blephamide

DESCRIPTION
BLEPHAMIDE® ophthalmic suspension is a topical anti-inflammatory/anti-infectivecombination product for ophthalmic use blephamide.

Chemical Names:
Sulfacetamide sodium: N-Sulfanilylacetamide monosodium salt monohydrate blephamide.

Prednisolone acetate: 11(beta), 17, 21-Trihydroxypregna-1, 4-diene-3, 20-dione21-acetate blephamide.

Contains:
Actives: sulfacetamide sodium 10%, prednisolone acetate (microfine suspension)0.2%: Preservative: benzalkonium chloride (0.004%): Inactives: polyvinyl alcohol1.4%; polysorbate 80; edetate disodium; sodium phosphate, dibasic; potassiumphosphate, monobasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxideto adjust the pH; and purified water blephamide.

CLINICAL PHARMACOLOGY
Corticosteroids suppress the inflammatory response to a variety of agents andthey probably delay or slow healing blephamide. Since corticosteroids may inhibit the body'sdefense mechanism against infection, a concomitant antibacterial drug may beused when this inhibition is considered to be clinically significant in a particularcase blephamide.

When a decision to administer both a corticosteroid and an antibacterial ismade, the administration of such drugs in combination has the advantage of greaterpatient compliance and convenience, with the added assurance that the appropriatedosage of both drugs is administered blephamide. When both types of drugs are in the sameformulation, compatibility of ingredients is assured and the correct volumeof drug is delivered and retained blephamide. The relative potency of corticosteroids dependson the molecular structure, concentration, and release from the vehicle blephamide.

Microbiology: Sulfacetamide sodium exerts a bacteriostatic effect against susceptiblebacteria by restricting the synthesis of folic acid required for growth throughcompetition with p-aminobenzoic acid blephamide.

Some strains of these bacteria may be resistant to sulfacetamide or resistantstrains may emerge in vivo blephamide.

The anti-infective component in these products is included to provide actionagainst specific organisms susceptible to it blephamide. Sulfacetamide sodium is activein vitro against susceptible strains of the following microorganisms: Escherichiacoli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridansgroup), Haemophilus influenzae, Klebsiella species, and Enterobacter species blephamide. This product does not provide adequate coverage against: Neisseria species,Pseudomonas species, and Serratia marcescens (see INDICATIONS AND USAGE ) blephamide.

INDICATIONS AND USAGE
A steroid/anti-infective combination is indicated for steroid-responsive inflammatoryocular conditions for which a corticosteroid is indicated and where superficialbacterial ocular infection or a risk of bacterial ocular infection exists blephamide.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebraland bulbar conjunctiva, cornea, and anterior segment of the globe where theinherent risk of corticosteroid use in certain infective conjunctivitides isaccepted to obtain a diminution in edema and inflammation blephamide. They are also indicatedin chronic anterior uveitis and corneal injury from chemical, radiation, orthermal burns or penetration of foreign bodies blephamide.

The use of a combination drug with an anti-infective component is indicatedwhere the risk of superficial ocular infection is high or where there is anexpectation that potentially dangerous numbers of bacteria will be present inthe eye blephamide.

The particular antibacterial drug in this product is active against the followingcommon bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcuspneumoniae, Streptococcus ( viridans group), Haemophilus influenzae, Klebsiellaspecies, and Enterobacter species blephamide. This product does not provide adequate coverageagainst Neisseria species, Pseudomonas species, and Serratia marcescens blephamide.

A significant percentage of staphlococcal isolates are completely resistantto sulfa drugs blephamide.

CONTRAINDICATIONS
BLEPHAMIDE® ophthalmic suspension is contraindicated in most viral diseasesof the cornea and conjunctiva including epithelial herpes simplex keratitis(dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infectionof the eye and fungal diseases of ocular structures blephamide.

This product is also contraindicated in individuals with known or suspectedhypersensitivity to any of the ingredients of this preparation, to other sulfonamidesand to other corticosteroids blephamide. See WARNINGS blephamide. (Hypersensitivity to the antimicrobialcomponent occurs at a higher rate than for other components.)

WARNINGS
NOT FOR INJECTION INTO THE EYE blephamide.

Prolonged use of corticosteroids may result in ocular hypertension/glaucomawith damage to the optic nerve, defects in visual acuity and fields of vision,and in posterior subcapsular cataract formation blephamide.

