ENROFLOXACIN FLAVORED- enrofloxacin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

FELIX PHARMACEUTICALS PRIVATE LIMITED

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.

Product summary:

Enrofloxacin Flavored Tablets Tablet Size

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ENROFLOXACIN FLAVORED- ENROFLOXACIN TABLET
FELIX PHARMACEUTICALS PRIVATE LIMITED
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ENROFLOXACIN
FLAVORED TABLETS
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 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. Mos