FUNDUSCEIN-25
Clinical safety rating: caution
Comprehensive clinical and safety monograph for FUNDUSCEIN-25 (FUNDUSCEIN-25).
Fluorescein sodium absorbs blue light (465–490 nm) and emits yellow-green fluorescence (520–530 nm), allowing visualization of retinal and choroidal vasculature. It binds to serum proteins and leaks from abnormal blood vessels, highlighting areas of neovascularization or edema.
| Metabolism | Primarily metabolized via glucuronidation (liver) and renal excretion; undergoes rapid hepatic conjugation to inactive glucuronides. |
| Excretion | Primarily renal elimination of unchanged fluorescein and its glucuronide conjugate (80% within 24 hours). Biliary/fecal excretion accounts for <5%. |
| Half-life | Terminal elimination half-life is approximately 26 minutes in adults (range 20–30 minutes). Clinical context: Rapid clearance allows repeated injections within 30–60 minutes if needed. |
| Protein binding | Approximately 80% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 0.3–0.5 L/kg, indicating distribution mainly in extracellular fluid and plasma volume. |
| Bioavailability | Intravenous: 100% (only route used clinically). Oral: Approximately 50–60%, but not used due to slow and unpredictable absorption for angiography. |
| Onset of Action | Intravenous: 8–12 seconds to appearance in retinal arteries; 30–60 seconds for complete retinal vascular filling. Intramuscular or subcutaneous: Not clinically used for angiography due to unreliable and slower absorption. |
| Duration of Action | Intravenous: Diagnostic fluorescence lasts 5–10 minutes for retinal angiography, fading by 20 minutes. Clinical notes: Photographs optimally obtained within first 60 seconds after injection. |
0.5 mL of FUNDUSCEIN-25 (25 mg/mL) administered intravenously as a single bolus injection over 5-10 seconds.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment as fluorescein is not significantly renally excreted. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | 7.5 mg/kg (0.3 mL/kg) intravenously as a single bolus injection, maximum 500 mg. |
| Geriatric use | No specific dose adjustment; use standard adult dose with caution due to increased risk of adverse reactions. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for FUNDUSCEIN-25 (FUNDUSCEIN-25).
| Breastfeeding | Sodium fluorescein is excreted into human breast milk. After intravenous administration, peak milk concentrations occur within 1 hour and decline rapidly. The M/P ratio is approximately 1.0. Theoretical risk of infant hypersensitivity or photosensitivity. Use caution; consider pumping and discarding milk for 24-48 hours after dose to minimize infant exposure. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. In animal reproduction studies, intravenous administration of sodium fluorescein to pregnant rats during organogenesis at doses up to 100 mg/kg/day (approximately 2 times the human dose based on body surface area) resulted in no evidence of fetal harm. However, fluorescein crosses the placenta and can be detected in fetal tissues. Risk cannot be ruled out. First trimester: unknown risk; second and third trimesters: potential for fetal exposure, but no known teratogenicity. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to fluorescein sodium or any product components","Use in angiography is contraindicated if patient has severe renal impairment (e.g., ESRD) without dialysis"]
| Precautions | ["Anaphylaxis and severe allergic reactions including anaphylactic shock and anaphylactoid reactions","Extravasation at injection site can cause severe pain, inflammation, and tissue necrosis","Transient nausea and vomiting commonly occur within 30 seconds of injection"] |
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| Fetal Monitoring | No specific fetal monitoring required beyond routine obstetric care. Monitor maternal injection site for extravasation and allergic reactions (urticaria, anaphylaxis). Observe for severe nausea or vomiting which may occur. Document any adverse maternal effects. |
| Fertility Effects | No known effects on fertility in humans. Animal studies: intravenous sodium fluorescein in rats at doses up to 100 mg/kg/day showed no impairment of fertility or reproductive performance. |