ENROFLOXACIN injection solution

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 in 1 mL

Prescription type:

PRESCRIPTION

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ENROFLOXACIN- ENROFLOXACIN INJECTION, SOLUTION
PUTNEY, INC.
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PACKAGE INSERT FOR DOGS
ANADA 200-527, Approved by FDA
ENROFLOXACIN ANTIBACTERIAL INJECTABLE SOLUTION
2.27%
NDC# 26637-721-02
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). 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
of _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
1
MIC values for enrofloxacin against these isolates are presented in
Table I. Most strains of these
organ