SULFACETAMIDE SODIUM solution/ drops

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

DIRECT RX

Designació comuna internacional (DCI):

SULFACETAMIDE SODIUM

Composición:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Hypersensitivity to sulfonamides or to any ingredient of the preparation

Resumen del producto:

Sulfacetamide Sodium Ophthalmic Solution USP, 10%, is supplied in a plastic squeeze bottle with a controlled drop tip in the following size: 15 mL bottle - Prod. No. 03011 DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT Storage: Store between 2° - 30°C (36° - 86°F). Sulfonamide solutions, on long standing, will darken in color and should be discarded. KEEP OUT OF REACH OF CHILDREN. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9113200 (Folded) 9113300 (Flat)

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM SOLUTION/ DROPS
DIRECT RX
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SULFACETAMIDE SODIUM
DESCRIPTION SECTION
Sulfacetamide Sodium Ophthalmic Solution USP, 10%, is a sterile,
topical, anti-bacterial 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 (10%);
INACTIVES: Methycellulose,
Sodium Thiosulfate, Purified Water. Sodium Phosphate Monobasic may be
added to adjust pH (6.8 -
8.0).
PRESERVATIVES ADDED: Methylparaben 0.05% and Propylparaben 0.01%. The
osmolality range is
700-1300 mOsm/kg.
CLINICAL PHARMACOLOGY SECTION
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 & USAGE SECTION
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, a