SODIUM ROSE BENGAL I 131
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SODIUM ROSE BENGAL I 131 (SODIUM ROSE BENGAL I 131).
Sodium rose bengal I 131 is a radioactive diagnostic agent that is taken up by hepatocytes and excreted into the bile, allowing imaging of the hepatobiliary system. The radioactive iodine (I-131) emits gamma rays, which can be detected externally to assess liver and gallbladder function.
| Metabolism | Sodium rose bengal is taken up by the liver and excreted unchanged into the bile via the biliary system without significant metabolism. |
| Excretion | Primarily hepatic excretion into bile (90-95%), with minimal renal excretion (5-10%). |
| Half-life | Terminal elimination half-life is approximately 3-7 days, reflecting slow clearance from the liver and bile. |
| Protein binding | Highly bound to serum albumin (>95%). |
| Volume of Distribution | Approximately 0.3-0.5 L/kg, indicating distribution primarily in the vascular and hepatic compartments. |
| Bioavailability | 100% after intravenous administration; oral bioavailability is negligible (<1%) due to degradation in the gastrointestinal tract. |
| Onset of Action | Onset occurs within 1-2 hours after intravenous administration for hepatobiliary imaging. |
| Duration of Action | Duration is prolonged, up to 24-48 hours for imaging, due to enterohepatic circulation. |
5-50 µCi (0.185-1.85 MBq) intravenous bolus for hepatic function imaging. For functional imaging of hepatobiliary system, typical dose: 150-300 µCi (5.55-11.1 MBq) IV.
| Dosage form | INJECTABLE |
| Renal impairment | No specific GFR-based adjustments required as drug is primarily hepatobiliary excreted. Use with caution in severe renal impairment due to possible prolonged blood clearance. |
| Liver impairment | Child-Pugh Class A: No adjustment. Class B: Consider reduced dose due to impaired hepatic extraction. Class C: Avoid use or use lowest possible dose with close monitoring. |
| Pediatric use | Weight-based: 0.1-0.5 µCi/kg (0.0037-0.0185 MBq/kg) IV, not to exceed adult dose. Minimum dose: 0.1 µCi. |
| Geriatric use | Elderly patients may require reduced dose due to age-related decline in hepatic function; start at lower end of dosing range (e.g., 1-2 µCi) and titrate based on imaging quality. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SODIUM ROSE BENGAL I 131 (SODIUM ROSE BENGAL I 131).
| Breastfeeding | Contraindicated during breastfeeding. Iodine-131 concentrates in breast milk and is excreted. Radioactive contamination of infant via milk. M/P ratio not established; however, significant transfer occurs. Breastfeeding should be discontinued permanently after administration. |
| Teratogenic Risk | FDA Pregnancy Category X. Radioactive iodine-131 crosses the placenta and can cause permanent thyroid damage or hypothyroidism in the fetus. First trimester exposure carries risk of fetal thyroid ablation; second/third trimester exposure risk of neonatal hypothyroidism, cognitive impairment, and increased cancer risk. Contraindicated in pregnancy. |
■ FDA Black Box Warning
None reported.
| Serious Effects |
["Hypersensitivity to rose bengal or iodine","Pregnancy (relative contraindication; use only if clearly needed)"]
| Precautions | ["Radiation exposure: Use only when potential benefits outweigh risks of radiation exposure, especially in pregnant women and children.","Hypersensitivity reactions: Allergic reactions may occur in patients sensitive to rose bengal or iodine.","Thyroid uptake of free I-131: May cause thyroid accumulation; consider thyroid blockade with stable iodine before administration."] |
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| Fetal Monitoring | Before administration: confirm negative pregnancy test. Post-administration: monitor fetal thyroid function if inadvertent exposure; assess neonatal thyroid function at birth (TSH, T4). Monitor mother for radiation effects. |
| Fertility Effects | Iodine-131 can cause temporary or permanent gonadal damage depending on dose. Ovarian irradiation may affect fertility; risk of amenorrhea and reduced ovarian reserve. Menstrual irregularities reported. Genetic damage to germ cells theoretical risk but not quantified. |