FLUORESCITE fluorescein sodium
Refer to the “Also Known As” section to reference different products that include the same medication as FLUORESCITE.
Brand Name: FLUORESCITE
Generic Name: FLUORESCEIN SODIUM
Drug Type: HUMAN PRESCRIPTION DRUG
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
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.
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.
Nausea, vomiting, and gastrointestinal distress are common adverse events. A strong taste may develop after injection.
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)].
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)]
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
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