Fluorescite Injection (Alcon)

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Description: FLUORESCITE® Injection is a sterile aqueous solution in two strengths for use intravenously as a diagnostic aid.

Established name:

    Fluorescein Sodium

Chemical name:

    Spiro[isobenzofuran-1(3 H ),9'-[9 H ]  xanthene]-3-one, 3'6' dihydroxy, disodium salt.

The solution contains Fluorescein Sodium (equivalent to Fluorescein 10% or 25%), Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH), and Water for Injection.

Clinical Pharmacology:    The yellowish-green fluorescence of the drug demarcates the vascular area under observation, distinguishing it from adjacent areas.

Indications and Usage:    Indicated in diagnostic fluorescein angiography or angioscopy of the fundus and of the iris vasculature.

Contraindications: Contraindicated in those persons who have shown hypersensitivity to any component of this preparation.

Warning:

FOR OPHTHALMIC USE ONLY. Care must be taken to avoid extravasation during injection as the high pH of fluorescein solution can result in severe local tissue damage. 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 curve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When significant extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. Do not mix or dilute with other solutions or drugs in syringe. Flush intravenous cannulas before and after drugs are injected to avoid physical incompatibility reactions. Rare cases of death due to anaphylaxis have been reported (See PRECAUTIONS ).

Precautions:    General: Caution is to be exercised in patients with a history of allergy or bronchial asthma. An emergency tray including such items as 0.1% epinephrine for intravenous or intramuscular use; an antihistamine, soluble steroid, and aminophyllene for IV use; and oxygen should always be available in the event of possible reaction to fluorescein injection. ¹ Use only if the container is undamaged.

Information for Patients:    Skin will attain a temporary yellowish discoloration. Urine attains a bright yellow color. Discoloration of the skin fades in 6 to 12 hours; urine fluorescein in 24 to 36 hours.

Carcinogenesis, Mutagenesis, Impairment of Fertility:    There have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.

Use in Pregnancy:    Avoid angiography on patients who are pregnant, especially those in first trimester. There have been no reports of fetal complications from fluorescein injection during pregnancy.

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

Geriatric Use:    No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions:    Nausea and headache, gastrointestinal distress, syncope, vomiting, hypotension, and other symptoms and signs of hypersensitivity have occurred. Cardiac arrest, basilar artery ischemia, severe shock, convulsions, thrombophlebitis at the injection site and rare cases of death have 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 WARNING.) Generalized hives and itching, bronchospasm and anaphylaxis have been reported. A strong taste may develop after injection.

Dosage and Administration: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not mix or dilute with other solutions or drugs. Flush intravenous cannulas before and after drugs are injected to avoid physical incompatibility reactions. Inject the contents of the ampule rapidly into the antecubital vein, after taking precautions to avoid extravasation. A syringe, filled with fluorescein, is attached to transparent tubing and a 25 gauge scalp vein 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 appears in the retina and choroidal vessels in 9 to 14 seconds and can be observed by standard viewing equipment. If 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. For children, the dose is calculated on the basis of 35 mg for each ten pounds of body weight.

How Supplied:    10% in 5 mL ampule and 25% in 2 mL ampule.

10% NDC 0065-0092-05

25% NDC 0065-0094-02

Storage:    Store at 8°-27°C (46°-80°F).

Rx Only

REFERENCE:

1. Schatz, Burton, Yannuzzi, Rabb. Interpretation of Fundus Fluorescein Angiography, Page 38, C. V. Mosby Co., St. Louis, 1978.

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