AK-FLUOR 25%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AK-FLUOR 25% (AK-FLUOR 25%).
Sodium fluorescein absorbs light in the blue spectrum (465-490 nm) and emits yellow-green fluorescence (520-530 nm), enabling visualization of the retinal and choroidal vasculature by highlighting areas of vascular leakage, staining defects, or filling defects.
| Metabolism | Metabolized by the liver via glucuronidation; primarily excreted unchanged in urine. |
| Excretion | Renal: >90% unchanged within 24-48 hours; <10% fecal via biliary elimination |
| Half-life | Terminal half-life: 1-2 minutes (fluorescence decay); clinical context: transient plasma fluorescence, minimal systemic accumulation |
| Protein binding | 10-20% bound primarily to albumin |
| Volume of Distribution | 0.1-0.3 L/kg (confined to extracellular space; does not penetrate cells) |
| Bioavailability | Topical: negligible systemic absorption (<1%); IV: 100% |
| Onset of Action | IV: immediate upon injection (fluorescence appears within seconds); topical: 10-15 minutes after corneal application |
| Duration of Action | IV: 10-20 minutes (fluorescence diminishes); topical: 30-60 minutes (corneal staining persists for examination) |
Intravenous administration: 5-15 mg/kg as a single bolus injection over 1-2 minutes. For ophthalmic use: 1-2 drops of 2% fluorescein solution topically.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required for fluorescein. Use caution in severe renal impairment (GFR <30 mL/min) as renal clearance may be reduced. |
| Liver impairment | No specific dose adjustment required for fluorescein. Use caution in severe hepatic impairment (Child-Pugh class C) as metabolism may be altered. |
| Pediatric use | For ophthalmic use: 1 drop of 2% fluorescein solution to each eye. For intravenous angiography: 7.5 mg/kg (maximum 500 mg) as a single bolus injection. Weight-based: 7.5 mg/kg. |
| Geriatric use | No specific dose adjustment required. Use lowest effective dose due to potential for increased sensitivity and slower clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AK-FLUOR 25% (AK-FLUOR 25%).
| Breastfeeding | Fluorescein sodium is excreted in human breast milk. The M/P ratio is not established. A nursing infant may be exposed to a small amount of the drug. Caution should be exercised when administered to a nursing woman. Consider temporary discontinuation of breastfeeding after administration. |
| Teratogenic Risk | Fluorescein sodium is classified as FDA Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. There is no evidence of teratogenicity from inadvertent exposure during pregnancy, but systematic studies are lacking. Use during pregnancy only if clearly needed. |
■ FDA Black Box Warning
Severe adverse reactions, including death, have been reported following intravenous administration. Resuscitative equipment and trained personnel should be immediately available.
| Serious Effects |
["Known hypersensitivity to sodium fluorescein or any component","Avoid intrathecal or intra-arterial administration"]
| Precautions | ["Anaphylaxis and severe hypersensitivity reactions may occur","Extravasation may cause severe local tissue damage and necrosis","Caution in patients with history of asthma or allergies","Renal impairment may prolong drug elimination","Photosensitivity reactions possible"] |
| Food/Dietary | No specific food interactions. Avoid grapefruit juice if patient is on CYP3A4 substrates? Not relevant. No dietary restrictions. Ensure patient is well-hydrated before procedure. |
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| Fetal Monitoring | No specific maternal or fetal monitoring is routinely required. However, due to the potential for allergic reactions, standard resuscitation equipment should be available. Fetal heart rate monitoring may be considered if administered during pregnancy, though not mandatory. |
| Fertility Effects | No studies on fertility effects are available. Fluorescein sodium is not known to impair fertility in humans. No reproductive toxicity data exist. |
| Clinical Pearls | AK-FLUOR 25% (fluorescein sodium) is used for diagnostic angiography of the retina and iris. Ensure patient has no history of hypersensitivity to fluorescein. Inject rapidly to achieve a good bolus. Adverse reactions include nausea, vomiting, and rarely anaphylaxis. Have resuscitation equipment available. Extravasation causes intense pain and tissue necrosis; use a large antecubital vein. Photosensitivity may occur for 24-48 hours. |
| Patient Advice | You may experience temporary yellowish discoloration of skin and urine for 24-48 hours after injection. · Avoid direct sunlight and tanning beds for 48 hours as your skin may be more sensitive. · Inform your doctor if you have a history of allergies, asthma, or reactions to dyes. · Common side effects include nausea, vomiting, and metallic taste; these usually resolve quickly. · If you experience difficulty breathing, hives, or swelling, seek emergency care immediately. |