ORBAX- orbifloxacin tablet, coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ORBIFLOXACIN (UNII: 660932TPY6) (ORBIFLOXACIN - UNII:660932TPY6)

Verfügbar ab:

Merck Sharp & Dohme Corp.

INN (Internationale Bezeichnung):

Orbifloxacin

Zusammensetzung:

Orbifloxacin 22.7 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION

Anwendungsgebiete:

INDICATIONS: ORBAX® (orbifloxacin) Tablets are indicated for the management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin. CONTRAINDICATIONS: Orbifloxacin 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. Orbifloxacin is contraindicated in immature dogs during the rapid growth phase (between 2 and 8 months of age in small and medium-sized breeds, and up to 18 months of age in large and giant breeds). Orbifloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.

Produktbesonderheiten:

HOW SUPPLIED: ORBAX® (orbifloxacin) Tablets are available in the following presentations: STORAGE CONDITIONS: Store between 2° and 30°C (36° and 86°F). Protect from excessive moisture.

Berechtigungsstatus:

New Animal Drug Application

Fachinformation

ORBAX- ORBIFLOXACIN TABLET, COATED
MERCK SHARP & DOHME CORP.
----------
ORBAX
TABLETS
(ORBIFLOXACIN)
FOR ORAL USE IN DOGS AND CATS ONLY
NADA #141-081, APPROVED BY FDA.
FEDERAL LAW PROHIBITS THE EXTRA LABEL USE OF THIS DRUG IN
FOOD-PRODUCING
ANIMALS.
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DRUG TO USE BY OR ON THE
ORDER OF A
LICENSED VETERINARIAN.
DESCRIPTION: Orbifloxacin is a synthetic broad-spectrum antibacterial
agent from the
class of fluoroquinolone carboxylic acid derivatives. Orbifloxacin is
the international
nonproprietary name for
1-cyclopropyl-5,6,8-trifluoro-1,4-dihydro-7-(_cis_-3,5-dimethyl- 1-
piperazinyl)-4-oxoquinoline-3-carboxylic acid. The chemical formula
for orbifloxacin is
C
H
F N O and its molecular weight is 395.38. The compound is slightly
soluble in
water; however, solubility increases in both acidic and alkaline
conditions. The compound
has two dissociation constants (pKa's): 5.95 and 9.01.
FIGURE 1. CHEMICAL STRUCTURE OF ORBIFLOXACIN.
INDICATIONS: ORBAX
(orbifloxacin) Tablets are indicated for the management of
diseases in dogs and cats associated with bacteria susceptible to
orbifloxacin.
EFFICACY CONFIRMATION: Clinical efficacy was established in skin and
soft tissue
infections (wounds and abscesses) in the dog and cat, and urinary
tract infections
(cystitis) in the dog, associated with bacteria susceptible to
orbifloxacin. Specific
bacterial pathogens isolated in clinical field trials are listed in
the MICROBIOLOGY
section.
DOSAGE AND ADMINISTRATION: For routine out-patient treatment of
infection
caused by a susceptible organism, in an otherwise healthy dog or cat,
the dose of
ORBAX
(orbifloxacin) Tablets is 2.5 to 7.5 mg/kg of body weight administered
once
daily. (See DRUG INTERACTIONS and TARGET ANIMAL SAFETY). In the cat,
ORBAX
(orbifloxacin) Tablets and ORBAX
(orbifloxacin) Oral Suspension are not
bioequivalent. On a mg/kg basis, ORBAX
(orbifloxacin) Oral Suspension provides lower
and more variable plasma levels of orbifloxacin than ORBAX
(orbifloxacin) Tablets. The
determinatio