Fluorescein

INDICATIONS: Intended for use when fitting contact lenses. DIRECTIONS FOR USE: To insure full fluorescence and patient comfort, the impregnated tip should be moistened before application. One or two drops of sterile irrigating or saline solution should be used for this purpose. Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application. Grasp tabs between thumbs & index fingers Gently pull tabs apart Remove strip taking care to touch only the white portion of the strip 83851-100: Vista Fluroescein Sodium

2. DOSAGE & ADMINISTRATION The normal adult dose of Fluorescein Injection 10%, is 5 mL (500 mg) and of Fluorescein Injection 25%, is 2 mL (500 mg) via intravenous administration. ( 2.1 ) For children, the dose should be calculated on the basis of 35 mg for each ten pounds of body weight (7.7 mg/kg body weight). ( 2.2 ) Do not mix or dilute with other solutions or drugs. ( 2.2 ) 2.1 Dosing Adult Dose The recommended dosage of Fluorescein Injection 10% (100 mg/mL) and of Fluorescein Injection 25% (250 mg/mL) is 500 mg via intravenous administration. Pediatric Dose For children, the dose is 7.7 mg/kg (actual body weight) up to a maximum of 500 mg, via intravenous infusion calculated on the basis of 35 mg for each 10 lbs. (4.54 kg) of body weight. 2.2 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. Discard unused portion. 2.3 Administration Inject the dose (over 5-10 seconds is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation. A syringe, fi led with Fluorescein, 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 500 mg to 200 mg Fluorescein Injection, 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.

WARNINGS AND PRECAUTIONS 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 minutes 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 )] .

4. CONTRAINDICATIONS Hypersensitivity to any component of this product. ( 4.1 ) 4.1 Hypersensitivity Fluorescein Injection, USP 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 )] .

6. ADVERSE REACTIONS The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lambda Therapeutics Limited at 1-855-642-2594or email: safety.nexuspharma@lambda-cro.com 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 ye lowish discoloration. Urine attains a bright ye llow 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 )] .

Mechanism of Action Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465 nm to 490 nm and fluoresces, i.e., emits light at wavelengths of 520 nm 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.