FLUORESCEIN SODIUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FLUORESCEIN SODIUM (FLUORESCEIN SODIUM).
Fluorescein sodium is a diagnostic dye that absorbs light in the blue range (465-490 nm) and emits yellow-green fluorescence (520-530 nm) when exposed to excitation light. In angiography, it highlights retinal and choroidal vasculature, allowing visualization of blood flow, leakage, or defects in the blood-retinal barrier. It does not have intrinsic therapeutic pharmacological activity.
| Metabolism | Primarily excreted unchanged by the kidneys; undergoes minimal hepatic metabolism, if any. |
| Excretion | Primarily renal (80-90% unchanged); minor biliary/fecal (<10%). |
| Half-life | Terminal half-life ~24-36 hours; prolonged in renal impairment. |
| Protein binding | 70-80% bound to albumin. |
| Volume of Distribution | 0.5-0.6 L/kg; indicates distribution into total body water. |
| Bioavailability | Oral: not applicable (not absorbed); ophthalmic: negligible systemic absorption. |
| Onset of Action | IV: 30-60 seconds; topical ophthalmic: 1-2 minutes. |
| Duration of Action | IV: 20-30 minutes for angiography; topical: 15-30 minutes for staining. |
5-10 mL of 10% solution (500-1000 mg) intravenously for angiography; 2 drops of 2% ophthalmic solution for diagnostic purposes.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for diagnostic use; consider reduced dose in severe renal impairment (GFR <30 mL/min) due to prolonged elimination. |
| Liver impairment | No specific Child-Pugh based adjustments; use with caution in severe hepatic impairment due to potential altered metabolism. |
| Pediatric use | Angiography: 7.5-10 mg/kg (0.075-0.1 mL/kg of 10% solution) intravenously, maximum 500 mg; ophthalmic: 2 drops of 2% solution. |
| Geriatric use | No specific dose adjustment; use standard adult dosing with caution due to increased risk of adverse reactions from slower elimination. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FLUORESCEIN SODIUM (FLUORESCEIN SODIUM).
| Breastfeeding | Excretion into breast milk unknown; minimal systemic absorption suggests low risk to infant. M/P ratio not available. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; limited human data. Considered low risk in all trimesters due to minimal systemic absorption after topical ophthalmic administration. |
| Fetal Monitoring | No specific monitoring required beyond standard ophthalmic examination. |
■ FDA Black Box Warning
None
| Serious Effects |
Known hypersensitivity to fluorescein sodium or any component of the formulation
| Precautions | Severe adverse reactions including anaphylaxis, cardiac arrest, and seizures have been reported. Emergency resuscitation equipment should be immediately available. Caution in patients with history of allergy, asthma, or previous reaction to fluorescein. Extravasation may cause severe pain, inflammation, and tissue necrosis. Use in pregnancy only if clearly needed. |
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| Fertility Effects | No known effects on fertility. |