Fml-s

• Allergan, Inc.

• Cheshire Pharm. Systems

• Compumed Pharmaceuticals, Inc.

Fml-s is part of the drug class:

• Antihemorrhoidal Corticosteroids

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fml-s, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Fml-s, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• are allergic to 'sulfa' drugs or corticosteroids
• are allergic to Fml-s or to any of its ingredients
• have or recently have had any fungal, viral, or bacterial infections
• have recently taken antibiotics for any reason
• have mustard gas keratitis or Sjögren's keratoconjunctivitis

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Store at 15°C - 30°C (59° -86°F).
• Protect from freezing and light.
• Shake well before using.
• Do not use if Fml-s is dark brown.
• Keep out of the reach of children.

Corticosteroids suppress the inflammatory response to a variety of agents and they 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. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

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.

The anti-infective component in FML-S® ophthalmic suspension is included to provide action against specific organisms susceptible to it. Sulfacetamide sodium is active in vitro 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.

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.

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.

Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following local use of steroids.

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 applications 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.