AK-FLUOR® (Fluorescein Injection, USP) is a sterile solution in Water for Injection, of Fluorescein prepared with the aid of Sodium Hydroxide. Hydrochloric Acid and/or Sodium Hydroxide may be used to adjust pH (8.0-9.8). AK-FLUOR® is used intravenously as a diagnostic aid. The active ingredient exists as a sodium salt of fluorescein and is represented by the chemical structure:

Established Name: Fluorescein Sodium

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

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

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.

: 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 tissues and to relieve pain should be implemented.

Precautions: 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 aminophylline for intravenous use; oxygen should always be available in the event of possible reaction to fluorescein injection. ¹

Pediatric Use: Safety and effectiveness in children have not been established.

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 for fluorescein injection during pregnancy.

Nursing Mothers: Caution should be exercised when AK-FLUOR® (Fluorescein Injection, USP) is administered to a nursing woman.

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

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, and 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 .) Generalized hives and itching, bronchospasm and anaphylaxis have been reported. A strong taste may develop after injection.

The most common reaction is nausea.

Dosage and Administration: Inject the contents of the ampul or vial 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' blood to the hub of the syringe so that a small air bubble separates the patient' 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' 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 pediatric patients, the dose is calculated on the basis of 35 mg for each ten pounds of body weight.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

How Supplied: AK-FLUOR®, 10% (Fluorescein Injection, USP--Sterile) 100 mg/mL

NDC 17478-253-10 12 × 5 mL Single Dose Vials

NDC 17478-254-10 25 × 5 mL Ampuls

AK-FLUOR®, 25% (Fluorescein Injection, USP--Sterile) 250 mg/mL

NDC 17478-250-20 12 × 2 mL Single Dose Vials

NDC 17478-251-20 12 × 2 mL Ampuls

Storage: Store at 15°-25°C (59°-77°F); protect from freezing.

Reference:

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

Rx only

AKORN

Buffalo Grove, IL 60089

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.