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DOSAGE
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Instill 1/2" ribbon qD to TID
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GENERIC
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gentamicin sulfate 0.3%, prednisolone acetate 0.6%
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INDICATIONS
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PRED-G® 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 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.
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MECHANISM OF ACTION
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aminoglycoside, corticosteroid: Aminoglycosides inhibit bacterial protein synthesis. Corticosteroids inhibit arachidonic acid release .
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MICROBIOLOGY
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PRED-G® ophthalmic ointment is included to provide action against specific aerobic organisms susceptible to it. Gentamicin sulfate is active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
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CONTRAINDICATIONS & WARNINGS
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PRED-G® 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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Pred G ointment is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation or to other corticosteroids.
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PEDIATRIC USE
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Safety and effectiveness in pediatric patients have not been established.
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Gentamicin has been shown to depress newborn body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses of approximately 500 times the maximum recommended ophthalmic dose in humans. There are no adequate and well controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 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. PRED-G® ophthalmic ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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NOTE
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Exercise caution with severe or unresponsive keratitis as steroids will exacerbate many nonbacterial infections.
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Glaucoma and cataract risk with extended use.
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