GENTAMICIN SULFATE solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)

Disponibil de la:

NuCare Pharmaceuticals,Inc.

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Gentamicin Sulfate Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens. Gentamicin Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

Rezumat produs:

Gentamicin Sulfate Ophthalmic Solution: 5 mL in plastic DROP-TAINER * dispenser. NDC 68071-4775-5 STORAGE: Protect from light and store away from heat. Store at controlled room temperature 15°-30°C (59°-86°F). To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. *DROP-TAINER is a registered trademark of Alcon Research, Ltd. Rx Only

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION
NUCARE PHARMACEUTICALS,INC.
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GENTAMICIN SULFATE
OPHTHALMIC SOLUTION USP
DESCRIPTION
Gentamicin Sulfate is a water-soluble antibiotic of the aminoglycoside
group. Gentamicin
Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to
approximately pH 7
for ophthalmic use. Gentamicin is obtained from cultures of
_Micromonospora purpurea_.
It is a mixture of the sulfate salts of gentamicin C
, C
, and C
. All three components
appear to have similar antimicrobial activities. Gentamicin sulfate
occurs as white powder
and is soluble in water and insoluble in alcohol. The structure is as
follows:
Established name: Gentamicin Sulfate
Chemical name:
0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-
[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-
streptamine.
INGREDIENTS: EACH ML CONTAINS: ACTIVE: Gentamicin Sulfate USP
(equivalent to 3 mg
gentamicin). PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).
INACTIVES: Sodium
Chloride, Dried Sodium Phosphate, Tyloxapol, Sodium Hydroxide and/or
Hydrochloric
Acid (to adjust pH) and Purified Water.
1
2
1A
CLINICAL PHARMACOLOGY
Microbiology: Gentamicin sulfate is active _in vitro _against many
strains of the following
microorganisms:
_Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus
pyogenes,_
_Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli,
Haemophilus_
_influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas
aeruginosa, and_
_Serratia marcescens._
INDICATIONS AND USAGE
Gentamicin Sulfate Ophthalmic Solution is indicated in the topical
treatment of ocular
bacterial infections, including conjunctivitis, keratitis,
keratoconjunctivitis, corneal ulcers,
blepharitis, blepharoconjunctivitis, acute meibomianitis, and
dacryocystitis caused by
susceptible strains of the following microorganisms: _Staphylococcus
aureus,_
_Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus
pneumoniae,_
_Enterobacter aerogenes