Sulfacetamide Sodium Ointment

Sulfacetamide Sodium Ointment

Sulfacetamide Sodium Ointment Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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

    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 aeroginosa.  A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

History

There is currently no drug history available for this drug.

Other Information


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 soluable 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:

Fera Sulfacetamide Sodium Ointment Structural Formula



Molecular Formula: C8H9N2NaO3S•H2O
Molecular Weight 254.24

Sulfacetamide Sodium Ointment Manufacturers


  • Fera Pharmaceuticals, Llc
    Sulfacetamide Sodium Ointment [Fera Pharmaceuticals, Llc]
  • Paddock Laboratories, Llc
    Sulfacetamide Sodium Ointment [Paddock Laboratories, Llc]

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