Ak-fluor

fluorescein · Injection · Intravenous

Uses

1 INDICATIONS AND USAGE 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. ( 1 )

Dosage and administration

The normal adult dose of AK-FLUOR ® 10% is 5 mL (500 mg) via intravenous administration. ( 2.1 ) For children, the dose should be calculated on the basis of 35 mg for each 4.54 kg of body weight. (7.7 mg/kg body weight) ( 2.1 ) Do not mix or dilute with other solutions or drugs. ( 2.2 ) 2.1 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. 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. Discard unused portion. 2.3 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

Injection: 10% (500 mg/ 5 mL) (100 mg/mL) of fluorescein sodium as a dark reddish orange, clear solution in a single-dose vial. 25% (500 mg/2 mL) (250 mg/mL) of fluorescein sodium as a dark reddish orange, clear solution in a single-dose vial (this strength is currently not being marketed). Injection ( 3 ): 10% (500 mg/5 mL) (100 mg/mL) of fluorescein sodium in a single-dose vial 25% (500 mg/2 mL) (250 mg/mL) of fluorescein sodium in a single-dose vial (this strength is currently not being marketed)

Contraindications

Hypersensitivity to any component of this product. ( 4.1 ) 4.1 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 [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )].

Warnings and precautions

Respiratory reactions ( 5.1 ) Severe local tissue damage ( 5.2 ) 5.1 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. 5.2 Severe local tissue damage Extravasation during injection can result in severe local tissue damage due to 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. [see Administration ( 2.3 ) and Adverse Reactions ( 6.6 ) ].

Side effects

The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Long Grove Pharmaceuticals, LLC at 1-855-642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 ) 6.1 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. 6.2 Gastrointestinal Reaction The next most common adverse reaction is nausea. Vomiting, and gastrointestinal distress have also occurred. A strong taste may develop after injection. 6.3 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 ) ] 6.4 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 ) ] 6.5 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. [see Administration ( 2.3 ) and Warnings and Precautions ( 5.2 ) ].

Use in specific populations

Caution should be exercised when fluorescein sodium is administered to a nursing woman. ( 8.3 ) 8.1 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. 8.3 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. 8.4 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. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Pregnancy

8.1 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

8.4 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

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

Description

(fluorescein injection) contains fluorescein sodium, a diagnostic aid, in a sterile solution for use intravenously. It is a dark reddish orange clear solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'- dihydroxy, disodium salt. Its molecular weight is 376.27. The active ingredient is represented by the chemical structure: AK-FLUOR (500 mg/5 mL) (100 mg/mL) 10% contains: Active ingredient: fluorescein sodium (10 % w/v, 100 mg/mL), equivalent to 88.3 mg/ml of fluorescein Inactive ingredients: sodium hydroxide and/or hydrochloric acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. AK-FLUOR 25% (500 mg/2 mL) (250 mg/mL) contains (this strength is currently not being marketed): Active ingredient: fluorescein sodium (25% w/v, 250 mg/mL), equivalent to 220.8 mg/ml of fluorescein Inactive ingredients: sodium hydroxide and/or hydrochloric acid may be used to adjust pH (8.3 to 9.8), and Water for Injection. Chemical Structure

Mechanism of action

12.1 Mechanism of Action Fluorescein sodium responds to electromagnetic radiation and light between the wavelengths of 465 to 490 nm and fluoresces, i.e., emits light at wavelengths of 520 to 530 nm. Thus, the hydrocarbon is excited by blue light and emits light that appears yellowish green. Following intravenous injection of fluorescein sodium in an aqueous solution, the unbound fraction of the fluorescein can be excited with a blue light flash from a fundus camera as it circulates through the ocular vasculature, and the yellowish green fluorescence of the dye is captured by the camera. In the fundus, the fluorescence of the dye demarcates the retinal and/or choroidal vasculature under observation, distinguishing it from adjacent areas/structures.

How supplied

10% (fluorescein injection) 500 mg/5 mL (100mg/mL) of fluorescein sodium is a dark reddish orange, clear solution in a single-dose vial. (NDC 81298-8660-3) 5 mL, single dose vials in a package of 12. AK-FLUOR (fluorescein injection) 25%, 500 mg/2 mL (250 mg/mL) of fluorescein sodium is a dark reddish orange, clear solution in a single-dose vial. This strength is currently not being marketed. Store AK-FLUOR at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Do not freeze. Discard unused portion.

Patient information

After administration of fluorescein sodium, 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. [see Warnings and Precautions ( 6.1 ) ]. Rx only Manufactured for: Long Grove Pharmaceuticals, LLC Rosemont, IL 60018 Made in India Rev. 02/26

Label text from the FDA structured product label by Long Grove Pharmaceuticals, LLC (revised Feb 26, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Fluorescein Sodium in 1 product

Ak-fluor NDC products (1)

NDC	Strength & form	Labeler	Type
81298-8660	Fluorescein Sodium 100 mg/mL Injection	Long Grove Pharmaceuticals, LLC	NDA

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Ak-fluor is listed by 1 labeler in the FDA NDC directory, including Long Grove Pharmaceuticals, LLC.