MARBOQUIN- marbofloxacin tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

marbofloxacin (UNII: 8X09WU898T) (marbofloxacin - UNII:8X09WU898T)

Disponible depuis:

Dechra Veterinary Products LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION

indications thérapeutiques:

INDICATIONS AND USAGE: Marboquin (marbofloxacin) tablets are indicated for the treatment of infections in dogs and cats associated with bacteria susceptible to marbofloxacin. 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.

Descriptif du produit:

HOW SUPPLIED: Marboquin tablets are available in the following strengths of marbofloxacin and bottle sizes:

Statut de autorisation:

Abbreviated New Animal Drug Application

Résumé des caractéristiques du produit

MARBOQUIN- MARBOFLOXACIN TABLET
DECHRA VETERINARY PRODUCTS LLC
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MARBOQUIN™ (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