SULFACETAMIDE- sulfacetamide sodium solution/ drops

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5)

Pieejams no:

Pacific Pharma, Inc.

Ievadīšanas:

OPHTHALMIC

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Sulfacetamide sodium ophthalmic solution, USP 10% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with white high impact polystyrene (HIPS) caps as follows:                   5 mL in 10 mL bottle - NDC 60758-018-05 Store at 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded. Revised : 9/2018 Distributed for: Allergan USA, Inc. Madison, NJ 07940 © 2018 Allergan. All rights reserved. All trademarks are the property of their respective owners. v1.0USPI018

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

SULFACETAMIDE- SULFACETAMIDE SODIUM SOLUTION/ DROPS
PACIFIC PHARMA, INC.
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SULFACETAMIDE SODIUM
OPHTHALMIC SOLUTION, USP 10%
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:
CHEMICAL NAME: _N_-Sulfanilylacetamide monosodium salt monohydrate.
CONTAINS: ACTIVE: sulfacetamide sodium 10% (100 mg/mL)
PRESERVATIVE: benzalkonium chloride 0.005%
LNACTIVES: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%;
purified water; sodium phosphate
dibasic; sodium phosphate monobasic; sodium thiosulfate; hydrochloric
acid and/or sodium hydroxide
to adjust pH (6.8 to 7.5).
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 solution 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_