FLUORESCITE fluorescein sodium

Get an overview of FLUORESCITE (fluorescein sodium injection, solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in FLUORESCITE can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as FLUORESCITE.

Drug Basics

Brand Name: FLUORESCITE

Generic Name: FLUORESCEIN SODIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: OPHTHALMIC

Dosage Form: INJECTION, SOLUTION

Data Current As Of: 2018-10-07

indications & usage

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

warnings & precautions

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 & / 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.

adverse reactions

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 (4.1) and Warnings and Precautions (5.1)].

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 Administration (2.3) and Warnings and Precautions (5.2)].

patient counseling information

After administration of fluorescein sodium, skin will attain a temporary yellowish discoloration. Urine attains 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. [see Adverse Reactions (6)]

Distributed By:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

© 2006, 2016 Novartis

Revised: 2/2016

9012850-0216

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. 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.
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