Sulfacetamide Sodium - Preferred Pharmaceuticals, Inc

Rx only

FOR TOPICAL EYE USE ONLY

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.

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 USP, 10% 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.

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 .

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 in a plastic squeeze bottle with a controlled drop tip in the following size:
 

NDC 68788-9871-115 mL bottle
donotuse

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