SULFACETAMIDE SODIUM solution/ drops

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Central Texas Community Health Centers

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

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 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)

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM SOLUTION/ DROPS
CENTRAL TEXAS COMMUNITY HEALTH CENTERS
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SULFACETAMIDE SODIUM
OPHTHALMIC SOLUTION USP, 10%
(STERILE)
RX ONLY
FOR USE IN THE EYES ONLY
DESCRIPTION:
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:
C H N NaO S • H O
Mol. Wt. 254.24
CHEMICAL NAME: _N_-Sulfanilylacetamide monosodium salt monohydrate.
EACH ML CONTAINS: ACTIVE: Sulfacetamide Sodium, 100 mg (10%);
INACTIVES: Methylcellulose,
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:
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:
8
9
2
3
2
For the treatment of conjunctivitis and other superficial ocular
infections due to susceptible
microorganisms, and as an adjunctive in systemic sulfonamide therapy
of trachom