FLUORESCEIN injection, solution

Drug Labeling and Warnings

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Fluorescein Injection 10% (100 mg/mL)  is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. (1)

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Dosing

    Adult Dose

    The recommended dosage of Fluorescein Injection 10% (100 mg/mL) is 500 mg via intravenous administration.

    Pediatric Dose

    For children, the dose is 7.7 mg/kg (actual body weight) up to a maximum of 500 mg, via intravenous infusion calculated on the basis of 35 mg for each 4.54 kg of body weight.

    2.2 Preparation for Administration

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not mix or dilute with other solutions or drugs.Discard unused portion.

    2.3 Administration

    Inject the dose (over 5-10 seconds is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation. A syringe, filled with Fluorescein, may be attached to transparent tubing and a 23 gauge butterfly needle for injection. Insert the needle and draw the patient's blood to the hub of the syringe so that a small air bubble separates the patient's blood in the tubing from the fluorescein. With the room lights on, slowly inject the blood back into the vein while watching the skin over the needle tip. If the needle has extravasated, the patient's blood will be seen to bulge the skin and the injection should be stopped before any fluorescein is injected. When assured that extravasation has not occurred, the room light may be turned off and the fluorescein injection completed. Luminescence usually appears in the retina and choroidal vessels in 7 to 14 seconds and can be observed by standard viewing equipment.

    Reduction in dose from 500 mg to 200 mg of Fluorescein Injection, 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.

  • 3 DOSAGE FORMS AND STRENGTHS

    Injection:

    • 10%, (500 mg/5 mL) (100 mg/mL) of fluorescein sodium as a dark reddish orange, clear solution in a single-dose vial.
  • 4 CONTRAINDICATIONS

    4.1 Hypersensitivity

    Fluorescein Injection is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)].

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Respiratory Reactions

    Caution should be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should always be available.

    If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.

    5.2 Severe local tissue damage

    Extravasation during injection can result in severe local tissue damage due to high pH of fluorescein solution. The following complications resulting from extravasation of fluorescein have been noted to occur: Sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median nerve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. [see Administration (2.3) and Adverse Reactions (6.6)].

  • 6 ADVERSE REACTIONS

    6.1 Skin and urine discoloration

    The most common reaction is discoloration of the skin and urine. Skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours.

    6.2 Gastrointestinal Reaction

    The next most common adverse reaction is nausea. Vomiting, and gastrointestinal distress have also occurred. A strong taste may develop after injection.

    6.3 Hypersensitivity Reactions

    Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. [see Contraindications (4.1) and Warnings and Precautions (5.1)]

    6.4 Cardiopulmonary Reactions

    Syncope and hypotension may occur. Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely. [see Warnings and Precautions(5.1)]

    6.5 Neurologic Reactions

    Headache may occur. Convulsions may rarely occur following injection.

    6.6 Thrombophlebitis

    Thrombophlebitis at the injection site has been reported. Extravasation of the solution at the injection site causes intense pain at the site and a dull aching pain in the injected arm. [see Administration (2.3) and Warnings and Precautions (5.2)].

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Pregnancy Category C. Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.

    8.3 Nursing Mothers

    Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.

    8.4 Pediatric Use

    Pediatric patients have been included in clinical studies. No overall differences in safety or effectiveness have been observed between pediatric and adult patients.

    8.5 Geriatric Use

    No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

  • 11 DESCRIPTION

    Fluorescein Injection, USP contains fluorescein sodium, a diagnostic aid, in a sterile solution for use intravenously. It is a dark reddish orange clear solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg.


    Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. Its molecular weight is 376.27. The active ingredient is represented by the chemical structure:

    Structure

    Fluorescein Injection, USP 500 mg/5 mL (100 mg/mL) 10% contains:

    • Active ingredient: fluorescein sodium (10% w/v, 100 mg/mL), equivalent to 88.3 mg/mL of fluorescein
    • Inactive ingredients: sodium hydroxide and/or hydrochloric acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465 to 490 nm and fluoresces, i.e., emits light at wavelengths of 520 to 530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish green. Following intravenous injection of fluorescein sodium in an aqueous solution, the unbound fraction of the fluorescein can be excited with a blue light flash from a fundus camera as it circulates through the ocular vasculature, and the yellowish green fluorescence of the dye is captured by the camera. In the fundus, the fluorescence of the dye demarcates the retinal and/or choroidal vasculature under observation, distinguishing it from adjacent  areas/structures.

    12.3 Pharmacokinetics

    Distribution.

    Within 7 to 14 seconds after IV administration into the antecubital vein, fluorescein usually appears in the central retinal artery of the eye. Within a few minutes of IV administration of fluorescein sodium, a yellowish discoloration of the skin occurs, which begins to fade 6 to 12 hours after dosing. Various estimates of volume of distribution indicate that fluorescein distributes into interstitial space (0.5 L/kg).

    Metabolism.

    Fluorescein is metabolized to fluorescein monoglucuronide. After IV administration of fluorescein sodium (14 mg/kg) to 7 healthy subjects, approximately 80% of fluorescein in plasma was converted to glucuronide conjugate after a period of 1 hour post dose.

    Excretion.

    Fluorescein and its metabolite are mainly eliminated via renal excretion. After IV administration, the urine remains slightly fluorescent for 24 to 36 hours. A renal clearance of 1.75 mL/min/kg and a hepatic clearance (due to conjugation) of 1.50 mL/min/kg have been estimated. The systemic clearance of fluorescein was essentially complete by 48 to 72 hours after administration of 500 mg fluorescein.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    There have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Fluorescein Injection, USP 10%, 500 mg/5 mL (100 mg/mL) of fluorescein sodium is a dark reddish orange, clear solution in a single-dose vial.


    (NDC: 54288-179-10) 5 mL, single dose vials in a package of 10.


    Store fluorescein injection at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Do not freeze. Discard unused portion.

  • 17 PATIENT COUNSELING INFORMATION

    After administration of fluorescein sodium, skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color. Discoloration of the skin usually fades in 6 to 12 hours and usually fades in urine in 24 to 36 hours. [see Warnings and Precautions (6.1)].


    Rx only

    Manufactured by:
    BPI Labs, LLC
    12393 Belcher Road S, Suite 450
    Largo, FL 33773 USA

    LI69I
    R-2605
    Revised: May 2026

  • Principal Display Panel – Carton Label

    Principal Display Panel – 5 mL Carton Label

    NDC: 54288-179-10
    Rx Only
    Fluorescein Injection, USP 10%
    500 mg/5 mL (100 mg/mL) / 10x5 mL sterile Single-dose Vials

    Carton Label

  • Principal Display Panel – Container Label

    Principal Display Panel – 5 mL Label
    NDC: 54288-179-01
    Rx Only
    Fluorescein Injection, USP 10% 500 mg/5 mL (100 mg/mL)

    Container Label

  • INGREDIENTS AND APPEARANCE
    FLUORESCEIN 
    fluorescein injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 54288-179
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    fluorescein sodium (UNII: 93X55PE38X) (fluorescein - UNII:TPY09G7XIR) fluorescein sodium500 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium hydroxide (UNII: 55X04QC32I)  
    hydrochloric acid (UNII: QTT17582CB)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 54288-179-1010 in 1 CARTON05/20/2026
    1NDC: 54288-179-015 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA22004605/20/2026
    Labeler - BPI Labs LLC (078627620)
    Registrant - BPI Labs LLC (078627620)
    Establishment
    NameAddressID/FEIBusiness Operations
    BPI Labs LLC078627620analysis(54288-179) , manufacture(54288-179)
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