Fluorescein
Hf Acquisition Co Llc, Dba Healthfirst
Human Prescription Drug
NDC 51662-1533Fluorescein is a human prescription drug labeled by 'Hf Acquisition Co Llc, Dba Healthfirst'. National Drug Code (NDC) number for Fluorescein is 51662-1533. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Fluorescein drug includes Fluorescein Sodium - 100 mg/mL . The currest status of Fluorescein drug is Active.
Drug Information:
| Drug NDC: | 51662-1533 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Fluorescein |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Fluorescein |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hf Acquisition Co Llc, Dba Healthfirst |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | FLUORESCEIN SODIUM - 100 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 10 May, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA022186 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | HF Acquisition Co LLC, DBA HealthFirst
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | 93X55PE38X
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Diagnostic Dye [EPC]
Dyes [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51662-1533-3 | 12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE | 10 May, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Fluorescein fluorescein fluorescein sodium fluorescein hydrochloric acid water sodium hydroxide
Indications and Usage:
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.
Warnings and Cautions:
5. warnings and precautions 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 severa
Read more...l 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) ].
Dosage and Administration:
2. dosage & administration 2.1 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. 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. 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 fro
Read more...m 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 Strength:
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.
Contraindications:
4. contraindications 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) ].
Adverse Reactions:
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 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 ] 6.5 neurologic reactions headache may occur. convulsions may rarely occur following inje
Read more...ction. 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 Population:
8. use in specific populations 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.
Description:
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 = 376.27 ak-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. structure
Clinical Pharmacology:
12. clinical pharmacology 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. 12.3 pharmacokinetics distribution. 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 administ
Read more...ration 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.
Nonclinical Toxicology:
13. nonclinical toxicology 13.1 carcinogenesis, mutagenesis, impairment of fertility there have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.
How Supplied:
16. how supplied is supplied in the following dosage forms. ndc 51662-1533-2 ak-fluor® 10% fluorescein injection, usp 100mg/ml 5ml vial ndc 51662-1533-3 ak-fluor® 10% fluorescein injection, usp 100mg/ml 5ml vial (box of 12) hf acquisition co llc, dba healthfirst mukilteo, wa 98275 also supplied in the following manufacture supplied dosage forms: 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
Read more... 25°c (68° to 77°f). do not freeze.
Package Label Principal Display Panel:
Principal display panel - 51662-1533 vial label 51662-1533-2 pouch label 51662-1533-3 serialized box label 51662-1533-3 box label vial pouch label serialized label box label