ZENIQUIN- marbofloxacin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MARBOFLOXACIN (UNII: 8X09WU898T) (MARBOFLOXACIN - UNII:8X09WU898T)

Available from:

Zoetis Inc.

INN (International Name):

MARBOFLOXACIN

Composition:

MARBOFLOXACIN 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Zeniquin (marbofloxacin) tablets are indicated for the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin. 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.

Product summary:

Zeniquin tablets are available in the following strengths of marbofloxacin and bottle sizes: 25 mg scored tablets supplied in bottles that contain 100 or 250 tablets 50 mg scored tablets supplied in bottles that contain 100 or 250 tablets 100 mg scored tablets supplied in a 50 tablet bottle 200 mg scored tablets supplied in a 50 tablet bottle

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ZENIQUIN- MARBOFLOXACIN TABLET
ZOETIS INC.
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ZENIQUIN
(MARBOFLOXACIN)
TABLETS
_For oral use in dogs and cats only_
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
Marbofloxacin is a synthetic broad-spectrum antibacterial agent from
the fluoroquinolone class of
chemotherapeutic agents. Marbofloxacin is the non-proprietary
designation for 9-fluoro-2,3-dihydro-3-
methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[3,2,1-ij][4,1,2]
benzoxadiazine-6-carboxylic
acid. The empirical formula is C
H FN O and the molecular weight is 362.36. The compound is
soluble in water; however, solubility decreases in alkaline
conditions. The N-octanol/water partition
coefficient (Kow) is 0.835 measured at pH 7 and 25°C.
FIGURE 1: Chemical structure of marbofloxacin
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 urine . 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