#
Orbax Suspension
  • Professionals
  • FDA PI

Orbax Suspension

Generic name: orbifloxacin
Dosage form: oral suspension

For Oral Use in Dogs Only.

NADA #141-305, Approved by FDA.

Federal law prohibits the extralabel use of this drug in food-producing animals

CAUTION: Federal 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 C19H20F3N3O3 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.

ORBAX® Oral Suspension is a malt flavored antibiotic suspension containing 30 mg/mL of orbifloxacin and sorbic acid as a preservative.

FIGURE 1. Chemical structure of orbifloxacin

INDICATIONS: ORBAX® Oral Suspension is indicated for the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius,Proteus mirabilis,Escherichia coli and Enterococcus faecalis . ORBAX® Oral Suspension is also indicated for skin and soft tissue infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius,Staphylococcus aureus, coagulase positive staphylococci, Pasteurella multocida,Proteus mirabilis,Pseudomonas spp., Klebsiella pneumoniae,Escherichia coli,Enterobacter spp., Citrobacter spp., Enterococcus faecalis, β-hemolytic streptococci (Group G) and Streptococcus equisimilis.

DOSAGE AND ADMINIST...