Orbax for Dogs & Cats - 68 mg (per tab) - [Skin Health]

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.

Key Benefits

• Once-a day dosing for better compliance.
• Approved for use in both cats and dogs.
• Flexible dose range for treatment in accordance with the clinical severity of the condition.
• Broad spectrum bactericidal activity for high first-treatment cure rates.
• Color coded tablets for simplified dosing.
• E-Z Break scoring for breaking larger sized tablets without a pill cutter.
• Low protein binding level.¹

How it works

Orbax (orbifloxacin) belongs to a class of drugs known as fluoroquinolone antibiotics. It acts by inhibiting the synthesis of bacterial DNA, resulting in death of the bacteria.

Indications

Orbax (orbifloxacin) Tablets are indicated for the management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin.

• Orbax is a prescription broad-spectrum antibiotic used in cats and dogs to treat bacterial infections of the urinary tract, skin, and soft tissue caused by susceptible bacteria.
• Orbax is available as 22.7 mg and 68 mg tablets and an oral suspension 30 mg/ml 20 ml bottle.
• Allow plenty of water for your pet to drink.
• For Orbax Oral Suspension, shake the bottle well before use, and follow your veterinarian's instructions exactly as directed. For accurate dosing use the dosing syringe included with Orbax Oral Suspension.
• This is an antibiotic which can have a wide dosing range depending on what the veterinarian feels is appropriate for your pet. Factors including the age of the pet, kidney function, liver function, condition and health of your pet, and other factors can contribute to the dose that is finally chosen after examining your pet. Please consult your veterinarian to ensure the correct dose is being given

Tip: Give all of the medication your veterinarian has prescribed. Symptoms may start to improve before the infection is completely treated.

Cautions:

Orbax should be used with caution in young, growing pets as well as with pregnant or nursing pets. It should not be given with meals.

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:

Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of the development of drug-resistant animal pathogens.

The use of fluoroquinolones in cats has been reported to adversely affect the retina. Such products should be used with caution in cats. Blindness has also been reported post-approval in cats. In some cases, blindness has been temporary. Do not exceed 3.4 mg/lb (7.5 mg/kg) Body weight per day 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.

Administer orbifloxacin with caution in the presence of hepatic insufficiency/impairment. 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:

In clinical trials, when the drug was administered at 2.5 mg/kg/day, no drug-related adverse reactions were reported.

Post Approval Experience with ORBAX (orbifloxacin) Tablets (Rex 2010): The following adverse events are based on postapproval adverse drug experience reporting with ORBAX (orbifloxacin) Tablets. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are listed in decreasing order of reporting frequency:

CAT: Blindness, mydriasis, anorexia, ataxia, depression/lethargy, vomiting, convulsions, abnormal retina, hypersalivation. In some cases, blindness has been temporary.

DOG: Vomiting, convulsions, depression/lethargy, anorexia.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Target Animal Safety:

Orbifloxacin administered to young, clinically healthy, adult dogs and cats at doses of 7.5 mg/kg, 22.5 mg/kg, and 37.5 mg/kg for 30 consecutive days was well tolerated. At the exaggerated doses of 22.5 and 37.5 mg/kg/day, orbifloxacin caused mild gastrointestinal effects (soft feces) in both male and female cats. Emesis (males only), diarrhea (males only), reduced food consumption with subsequent reduced body weight were evident in cats administered ORBAX® (orbifloxacin) Tablets at 75 mg/kg/day for 10 days. 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. In 8- to 10-week-old beagle puppies dosed daily with orbifloxacin for 30 days, microscopic lesions consistent with fluoroquinolone-induced arthropathy of the articular cartilage was seen in only one of eight dogs dosed at 12.5 mg/kg, and in all eight dogs dosed at 25 mg/kg. (See Contraindications.) No arthropathy was noted in 12-week-old kittens administered orbifloxacin at doses as high as 25 mg/kg for 1 month.