BAYTRIL- enrofloxacin injection, solution

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:

Elanco US Inc.

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. 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 large and giant breeds during the rapid growth phase. Large breeds may be in this phase for up to one year of age and the giant breeds for up to 18 months. In clinical field trials utilizing a daily oral dose of 5.0 mg/kg, there were no reports of lameness or joint problems in any breed. However, controlled studies with histological examination of the articular cartilage have not been conducted in the large or giant breeds.

Product summary:

Baytril Injectable Solution 22.7 mg/mL Vial Size 20 mL

Authorization status:

New Animal Drug Application

Summary of Product characteristics

BAYTRIL- ENROFLOXACIN INJECTION, SOLUTION
ELANCO US INC.
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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 found to be susceptible to enrof