Fml

Fluorometholone

Allergan, Inc.
Human Prescription Drug
NDC 11980-211

Fml also known as Fluorometholone is a human prescription drug labeled by 'Allergan, Inc.'. National Drug Code (NDC) number for Fml is 11980-211. This drug is available in dosage form of Suspension/ Drops. The names of the active, medicinal ingredients in Fml drug includes Fluorometholone - 1 mg/mL . The currest status of Fml drug is Active.

Drug Information:

Drug NDC:	11980-211
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:	Fml
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:	Fluorometholone
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Allergan, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Suspension/ Drops
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:	FLUOROMETHOLONE - 1 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	OPHTHALMIC
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:	01 Feb, 1972
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	17 Dec, 2025
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:	NDA016851
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:	Allergan, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	310377 545243
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175576 N0000175450
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	SV0CSG527L
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 MOA:	Corticosteroid Hormone Receptor Agonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Corticosteroid [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:	Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC]
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
11980-211-05	1 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPER	01 Feb, 1972	N/A	No
11980-211-10	1 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 10 mL in 1 BOTTLE, DROPPER	01 Feb, 1972	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.

Other medicines with the same generic name

Fml

Fluorometholone

Suspension/ Drops
Allergan, Inc.
NDC: 11980-211

Fluorometholone

Solution/ Drops
Pacific Pharma, Inc.
NDC: 60758-880

Fml Forte

Fluorometholone

Suspension/ Drops
Allergan, Inc.
NDC: 11980-228

Product Elements:

Fml fluorometholone fluorometholone fluorometholone benzalkonium chloride edetate disodium polysorbate 80 polyvinyl alcohol, unspecified water sodium chloride sodium phosphate, dibasic, unspecified form sodium phosphate, monobasic, unspecified form sodium hydroxide

Indications and Usage:

Indications and usage fml suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Warnings:

Warnings prolonged use of corticosteroids may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. if this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. steroids should be used with caution in the presence of glaucoma. intraocular pressure should be checked frequ Read more...

ently. the use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

General Precautions:

General the initial prescription and renewal of the medication order beyond 20 milliliters of fml suspension 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 two days, the patient should be re-evaluated. as fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. fungal cultures should be taken when appropriate. if this product is used for 10 days or longer, intraocular pressure should be monitored (see warnings ).

Dosage and Administration:

Dosage and administration shake well before using. instill one drop into the conjunctival sac two to four times daily. during the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. care should be taken not to discontinue therapy prematurely. if signs and symptoms fail to improve after two days, the patient should be re-evaluated (see precautions ). the dosing of fml suspension may be reduced, but care should be taken not to discontinue therapy prematurely. in chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

Contraindications:

Contraindications fml suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye, and fungal diseases of ocular structures. fml suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Adverse Reactions:

Adverse reactions adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (iop) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical dermatologic steroids applied to the skin. corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. the development of secondary ocular infection (bacterial, fungal and viral) has occurred. fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. the possibility of fungal invasi Read more...

on should be considered in any persistent corneal ulceration where steroid treatment has been used (see warnings ). transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of fml suspension. other adverse events reported with the use of fluorometholone include: allergic reactions; foreign body sensation; erythema of eyelid; eyelid edema/eye swelling; eye discharge; eye pain; eye pruritus; lacrimation increased; rash; taste perversion; visual disturbance (blurry vision); and visual field defect.

Use in Pregnancy:

Pregnancy teratogenic effects 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.

Pediatric Use:

Pediatric use safety and effectiveness in infants below the age of two years have not been established.

Geriatric Use:

Geriatric use no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Description:

Description fml Â® (fluorometholone ophthalmic suspension, usp) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use. chemical name fluorometholone: 9-fluoro-11Î²,17-dihydroxy-6Î±-methylpregna-1,4-diene-3,20-dione. structural formula contains active: fluorometholone 0.1%. preservative: benzalkonium chloride 0.004%. inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust ph. fml suspension is formulated with a ph from 6.2 to 7.5. it has an osmolality range of 290-350 mosm/kg. the structural formula for fluorometholone is 9-fluoro-11Î²,17-dihydroxy-6Î±-methylpregna-1,4-diene-3,20-dione.

Clinical Pharmacology:

Clinical pharmacology corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. they inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. there is no generally accepted explanation for the mechanism of action of ocular corticosteroids. however, corticosteroids are thought to act by the induction of phospholipase a 2 inhibitory proteins, collectively called lipocortins. it is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. arachidonic acid is released from membrane phospholipids by phospholipase a 2 . corticosteroids are capable of producing a rise in intraocular pressure. in clinical studies of documented steroid-responders, fl Read more...

uorometholone demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small percentage of individuals, a significant rise in intraocular pressure occurred within one week. the ultimate magnitude of the rise was equivalent for both drugs.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, m utagenesis, i mpairment of f ertility no studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

How Supplied:

How supplied fml (fluorometholone ophthalmic suspension, usp) 0.1% is supplied sterile in opaque white ldpe plastic bottles with white high impact polystyrene (hips) caps as follows: 5 ml in 10 ml bottle ndc 11980-211-05 10 ml in 15 ml bottle ndc 11980-211-10 storage : store at 2Â°-25Â°c (36Â°-77Â°f); protect from freezing. store in an upright position. revised : 0 6 /2018 distributed by: allergan usa, inc. madison, nj 07940 Â© 2019 allergan. all rights reserved. all trademarks are the property of their respective owners. v1.0uspi211 allergan

Information for Patients:

Information for patients if inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician. this product is sterile when packaged. to prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. the use of this bottle by more than one person may spread infection. keep bottle tightly closed when not in use. keep out of the reach of children. the preservative in fml suspension, benzalkonium chloride, may be absorbed by soft contact lenses. patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling fml suspension to insert soft contact lenses.

Package Label Principal Display Panel:

Principal display panel ndc 11980-211-05 rx only fml Â® (fluorometholone ophthalmic suspension, usp) 0.1% sterile 5 ml principal display panel ndc 11980-211-05 rx only fmlÂ® (fluorometholone ophthalmic suspension, usp) 0.1% sterile 5 ml

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