BAYTRIL- enrofloxacin tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENROFLOXACIN (UNII: 3DX3XEK1BN) (ENROFLOXACIN - UNII:3DX3XEK1BN)

Available from:

Elanco US Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Baytril (brand of enrofloxacin) Antibacterial Tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Baytril Antibacterial Tablets are indicated for use in dogs and cats. Enrofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones. Dogs: 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 Tablets Tablet Size Tablets/Bottle 22.7 mg 100 Double Scored 22.7 mg 500 Double Scored 68.0 mg 50 Double Scored 68.0 mg 250 Double Scored

Authorization status:

New Animal Drug Application

Summary of Product characteristics

BAYTRIL- ENROFLOXACIN TABLET, COATED
ELANCO US INC.
----------
APPROVED BY FDA UNDER NADA # 140-441
ELANCO™
BAYTRIL
(ENROFLOXACIN)
22.7 MG ANTIBACTERIAL TABLETS
68 MG ANTIBACTERIAL TABLETS
FOR DOGS AND CATS
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). It is
rapidly absorbed from the
digestive tract, penetrating into all measured body tissues and fluids
(See Table III).
Tablets are available in two sizes (22.7 and 68.0 mg enrofloxacin).
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
39 isolates representing 9 genera of bacteria from natural infections
in dogs and cats,
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 the