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AK-Fluor (Fluorescein Sodium) - Indications and Dosage

 
 



INDICATIONS AND USAGE

AK-FLUOR® 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

DOSAGE AND ADMINISTRATION

Dosing

Adult Dose

The recommended dosage of AK-FLUOR® 10% (100 mg/mL) and of 25% (250 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 10 lbs. (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.

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.

DOSAGE FORMS AND STRENGTHS

AK-FLUOR® (fluorescein injection, USP) 10%, 100 mg/mL in a 5 mL single use vial.

AK-FLUOR® (fluorescein injection, USP) 25%, 250 mg/mL in a 2 mL single use vial.

HOW SUPPLIED/STORAGE AND HANDLING

AK-FLUOR® (fluorescein injection, USP) 10% is supplied in a single-use 5 mL glass vial with a gray bromobutyl serum siliconized stopper and orange flip-off cap. It contains a sterile dark reddish orange solution of fluorescein sodium.

(NDC 17478-253-10) 5 mL, single dose vials in a package of 12.

AK-FLUOR® (fluorescein injection, USP) 25% is supplied in a single-use 2 mL glass vial with a gray bromobutyl serum siliconized stopper and orange flip-off cap. It contains a sterile dark reddish orange solution of fluorescein sodium.

(NDC 17478-250-20) 2 mL, single dose vials in a package of 12.

AK-FLUOR® should be stored at 20° to 25°C (68° to 77°F). Do not freeze.

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