Description: FML-S® LIQUIFILM sterile ophthalmic suspension is a topical anti-inflammatory/anti-infective combination product for ophthalmic use.
Chemical Names: Fluorometholone: 9-Fluoro-11(beta), 17-dihydroxy-6(alpha)-methylpregna-1,4-diene-3, 20-dione.
Sulfacetamide sodium: N-Sulfanilylacetamide monosodium salt monohydrate.
Contains: Actives: fluorometholone 0.1%, sulfacetamide sodium 10%. Preservative: benzalkonium chloride (0.006%). Inactives: Liquifilm® (polyvinyl alcohol) 1.4%; edetate disodium; polysorbate 80; povidone; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust the pH; and purified water.
Clinical Pharmacology: Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Corticosteroids and their derivatives are capable of producing a rise in intraocular pressure. Since corticosteroids may inhibit the body' defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
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.
The anti-infective component in FML-S® is included to provide action against specific organisms susceptible to it. Sulfacetamide sodium is active invitro against susceptible strains of the following microorganisms: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Some strains of these bacteria may be resistant to sulfacetamide or resistant strains may emerge in vivo.
When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.
The relative potency of corticosteroid formulations depends on the molecular structure, concentration, and release from the vehicle.
Indications and Usage: FML-S® is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The anti-infective drug in this product, sulfacetamide, is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species
The product does not provide adequate coverage against: Neisseria species and Serratia marcescens. A significant percentage of Staphylococcal isolates are completely resistant to sulfa drugs.
Contraindications: FML-S® 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-S® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to sulfonamides and to other corticosteroids.
Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. If used for longer than 10 days, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Prolonged use of steroids may suppress the host immune response in ocular tissues 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. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye.
Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.
FATALITIES HAVE OCCURRED, ALTHOUGH RARELY, DUE TO SEVERE REACTIONS TO SULFONAMIDES INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA, AND OTHER BLOOD DYSCRASIAS. Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue use of this preparation (see Adverse Reactions ).
Cross-sensitivity among corticosteroids has been demonstrated.
A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
General: The initial prescription and renewal of the medication order beyond 20 milliliters should be made only by a physician after evaluation of the patient' intraocular pressure, examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
Keep this and all drugs out of the reach of children.
Drug Interactions: Sulfacetamide preparations are incompatible with silver preparations.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone or sulfacetamide.
Pregnancy: Pregnancy Category C: Animal studies have not been conducted with FML-S® Liquifilm Ophthalmic Suspension. Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human dose. Fluorometholone was applied ocularly to rabbits daily on days 8-18 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. Kernicterus may be precipitated in infants by sulfonamides being given systemically during the third trimester of pregnancy. There are no adequate and well-controlled studies of FML-S® Liquifilm Ophthalmic Suspension in pregnant women, and it is not known whether FML-S® can cause fetal harm when administered to a pregnant woman. FML-S® Liquifilm Ophthalmic Suspension 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 administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for serious adverse reactions in nursing infants from FML-S, a decision should be made whether to discontinue nursing or to discontinue the medication.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Adverse Reactions: Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.
Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see Warnings ). Sulfacetamide sodium may cause local irritation.
The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
Secondary Infection: The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term application of corticosteroids. When signs of chronic ocular inflammation persist following prolonged corticosteroid dosing, the possibility of fungal infections of the cornea should be considered.
Secondary bacterial ocular infection following suppression of host responses also occurs.
Dosage and Administration: One drop of FML-S® should be instilled into the conjunctival sac four times daily. Care should be taken not to discontinue therapy prematurely.
Not more than 20 milliliters should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in Precautions above.
How Supplied: FML-S® (fluorometholone, sulfacetamide sodium) Liquifilm® Sterile Ophthalmic Suspension is supplied in plastic dropper bottles in the following sizes:
5 mL--NDC 11980-422-05
10 mL--NDC 11980-422-10
Note: Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing and light. SHAKE WELL BEFORE USING. Do not use suspension if it is dark brown.
Rx only