orbifloxacin

For the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Proteus mirabilis, Escherichia coli and Enterococcus faecalis; and for the treatment of 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, B-hemolytic streptococci (Group G) and Streptococcus equisimilis.

Federal law prohibits the extralabel use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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).

Orbax®

POSATEX Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Posatex® Otic Suspension

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

Administer orally 2.5 milligrams per kilogram of body weight once daily for 2 to 3 days beyond cessation of clinical signs for up to a maximum of 30 days. May be increased to 7.5 milligrams per kilogram if needed. For treatment of skin and associated soft tissue infections, administer for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days. For treatment of urinary tract infections, use for at least 10 consecutive days. If no improvement is seen within 5 days, diagnosis should be reevaluated and a different course of therapy considered. Orbifloxacin is contraindicated in immature dogs during the rapid growth phase. Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species. 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.

Orbax® Tablets

For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Pasteurella multocida.

Do not exceed 3.4 mg/lb (7.5 mg/kg) of body weight per day in cats. Federal law prohibits the extralabel use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Orbax®

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

Administer orally 2.5 milligrams per kilogram of body weight once daily for 2 to 3 days beyond cessation of clinical signs for up to a maximum of 30 days. May be increased to 7.5 milligrams per kilogram if needed. For treatment of skin and associated soft tissue infections, administer for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days. For treatment of urinary tract infections, use for at least 10 consecutive days. If no improvement is seen within 5 days, diagnosis should be reevaluated and a different course of therapy considered. Orbifloxacin is contraindicated in immature dogs during the rapid growth phase. Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species. 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.

Orbax® Tablets

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.

ORBAX® (Orbifloxacin) Oral Suspension

INDICATIONS: POSATEX® Otic Suspension is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (coagulase positive staphylococci, Pseudomonas aeruginosa, and Enterococcus faecalis).

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

INDICATIONS: ORBAX® Oral Suspension is indicated for the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Staphylococcus aureus , Escherichia coli , and Pasteurella multocida.

ORBAX® (Orbifloxacin) Oral Suspension

CLINICAL PHARMACOLOGY:

ORBAX® (Orbifloxacin) Oral Suspension

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 known to be hypersensitive to quinolones.

ORBAX® (Orbifloxacin) Oral Suspension

CONTRAINDICATIONS: POSATEX® Otic Suspension is contraindicated in dogs with known or suspected hypersensitivity to quinolones, mometasone furoate monohydrate, or posaconazole. Do not use in dogs with known tympanic perforation (see PRECAUTIONS ).

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

HUMAN WARNING: For use in animals only. Keep out of the reach of children. 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. 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.

ORBAX® (Orbifloxacin) Oral Suspension

ADVERSE REACTIONS: In a field study, when the tablet formulation of orbifloxacin was administered at 2.5 mg/kg/day, no drug-related adverse reactions were reported. In a foreign field study using the oral suspension at 7.5 mg/kg/day, vomiting was reported for ORBAX® Oral Suspension and the comparator. Post Approval Experience with ORBAX® (orbifloxacin) Tablets (Rev. 2010): The following adverse events are based on post-approval adverse drug experience reporting with ORBAX® 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. For a complete listing of adverse reactions for ORBAX® (orbifloxacin) Tablets reported to the CVM see: http://www.fda.gov/reportanimalae For technical assistance or to report a suspected adverse reaction call 1-800-224-5318.

ORBAX® (Orbifloxacin) Oral Suspension

ADVERSE REACTIONS: In a field study, when the tablet formulation of orbifloxacin was administered at 2.5 mg/kg/day, no drug-related adverse reactions were reported. In a foreign field study using the oral suspension at 7.5 mg/kg/day, vomiting was reported for ORBAX® Oral Suspension and the comparator. Post Approval Experience with ORBAX® (orbifloxacin) Tablets (Rev. 2010): The following adverse events are based on post-approval 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: DOG: Vomiting, convulsions, depression/lethargy, anorexia For a complete listing of adverse reactions for ORBAX® (orbifloxacin) Tablets reported to the CVM see: http://www.fda.gov/reportanimalae For technical assistance or to report a suspected adverse reaction call 1-800-224-5318.

ORBAX® (Orbifloxacin) Oral Suspension

ADVERSE REACTIONS: In the field study, 143 dogs were treated with POSATEX® Otic Suspension. Of those, 1 dog with bilateral otitis externa developed hearing loss. POSATEX® Otic Suspension treatment was discontinued and the condition resolved after one week. To report suspected adverse reactions, call 1-800-224-5318. For a copy of the Material Safety Data Sheet (MSDS) call 1-800-770-8878.

