Ak Fluor Drug Information

AK-FLUOR ® 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. AK-FLUOR is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

Dosing Adult Dose

The recommended dosage of AK-FLUOR ® 10% (100 mg/mL) is 500 mg via intravenous administration. Pediatric Dose For children, the dose is 7.7 mg/kg (actual body weight) up to a maximum of 500 mg, via intravenous infusion calculated on the basis of 35 mg for each 4.54 kg of body weight.

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. Discard unused portion.

Administration Inject the dose (over 5-10 seconds is normally recommended) into the

antecubital vein, after taking precautions to avoid extravasation. A syringe, filled with AK-FLUOR ®, 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 500 mg to 200 mg of AK-FLUOR ® 10% may be appropriate in cases when a highly sensitive imaging system e.g., scanning laser ophthalmoscope is used.

Skin and urine discoloration

The most common reaction is discoloration of the skin and urine. 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.

Gastrointestinal Reaction

The next most common adverse reaction is nausea. Vomiting, and gastrointestinal distress have also occurred. 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.

Cardiopulmonary Reactions Syncope and hypotension may occur. Cardiac arrest, basilar artery ischemia

severe shock and death may occur rarely.

Neurologic Reactions Headache may occur. Convulsions may rarely occur following injection. 6.6

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..

Pregnancy Pregnancy Category C. Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.

Pediatric Use Pediatric patients have been included in clinical studies. No overall differences in safety or effectiveness have been observed between pediatric and adult patients.

Hypersensitivity AK-FLUOR 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.