MARBOFLOXACIN tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

FELIX PHARMACEUTICALS PRIVATE LIMITED

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Marbofloxacin 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.

Product summary:

Marbofloxacin 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. 86101-016-11) or 250 tablets (NDC No. 86101-016-16) 50 mg scored tablets supplied in bottles that contain 100 tablets (NDC No. 86101-017-11) or 250 tablets (NDC No. 86101-017-16) 100 mg scored tablets supplied in a 50 tablet bottle (NDC No. 86101-018-50) 200 mg scored tablets supplied in a 50 tablet bottle (NDC No. 86101-019-50)

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

MARBOFLOXACIN- MARBOFLOXACIN TABLET, CHEWABLE
FELIX PHARMACEUTICALS PRIVATE LIMITED
----------
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:
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
17
19
4
4
1
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 tab