FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
FOR TOPICAL EYE USE ONLY - NOT FOR INJECTION.
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. Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Sulfacetamide sodium 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.
History
There is currently no drug history available for this drug.
Other Information
Sulfacetamide sodium ophthalmic solution, USP 10% is a sterile, topical anti-bacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula:
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 pH (6.8 to 7.5).
Sources
Sulfacetamide Manufacturers
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Pacific Pharma
Sulfacetamide | Pacific Pharma
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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