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Basic Drug Info
Drug Name:Sulfacetamide Sodium
Manufacturer:Bausch & Lomb Incorporated
Other Info:

Bausch & Lomb IncorporatedTampa, FL 33637┬ęBausch & Lomb IncorporatedXO50045 (Folded)XM10001 (Flat)R.

11/03-62



Clinical Trials:


Indications and Usage

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.
Conjunctivitis -- inflammation of the mucous membrane that lines the inner surface of the eyelids and the anterior part of the sclera; also called pinkeye and redeye.

Eye Infections -- Infection, moderate to severe, caused by bacteria, fungi, or viruses, which occurs either on the external surface of the eye or intraocularly with probable inflammation, visual impairment, or blindness.

Contraindications
Hypersensitivity to sulfonamides or to any ingredient of the preparation.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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.
Branded Drugs
The following US Branded drugs contain Sulfacetamide Sodium


FML-S -- ALLERGAN PHARMACEUTICAL

BLEPHAMIDE S.O.P. -- ALLERGAN PHARMACEUTICAL

CETAPRED -- ALCON LABORATORIES INC

METIMYD -- SCHERING CORP SUB SCHERING PLOUGH CORP

PREDSULFAIR -- PHARMAFAIR INC

VASOCIDIN -- NOVARTIS PHARMACEUTICALS CORP

PREDAMIDE -- AKORN INC

PREDSULFAIR II -- PHARMAFAIR INC

SULPHRIN -- BAUSCH AND LOMB INC

BLEPHAMIDE -- ALLERGAN PHARMACEUTICAL

ISOPTO CETAPRED -- ALCON LABORATORIES INC

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE -- ALCON INC

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE -- BAUSCH AND LOMB PHARMACEUTICALS INC

SULSTER -- AKORN INC

KLARON -- SANOFI AVENTIS US LLC

BLEPH-10 -- ALLERGAN PHARMACEUTICAL

CETAMIDE -- ALCON LABORATORIES INC

SODIUM SULAMYD -- SCHERING CORP SUB SCHERING PLOUGH CORP

SULFAIR 10 -- PHARMAFAIR INC

BLEPH-10 -- ALLERGAN

BLEPH-30 -- ALLERGAN

ISOPTO CETAMIDE -- ALCON LABORATORIES INC

OCUSULF-10 -- MIZA PHARMACEUTICALS USA INC

OCUSULF-30 -- MIZA PHARMACEUTICALS USA INC

SODIUM SULFACETAMIDE -- AKORN INC

SODIUM SULFACETAMIDE -- SOLA BARNES HIND

SULF-10 -- NOVARTIS PHARMACEUTICALS CORP

SULF-15 -- NOVARTIS PHARMACEUTICALS CORP

SULFACEL-15 -- OPTOPICS LABORATORIES CORP

SULFAIR FORTE -- PHARMAFAIR INC

SULFAIR-15 -- PHARMAFAIR INC

SULTEN-10 -- BAUSCH AND LOMB INC


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