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Basic Drug Info
Drug Name:FML-S
Manufacturer:Allergan, Inc.
Other Info:

Contains: Actives: fluorometholone 0.1%; and sulfacetamide sodium 10%.

Preservative: benzalkonium chloride 0.006%.

Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol (1.4%); povidone; purified water; sodium chloride; sodium phosphate dibasic; sodium phosphate, monobasic; sodium thiosulfate; and hydrochloric acid and/or sodium hydroxide to adjust the pH to 7.0 to 7.5.



Clinical Trials:


Indications and Usage

FML-S® ophthalmic suspension 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.This product does not provide adequate coverage against Neisseria species and Serratia marcescens.

A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
Corneal Diseases -- Diseases of the cornea.

Infective conjunctivitis --

Edema -- Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.

Inflammation -- A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.

Superficial Infection --

Eye Infections -- Infection, moderate to severe, caused by bacteria, fungi, or viruses, which occurs either on the external surface of the eye or intraocularly with probable inflammation, visual impairment, or blindness.

Contraindications

FML-S® ophthalmic 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® ophthalmic 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.
Virus Diseases -- A general term for diseases produced by viruses.

Corneal Diseases -- Diseases of the cornea.

Dendritic keratitis -- A form of herpetic keratitis characterized by the formation of small vesicles which break down and coalesce to form recurring dendritic ulcers, characteristically irregular, linear, branching, and ending in knoblike extremities. (Dictionary of Visual Science, 3d ed)

Vaccinia -- The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.

Chickenpox -- A highly contagious infectious disease caused by the varicella-zoster virus (HERPESVIRUS 3, HUMAN). It usually affects children, is spread by direct contact or respiratory route via droplet nuclei, and is characterized by the appearance on the skin and mucous membranes of successive crops of typical pruritic vesicular lesions that are easily broken and become scabbed. Chickenpox is relatively benign in children, but may be complicated by pneumonia and encephalitis in adults. (From Dorland, 27th ed)

Mycobacterium Infections -- Infections with bacteria of the genus MYCOBACTERIUM.

Mycoses -- disease caused by a fungus.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Prolonged use of corticosteroids may result 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.FML-S® ophthalmic suspension is not for injection.

It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.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.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.