New Release: Alpha testing version has been released.

Fluorescein

S01J - Diagnostic agents ATC N01BB52 Small molecule approved 1976 Parenteral Topical Natural product

JFDA label: Minims Lidocaine 4% & Fluorescein 0.25%

Mechanism of Action

Fluorescein sodium, a fluoresce dye, responds to wavelengths between 465-490 nm of electromagnetic radiation and light, and fluoresces at wavelengths of 520-530 nm.

Indications

Approved

  • Ophthalmic angiography/angioscopy (injection)
  • Ophthalmic diagnostic staining (strips)

Contraindications

Source: Lexicomp

  • Hypersensitivity to fluorescein or any other component of the formulation Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (4)

Not Known Arterial ischemia (basilar; rare) · hypotension · shock · syncope

Nervous system disorders (5)

Not Known Convulsions (rare) · dizziness (Kwan 2006) · headache · nerve palsy (localized; [Kwan 2006]) · seizure (rare; [Kwan 2006])

Renal and urinary disorders (1)

Not Known Urine discoloration (bright yellow)

Blood and lymphatic system disorders (2)

Not Known Hemolytic anemia (Kwan 2006) · sickle cell disease (Kwan 2006, Acheson 1985)

Immune system disorders (2)

Not Known Anaphylaxis · hypersensitivity reaction

Gastrointestinal disorders (4)

Not Known Dysgeusia · gastrointestinal distress · nausea (common) · vomiting

Skin and subcutaneous tissue disorders (4)

Not Known Pruritus · rash at injection site · skin discoloration (yellow) · urticaria

General disorders and administration site conditions (2)

Not Known Extravasation · inflammation at injection site

Respiratory, thoracic and mediastinal disorders (2)

Not Known Bronchospasm · pulmonary edema (acute; [Kwan 2006])

Dosing

Source: Lexicomp

Diagnostic staining: Ophthalmic: Strips: Moisten strip with sterile water, saline or ophthalmic fluid. Touch conjunctiva or fornix with tip of strip until adequately stained. Ophthalmic angiography/angioscopy: Note: Prior to injection, an intradermal test dose of 0.05 mL may be used if an allergy is suspected. Evaluate 30-60 minutes following intradermal injection. A negative skin test does not exclude the potential for a reaction to occur. IV: 500 mg as a single dose into antecubital vein; a dose of 200 mg may be appropriate in cases when a highly sensitive imaging system (eg, scanning laser ophthalmoscope) is used. Oral (off-label route): 1 g of injection solution has been administered orally; clarity of photographs, particularly during early arterial phase, is reportedly poorer than photographs obtained following IV administration (Hara, 1998)
(For additional information see "Fluorescein: Pediatric drug information") Diagnostic staining: Children and Adolescents: Ophthalmic: Strips: Refer to adult dosing. Ophthalmic angiography/angioscopy: Children and Adolescents: Note: Prior to injection, an intradermal test dose of 0.05 mL may be used if an allergy is suspected. Evaluate 30-60 minutes following intradermal injection. A negative skin test does not exclude the potential for a reaction to occur. IV: 7.7 mg/kg as a single dose into antecubital vein; maximum dose: 500 mg
Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustment provided in the manufacturer's labeling.

Warnings & Precautions

Source: Lexicomp

Anaphylaxis/hypersensitivity reactions

Hypersensitivity and anaphylactic reactions may occur (death has been reported rarely); immediate treatment (including epinephrine) should be available. Serious intolerance reactions may be induced; history of adverse reaction to fluorescein or allergic reaction to foods or drugs, such as urticaria, asthma, eczema, or allergic rhinitis, may increase risk. Premedicating some patients (eg, antihistamines, corticosteroids) may be advisable. An intradermal skin test may be performed prior to use when allergy is suspected; however, a negative skin test does not rule out the potential for a reaction to occur.

Gastrointestinal effects

Nausea and/or vomiting and gastrointestinal distress occur commonly within the first few minutes following injection; these reactions usually subside within 10 minutes.

Skin/urine discoloration

Following use of the injection, skin may temporarily turn a yellow color within a few minutes of administration and usually fades in 6 to 12 hours. Urine may appear bright yellow for 24 to 36 hours. Disease-related concerns:

Allergies/asthma

Respiratory reactions may occur, especially in patients with a history of allergies or bronchial asthma; use with caution. Special populations:

Contact lens wearers

Ophthalmic products should not be used in patients with soft contact lenses, will cause them to discolor. Flush eyes with saline following use and wait at least 1hour prior to replacing contact lenses. Dosage form specific issues:

Injection

For administration via antecubital vein only; not for intrathecal or arterial injection. Avoid extravasation; severe local tissue damage may result, including skin sloughing, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. Following extravasation, severe pain may last up to several hours. Discontinue immediately if extravasation occurs.

Pregnancy & Lactation

Pregnancy

FDA category C

Animal reproduction studies have not been conducted. Pregnancy outcome information is available following fluorescein use in pregnant women (Halperin 1990; Olk 1991).

Lactation

Fluorescein is excreted into breast milk when administered by injection (Maquire 1988) and ophthalmic drops (Mattern 1990). Measurable concentrations can be detected for at least 4 days following injection; pumping and discarding milk during this time period is recommended by the manufacturer.

Monitoring

Clinical pearlInjection: Hypersensitivity reactions (during procedure and after)

Chemistry & Properties

2D structure
FormulaC20H12O5
Molecular weight332.31 g/mol
IUPAC name3',6'-dihydroxyspiro[2-benzofuran-3,9'-xanthene]-1-one
CAS2321-07-5
PubChem CID16850
InChIKeyGNBHRKFJIUUOQI-UHFFFAOYSA-N
logP3.67 (XLogP 3.4)
Polar surface area75.99 Ų
H-bond acceptors / donors5 / 2
Drug-likeness (QED)0.61
Lipinski violations0
SMILESO=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrantNo

Enzyme interactions

EnzymeRoleDetail
CYP1A2Inhibitor
CYP1A2Substrate
CYP2B6Inhibitor
CYP2B6Substrate
CYP2C19Inhibitor IC₅₀ 0.9074 µM
CYP2C19Substrate
CYP2C8Inhibitor
CYP2C9Inhibitor
CYP2C9Substrate
CYP2D6Substrate
CYP3A4Inhibitor
CYP3A4Substrate

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)MRP2 (Inhibitor)MRP3 (Inhibitor)OAT1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)P-gp (Inhibitor)BSEP (Substrate)MRP1 (Substrate)OAT1 (Substrate)OATP1A2 (Substrate)OATP1B1 (Substrate)OATP1B3 (Substrate)OATP1C1 (Substrate)OATP2A1 (Substrate)OATP2B1 (Substrate)OATP3A1 (Substrate)OATP4A1 (Substrate)OATP4C1 (Substrate)OATP5A1 (Substrate)OATP6A1 (Substrate)P-gp (Substrate)

Registered Products (5)

BrandForm / strengthPackAgentCitizen (JOD)
Fluorescein Sodium USP IV Ampoule 10 g/100 ml 100 amp JAWEDA INT. DRUD STORE
Minims Fluorescein Sod.B.P 1% e/d Ophthalmic Solution 1 % 0.5 ml Petra Drug Store
Minims Fluorescein Sod.B.P 2% e/d Ophthalmic Solution 2 % 20 S.D.U Petra Drug Store
Minims Lidocaine 4% & Fluorescein Solution 0.25 %, 4 % 0.5 ml Petra Drug Store
SunnyFloresin Ampoule 500 mg/5 ml 5 amp Sahar Drug Store