ORBAX TABLETS
(orbifloxacin)
ORBAX (orbifloxacin) is a broad spectrum antibiotic indicated for treatment of skin and soft tissue infections (wounds and abscesses) in dogs and cats, and urinary tract infections (cystitis) in dogs, associated with bacteria susceptible to orbifloxacin.
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. For the treatment of skin and associated soft tissue infections, ORBAX Tablets should be given for two (2) to three (3) days beyond the cessation of clinical signs to a maximum of 30 days. For the treatment of urinary tract infections, ORBAX Tablets should be administered for at least 10 consecutive days. If no improvement is seen within five (5) days, the diagnosis should be re-evaluated and a different course of therapy considered.
Drug Interactions: Compounds (eg, sucralfate, antacids, and multivitamins) containing divalent and trivalent cations (eg, iron, aluminum, calcium, magnesium, and zinc) may substantially interfere with the absorption of quinolones resulting in a decrease in product bioavailability. Therefore, the concomitant oral administration of quinolones with foods, supplements, or other preparations containing these compounds should be avoided.
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.
Precautions: The use of fluoroquinolones in cats has been reported to adversely affect the retina. Such products should be used with caution in cats. Quinolones should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures. Quinolones have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. The safety of orbifloxacin in animals that are used for breeding or that are pregnant and/or lactating has not been demonstrated.
Warnings: For use in animals only. Do not exceed 7.5 mg/kg body weight per day in cats. Keep out of the reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposure. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight.
Adverse Reactions: The following adverse reactions are rare and include Hypersensitivity (facial edema, anaphylaxis/anaphylactoid reactions, neurologic: seizures, ataxia), behavioral (depression, lethargy), and gastrointestinal (vomiting, anorexia).
How Supplied: ORBAX (orbifloxacin) Tablets are available in 5.7 mg/250 yellow tablets; 22.7 mg/250 green, single-scored tablets; 68 mg/100 blue, single-scored tablets
Storage: Store between 2° and 30°C (36° and 86°F). Protect from excessive moisture.
Federal (USA) 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.
