FLUORESCEIN LITE  - d&c yellow no. 8 injection, solution 
Altaire Pharmaceuticals Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

DESCRIPTION

Fluorescein Injection is a sterile, aqueous solution for intravenous injection. Each 5mL vial contains: Fluorescein Sodium 500 mg (100 mg/mL) in Water for Injection. Each 2 mL vial contains: Fluorescein Sodium 500 mg (250 mg/mL) in Water for Injection. pH (range 8.0 -9.8) adjusted with Sodium Hydroxide and/or Hydrochloric Acid. Fluorescein sodium is the simplest of the fluorane dyes and is chemically related to the phenolphthalein dyes. The chemical name for fluorescein sodium is: Spiro [isobenzofuran -1(3H), 9'-[9H]xanthene]-3-one, 3'6'-dihydroxy, disodium salt; and the structural formula is:

Fluoresceinlite


Molecular Formula: C20H10Na2O5                                                             Molecular Weight 376.27

CLINICAL PHARMACOLOGY

Fluorescein sodium is a diagnostic dye that produces a yellow-green fluorescence which appears readily in the extracellular fluid and gains access only to viable cells. The fIuorescence distinguishes the area under observation from the adjacent areas.      After intravenous injection. the dye is rapidly distributed through the body. Fluorescence of the retinal vessels should occur within 12-30 seconds. The dye is excreted by the kidneys and appears in the urine. The urine attains a bright yellow color that fades in 24-36 hours. It is not known whether any of the dye is metabolized.

INDICATIONS AND USAGE

Fluorescein sodium is indicated for ophthalmic angiography and angioscopy in diagnostic examination of the fundus: in evaluation of the iris vasculature; to differentiate between viable and non-viable tissue; to assess aqueous flow; in differential diagnosis of malignant and non-malignant tumors; and in determination of circulation time and adequacy of the circulation.

CONTRAINDICATIONS

Hypersensitivity to fluorescein sodium or any of the components.

WARNINGS

Severe adverse reactions have been reported with the use of fluorescein sodium injection. These are cardiac arrest, acute myocardial infarction, basilar artery ischemia, severe shock and other signs and symptoms of hypersensitivity. convulsions. syncope. thrombophlebitis at the injection site, and transient dyspnea. See PRECAUTIONS.

PRECAUTIONS

General: Appropriate consideration of the cardiac status of the patient must be made before administration of the fluorescein sodium injection. Caution is to be exercised in patients with a history of hypersensitivity, allergies. or asthma.

In case of emergency, a tray including such items as 1: 1,000 epinephrine for intravenous or intramuscular use; an antihistamine, soluble steroid, aminophylline for IV use; and oxygen should always be available for possible reaction. to fluorescein sodium injection. 

This solution is supplied sterile in the unopened container and is intended for one-time use. Discard any unused solution.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No long-term animal studies have been performed to assess the carcinogenesis, mutagenesis or impairment of fertility due to fluorescein sodium.

Pregnancy:

Teratogenic Effects -Pregnancy Category C. 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 or can affect reproduction capacity. Fluorescein sodium should be given to a pregnant woman only if clearly needed.

Nursing mothers:

it is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when fluorescein sodium injection is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children have not been established.

ADVERSE REACTIONS

The following adverse reactions have been reported after use of fluorescein sodium injection: cardiac arrest, acute myocardial infarction, basilar artery ischemia, thrombophlebitis at the injection site, severe shock, and other signs and symptoms of hypersensitivity, convulsions, syncope, pyrexia, transient dyspnea, angioneurotic edema, moderate to marked nausea and headache, gastrointestinal distress, slight dizziness, urticaria and pruritus.  Rare cases of death have been reported.

The most common reaction is nausea, reported to occur in 1-15% of all patients.

Extravasation of the solution at the injection site causes intense pain at the site and dull, aching pain in the injection arm, These symptoms are self-limiting,

These reactions generally are noted soon after injection and may occur irrespective of previous exposure to the dye.

Localized eczematous dermatitis is reported rarely to have occurred one day after injection.

To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc. at (631) 722-5988 • 9am -5pm CST Monday -Friday.

DOSAGE AND ADMINISTRATION

In case of emergency, a tray including such items as 1; 1,000 epinephrine for intravenous or intramuscular use; an antihistamine, soluble steroid, aminophylline for IV use; and oxygen should always be available for possible reaction to fluorescein sodium injection.

FLUORESCEIN INJECTION 10% LITE STERILE

                  Adults: 5ml (500mg) injected rapidly into the antecubital vein.

                  Children: 0.035ml (3.5 mg) for each pound of body weight injected rapidly into the antecubital vein.

FLUORESCEIN INJECTION 25%  LITE STERILE 

                 Adults 2mL (500mg) (3mL=750mg) injected rapidly into the antecubital vein.


                Children: 0.02mL (5mg) for each pound of body weight, injected rapidly into the antecubital vein.

Fluorescence of the retinal vessels should occur within 12-30 seconds. Inject rapidly into the antecubital vein. The dye should appear in the central retinal artery in 9 to 15 seconds. This may be observed with standard viewing equipment

In patients with inaccessible veins where early phases of an angiogram are not necessary, such as cystoid macular edema, one gram of FLUORESCEIN INJECTION LITE has been administered orally. Ten to fifteen minutes is usually required before evidence of dye appears in the fundus.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit

HOW SUPPLIED


FLUORESCEIN INJECTION 10%  LITE                              100 mg/mL as follows:
                                       5 mL Single Dose Vials                    Boxes of 12 Vials

FLUORESCEIN INJECTION 25%  LITE                              250 mg/mL as follows:
                                        2 mL Single Dose Vials                   Boxes of 12 Vials


Rx only   Rev. 01/10   MG# 17018
Manufactured by:   ALTAIRE Pharmaceuticals Inc.  Aquebogue, NY 11931


Storage and Handling

Protect from light.  Store at room temperature 15 - 25 degree C  (59-77 degree F).   DO NOT PERMIT TO FREEZE   Discard unused portion.

12 x 2 mL Sterile SINGLE DOSE VIALS       NDC  59390-187-02   FLUORESCEIN LITE 25%  Fluorescein Injection 250 mg/mL   FOR INTRAVENOUS INJECTION ONLY  Rx only   REV 07/09

Product Outer Label

Fluoresceinlite 25


FLUORESCEIN LITE 
fluorescein sodium injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59390-187
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
D&C YELLOW NO. 8 (D&C YELLOW NO. 8) D&C YELLOW NO. 8250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:59390-187-0212 VIAL ( VIAL) in 1 BOXcontains a VIAL
12 mL in 1 VIALThis package is contained within the BOX (59390-187-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/200202/29/2012

Labeler - Altaire Pharmaceuticals Inc. (786790378)

Revised: 03/2012 Altaire Pharmaceuticals Inc.