NDC 51662-1533 Fluorescein

Fluorescein

NDC Product Code 51662-1533

NDC 51662-1533-3

Package Description: 12 POUCH in 1 BOX > 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) > 5 mL in 1 VIAL, SINGLE-DOSE

NDC Product Information

Fluorescein with NDC 51662-1533 is a a human prescription drug product labeled by Hf Acquisition Co Llc, Dba Healthfirst. The generic name of Fluorescein is fluorescein. The product's dosage form is injection and is administered via intravenous form.

Labeler Name: Hf Acquisition Co Llc, Dba Healthfirst

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Fluorescein Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • FLUORESCEIN SODIUM 100 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Diagnostic Dye - [EPC] (Established Pharmacologic Class)
  • Dyes - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Hf Acquisition Co Llc, Dba Healthfirst
Labeler Code: 51662
FDA Application Number: NDA022186 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-10-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Fluorescein Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Highlights Of Prescribing Information

These highlights do not include all the information needed to use AK-FLUOR® 10% and AK-FLUOR® 25% safely and effectively. See full prescribing information for the products in AK-FLUOR® 10% and AK-FLUOR® 25%.

AK-FLUOR® (fluorescein injection, USP) 10% and AK-FLUOR® (fluorescein injection, USP) 25%

Intravenous injection

Initial U.S. Approval: 1976
INDICATIONS AND USAGEAK-FLUOR® is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. (1)DOSAGE AND ADMINISTRATIONThe normal adult dose of AK-FLUOR® 10% is 5 mL (500 mg) and of AK-FLUOR® 25% is 2 mL (500 mg) via intravenous administration. (
2.1)

For children, the dose should be calculated on the basis of 35 mg for each ten pounds of body weight (7.7 mg/kg body weight). (
2.2)

Do not mix or dilute with other solutions or drugs. (
2.2)
DOSAGE FORMS AND STRENGTHSAK-FLUOR® (fluorescein injection, USP) 10%, 100 mg/mL in a 5 mL single dose vial (
3)

AK-FLUOR® (fluorescein injection, USP) 25%, 250 mg/mL in a 2 mL single dose vial (
3)
CONTRAINDICATIONSHypersensitivity to any component of this product. (
4.1)
WARNINGS AND PRECAUTIONSRespiratory reactions.(
5.1)

Severe local tissue damage. (
5.2)
ADVERSE REACTIONSThe most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress. (
6)
To report SUSPECTED ADVERSE REACTIONS, contact Akorn at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (
6)
USE IN SPECIFIC POPULATIONSCaution should be exercised when fluorescein sodium is administered to a nursing woman. (
8.3)
See 17 for PATIENT COUNSELING INFORMATION.Revised: 8/2019

Table Of Contents

FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION

2.1 Dosing

2.2 Preparation for Administration

2.3 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS

4.1 Hypersensitivity
5 WARNINGS AND PRECAUTIONS

5.1 Respiratory Reactions

5.2 Severe local tissue damage
6 ADVERSE REACTIONS

6.1 Skin and urine discoloration

6.2 Gastrointestinal Reaction

6.3 Hypersensitivity Reactions

6.4 Cardiopulmonary Reactions

6.5 Neurologic Reactions

6.6 Thrombophlebitis
8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*

Sections or subsections omitted from the full prescribing information are not listed.

1. Indications & 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.

2. Dosage & Administration

2.1 DosingAdult DoseThe recommended dosage of AK-FLUOR® 10% (100 mg/mL) and of 25% (250 mg/mL) is 500 mg via intravenous administration.Pediatric DoseFor 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.2.2 Preparation for AdministrationParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not mix or dilute with other solutions or drugs.2.3 AdministrationInject 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.

3. Dosage Forms & Strengths

AK-FLUOR® (fluorescein injection, USP) 10%, 100 mg/mL in a 5 mL single-dose vial.AK-FLUOR® (fluorescein injection, USP) 25%, 250 mg/mL in a 2 mL single-dose vial.

4. Contraindications

4.1 HypersensitivityAK-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)].

5. Warnings And Precautions

5.1 Respiratory ReactionsCaution 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 damageExtravasation 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)].

6. Adverse Reactions

WARNINGS AND PRECAUTIONS (5.1)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 ReactionThe next most common adverse reaction is nausea. Vomiting, and gastrointestinal distress have also occurred. A strong taste may develop after injection.6.3 Hypersensitivity ReactionsSymptoms 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 ReactionsSyncope and hypotension may occur. Cardiac arrest, basilar artery ischemia, severe shock and death may occur rarely. [see ]6.5 Neurologic ReactionsHeadache may occur. Convulsions may rarely occur following injection.6.6 ThrombophlebitisThrombophlebitis 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)].

8. Use In Specific Populations

8.1 PregnancyPregnancy 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 MothersFluorescein 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 UsePediatric 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 UseNo overall differences in safety or effectiveness have been observed between elderly and other adult patients.

11. Description

AK-FLUOR® (fluorescein injection, USP) is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%. Its chemical name is spiro[isobenzofuran-1 (3H),9'-[9H]xanthene]-3-one,3'6'-dihydroxy, disodium salt. The active ingredient is represented by the chemical structure:MW = 376.27AK-FLUOR® 10% contains:Active: 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:Active: 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.

12. Clinical Pharmacology

12.1 Mechanism of ActionFluorescein 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.12.3 PharmacokineticsDistribution.Within 7 to 14 seconds after IV administration into the antecubital vein, fluorescein usually appears in the central retinal artery of the eye. Within a few minutes of IV administration of fluorescein sodium, a yellowish discoloration of the skin occurs, which begins to fade 6 to 12 hours after dosing. Various estimates of volume of distribution indicate that fluorescein distributes into interstitial space (0.5 L/kg).Metabolism.Fluorescein is metabolized to fluorescein monoglucuronide. After IV administration of fluorescein sodium (14 mg/kg) to 7 healthy subjects, approximately 80% of fluorescein in plasma was converted to glucuronide conjugate after a period of 1 hour post dose.Excretion.Fluorescein and its metabolite are mainly eliminated via renal excretion. After IV administration, the urine remains slightly fluorescent for 24 to 36 hours. A renal clearance of 1.75 mL/min/kg and a hepatic clearance (due to conjugation) of 1.50 mL/min/kg have been estimated. The systemic clearance of fluorescein was essentially complete by 48 to 72 hours after administration of 500 mg fluorescein.

13. Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityThere have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.

16. How Supplied

AK-FLUOR® (fluorescein injection, USP) 10% is supplied in a single-dose 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-dose 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.

17. Patient Counseling 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 AND
ADVERSE REACTIONS (6.1)].

Other

Rx onlyAkornManufactured by:

Akorn Inc.

Lake Forest, IL 60045
FL00N Rev. 08/19

* Please review the disclaimer below.