SULFACETAMIDE SODIUM ointment

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Padagis US LLC

INN (International ime):

SULFACETAMIDE SODIUM

Sastav:

SULFACETAMIDE SODIUM 100 mg in 1 g

Administracija rute:

OPHTHALMIC

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms: Escherichia coli, Staphylococcus aureus, Staphylococcus pneumonia, 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 aeroginosa . A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs. Hypersensitivity to sulfonamides or to any ingredient of the preparation.

Proizvod sažetak:

Sulfacetamide Sodium Ophthalmic Ointment USP, 10%, is supplied in 3.5 gram (1/8 oz) sterile, tamper evident tubes, NDC 0574-4190 -35 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM OINTMENT
PADAGIS US LLC
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SULFACETAMIDE SODIUM OPHTHALMIC OINTMENT USP, 10%
STERILE
Rx Only
DESCRIPTION:
Sulfacetamide Sodium Ointment USP, 10%, is a sterile, topical
anti-bacterial agent for
ophthalmic use. Each gram contains Sulfacetamide Sodium USP, 100 mg in
an ointment
base of white petrolatum and mineral oil. Sulfacetamide sodium is an
odorless, white,
crystalline powder. It is freely soluble in water, sparingly soluble
in alcohol, and practically
insoluble in benzene, chloroform, and ether. Chemically it is
_N_-sulfanilylacetamide
monosodium salt monohydrate, and is represented by the following
structural formula:
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 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 aeroginosa_. A significant percentage of staphylococcal
isolates are
completely resistant to sulfa drugs.
INDICATIONS AND USAGE:
INDICATIONS AND USAGE:
For the treatment of conjunctivitis and other superficial ocular
infections due to
susceptible microorganisms:
_Escherichia coli, Staphylococcus aureus, Staphylococcus pneumonia,
Streptococcus_
(viridans group), _Haemophilus influenzae, Klebsiella _species, and
_Enterobacter species_.
Topica