SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION USP, 10%

Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile topical antibacterial agents for ophthalmic use. The active ingredient is represented by the following structural formula:

C ₈H ₉N ₂Na0 ₃S • H ₂O

MW = 254.24

Chemical Name:

N-Sulfanilylacetamide monosodium salt monohydrate.

Contains:

Active: sulfacetamide sodium 10% (100 mg/mL).

Preservative: methylparaben and propylparaben

Inactives: sodium thiosulfate, methylcellulose, and monobasic sodium phosphate

Microbiology: The sulfonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid.

Topically applied sulfonamides are considered active against susceptible strains of the following common bacterial eye pathogens: 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.

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.

Sulfacetamide Sodium Ophthalmic Solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

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.

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.

Sulfacetamide Sodium Ophthalmic Solution USP, 10% is supplied sterile in plastic bottles in the following sizes:

15 mL: NDC 66267-941-15

Note: Store between 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded.

Rx Only

Dist. by:

FALCON Pharmaceuticals, Ltd

Fort Worth, Texas 76134

Mfd. by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134

Printed in USA

340192-1102

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