Sulfacetamide Sodium Ophthalmic Solution USP, 10% (Sterile)

Rx only

FOR USE IN THE EYES ONLY

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:

C₈H₉N₂NaO₃S • H₂O

Mol. Wt. 254.24

Chemical name: N-Sulfanilylacetamide monosodium salt monohydrate.

Each mL Contains: ACTIVE: Sulfacetamide Sodium, 100 mg (10%); INACTIVES: Methylcellulose, Sodium Thiosulfate, Purified Water. Sodium Phosphate Monobasic may be added to adjust pH (6.8 - 8.0).

PRESERVATIVES ADDED: Methylparaben 0.05% and Propylparaben 0.01%. The osmolality range is 700-1300 mOsm/kg.

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.

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).

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:

15 mL bottle - Prod. No. 03011

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW symbol IS NOT INTACT

CommUnity Care Federally Qualified Centers

SULF.
SOD.
OPHT.SOL
10% 15 ML

Date:

Name:
Dr.

INSTILL 2 DROPS IN AFFECTED EYE(S) 3 TIMES A DAY FOR 7
DAYS.

123456

1/1/01

SULFACETamide SOD10% OPH SOL15MLNDC 76413-126-15

Batch: 123456
Lot: 123456
Exp: 1/1/01
Bausch & Lomb

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.