NDC 0023-0316 Fml

Fluorometholone

NDC Product Code 0023-0316

NDC 0023-0316-04

Package Description: 1 TUBE in 1 CARTON > 3.5 g in 1 TUBE

NDC Product Information

Fml with NDC 0023-0316 is a a human prescription drug product labeled by Allergan, Inc.. The generic name of Fml is fluorometholone. The product's dosage form is ointment and is administered via ophthalmic form.

Labeler Name: Allergan, Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Fml 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.

  • FLUOROMETHOLONE 1 mg/g

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.

  • PHENYLMERCURIC ACETATE (UNII: OSX88361UX)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Administration Route(s)

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

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

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

  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Corticosteroid Hormone Receptor Agonists - [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: Allergan, Inc.
Labeler Code: 0023
FDA Application Number: NDA017760 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: 12-09-1985 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: 12-31-2019 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 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. Values = ‘Y’ or ‘N’.

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Information for Patients

Sulfacetamide Ophthalmic

Sulfacetamide Ophthalmic is pronounced as (sul fa see' ta mide)

Why is sulfacetamide ophthalmic medication prescribed?
Ophthalmic sulfacetamide stops the growth of bacteria that cause certain eye infections. It is used to treat eye infections and to prevent them after injuries....
[Read More]

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Fml 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

Other

Sterile

Description

FML® (fluorometholone ophthalmic ointment) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Chemical Name

Fluorometholone: 9-Fluoro-11β,
17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione Structural FormulaContainsActive:
fluorometholone 0.1%. Preservative: phenylmercuric acetate (0.0008%). Inactives: mineral oil;
petrolatum (and) lanolin alcohol; and white
petrolatum.

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 A2 inhibitory
proteins, collectively called lipocortins. It is postulated that these
proteins control the biosynthesis of potent mediators of inflammation
such as prostaglandins and Ieukotrienes by inhibiting the release of
their common precursor, arachidonic acid. Arachidonic acid is released
from membrane phospholipids by phospholipase A2.Corticosteroids are capable of producing a rise in intraocular
pressure. In clinical studies of documented steroid-responders,
fluorometholone 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.

Indications And Usage

FML® ointment is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Contraindications

FML® ointment 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® ointment is also
contraindicated in individuals with known or suspected hypersensitivity
to any of the ingredients of this preparation and to other
corticosteroids.

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 frequently.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

The initial prescription and renewal of the medication
order beyond 8 grams of FML® ointment 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).Ophthalmic ointments may retard corneal
healing.

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 tube
tip to eyelids or to any other surface. The use of this tube by
more than one person may spread infection. Keep tube tightly
closed when not in use. Keep out of the reach of
children.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

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

Teratogenic Effects

Teratogenic effects. Pregnancy Category CFluorometholone 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

It is not known whether topical ophthalmic administration
of corticosteroids could result in sufficient systemic
absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk
and could suppress growth, interfere with endogenous
corticosteroid production, or cause other untoward effects.
Because of the potential for serious adverse reactions in
nursing infants from fluorometholone, a decision should be made
whether to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the
mother.

Pediatric Use

Safety and effectiveness in infants below the age of two years have not been established.

Geriatric Use

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

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 invasion should be considered in
any persistent corneal ulceration where steroid treatment has been used
(see WARNINGS).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; ocular irritation; rash; taste perversion; visual disturbance (blurry vision); and visual field defect.

Dosage And Administration

A small amount (approximately 1/2 inch ribbon) of ointment should be applied to the conjunctival sac one to three 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® ointment 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.

How Supplied

FML® (fluorometholone ophthalmic ointment) 0.1% is supplied in a collapsible aluminum tube with a black low density polyethylene screw cap in the following size: 3.5 g in 3.5 g tube – NDC 0023-0316-04

Storage And Handling

Storage: Store at 15°-25°C (59°-77°F). Avoid exposure to temperatures above 40°C (104°F).Revised: 02/2013© 2013 Allergan, Inc.Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Made in the U.S.A.71091US13

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