Fluorescite®

GoodRx

Fluorescein 10% · injectable solution

Diagnostic Dye, Injections & Implants

Approved uses

Fluorescein angiography or angioscopy of the retina and iris vasculature

Adults 500 mg intravenously; children 7.7 mg/kg (35 mg per 10 pounds) up to a maximum of 500 mg, injected at about 1 mL per second into the antecubital vein

FDA label, Indications and Usage, Dosage and Administration, and Clinical Pharmacology; Yannuzzi LA, Rohrer KT, Tindel LJ, et al. Fluorescein angiography complication survey. Ophthalmology. 1986;93(5):611-617 (PubMed article types journal article, research support, and review; the abstract describes it as a national survey); Kalogeromitros DC, Makris MP, Aggelides XS, et al. Allergy skin testing in predicting adverse reactions to fluorescein, a prospective clinical study. Acta Ophthalmol. 89(5):480-483 (PMID 19906081, doi 10.1111/j.1755-3768.2009.01722.x; PubMed returns the publication date as 10 November 2009 against volume 89 issue 5, so no year is asserted here).

OFF-LABELNot in the FDA label for this product

Oral fluorescein angiography when intravenous access is refused or not tolerated

Sodium fluorescein 25 mg/kg mixed in 20 mL of water and swallowed in a single gulp in the largest pediatric comparison, which cites 20 to 30 mg/kg as the reported range

Comparative series · n=40

Comparative case series of 40 children aged 3 to 16 who underwent both routes within one week. All 40 completed the oral study against 24 of 40 for the intravenous study (100% versus 60%, P<0.0001), and among preschoolers 19 of 19 against 7 of 19 (P<0.0001); the 16 intravenous failures were needle fear in 14 and a positive fluorescein skin test in 2. Graded image quality was similar for foveal avascular zone visualization (P=0.8972), for clinically important findings (P>0.9999), and overall (P=0.2500). Median time to dye entry was 5.2 minutes and to the optimal angiogram 10.5 minutes. No adverse event occurred in either arm, but the authors state their sample was too small to evaluate the safety of the oral route.

Jiang Z, Sun L, Hou A, Zhang T, Lai Y, Huang L, Ding X. Oral fluorescein angiography with ultra-wide-field scanning laser ophthalmoscopy in pediatric patients. J Clin Med. 2022;11(18):5421. PubMed indexes it as a journal article; the authors describe it as a comparative case series. The report names sodium fluorescein but not the product swallowed, and the oral route is not on this label.

Contraindications

Known hypersensitivity to fluorescein or any other ingredient in the product.

Available Forms

Injection 500 mg/5 mL (100 mg/mL), single-dose 5 mL glass vial, carton of 12 vials

Mechanism of Action

Excited by light between 465 and 490 nm, the dye fluoresces yellowish green at 520 to 530 nm. After rapid intravenous injection the unbound fraction circulating through the ocular vasculature is excited by the fundus camera flash, demarcating the retinal and choroidal vessels against adjacent structures.

Warnings & Precautions

Anaphylaxis and death: Rare deaths due to anaphylaxis have been reported, and intolerance reactions are always unpredictable, but they are more frequent in patients who have previously had an adverse reaction after an injection with symptoms other than nausea and vomiting, and in patients with a history of allergy such as food or drug induced urticaria, asthma, eczema, or allergic rhinitis, so question each patient in detail before angiography.
Respiratory reactions: Monitor closely in patients with a history of allergy or bronchial asthma, and keep an emergency tray available; an intradermal skin test of 0.05 mL read at 30 to 60 minutes may be performed when allergy is suspected, but a negative skin test is not proof that a patient is not allergic.
Severe local tissue damage: The high pH of the solution makes extravasation damaging, with reports of severe arm pain for several hours, sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area; stop the injection and treat the tissue and pain conservatively if significant extravasation occurs.
Incompatibility: Do not mix or dilute with other solutions or drugs, and flush the intravenous line before and after other drugs to avoid physical incompatibility reactions.
Storage: Store at 2 to 25 degrees C and do not freeze.

Common Side Effects

Skin and urine discoloration: Most common reaction, a temporary yellowish skin discoloration that fades in 6 to 12 hours and bright yellow urine that clears in 24 to 36 hours.
Gastrointestinal: Nausea, vomiting, and gastrointestinal distress are common within the first few minutes and usually subside within 10 minutes; a strong taste and diarrhea are also reported.
Hypersensitivity: Generalized hives and itching, bronchospasm, and anaphylaxis, with rare deaths.
Cardiopulmonary: Cardiac arrest, basilar artery ischemia, severe shock, and death occur rarely.
Neurologic: Headache, with rare convulsions and syncope after injection.
Injection site: Thrombophlebitis, and intense local pain with a dull aching pain in the injected arm when solution extravasates.

Pregnancy & Lactation

Pregnancy: Insufficient data in pregnant women to inform a drug-associated risk, and adequate animal reproduction studies have not been conducted; a single intravenous dose in pregnant rats distributed rapidly into the amniotic fluid and fetus, so give only if clearly needed.

Lactation: Demonstrated to transfer into human milk for up to 4 days after intravenous administration, and the label advises caution in a nursing woman.

Pediatric Use

Pediatric patients were included in clinical studies, with no overall difference in safety or effectiveness from adults.