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FLUORESCITE® (fluorescein injection, USP)

FLUORESCITE^®(fluorescein injection, USP) 10% contains 10% w/v fluorescein. It is a sterile solution for use intravenously as a diagnostic aid. Its chemical name is 3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3one. The molecular weight is 332.31 g/mol.

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

Inactive Ingredients: Sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.

FLUORESCITE® INDICATIONS AND USAGE

FLUORESCITE^®Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

FLUORESCITE® Mechanism of Action

Fluorescein responds to electromagnetic radiation and light between the wavelengths of 465-490 nm and fluoresces, i.e., emits light at wavelengths of 520-530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish-green. Following IV injection of fluorescein 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.

FLUORESCITE® DOSAGE AND ADMINISTRATION

Adult Dose: The normal adult dose of FLUORESCITE^®Injection 10% (100 mg/mL) is 500 mg via intravenous (IV) administration.

Pediatric Dose: For children, the dose should be calculated on the basis of 7.7 mg for each kg of actual body weight (or 35 mg for each 10 pounds of body weight) up to a maximum of 500 mg via IV administration.

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. Flush IV cannulas before and after drugs are injected to avoid physical incompatibility reactions.

Administration

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.

FLUORESCITE® CONTRAINDICATIONS

Hypersensitivity: FLUORESCITE^®Injection 10% is contraindicated in patients with known hypersensitivity to fluorescein or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported.

FLUORESCITE® WARNINGS AND PRECAUTIONS

Respiratory Reactions: Monitor closely when used 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%.

Severe Local Tissue Damage: 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 reported: 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.

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

FLUORESCITE® ADVERSE REACTIONS

Skin and Urine Discoloration: 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.

Gastrointestinal Reactions: Nausea, vomiting, and gastrointestinal distress are common adverse events. A strong taste may develop after injection.

Hypersensitivity Reactions: Symptoms and signs of hypersensitivity have occurred. Generalized hives and itching, bronchospasm and anaphylaxis have been reported. Rare cases of death have been reported

Cardiopulmonary Reactions: Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely.

Neurologic Reactions: Headache may occur. Convulsions and syncope may rarely occur following injection.

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.

FLUORESCITE® USE IN SPECIFIC POPULATIONS

Pregnancy: There is insufficient data with the use of fluorescein in pregnant women to inform a drug-associated risk. Adequate animal reproduction studies have not been conducted with fluorescein. Fluorescein should only be given to a pregnant woman if clearly needed.

Lactation: Fluorescein injection has been demonstrated to be transferred into human milk for up to 4 days following IV administration.

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.

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

FLUORESCITE® (fluorescein injection, USP) 10%

FLUORESCITE® (fluorescein injection, USP)