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)

For dogs weighing less than 30 lbs. instill 4 drops of POSATEX Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy should continue for 7 consecutive days. Four drops of POSATEX Otic Suspension delivers approximately 1.0 mg of orbifloxacin, 0.1 mg of mometasone furoate monohydrate, and 0.1 mg of posaconazole.

Otic

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Posatex® Otic Suspension

Administer 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg) of body weight once daily.

Oral

Federal law prohibits the extralabel use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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).

Orbax®

2.5 to 7.5 mg/kg of body weight administered once daily.

Oral

Administer orally 2.5 milligrams per kilogram of body weight once daily for 2 to 3 days beyond cessation of clinical signs for up to a maximum of 30 days. May be increased to 7.5 milligrams per kilogram if needed. For treatment of skin and associated soft tissue infections, administer for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days. For treatment of urinary tract infections, use for at least 10 consecutive days. If no improvement is seen within 5 days, diagnosis should be reevaluated and a different course of therapy considered. Orbifloxacin is contraindicated in immature dogs during the rapid growth phase. Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species. 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.

Orbax® Tablets

Administer 3.4 mg/lb (7.5 mg/kg) of body weight once daily.

Oral

Do not exceed 3.4 mg/lb (7.5 mg/kg) of body weight per day in cats. Federal law prohibits the extralabel use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Orbax®

2.5 to 7.5 mg/kg of body weight administered once daily.

Oral

Administer orally 2.5 milligrams per kilogram of body weight once daily for 2 to 3 days beyond cessation of clinical signs for up to a maximum of 30 days. May be increased to 7.5 milligrams per kilogram if needed. For treatment of skin and associated soft tissue infections, administer for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days. For treatment of urinary tract infections, use for at least 10 consecutive days. If no improvement is seen within 5 days, diagnosis should be reevaluated and a different course of therapy considered. Orbifloxacin is contraindicated in immature dogs during the rapid growth phase. Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species. 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.

Orbax® Tablets

DOSAGE AND ADMINISTRATION: Shake Well Before Use. BEFORE INITIAL USE, remove the cap and insert the syringe adaptor by pressing firmly into top of bottle. Insert the syringe tip into the adaptor opening and invert the bottle. Withdraw the required amount of medication with the calibrated syringe. After use, replace cap, leaving adaptor in the bottle, and rinse the syringe with water. The dose of ORBAX® Oral Suspension in the dog is 1.1 to 3.4 mg/lb (2.5 to 7.5 mg/kg) of body weight administered once daily (See Drug interactions and Animal Safety). The determination of dosage for any particular patient must take into consideration such factors as the severity and nature of the infection, the susceptibility of the causative organism, and the integrity of the patient's host-defense mechanisms. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Therapy with ORBAX® Oral Suspension may be initiated before results of these tests are known. Once results become available, continue with appropriate therapy. For the treatment of skin infections, ORBAX® Oral Suspension 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® Oral Suspension 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.

ORAL

ORBAX® (Orbifloxacin) Oral Suspension

DOSAGE AND ADMINISTRATION: Shake Well Before Use. BEFORE INITIAL USE, remove the cap and insert the syringe adaptor by pressing firmly into top of bottle. Insert the syringe tip into the adaptor opening and invert the bottle. Withdraw the required amount of medication with the calibrated syringe. After use, replace cap, leaving adaptor in the bottle, and rinse the syringe with water. In the cat, ORBAX® Oral Suspension and ORBAX® (orbifloxacin) Tablets are not bioequivalent. On a mg/kg basis, ORBAX® Oral Suspension provides lower and more variable plasma levels of orbifloxacin than ORBAX® (orbifloxacin) Tablets (See Clinical Pharmacology and Precautions). The dose of ORBAX® Oral Suspension in the cat is 3.4 mg/lb (7.5 mg/kg) of body weight administered once daily. DO NOT EXCEED 3.4 mg/lb (7.5 mg/kg) BODY WEIGHT PER DAY IN CATS. ORBAX® Oral Suspension should be given for two (2) to three (3) days beyond the cessation of clinical signs. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Therapy with ORBAX® Oral Suspension may be initiated before results of these tests are known. Once results become available, continue with appropriate therapy. If no improvement is seen within 3 to 4 days, the diagnosis should be re-evaluated and a different course of therapy considered.

ORAL

ORBAX® (Orbifloxacin) Oral Suspension

DOSAGE AND ADMINISTRATION: Shake well before use. For dogs weighing less than 30 lbs. instill 4 drops of POSATEX® Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs. or more, instill 8 drops once daily into the ear canal. Therapy should continue for 7 consecutive days.

AURICULAR (OTIC)

Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)