Fluorescite

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. [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

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. [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Included as part of the "PRECAUTIONS" Section

In the U.S.

• AK-Fluor
• Angioscein
• Fluorescite

Available Dosage Forms:

• Solution

Therapeutic Class: Disclosing Agent

Fluorescein injection is used to help certain parts of the eye (eg, retina, iris) become more visible during eye medical procedures.

This medicine is to be given only by or under the direct supervision of your doctor.

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

Dosing

Adult Dose- The normal adult dose of Fluorescite® Injection 10% (100 mg/mL) is 500 mg via intravenous administration.

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 intravenous 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 intravenous 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.

Respiratory Reactions

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.

Severe Local Tissue Damage

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. [see Administration (2.3) and Adverse Reactions(6)].

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.

Pregnancy

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.

Nursing Mothers

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.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.