Fluorescite
(Fluorescein Sodium)Fluorescite Prescribing Information
FLUORESCITE® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
Single use 5 mL vial containing 100 mg/mL fluorescein.
Caution should be exercised when fluorescein sodium is administered to a nursing woman.
Fluorescein sodium injection has been demonstrated to be excreted in human milk for up to 4 days. Following fluorescein angiography, breast-feeding should therefore be discontinued for at least 4 days and the milk should be pumped off and discarded during this period.
FLUORESCITE® Injection 10% 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.
Caution is to be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should be available in the event of possible reaction to FLUORESCITE®Injection 10%.
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.
The most common reaction is temporary yellowish discoloration of the skin and urine. Urine may attain 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.
Nausea, vomiting, and gastrointestinal distress are common adverse events. A strong taste may develop after injection.
Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. Rare cases of death have been reported.
Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely.
Headache may occur. Convulsions and syncope may rarely occur following injection.
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.
The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress. (6)
Fluorescein sodium can induce serious intolerance reactions. These reactions of intolerance are always unpredictable but they are more frequent in patients who have previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and vomiting) or in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis.
Detailed questioning of each patient is recommended before the angiography to evaluate any prior history of allergy.
The most common reaction is temporary yellowish discoloration of the skin and urine. Urine may attain 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.
Nausea, vomiting, and gastrointestinal distress are common adverse events. A strong taste may develop after injection.
Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. Rare cases of death have been reported.
Caution is to be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should be available in the event of possible reaction to FLUORESCITE®Injection 10%.
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.
Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely.
Headache may occur. Convulsions and syncope may rarely occur following injection.
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.
Inject the dose rapidly (1 mL per second is normally recommended) intravenously into the antecubital vein, after taking precautions to avoid extravasation. A syringe, filled with FLUORESCITE®, 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 5 mL to 2 mL of FLUORESCITE®Injection 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.
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: severe pain in the arm for several hours, sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. When significant extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented.
FLUORESCITE® (fluorescein injection, USP) 10% is supplied as a sterile, unpreserved, unit dose aqueous solution, that has a pH of 8.0 – 9.8 and an osmolality of 572-858 mOsm/kg.
Active ingredient: fluorescein sodium
Inactive Ingredients: Sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.