Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
MARBOFLOXACIN (UNII: 8X09WU898T) (MARBOFLOXACIN - UNII:8X09WU898T)
MWI
ORAL
PRESCRIPTION
FluoroFlox Chewable 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.
FluoroFlox Chewable Tablets are available in the following strengths of marbofloxacin and bottle sizes: 25 mg scored tablets supplied in bottles that contain 100 tablets (NDC No. 86136-020-10) or 250 tablets (NDC No. 86136-020-25) 50 mg scored tablets supplied in bottles that contain 100 tablets (NDC No. 86136-021-10) or 250 tablets (NDC No. 86136-021-25) 100 mg scored tablets supplied in a 50 tablet bottle (NDC No. 86136-022-50) 200 mg scored tablets supplied in a 50 tablet bottle (NDC No. 86136-023-50)
Abbreviated New Animal Drug Application
FLUROFLOX - MARBOFLOXACIN TABLET, CHEWABLE MWI ---------- FLUROFLOXTM (MARBOFLOXACIN) CHEWABLE 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: 17 19 4 4 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 Lire le document complet