Acute anterior uveitis may occur in susceptible individuals, primarily Blacks blephamide.

Prolonged use of BLEPHAMIDE® ophthalmic suspension may suppress the hostresponse and thus increase the hazard of secondary ocular infections blephamide. In thosediseases causing thinning of the cornea or sclera, perforation has been knownto occur with the use of topical corticosteroids blephamide. In acute purulent conditionsof the eye, corticosteroids may mask infection or enhance existing infection blephamide.

If the product is used for 10 days or longer, intraocular pressure should beroutinely monitored even though it may be difficult in children and uncooperativepatients blephamide. Corticosteroids should be used with caution in the presence of glaucoma blephamide. Intraocular pressure should be checked frequently blephamide.

A significant percentage of staphylococcal isolates are completely resistantto sulfonamides blephamide.

The use of steroids after cataract surgery may delay healing and increase theincidence of filtering blebs blephamide.

The use of ocular corticosteroids may prolong the course and may exacerbatethe severity of many viral infections of the eye (including herpes simplex) blephamide. Employment of corticosteroid medication in the treatment of herpes simplex requiresgreat caution blephamide.

Topical steroids are not effective in mustard gas keratitis and Sjogren's keratoconjunctivitis blephamide.

Fatalities have occurred, although rarely, due to severe reactions to sulfonamidesincluding Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepaticnecrosis, agranulocytosis, aplastic anemia and other blood dyscrasias blephamide. Sensitizationmay recur when a sulfonamide is readministered, irrespective of the route ofadministration blephamide.

If signs of hypersensitivity or other serious reactions occur, discontinueuse of this preparation blephamide. Cross-sensitivity among corticosteroids has been demonstrated(see ADVERSE REACTIONS ) blephamide.

PRECAUTIONS
General: The initial prescription and renewal of the medication order beyond20 milliliters of the suspension should be made by a physician only after examinationof the patient with the aid of magnification, such as slit lamp biomicroscopyand, where appropriate, fluorescein staining blephamide. If signs and symptoms fail toimprove after two days, the patient should be re-evaluated blephamide.

The possibility of fungal infections of the cornea should be considered afterprolonged corticosteroid dosing blephamide. Use with caution in patients with severe dryeye blephamide. Fungal cultures should be taken when appropriate blephamide.

The p-amino benzoic acid present in purulent exudates competes with sulfonamidesand can reduce their effectiveness blephamide.

Information for Patients: If inflammation or pain persists longer than 48 hoursor becomes aggravated, the patient should be advised to discontinue use of themedication and consult a physician (see WARNINGS ) blephamide. Contact lenses should notbe worn during the use of this product blephamide.

This product is sterile when packaged blephamide. To prevent contamination, care shouldbe taken to avoid touching the applicator tip to eyelids or to any other surface blephamide. The use of this bottle by more than one person may spread infection blephamide. Keep bottletightly closed when not in use blephamide. Protect from light blephamide. Sulfonamide solutions darkenon prolonged standing and exposure to heat and light blephamide. Do not use if solutionhas darkened blephamide. Yellowing does not affect activity blephamide. Keep out of the reach of children blephamide.

Laboratory Tests: Eyelid cultures and tests to determine the susceptibilityof organisms to sulfacetamide may be indicated if signs and symptoms persistor recur in spite of the recommended course of treatment with BLEPHAMIDE®ophthalmic suspension blephamide.

Drug Interactions: BLEPHAMIDE® ophthalmic suspension is incompatible withsilver preparations blephamide. Local anesthetics related to p-amino benzoic acid may antagonizethe action of the sulfonamides blephamide.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Prednisolone has beenreported to be noncarcinogenic blephamide. Long-term animal studies for carcinogenic potentialhave not been performed with sulfacetamide blephamide.

One author detected chromosomal nondisjunction in the yeast Saccharomyces cerevisiaefollowing application of sulfacetamide sodium blephamide. The significance of this findingto topical ophthalmic use of sulfacetamide sodium in the human is unknown blephamide.

Mutagenic studies with prednisolone have been negative blephamide. Studies on reproductionand fertility have not been performed with sulfacetamide blephamide. A long-term chronictoxicity study in dogs showed that high oral doses of prednisolone preventedestrus blephamide. A decrease in fertility was seen in male and female rats that were matedfollowing oral dosing with another glucocorticosteroid blephamide.

