Baytril® (enrofloxacin) Antibacterial Injectable Solution 2.27% For Dogs Only

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENROFLOXACIN (UNII: 3DX3XEK1BN) (ENROFLOXACIN - UNII:3DX3XEK1BN), BUTYL ALCOHOL (UNII: 8PJ61P6TS3) (BUTYL ALCOHOL - UNII:8PJ61P6TS3)

Available from:

Bayer HealthCare LLC Animal Health Division

INN (International Name):

ENROFLOXACIN

Composition:

ENROFLOXACIN 22.7 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Baytril® (brand of enrofloxacin) Injectable Solution is indicated for the management of diseases in dogs associated with bacteria susceptible to enrofloxacin. EFFICACY CONFIRMATION: Clinical efficacy was established in dermal infections (wounds and abscesses) associated with susceptible strains of Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , and Staphylococcus intermedius ; respiratory infections (pneumonia, tonsillitis, rhinitis) associated with susceptible strains of Escherichia coli and Staphylococcus aureus ; and urinary cystitis associated with susceptible strains of Escherichia coli , Proteus mirabilis , and Staphylococcus aureus . Enrofloxacin is contraindicated in dogs known to be hypersensitive to quinolones. Based on the studies discussed under the section on Animal Safety Summary, the use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in lar

Product summary:

Code Number Baytril Injectable Solution 22.7 mg/mL Vial Size 08713254-186599 20 mL Bayer, the Bayer Cross, Baytril and the dog logo are registered trademarks of Bayer

Authorization status:

New Animal Drug Application

Summary of Product characteristics

BAYTRIL- ENROFLOXACIN INJECTION, SOLUTION
BAYER HEALTHCARE LLC ANIMAL HEALTH DIVISION
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BAYTRIL
(ENROFLOXACIN)
ANTIBACTERIAL INJECTABLE SOLUTION 2.27%
FOR DOGS ONLY
CAUTION:
Federal (U.S.A.) law restricts this drug to use by or on the order of
a licensed
veterinarian.
Federal law prohibits the extralabel use
of this drug in food-producing animals.
DESCRIPTION:
Enrofloxacin is a synthetic chemotherapeutic agent from the class of
the quinolone
carboxylic acid derivatives. It has antibacterial activity against a
broad spectrum of Gram
negative and Gram positive bacteria (See Tables I and II). Each mL of
injectable solution
contains: enrofloxacin 22.7 mg, n-butyl alcohol 30 mg, potassium
hydroxide for pH
adjustment and water for injection, q.s.
CHEMICAL NOMENCLATURE AND STRUCTURAL FORMULA:
1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic
acid.
®
ACTIONS:
MICROBIOLOGY: Quinolone carboxylic acid derivatives are classified as
DNA gyrase
inhibitors. The mechanism of action of these compounds is very complex
and not yet
fully understood. The site of action is bacterial gyrase, a synthesis
promoting enzyme.
The effect on _Escherichia coli _is the inhibition of DNA synthesis
through prevention of
DNA supercoiling. Among other things, such compounds lead to the
cessation of cell
respiration and division. They may also interrupt bacterial membrane
integrity.
Enrofloxacin is bactericidal, with activity against both Gram negative
and Gram positive
bacteria. The minimum inhibitory concentrations (MICs) were determined
for a series of
37 isolates representing 9 genera of bacteria from natural infections
in dogs, selected
principally because of resistance to one or more of the following
antibiotics: ampicillin,
cephalothin, colistin, chloramphenicol, erythromycin, gentamicin,
kanamycin, penicillin,
streptomycin, tetracycline, triple sulfa and sulfa/trimethoprim. The
MIC values for
enrofloxacin against these isolates are presented in Table I. Most
strains of these
organisms were fou