GENONE- gentamicin sulfate with betamethasone valerate spray

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG), BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)

Tillgänglig från:

MWI

INN (International namn):

GENTAMICIN SULFATE

Sammansättning:

GENTAMICIN 0.57 mg in 1 mL

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION

Terapeutiska indikationer:

INDICATIONS : For the treatment of infected superficial lesions in dogs caused by bacteria sensitive to gentamicin. CONTRAINDICATIONS : If hypersensitivity of any of the components occurs, treatment with this product should be discontinued and appropriate therapy instituted.

Produktsammanfattning:

HOW SUPPLIED : Plastic spray bottle containing 60 mL, 120 mL and 240 mL of Gentamicin Sulfate with Betamethasone Valerate Topical Spray.

Bemyndigande status:

Abbreviated New Animal Drug Application

Produktens egenskaper

GENONE - GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE SPRAY
MWI
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GENONE SPRAY TOPICAL
ANADA # 200-188, APPROVED BY FDA
VETERINARY
FOR TOPICAL USE IN DOGS ONLY.
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A LICENSED VETERINARIAN.
DESCRIPTION: Each mL contains: gentamicin sulfate equivalent to 0.57
mg gentamicin base,
betamethasone valerate equivalent to 0.284 mg
betamethasone, 163 mg isopropyl alcohol, propylene glycol,
methylparaben and propylparaben as
preservatives, purified water q.s. Hydrochloric acid
may be added to adjust pH.
CHEMISTRY: Gentamicin is a mixture of aminoglycoside antibiotics
derived from the fermentation of
_Micromonospora purpurea_.
Gentamicin sulfate is a mixture of sulfate salts of the antibiotics
produced in this fermentation. The salts
are weakly acidic and
freely soluble in water.
Gentamicin sulfate contains not less than 500 micrograms of gentamicin
base per milligram.
Betamethasone valerate is a synthetic glucocorticoid.
PHARMACOLOGY: Gentamicin, a broad-spectrum antibiotic, is a highly
effective topical treatment for
bacterial infections of the skin. _In vitro_, gentamicin is
bactericidal against a wide variety of gram-
positive and gram-negative bacteria isolated from domestic animals.
Specifically, gentamicin is
active against the following organisms isolated from canine skin:
_Alcaligenes_ sp., _Citrobacter_ sp.,
_Klebsiella_ sp., _Pseudomonas aeruginosa_, indole-positive and
negative _Proteus_ sp., _Escherichia coli_,
_Enterobacter_ sp., _Staphylococcus_ sp. and _Streptococcus_ sp.
Betamethasone valerate emerged from intensive research as the most
promising of some 50 newly
synthesized corticosteroids in the experimental
model described by McKenzie,
et al. This human bioassay technique has been found reliable for
evaluating the vasoconstrictor properties of new
topical corticosteroids and is useful in predicting clinical efficacy.
Betamethasone valerate in veterinary medicine has been shown to
provide anti-inflammatory and
antipruritic activi