FLUORESCITE Solution for injection Ref.[10815] Active ingredients: Fluorescein

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

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

2. Dosage and Administration

2.1 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.

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. Flush intravenous cannulas before and after drugs are injected to avoid physical incompatibility reactions.

2.3 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.

16.2. Storage and Handling

Store at 2°-25°C (36°-77°F).

Do Not Freeze.

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