SULFACETAMIDE SODIUM solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

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 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 sterile in plastic bottles in the following sizes: 15 mL: NDC 61314-701-01 Note: Store between 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded. Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SULFACETAMIDE SODIUM - SULFACETAMIDE SODIUM SOLUTION
H.J. HARKINS COMPANY, INC.
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SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION USP, 10%
DESCRIPTION
Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile topical
antibacterial agents for ophthalmic
use. The active ingredient is represented by the following structural
formula:
C H N Na0 S • H O
MW = 254.24
CHEMICAL NAME:
N-Sulfanilylacetamide monosodium salt monohydrate.
CONTAINS :
ACTIVE: sulfacetamide sodium 10% (100 mg/mL).
PRESERVATIVE: methylparaben and propylparaben
INACTIVES: sodium thiosulfate, methylcellulose, and monobasic sodium
phosphate
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.
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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:
_Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae,
Streptococcus _(viridans group),
_Haemophilus influenzae, Kleb