BAYTRIL OTIC- enrofloxacin, silver sulfadiazine emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENROFLOXACIN (UNII: 3DX3XEK1BN) (ENROFLOXACIN - UNII:3DX3XEK1BN), SILVER SULFADIAZINE (UNII: W46JY43EJR) (SULFADIAZINE - UNII:0N7609K889)

Available from:

Elanco US Inc.

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION

Therapeutic indications:

Baytril Otic is indicated as a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine (see Microbiology section). Baytril Otic is contraindicated in dogs with suspected or known hypersensitivity to quinolones and/or sulfonamides.

Product summary:

Baytril Otic (enrofloxacin/silver sulfadiazine) Size Presentation 15 mL Oval plastic bottle with dropper tip and extended tip closure

Authorization status:

New Animal Drug Application

Summary of Product characteristics

BAYTRIL OTIC- ENROFLOXACIN, SILVER SULFADIAZINE EMULSION
ELANCO US INC.
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BAYTRIL OTIC
(ENROFLOXACIN/SILVER SULFADIAZINE)
ANTIBACTERIAL-ANTIMYCOTIC EMULSION
FOR OTOTOPICAL USE IN DOGS
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.
PRODUCT DESCRIPTION:
Each milliliter of Baytril Otic contains: enrofloxacin 5 mg (0.5%
w/v), silver sulfadiazine
(SSD) 10 mg (1.0% w/v), benzyl alcohol (as a preservative) and
cetylstearyl alcohol (as a
stabilizer) in a neutral oil and purified water emulsion. The active
ingredients are delivered
via a physiological carrier (a nonirritating emulsion).
CHEMICAL NOMENCLATURE AND STRUCTURE:
ENROFLOXACIN
1 -Cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,
4-dihydro-4-oxo-3-
quinolinecarboxylic acid.
SILVER SULFADIAZINE
Benzenesulfonamide, 4-amino-N-2-pyrimidinyl-monosilver
®
ACTIONS:
Enrofloxacin, a 4-fluoroquinolone compound, is bactericidal with
activity against a broad
spectrum of both Gram negative and Gram positive bacteria.
Fluoroquinolones elicit their
bactericidal activities through interactions with two intracellular
enzymes, DNA gyrase
(DNA topoisomerase II) and DNA topoisomerase IV, which are essential
for bacterial
DNA transcription, synthesis and replication. It is believed that
fluoroquinolones actively
bind with bacterial DNA:ENZYME complexes and thereby inhibit the
essential processes
catalyzed by the enzymes (DNA supercoiling and chromosomal
decatenation).
The
ultimate outcome of the fluoroquinolone intervention is DNA
fragmentation and bacterial
cell death.
Silver sulfadiazine (SSD) is synthesized from silver nitrate and
sodium sulfadiazine.
This
compound has a wide spectrum of antimicrobial activity against Gram
negative and
Gram positive bacteria and is also an effective antimycotic.
SSD suppresses microbial
growth through inhibition of DNA replication and modification of the
cell membrane.
MICROBIOLOGY:
In clinical field tr