AK-Fluor

Name: AK-Fluor

Indications

Indicated in diagnostic fluorescein angiography or angioscopy of the fundus and of the iris vasculature.

Side effects

Nausea and headache, gastrointestinal distress, syncope, vomiting, hypotension, and other symptoms and signs of hypersensitivity have occurred. Cardiac arrest, basilar artery ischemia, severe shock, convulsions, and thrombophlebitis at the injection site and rare cases of death have 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 WARNINGS.) Generalized hives and itching, bronchospasm and anaphylaxis have been reported. A strong taste may develop after injection.

The most common reaction is nausea.

Warnings

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: sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When significant extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissues and to relieve pain should be implemented. Do not mix or dilute with other solutions or drugs in syringe. Flush intravenous cannulas before and after drugs are injected to avoid physical incompatibility reactions. Rare cases of death due to anaphylaxis have been reported (See PRECAUTIONS).

Proper Use of fluorescein

This section provides information on the proper use of a number of products that contain fluorescein. It may not be specific to AK-Fluor. Please read with care.

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Precautions While Using AK-Fluor

Your doctor will check your progress closely while you or your child is receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it and to check for unwanted effects.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Tell your doctor right away if you or your child has redness, swelling, or peeling of the skin, or severe pain or loss of feeling in the arm for several hours after receiving this medicine.

Tell your doctor if you or your child has nausea, vomiting, diarrhea, or stomach pain after receiving this medicine.

You or your child may notice a strong taste in your mouth after this medicine is injected. Your skin may have a yellowish discoloration for about 6 to 12 hours after your test. Your urine may appear bright yellow for up to 36 hours after your test.

AK-FLUOR 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.

Adverse Reactions

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. [see Contraindications (4.1) and Warnings and Precautions (5.1)]

Cardiopulmonary Reactions

Syncope and hypotension may occur. Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely. [see Warnings and Precautions (5.1)]

Neurologic Reactions

Headache may occur. Convulsions 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)].

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.

Administrative Information

LactMed Record Number

537

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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