ENROFLOXACIN FLAVORED- enrofloxacin tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Putney, Inc.

INN (International Name):

ENROFLOXACIN

Composition:

ENROFLOXACIN 22.7 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Enrofloxacin Flavored Tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Enrofloxacin Flavored 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.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ENROFLOXACIN FLAVORED- ENROFLOXACIN TABLET, CHEWABLE
PUTNEY, INC.
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ENROFLOXACIN FLAVORED TABLETS
CAUTION:
Federal 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 three sizes (22.7, 68.0 and
136.0 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 these
isolates are presented in Table I.
Most strains of these organisms were found to be susceptible to
enr