Zeniquin [marbofloxacin] tablets are indicated
for the treatment of infections in dogs and cats associated with
bacteria susceptible to marbofloxacin. Clinical effectiveness was
confirmed in bacterial skin and soft tissue infections in dogs and cats and
urinary tract infections [cystitis] in dogs associated with bacteria
susceptible to marbofloxacin.
Marbofloxacin is a synthetic broad-spectrum
antibacterial agent from the fluoroquinolone class of chemotherapeutic
agents.
Dosage and Administration: For oral use in dogs and cats only.
The recommended dosage for oral
administration to dogs and cats is 1.25 mg marbofloxacin per lb of body
weight once daily, but the dosage may be safely increased to 2.5 mg/lb.
For the treatment of skin and soft tissue infections, Zeniquin
tablets should be given for 2-3 days beyond the cessation of clinical
signs for a maximum of 30 days. For the treatment of urinary tract
infections, Zeniquin tablets should be administered for at least 10
days. If no improvement is noted within 5 days, the diagnosis should be
re-evaluated and a different course of therapy considered.
CLINICAL PHARMACOLOGY: Marbofloxacin is rapidly and almost
completely absorbed from the gastrointestinal tract following oral
administration to fasted animals. Divalent cations are generally known
to diminish the absorption of fluoroquinolones. The effects of
concomitant feeding on the absorption of marbofloxacin have not been
determined. [See Drug Interactions.] In the dog, approximately
40% of an oral dose of marbofloxacin is excreted unchanged in the urine1.
Excretion in the feces, also as unchanged drug, is the other major route
of elimination in dogs. Ten to 15% of marbofloxacin is metabolized by
the liver in dogs. In vitro plasma protein binding of
marbofloxacin in dogs was 9.1% and in cats was 7.3%. In the cat,
approximately 70% of an oral dose is excreted in the urine as
marbofloxacin and metabolites with approximately 85% of the excreted
material as unchanged drug. Pharmacokinetic parameters related to
intravenous dosing were estimated in a study of 6 healthy adult beagle
dogs, and are summarized in Table 1. The absolute bioavailability
following dosing of oral tablets to the same animals was 94%.
Marbofloxacin plasma concentrations were determined over time in
healthy adult beagle dogs [6 dogs per dosage group] following single
oral doses of 1.25 mg/lb or 2.5 mg/lb. Absorption of orally administered marbofloxacin increases proportionally over the dose range of 1.25 to
2.5 mg/lb. Marbofloxacin plasma concentrations were determined over time
in 7 healthy adult male cats following a single oral dose of 2.5 mg/lb.
Plasma pharmacokinetic parameters following oral dosing of dogs and cats
are summarized in Figures 2 and 3 and in Table 2. Based on the terminal
elimination half-life and the dosing interval, steady-state levels are
reached after the third dose and are expected to be approximately 25%
greater in dogs and 35% greater in cats than those achieved after a
single dose. Marbofloxacin is widely distributed in canine tissues.
Tissue concentrations of marbofloxacin were determined in healthy male
beagle dogs [4 dogs per time period] at 2, 18 and 24 hours after a
single oral dose [1.25 or 2.5 mg/lb] and are summarized in Tables 3a and
3b.
The primary action of fluoroquinolones is to
inhibit the bacterial enzyme, DNA gyrase. In susceptible organisms,
fluoroquinolones are rapidly bactericidal at relatively low
concentrations. Marbofloxacin is bactericidal against a broad range of
gram-negative and gram-positive organisms.
DRUG INTERACTIONS: Compounds [e.g., sucralfate, antacids, and
mineral supplements] containing divalent and trivalent cations [e.g.,
iron, aluminum, calcium, magnesium, and zinc] can interfere with the
absorption of quinolones which may result in a decrease in product
bioavailability. Therefore, the concomitant oral administration of
quinolones with foods, supplements, or other preparations containing
these compounds should be avoided.
CONTRAINDICATIONS: Marbofloxacin and other quinolones have
been shown to cause arthropathy in immature animals of most species
tested, the dog being particularly sensitive to this side effect.
Marbofloxacin is contraindicated in immature dogs during the rapid
growth phase [small and medium breeds up to 8 months of age, large
breeds up to 12 months of age and giant breeds up to 18 months of age]. Marbofloxacin is contraindicated in cats under 12 months of age.
Marbofloxacin is contraindicated in dogs and cats known to be
hypersensitive to quinolones.
PRECAUTIONS: Quinolones should be used with caution in animals
with known or suspected central nervous system [CNS] disorders. In such
animals, quinolones have, in rare instances, been associated with CNS
stimulation which may lead to convulsive seizures. Quinolones have been
shown to produce erosions of cartilage of weight-bearing joints and
other signs of arthropathy in immature animals of various species. The
use of fluoroquinolones in cats has been reported to adversely affect
the retina. Such products should be used with caution in cats. The
safety of marbofloxacin in animals used for breeding purposes, pregnant,
or lactating has not been demonstrated.
HUMAN WARNING: For use in animals only. Keep out of reach of
children. Avoid contact with eyes. In case of contact, immediately
flush eyes with copious amounts of water for 15 minutes. In case of
dermal contact, wash skin with soap and water. Consult a physician if
irritation persists following ocular or dermal exposure. Individuals
with a history of hypersensitivity to fluoroquinolones should avoid this
product. In humans, there is a risk of user photosensitization within a
few hours after excessive exposure to quinolones. If excessive
accidental exposure occurs, avoid direct sunlight.
ADVERSE REACTIONS: The following clinical signs were reported
during the course of clinical field studies in dogs receiving
marbofloxacin at dosages up to 2.5 mg/lb daily: decreased or loss of
appetite [5.4%], decreased activity [4.4%], and vomiting [2.9%].
The following signs were reported in less than 1% of cases in dogs:
increased thirst, soft stool/diarrhea, behavioral changes,
shivering/shaking/tremors, and ataxia. One dog which had a seizure the
day before study enrollment experienced a seizure while on marbofloxacin
therapy. The following clinical signs were reported during clinical
field studies in cats receiving 1.25 mg/lb/day: diarrhea [2.1%] and soft
stool [1.4%]. Vomiting was reported in less than 1% of cases in cats.
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
HOW SUPPLIED: Marbofloxacin is supplied in 25-mg, 50-mg,
100-mg, and 200-mg scored, coated tablets.
STORAGE CONDITIONS: Store below 30°C [86°F].
Manufacturer:
Pfizer
Animal Health