SULFACETAMIDE SODIUM solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)

Available from:

Bausch & Lomb Incorporated

INN (International Name):

SULFACETAMIDE SODIUM

Composition:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Sulfacetamide sodium ophthalmic solution USP, 10% is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

Product summary:

Sulfacetamide sodium ophthalmic solution USP, 10% is supplied in a plastic squeeze bottle with a controlled drop tip in the following size:   NDC 24208-670-04          15 mL bottle Sulfonamide solutions, on long standing, will darken in color and should be discarded. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: August 2023 9113204 (Folded) 9113304 (Flat)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM SOLUTION/ DROPS
BAUSCH & LOMB INCORPORATED
----------
SULFACETAMIDE SODIUM
OPHTHALMIC SOLUTION, USP
10%
(STERILE)
RX ONLY
FOR TOPICAL EYE USE ONLY
DESCRIPTION
Sulfacetamide sodium ophthalmic solution USP, 10% is a sterile,
topical antibacterial
agent for ophthalmic use. The active ingredient is represented by the
following structural
formula:
CHEMICAL NAME: _N_-Sulfanilylacetamide monosodium salt monohydrate.
EACH ML CONTAINS:
Active: sulfacetamide sodium, 100 mg/mL (10%);
Inactives: methylcellulose, purified water, sodium thiosulfate. Sodium
phosphate
monobasic may be added to adjust pH (6.8-8.0).
Preservatives: methylparaben 0.05% and propylparaben 0.01%. The
osmolality range is
700-1300 mOsm/kg.
CLINICAL PHARMACOLOGY
MICROBIOLOGY: THE SULFONAMIDES ARE BACTERIOSTATIC AGENTS AND THE
SPECTRUM
OF ACTIVITY IS SIMILAR FOR ALL. SULFONAMIDES INHIBIT BACTERIAL
SYNTHESIS OF
DIHYDROFOLIC ACID BY PREVENTING THE CONDENSATION OF THE PTERIDINE WITH
AMINOBENZOIC ACID THROUGH COMPETITIVE INHIBITION OF THE ENZYME
DIHYDROPTEROATE SYNTHETASE. RESISTANT STRAINS HAVE ALTERED
DIHYDROPTEROATE
SYNTHETASE WITH REDUCED AFFINITY FOR SULFONAMIDES OR PRODUCE INCREASED
QUANTITIES OF AMINOBENZOIC ACID.
Topically applied sulfonamides are considered active against
susceptible strains of the
following common bacterial eye pathogens:_ 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.
INDICATIONS AND USAGE
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:
_Es