VERAFLOX- pradofloxacin suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Elanco US Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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:

Bottle Size 15 mL 30 mL Approved by FDA under NADA # 141-344 90209274_PA502558X Made in Germany © 2022 Elanco or its affiliates. Veraflox, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Manufactured for: Elanco US Inc. Greenfield, IN 46140 U.S.A. Revised: May 2022 Elanco ™

Authorization status:

New Animal Drug Application

Summary of Product characteristics

VERAFLOX- PRADOFLOXACIN SUSPENSION
ELANCO US INC.
----------
VERAFLOX™
_ELANCO_™
(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.
INDICATION
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 this side
effect.