Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sulfacetamide sodium ophthalmic solution USP, 10% is supplied in a plastic squeeze bottle with a controlled drop tip in the following size: NDC 68788-9871-1 15 mL bottle Storage: Store between 2°C to 25°C (36°F to 77°F). Sulfonamide solutions, on long standing, will darken in color and should be discarded. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: August 2023 Relabeled By: Preferred Pharmaceuticals Inc. donotuse; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 68788-9871-1 Sulfacetamide Sodium Ophthalmic Solution, USP 10% (Sterile) FOR TOPICAL EYE USE ONLY Eye image symbol Rx only 15 mL BAUSCH + LOMB Relabeled By: Preferred Pharmaceuticals Inc. 9532102 AB0301 Sulfacetamide Sodium Ophthalmic Sol USP 10%
- HOW SUPPLIED Sulfacetamide sodium ophthalmic solution USP, 10% is supplied in a plastic squeeze bottle with a controlled drop tip in the following size: NDC 68788-9871-1 15 mL bottle Storage: Store between 2°C to 25°C (36°F to 77°F). Sulfonamide solutions, on long standing, will darken in color and should be discarded. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: August 2023 Relabeled By: Preferred Pharmaceuticals Inc. donotuse
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 68788-9871-1 Sulfacetamide Sodium Ophthalmic Solution, USP 10% (Sterile) FOR TOPICAL EYE USE ONLY Eye image symbol Rx only 15 mL BAUSCH + LOMB Relabeled By: Preferred Pharmaceuticals Inc. 9532102 AB0301 Sulfacetamide Sodium Ophthalmic Sol USP 10%
Overview
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: Chemical name: N -Sulfanilylacetamide monosodium salt monohydrate. Each mL contains: Active: sulfacetamide sodium, 100 mg/mL (10%); Inactives: methylcellulose, purified water, sodium thiosulfate. Sodium phosphate monobasic may be added to adjust pH (6.8-8.0). Preservatives: methylparaben 0.05% and propylparaben 0.01%. The osmolality range is 700-1300 mOsm/kg. chem
Indications & Usage
Sulfacetamide sodium ophthalmic solution USP, 10% 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.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS 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.
Contraindications
Sulfacetamide sodium ophthalmic solution USP, 10% is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.
Adverse Reactions
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 ). To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
Sulfacetamide preparations are incompatible with silver preparations.
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