Pregnancy: Teratogenic Effects: Pregnancy Category C blephamide. Animal reproduction studieshave not been conducted with sulfacetamide sodium blephamide. Prednisolone has been shownto be teratogenic in rabbits, hamsters, and mice blephamide. In mice, prednisolone hasbeen shown to be teratogenic when given in doses 1 to 10 times the human oculardose blephamide. Dexamethasone, hydrocortisone and prednisolone were ocularly applied toboth eyes of pregnant mice five times per day on days 10 through 13 of gestation blephamide. A significant increase in the incidence of cleft palate was observed in thefetuses of the treated mice blephamide. There are no adequate well-controlled studies inpregnant women dosed with corticosteroids blephamide.

Kernicterus may be precipitated in infants by sulfonamides being given systemicallyduring the third trimester of pregnancy blephamide. It is not known whether sulfacetamidesodium can cause fetal harm when administered to a pregnant woman or whetherit can affect reproductive capacity blephamide.

BLEPHAMIDE® ophthalmic suspension should be used during pregnancy onlyif the potential benefit justifies the potential risk to the fetus blephamide.

Nursing Mothers: It is not known whether topical administration of corticosteroidscould result in sufficient systemic absorption to produce detectable quantitiesin human milk blephamide. Systemically administered corticosteroids appear in human milkand could suppress growth, interfere with endogenous corticosteroid production,or cause other untoward effects blephamide. Systemically administered sulfonamides arecapable of producing kernicterus in infants of lactating women blephamide. Because of thepotential for serious adverse reactions in nursing infants from sulfacetamidesodium and prednisolone acetate ophthalmic suspensions, a decision should bemade whether to discontinue nursing or to discontinue the medication blephamide.

Pediatric Use: Safety and effectiveness in pediatric patients below the ageof six have not been established blephamide.

ADVERSE REACTIONS
Adverse reactions have occurred with corticosteroid/anti-bacterial combinationdrugs which can be attributed to the corticosteroid component, the antibacterialcomponent, or the combination blephamide. Exact incidence figures are not available sinceno denominator of treated patients is available blephamide.

Reactions occurring most often from the presence of the anti-bacterial ingredientare allergic sensitizations blephamide. Fatalities have occurred, although rarely, dueto severe reactions to sulfonamides including Stevens-Johnson syndrome, toxicepidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplasticanemia, and other blood dyscrasias (See WARNINGS ) blephamide.

Sulfacetamide sodium may cause local irritation blephamide.

The reactions due to the corticosteroid component in decreasing order of frequencyare: elevation of intraocular pressure (IOP) with possible development of glaucomaand infrequent optic nerve damage, posterior subcapsular cataract formation,and delayed wound healing blephamide.

Although systemic effects are extremely uncommon, there have been rare occurrencesof systemic hypercorticoidism after use of topical corticosteroids blephamide.

Corticosteroid-containing preparations can also cause acute anterior uveitisor perforation of the globe blephamide. Mydriasis, loss of accommodation and ptosis haveoccasionally been reported following local use of corticosteroids blephamide.

Secondary Infection: The development of secondary infection has occurred afteruse of combinations containing corticosteroids and antibacterials blephamide. Fungal andviral infections of the cornea are particularly prone to develop coincidentallywith long-term applications of corticosteroid blephamide. The possibility of fungal invasionmust be considered in any persistent corneal ulceration where corticosteroidtreatment has been used blephamide.

Secondary bacterial ocular infection following suppression of host responsesalso occurs blephamide.

DOSAGE AND ADMINISTRATION
SHAKE WELL BEFORE USING blephamide. Two drops should be instilled into the conjunctivalsac every four hours during the day and at bedtime blephamide.

Not more than 20 milliliters should be prescribed initially, and the prescriptionshould not be refilled without further evaluation as outlined in PRECAUTIONSabove blephamide.

BLEPHAMIDE® dosage may be reduced, but care should be taken not to discontinuetherapy prematurely blephamide. In chronic conditions, withdrawal of treatment should becarried out by gradually decreasing the frequency of application blephamide.

If signs and symptoms fail to improve after two days, the patient should bere-evaluated (see PRECAUTIONS ) blephamide.

Copyright 2005 D-S LTD.
All Rights Reserved.