FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Fluorescite Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
FOR INTRAVENOUS USE
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 tissue and to relieve pain should be implemented. Rare cases of death due to anaphylaxis have been reported (See PRECAUTIONS).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
FLUORESCITE® (fluorescein injection, USP) 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
History
There is currently no drug history available for this drug.
Other Information
FLUORESCITE® (fluorescein injection, USP) 10% contains fluorescein sodium (equivalent to fluorescein 10% w/v). It is a sterile solution for use intravenously as a diagnostic aid. Its chemical name is spiro[isobenzofuran-1(3H), 9'-[9H]xanthene]-3-one, 3'6'-dihydroxy,disodium salt. The active ingredient is represented by the chemical structure:
FLUORESCITE® (fluorescein injection, USP) 10% is supplied as a sterile, unpreserved, single-use aqueous solution, that has a pH of 8.0 - 9.8 and an osmolality of 572-858 mOsm/kg.
Active ingredient: fluorescein sodium
Inactive Ingredients
Sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.
Sources
Fluorescite Manufacturers
-
Alcon, Inc.
Fluorescite | Alcon, Inc.
The normal adult dose of FLUORESCITE® (fluorescein injection, USP) 10% is 500 mg (100 mg/mL) via intravenous administration.
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).
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.
Inject the dose rapidly (1 mL per second is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation. A syringe, filled with FLUORESCITE® (fluorescein injection, USP) 10%, 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® (fluorescein injection, USP) 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.
Login To Your Free Account