"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
DOSAGE AND ADMINISTRATION
The normal adult dose of FLUORESCITE® (fluorescein) Injection 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) ®, 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 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.
FLUORESCITE® (fluorescein injection, USP) 10% is supplied in a single use 5 mL glass vial with a gray FluroTec coated chlorobutyl (latex free) stopper and purple flip-off aluminum seal. It contains a sterile, red-orange solution of fluorescein sodium.
Store at 2°- 25°C (36°- 77°F). Do Not Freeze.
Mfd. for: ALCON, INC. Fort Worth, Texas 76134 USA. Mfd. by: International Medication Systems, Limited South El Monte, CA 91733 USA. FDA Rev date: 3/28/2006
Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Fluorescite Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.