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DOSAGE
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1/2 inch ribbon in conjunctival sac TID-QID daytime + once or twice qHS x 2 days. After two days, taper.
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If signs and symptoms fail to improve after two days, the patient should be re-evaluated
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GENERIC
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sulfacetamide 10%, prednisolone acetate 0.2%
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INDICATIONS
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BLEPHAMIDE® ophthalmic ointment 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 corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain 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.
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MECHANISM OF ACTION
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sulfonamide/corticosteroid: Sulfonamides inhibit bacterial folate synthesis. Corticosteroids inhibit the release of arachidonic acid.
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MICROBIOLOGY
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Sulfacetamide exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid required for growth through competition with p-aminobenzoic acid. Some strains of these bacteria may be resistant to sulfacetamide or resistant strains may emerge in vivo. The anti-infective component in BLEPHAMIDE® ointment 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. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens.
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CONTRAINDICATIONS & WARNINGS
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BLEPHAMIDE® ophthalmic 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.
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BLEPHAMIDE® ophthalmic ointment is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides and to other corticosteroids
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PEDIATRIC USE
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Safety and effectiveness in pediatric patients below the age of 6 years have not been established.
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PREGNANCY
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Category C: Teratogenic Effects Animal reproduction studies have not been conducted with sulfacetamide sodium. Prednisolone has been shown to be teratogenic in rabbits, hamsters, and mice. In mice, prednisolone has been shown to be teratogenic when given in doses 1 to 10 times the human ocular dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women dosed with corticosteroids. Kernicterus may be precipitated in infants by sulfonamides being given systemically during the third trimester of pregnancy. It is not known whether sulfacetamide sodium can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.
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NOTE
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Inadequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens. Many Staphylococcal isolates are completely resistant to sulfa drugs. Hypersensitivity to sulfonamides is common. Glaucoma risk.
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