GENTAMICIN SULFATE- 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:

A-S Medication Solutions

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:

Product: 50090-1883 NDC: 50090-1883-0 5 mL in a BOTTLE, PLASTIC

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION
A-S MEDICATION SOLUTIONS
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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 _Micromonosporapurpurea_. 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.
CLINICAL PHARMACOLOGY
Microbiology: Gentamicin sulfate is active _in vitro _against many
strains of the following
microorganisms:
_Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus
pyogenes, Streptococcus pneumoniae,_
_Enterobacteraerogenes, Escherichia coli, Haemophilusinfluenzae,
Klebsiellapneumoniae, Neisseria_
1
2
1A
_gonorrhoeae, Pseudomonas aeruginosa, and Serratiamarcescens._
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, Enterobacteraerogenes, Escherichia