Fluorescein

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

Injection: 10% (500 mg/ 5 mL) (100 mg/mL) of fluorescein sodium as a dark reddish orange, clear solution in a single-dose vial. 25% (500 mg/2 mL) (250 mg/mL) of fluorescein sodium as a dark reddish orange, clear solution in a single-dose vial (this strength is currently not being marketed). Injection ( 3 ): 10% (500 mg/5 mL) (100 mg/mL) of fluorescein sodium in a single-dose vial 25% (500 mg/2 mL) (250 mg/mL) of fluorescein sodium in a single-dose vial (this strength is currently not being marketed)

Hypersensitivity to any component of this product. ( 4.1 )

4.1 Hypersensitivity AK-FLUOR 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 )].

Respiratory reactions ( 5.1 ) Severe local tissue damage ( 5.2 )

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 ) ].

The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Long Grove Pharmaceuticals, LLC at 1-855-642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 )

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 ) ].

Caution should be exercised when fluorescein sodium is administered to a nursing woman. ( 8.3 )

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.

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.