GENTAMICIN SULFATE solution/ drops

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Gentamicin Sulfate (UNII: 8X7386QRLV) (Gentamicin - UNII:T6Z9V48IKG)

Tilgængelig fra:

Akorn

INN (International Name):

Gentamicin Sulfate

Sammensætning:

Gentamicin 3 mg in 1 mL

Indgivelsesvej:

OPHTHALMIC

Recept type:

PRESCRIPTION

Terapeutiske indikationer:

Gentamicin Sulfate Ophthalmic Solution is indicated for topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats.

Produkt oversigt:

Gentamicin Sulfate Ophthalmic Solution is supplied in a white low density polyethylene plastic squeeze bottle with a white controlled dropper tip and a white polypropylene cap in the following sizes: NDC 59399-101-05 5 mL; box of one Store solution at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Animal Drug Application

Produktets egenskaber

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION/ DROPS
AKORN
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Gentamicin Sulfate Ophthalmic Solution
Sterile
ANADA 200-576, Approved by FDA
VETERINARY
FOR USE IN DOGS AND CATS
DESCRIPTION:
Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside
group active
against a wide variety of pathogenic gram-negative and gram-positive
bacteria.
Gentamicin Sulfate Ophthalmic Solution is a sterile aqueous solution
for use in the eye.
Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg
gentamicin base).
Inactives: 2.9 mg Disodium Phosphate, 0.1 mg Monosodium Phosphate, and
7.40 mg
Sodium Chloride. The pH range is from 6.8 to 7.3. Preservative: 0.1 mg
Benzalkonium
Chloride as preservative.
CHEMISTRY:
Gentamicin is an aminoglycoside antibiotic mixture derived from
_Micromonospora_
_purpurea_ of the Actinomycetes group. It is a powder, white to buff
in color, readily
soluble in water, and heat stable.
ACTION:
Gentamicin sulfate, a broad spectrum antibiotic, is a highly effective
topical treatment in
primary and secondary bacterial infections of the eye and surrounding
tissues.
Gentamicin is bactericidal _in vitro_ against a wide variety of
gram-positive and gram-
negative bacteria. Concentrations of gentamicin sulfate required to
inhibit growth of
gram-positive and gram-negative clinical and laboratory strains of
bacteria tested were
less than those of neomycin in most instances.
Gentamicin is active against most
gram-negative bacteria including _Pseudomonas aeruginosa_, indole
positive and negative
_Proteus_ species, _Escherichia coli, Klebsiella_ sp. and
_Enterobacter_ sp. Gentamicin is also
active against strains of gram-positive bacteria including
_Staphylococcus_ species and
_Streptococcus_ species.
INDICATIONS:
Gentamicin Sulfate Ophthalmic Solution is indicated for topical
treatment of conjunctivitis
caused by susceptible bacteria in dogs and cats.
DOSAGE AND ADMINISTRATION:
Gentamicin Sulfate Ophthalmic Solution-1 or 2 drops instilled into the
conjunctival sac 2
1,2
to 4 times a