SULFACETAMIDE SODIUM solution/ drops

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Sulfacetamide Sodium (UNII: 4NRT660KJQ) (Sulfacetamide - UNII:4965G3J0F5)

Tilgjengelig fra:

Akorn

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Sulfacetamide Sodium Ophthalmic Solution, USP 30% NDC 17478-242-12          15 mL dropper bottle, box of one. Sulfacetamide Sodium Ophthalmic Solution, USP 10% NDC 17478-221-12          15 mL dropper bottle, box of one. STORAGE: Store between 2° and 30°C (36° to 86°F). Store away from heat. Sulfonamide solution, on long standing will darken in color and should be discarded. AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045 SU00N Rev. 02/14

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM SOLUTION/ DROPS
AKORN
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SULFACETAMIDE SODIUM
Ophthalmic Solution USP, 30%
Ophthalmic Solution USP, 10%
RX ONLY
DESCRIPTION
Sulfacetamide Sodium Ophthalmic Solution USP 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.
OPHTHALMIC SOLUTION 30%, EACH ML CONTAINS:
ACTIVE: Sulfacetamide Sodium 300 mg. INACTIVES: Sodium Thiosulfate 1.5
mg and
Monobasic Sodium Phosphate as buffer. PRESERVATIVES: Methylparaben 0.5
mg and
Propylparaben 0.1 mg.
OPHTHALMIC SOLUTION 10%, EACH ML CONTAINS:
ACTIVE: Sulfacetamide Sodium 100 mg. INACTIVES: Hydroxypropyl
Methylcellulose 5 mg,
Sodium Thiosulfate 3.1 mg and Monobasic Sodium Phosphate as buffer.
PRESERVATIVES: Methylparaben 0.5 mg and Propylparaben 0.1 mg.
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
For the treatment of conjunctivitis and other superficial ocular
infections due to
suscepti