fluorescite

Adult Dose: The normal adult dose of FLUORESCITE® Injection 10% (100 mg/mL) is 500 mg via intravenous administration. (2.1) Pediatric Dose: 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. (2.1) Do not mix or dilute with other solutions or drugs (2.2) 2.1 Dosing Adult Dose The normal adult dose of FLUORESCITE ® Injection 10% (100 mg/mL) is 500 mg via intravenous administration. Pediatric Dose 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 IV 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 following adverse reactions associated with the use of FLUORESCITE were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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. 6.1 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. 6.2 Gastrointestinal Reactions Nausea, vomiting, and gastrointestinal distress are common adverse events. A strong taste may develop after injection. Diarrhea has also been reported. 6.3 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) ]. 6.4 Cardiopulmonary Reactions Cardiac arrest, basilar artery…

FLUORESCITE ® Injection 10% is contraindicated in patients with known hypersensitivity to fluorescein or any other ingredients in this product (4.1) 4.1 Hypersensitivity FLUORESCITE ® Injection 10% is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported. [see Warnings and Precautions (5.1) and Adverse Reactions ( 6.3 , 6.4 )]. Fluorescein sodium can induce serious intolerance reactions. These reactions of intolerance are always unpredictable but they are more frequent in patients who have previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and vomiting) or in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis. Detailed questioning of each patient is recommended before the angiography to evaluate any prior history of allergy.