BLEPH®-10 (sulfacetamide sodium ophthalmic solution, USP) 10% is a sterile, topical antibacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula:
C8H9N2NaO3S•H2O ...... MW = 254.24 Chemical Name N-Sulfanilylacetamide monosodium salt monohydrate. Contains: Active: sulfacetamide sodium 10% (100 mg/mL). Preservative: benzalkonium chloride 0.005%. lnactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium phosphate dibasic; sodium phosphate monobasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust the pH (6.8 to 7.5).

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Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations. The most frequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions include non-specific conjunctivitis, conjunctival hyperemia, secondary infections and allergic reactions. 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). Read the Bleph 10 (sulfacetamide sodium ophthalmic solution 10%) Side Effects Center for a complete guide to possible side effectsLearn More »

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For conjunctivitis and other superficial ocular infections: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days. For trachoma: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

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Sulfacetamide preparations are incompatible with silver preparations.Last reviewed on RxList: 6/26/2008
This monograph has been modified to include the generic and brand name in many instances.

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BLEPH®-10 (sulfacetamide sodium ophthalmic solution 10%) solution is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

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BLEPH®-10 (sulfacetamide sodium ophthalmic solution 10%) solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation. Last reviewed on RxList: 6/26/2008
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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BLEPH®-10 (sulfacetamide sodium ophthalmic solution 10%) (sulfacetamide sodium ophthalmic solution, USP) 10% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10mL bottle.....................NDC 11980-011-05 Note: Store at 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded. Revised February 2005. Allergan, Inc. Irvine, CA 92714, U.S.A. FDA Rev date: 11/15/2002 Last reviewed on RxList: 6/26/2008
This monograph has been modified to include the generic and brand name in many instances.

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General Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop. The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur. At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician (see WARNINGS). Carcinogenesis, mutagenesis, impairment of fertility No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals. Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing mothers Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother. Pediatric use Safety and effectiveness in infants below the age of two months have not been established. Last reviewed on RxList: 6/26/2008
This monograph has been modified to include the generic and brand name in many instances.

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