Sulfacetamide Sodium Solution label

Sulfacetamide Sodium Solution

Sulfacetamide Sodium Solution Recall

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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.

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

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.

History

There is currently no drug history available for this drug.

Other Information

Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile topical antibacterial agents for ophthalmic use. The active ingredient is represented by the following structural formula:

    Chemical Structure

Chemical Name: 

N-Sulfanilylacetamide monosodium salt monohydrate.

C8H9N2Na03S·H2O

MW = 254.24

Contains:

Active: sulfacetamide sodium 10% (100 mg/mL).

Preservative: methylparaben and propylparaben

Inactives: sodium thiosulfate, methylcellulose, and monobasic sodium phosphate

Sulfacetamide Sodium Solution Manufacturers

  • Sulfacetamide Sodium Solution | Rebel Distributors Corp
    No Recall

    Sulfacetamide Sodium Solution | Rebel Distributors Corp

    Sulfacetamide Sodium Solution | Rebel Distributors Corp

    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.

  • Falcon Pharmaceuticals, Ltd.
    Sulfacetamide Sodium Solution | Falcon Pharmaceuticals, Ltd.
    No Recall

    Sulfacetamide Sodium Solution | Falcon Pharmaceuticals, Ltd.

    Sulfacetamide Sodium Solution | Falcon Pharmaceuticals, Ltd.

    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 Solution | H.j. Harkins Company, Inc.
    No Recall

    Sulfacetamide Sodium Solution | H.j. Harkins Company, Inc.

    Sulfacetamide Sodium Solution | H.j. Harkins Company, Inc.

    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.