VERAFLOX- pradofloxacin suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRADOFLOXACIN (UNII: 6O0T5E048I) (PRADOFLOXACIN - UNII:6O0T5E048I)

Available from:

Bayer HealthCare LLC Animal Health Division

INN (International Name):

PRADOFLOXACIN

Composition:

PRADOFLOXACIN 25 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

VERAFLOX is indicated for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida, Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, and Staphylococcus pseudintermedius. DO NOT USE IN DOGS. Pradofloxacin has been shown to cause bone marrow suppression in dogs. Dogs may be particularly sensitive to this effect, potentially resulting in severe thrombocytopenia and neutropenia. Quinolone-class drugs have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. Pradofloxacin is contraindicated in cats with a known hypersensitivity to quinolones.

Product summary:

Code Number Bottle Size 84364593 15 mL 84364607 30 mL NADA 141-344, Approved by FDA 81083770 84364593 / 84364607, R.0 Made in Germany © 2012 Bayer HealthCare LLC Bayer, the Bayer Cross and VERAFLOX are registered trademarks of Bayer. VERAFLOX is protected by the following U.S. Patent 6,323,213. Bayer HealthCare LLC Animal Health Division Shawnee Mission, Kansas 66201, U.S.A. May, 2012

Authorization status:

New Animal Drug Application

Summary of Product characteristics

VERAFLOX- PRADOFLOXACIN SUSPENSION
BAYER HEALTHCARE LLC ANIMAL HEALTH DIVISION
----------
VERAFLOX
(PRADOFLOXACIN)
ORAL SUSPENSION FOR CATS
25 MG/ML
DO NOT USE IN DOGS.
FEDERAL LAW PROHIBITS THE EXTRALABEL USE OF THIS DRUG IN
FOOD-PRODUCING ANIMALS.
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Pradofloxacin is a fluoroquinolone antibiotic and belongs to the class
of quinoline carboxylic acid
derivatives. Its chemical name is: 7-[(4aS) octahydro-6H-pyrrolo [3,
4-b] pyridine-6yl]-8-cyano-1-
cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-3-quinoline carboxylic acid.
Each mL of VERAFLOX Oral
Suspension provides 25 mg of pradofloxacin.
INDICATIONS
VERAFLOX is indicated for the treatment of skin infections (wounds and
abscesses) in cats caused by
susceptible strains of _Pasteurella multocida, Streptococcus canis,
Staphylococcus aureus, Staphylococcus_
_felis, _and _Staphylococcus pseudintermedius._
DOSAGE AND ADMINISTRATION
Shake well before use. To ensure a correct dosage, body weight should
be determined as accurately as
possible. The dose of VERAFLOX is 7.5 mg/kg (3.4 mg/lb) body weight
once daily for 7 consecutive
days. Use the syringe provided to ensure accuracy of dosing to the
nearest 0.1 mL. Rinse syringe
between doses.
A sample of the lesion should be obtained for culture and
susceptibility testing prior to beginning
antibacterial therapy. Once results become available, continue with
appropriate therapy. If acceptable
response to treatment is not observed, or if no improvement is seen
within 3 to 4 days, then the diagnosis
should be re-evaluated and appropriate alternative therapy considered.
CONTRAINDICATIONS
®
DO NOT USE IN DOGS. PRADOFLOXACIN HAS BEEN SHOWN TO CAUSE BONE MARROW
SUPPRESSION IN
DOGS. DOGS MAY BE PARTICULARLY SENSITIVE TO THIS EFFECT, POTENTIALLY
RESULTING IN SEVERE
THROMBOCYTOPENIA AND NEUTROPENIA.
Quinolone-class drugs have been shown to cause arthropathy in immature
animals of most species
tested, the dog being particularly sensitive to