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:

NuCare Pharmaceuticals,Inc.

Vía de administración:

OPHTHALMIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

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 - NDC 68071-5123-5 DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT. Store between 2°-25°C (36°-77°F). Sulfonamide solutions, on long standing, will darken in color and should be discarded. KEEP OUT OF REACH OF CHILDREN. Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA ©Bausch & Lomb Incorporated Revised June 2016 9113202 (Folded) 9113302 (Flat)

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM SOLUTION/ DROPS
NUCARE PHARMACEUTICALS,INC.
----------
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:
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/mL (10%);
INACTIVES:
Methylcellulose, Purified Water, Sodium Thiosulfate. 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
8
9
2
3
2
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 adju