GENTAMICIN SULFATE solution/ drops

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

NuCare Pharmaceuticals, Inc.

Az alkalmazás módja:

OPHTHALMIC

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Gentamicin Sulfate Sterile 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 Sterile Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the components.

Termék összefoglaló:

Gentamicin Sulfate ophthalmic solution - Sterile, 5-mL plastic dropper bottle, box of one. (NDC 66267-971-05) STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
NUCARE PHARMACEUTICALS, INC.
----------
GENTAMICIN SULFATE OPHTHALMIC SOLUTION USP, 0.3%
Sterile
Rx only
DESCRIPTION
Gentamicin sulfate is a water-soluble antibiotic of the aminoglycoside
group.
Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution
for ophthalmic use.
EACH ML CONTAINS:
ACTIVE: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base)
PRESERVATIVE: Benzalkonium Chloride
INACTIVES: Disodium Phosphate, Monosodium Phosphate, and Sodium
Chloride. The pH
range is from 6.8 to 7.3.
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 a white
powder and is soluble
in water and insoluble in alcohol. The structural formula is as
follows:
CLINICAL PHARMACOLOGY
MICROBIOLOGY
Gentamicin sulfate is active _in vitro_ against many strains of the
following
microorganisms:
1
2
1A
_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 Sterile 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._
CONTRAINDICATIONS
Gentamicin Sulfate Sterile Ophthalmic Solution is contraindicated in
patients with known
hypers