Frequently Asked Questions

What is AK-Fluor®?

  • 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® 10% contains:

  • Actives: Fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL)
  • Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.

AK-FLUOR® 25% contains:

  • Actives: Fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL)
  • Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.

What are the features and benefits of AK-Fluor®?

  • AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid
  • Indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature
  • Meets strict USP quality standards
  • 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 [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]
  • Available direct or through your authorized wholesaler or distributor

What is the indication for AK-Fluor®?

Is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

How is AK-Fluor® dosed and administered?

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.

What are the ingredients of AK-Fluor®?

AK-FLUOR® 10% contains:

  • Actives: Fluorescein sodium (equivalent to fluorescein 10 % w/v, 100 mg/mL)
  • Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.

AK-FLUOR® 25% contains:

  • Actives: Fluorescein sodium (equivalent to fluorescein 25% w/v, 250 mg/mL)
  • Inactives: Sodium Hydroxide and/or Hydrochloric Acid may be used to adjust pH (8.3 to 9.8), and Water for Injection.

How is AK-Fluor® packaged?

  • 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® use in specific populations.

  • 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.
  • Nursing Mothers: Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.
  • 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.
  • Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

What important safety information should I know about AK-Fluor®?

  • Contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product.
  • In rare cases of death due to anaphylaxis have been reported.

What is the shelf life of AK-Fluor®?

  • AK-Fluor® has a 24-month shelf life

How should AK-Fluor® be stored?

  • Store at 20° to 25°C (68° to 77°F)
  • Do not freeze

Important Safety Information

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

WARNINGS AND PRECAUTIONS

Respiratory Reactions

Caution should be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should always be available.

If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.

Severe local tissue damage

Extravasation during injection can result in severe local tissue damage due to the high pH of fluorescein solution. 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 nerve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented.

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 Reactions

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.

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.

USE IN SPECIFIC POPULATIONS

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.

Nursing Mothers

Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.

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.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Please refer to the Full Prescribing Information for complete safety information.