FLUORESCITE
Generic: FLUORESCEIN SODIUM
Basic Information
Manufacturer
Alcon, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
ebb3883c-71f6-4fd0-a7e6-0ba8e1136dd9
Indications & Usage
1 INDICATIONS AND USAGE FLUORESCITE ® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
FLUORESCITE ® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
(1)
FLUORESCITE ® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
(1)
Adverse Reactions
6 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) ].
The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories,Inc.
at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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) ].
The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories,Inc.
at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.