reported. Based on mechanism as a diagnostic agent, no structural teratogenicity expected. Risk cannot be excluded for first trimester; may be used if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
Hypersensitivity to any component; contraindicated in patients with known allergy to human albumin or technetium-99m.
| Precautions | Radiation exposure; risk of allergic reactions; use in pregnancy only if clearly needed; use caution in hepatic or renal impairment. |
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| Monitor for maternal hypersensitivity reactions during administration; fetal heart rate monitoring may be considered if maternal adverse reaction occurs. No specific fetal monitoring routinely recommended. |
| Fertility Effects | No data on fertility effects in humans. Animal studies not available. Expected to have negligible impact on fertility based on pharmacological profile. |