SULFACETAMIDE SODIUM
OPHTHALMIC OINTMENT USP, 10%

STERILE

Rx only

Sulfacetamide Sodium Ointment USP, 10%, is a sterile, topical anti-bacterial agent for ophthalmic use. Each gram contains Sulfacetamide Sodium USP, 100 mg in an ointment base of white petrolatum and mineral oil.

Sulfacetamide sodium is an odorless, white, crystalline powder. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in benzene, chloroform, and ether. Chemically it is N-sulfanilylacetamide monosodium salt monohydrate, and is represented by the following structural formula:

For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms:

    Escherichia coli, Staphylococcus aureus, Staphylococcus pneumonia, 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 aeroginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

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 been 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).

Sulfacetamide Sodium Ophthalmic Ointment USP, 10%, is supplied in 3.5 gram

(1/8 Oz) sterile, tamperproof tubes, NDC 0168-0079-38

Store at controlled room temperature 15°-30°C (59°-86°F).

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I27938D
#19
R3/98