SULFACETAMIDE SODIUM solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Sandoz Inc.

DCI (Dénomination commune internationale):

SULFACETAMIDE SODIUM

Composition:

SULFACETAMIDE SODIUM 100 mg in 1 mL

Mode d'administration:

OPHTHALMIC

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 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. Contraindications: Sulfacetamide Sodium Ophthalmic Solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

Descriptif du produit:

HOW SUPPLIED: Sulfacetamide Sodium Ophthalmic Solution USP, 10% is supplied sterile in plastic bottles in the following sizes: 15 mL: NDC 61314-701-01 Note: Store between 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded. Rx Only

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

SULFACETAMIDE SODIUM- SULFACETAMIDE SODIUM SOLUTION
SANDOZ INC.
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SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION USP, 10%
DESCRIPTION: Sulfacetamide Sodium Ophthalmic Solution 10% is a sterile
topical
antibacterial agent for ophthalmic use. The active ingredient is
represented by the
following structural formula:
C H N Na0 S • H O
MW = 254.24
CHEMICAL NAME:
N-Sulfanilylacetamide monosodium salt monohydrate.
CONTAINS:
ACTIVE: sulfacetamide sodium 10% (100 mg/mL).
PRESERVATIVE: methylparaben and propylparaben
INACTIVES: sodium thiosulfate, methylcellulose, and monobasic sodium
phosphate
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.
8
9
2
3
2
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 adjunctive in systemic
sulfonamide therapy of
trachoma:
_Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae,
Streptococcus_
(viridans group), _Haemophilus influenzae, Klebsiella _species