FLAREX- fluorometholone acetate suspension/ drops 
Eyevance Pharmaceuticals

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FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1%

Sterile

DESCRIPTION

FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1% is a corticosteroid prepared as a sterile topical ophthalmic suspension. The active ingredient, fluorometholone acetate, is a white to creamy white powder with an empirical formula of C 24H 31FO 5 and a molecular weight of 418.5. Its chemical name is 9-fluoro-11β, 17-dihydroxy-6α-methylpregna-1, 4-diene-3, 20-dione 17-acetate. The chemical structure of Fluorometholone Acetate is presented below:

Chemical Structure

Each mL of FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% contains: Active: fluorometholone acetate 1 mg (0.1%). Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, monobasic sodium phosphate, edetate disodium, hydroxyethyl cellulose, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water. The pH of the suspension is approximately 7.3, with an osmolality of approximately 300 mOsm/kg.

CLINICAL PHARMACOLOGY

Corticosteroids suppress the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced. Corticosteroids cause a rise in intraocular pressure (IOP) in susceptible individuals. In a small study, FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% demonstrated a significantly longer average time to produce a rise in IOP than did dexamethasone phosphate; however, the ultimate magnitude of the rise was equivalent for both drugs and in a small percentage of individuals a significant rise in IOP occurred within three days.

INDICATIONS AND USAGE

FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

CONTRAINDICATIONS

Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.

WARNINGS

FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION. Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. If these products are used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients.

PRECAUTIONS

General

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.

Prescription Guidelines

The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation.

Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the suspension. The preservative in FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% but may be reinserted 15 minutes after instillation.

Patients should be advised that their vision may be temporarily blurred following dosing with FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1%. Care should be exercised in operating machinery or driving a motor vehicle.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

Pregnancy

Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

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

ADVERSE REACTIONS

Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

Postmarketing Experience

The following reaction has been identified during post-marketing use of FLAREX ® (fluorometholone acetate ophthalmic suspension) 0.1% in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes: dysgeusia.

The following rare adverse reactions have been reported: Cushing's syndrome and adrenal suppression may occur after very frequent use of topical ophthalmic corticosteroids, particularly in very young children.

DOSAGE AND ADMINISTRATION

Shake Well Before Using. One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely.

Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation [see PRECAUTIONS] .

HOW SUPPLIED

FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is supplied in white low density polyethylene (LDPE) bottles, with natural LDPE dispensing plugs and pink polypropylene closures. The product is supplied as 5 mL in an 8 mL bottle.

5 mL:NDC 71776-100-05

STORAGE

Store upright between 2°C to 25°C (36°F to 77°F). After opening, FLAREX can be used until the expiration date on the bottle.

Protect from freezing.

Manufactured for:
Eyevance Pharmaceuticals, LLC
Fort Worth, TX 76102 USA
Revised: 7/2022

PRINCIPAL DISPLAY PANEL - 2.5 mL Bottle Carton

2.5 mLSample - Not for Sale

eyevance ®

pharmaceuticals

Flarex ®

(fluorometholone

acetate

ophthalmic

suspension) 0.1 %

FOR TOPICAL OPHTHALMIC

USE

2.5mL

Sterile

PRINCIPAL DISPLAY PANEL - 2.5 mL Bottle Carton

PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton

5 mLeyevance

pharmaceuticals

Flarex ®

(fluorometholone

acetate

ophthalmic

suspension) 0.1 %

FOR TOPICAL OPHTHALMIC

USE

5 mL

Sterile

PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton

FLAREX 
fluorometholone acetate suspension/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71776-100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUOROMETHOLONE ACETATE (UNII: 9I50C3I3OK) (FLUOROMETHOLONE - UNII:SV0CSG527L) FLUOROMETHOLONE ACETATE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
TYLOXAPOL (UNII: Y27PUL9H56)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71776-100-051 in 1 CARTON03/05/2019
15 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:71776-100-031 in 1 CARTON01/01/2022
22.5 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01907903/05/2019
Labeler - Eyevance Pharmaceuticals (080876046)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research LLC007672236manufacture(71776-100)
Establishment
NameAddressID/FEIBusiness Operations
Sicor Societa' Italiana Corticosteroidi s.r.l429369713api manufacture(71776-100)

Revised: 10/2023
Document Id: 0760a31d-934e-56a0-e063-6294a90acb70
Set id: 19918ea5-8568-44d6-b8ee-7b2197cee85c
Version: 6
Effective Time: 20231010
 
Eyevance Pharmaceuticals