AK-FLUOR 10%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AK-FLUOR 10% (AK-FLUOR 10%).
Fluorescein sodium is a diagnostic dye that absorbs light in the blue spectrum (465-490 nm) and emits green-yellow fluorescence (520-530 nm). It is used to visualize blood flow, detect corneal abrasions, and assess vascular integrity by highlighting areas of leakage or damage.
| Metabolism | Metabolized by the liver via glucuronidation; primarily excreted renally as glucuronide conjugate and unchanged drug. |
| Excretion | Primarily renal (unchanged). Approximately 80-90% of an administered dose is excreted unchanged in urine within 24 hours. Biliary/fecal excretion is minimal (<5%). |
| Half-life | Terminal elimination half-life is approximately 1-2 minutes in patients with normal renal function. This short half-life reflects rapid redistribution and renal clearance. |
| Protein binding | Approximately 60-80% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 0.5-0.8 L/kg, indicating distribution primarily within extracellular fluid with some tissue binding. |
| Bioavailability | Not applicable orally; administered intravenously or intra-arterially. Bioavailability by IV/IA routes is 100%. |
| Onset of Action | Intravenous administration: Onset of fluorescence is immediate (within seconds) upon reaching the retinal vasculature. Intra-arterial injection: Onset is similarly immediate. |
| Duration of Action | Intravenous: Fluorescence lasts for approximately 5-10 minutes, sufficient for imaging. The drug is rapidly cleared from circulation; late-phase images may be obtained up to 30 minutes post-injection. |
Intravenous injection: 5-10 mL (500-1000 mg fluorescein sodium) given rapidly over 4-5 seconds.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required; dose is small and excretion is rapid. Use caution in severe renal impairment (eGFR <30 mL/min) due to potential accumulation. |
| Liver impairment | No specific adjustments based on Child-Pugh score; use standard dosing. |
| Pediatric use | Intravenous: 0.033-0.1 mL/kg (3.3-10 mg/kg fluorescein sodium) of the 10% solution, maximum 5 mL (500 mg). |
| Geriatric use | No specific dose adjustment; use standard adult dose, but monitor for adverse reactions. Reduced clearance may occur, but single small dose remains safe. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AK-FLUOR 10% (AK-FLUOR 10%).
| Breastfeeding | It is not known whether fluorescein is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AK-FLUOR 10% is administered to a nursing woman. |
| Teratogenic Risk | FDA Pregnancy Category C. Animal reproduction studies have not been conducted with fluorescein. It is not known whether fluorescein can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluorescein should be given to a pregnant woman only if clearly needed. |
■ FDA Black Box Warning
Severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous administration. Resuscitative equipment and personnel trained in emergency management must be immediately available.
| Serious Effects |
["Known hypersensitivity to fluorescein sodium or any component of the formulation"]
| Precautions | ["Risk of hypersensitivity reactions including anaphylaxis, bronchospasm, and urticaria","Extravasation at injection site may cause severe pain and tissue necrosis","Caution in patients with history of allergies or asthma","Significant extravasation may require surgical consultation"] |
| Food/Dietary | No clinically significant food interactions have been reported with fluorescein sodium. Patients may eat normally before and after administration unless otherwise instructed for the specific diagnostic procedure. |
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| Fetal Monitoring |
| Monitor for signs of hypersensitivity reactions. No specific fetal monitoring required. |
| Fertility Effects | No studies on fertility effects have been conducted. No known impact on fertility. |
| Clinical Pearls | AK-FLUOR 10% (fluorescein sodium) is used primarily for diagnostic angiography and applanation tonometry. Avoid use in patients with known hypersensitivity. Ensure IV access is secure to prevent extravasation, which can cause severe local tissue necrosis. Transient nausea and vomiting may occur; premedication with antiemetics can be considered. Urine and skin will appear bright yellow for 24-48 hours; advise patients accordingly. |
| Patient Advice | Your skin and urine may turn bright yellow for up to 48 hours after the injection; this is normal and temporary. · You may experience temporary nausea or vomiting; this usually resolves quickly. · Inform your doctor if you have a history of allergies to fluorescein or other dyes. · Avoid touching your eyes after the procedure until the dye clears from your skin. · Contact lenses should be removed before the procedure and not reinserted for at least 24 hours. |