[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$f3iqzorhqo7l1k":5},{"data":4},[],{"data":6,"error":10},{"id":7,"documentId":8,"slug":9,"name":9,"proprietary_name":10,"non_proprietary_name":10,"is_proprietary":10,"active_ingredient":10,"administration_route":10,"available_strength":10,"dosage_form":10,"dose_schedule":10,"drug_unit":10,"is_available_generically":10,"mechanism_of_action":10,"overdosage":10,"warning":10,"species":11,"citations":12,"dose_schedules":27,"available_strengths":66,"label_statements":86,"drug_classes":136,"specialties":142,"medical_conditions":143,"animal_species":154},1871,"b2eikasc3sutxqaj056939kv","orbifloxacin",null,[],[13,19,23],{"source":14,"licence":15,"source_url":16,"harvested_by":17,"retrieved_at":18},"EMA centrally authorised medicines","EMA reuse with attribution","https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fdocuments\u002Freport\u002Fmedicines-output-medicines-report_en.xlsx","load-reference-corpus.cjs","2026-09-07",{"source":20,"licence":21,"source_url":22,"harvested_by":17,"retrieved_at":18},"FDA Green Book","US public domain","https:\u002F\u002Fanimaldrugsatfda.fda.gov\u002Fadafda\u002Fapp\u002Fsearch\u002Fpublic\u002FingredientsInformationExcel\u002FSection2ActiveIngredients",{"source":24,"licence":25,"source_url":26,"harvested_by":17,"retrieved_at":18},"UK VMD PID","OGL v3.0","https:\u002F\u002Fwww.vmd.defra.gov.uk\u002Fproductinformationdatabase\u002Fdownloads\u002Fvmd_productinformationdatabase.xlsx",[28,35,41,46,51,53,58,61],{"id":29,"dose_text":30,"species":31,"administration_route":32,"limitation":33,"source_label":34},13803,"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.","Dogs","Otic","Federal law restricts this drug to use by or on the order of a licensed veterinarian.","Posatex® Otic Suspension",{"id":36,"dose_text":37,"species":31,"administration_route":38,"limitation":39,"source_label":40},13804,"Administer 1.1 to 3.4 mg\u002Flb (2.5 to 7.5 mg\u002Fkg) 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®",{"id":42,"dose_text":43,"species":31,"administration_route":38,"limitation":44,"source_label":45},13805,"2.5 to 7.5 mg\u002Fkg of body weight administered once\ndaily.","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.\nFederal law restricts this drug to use by or on\nthe order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food producing animals.","Orbax® Tablets",{"id":47,"dose_text":48,"species":49,"administration_route":38,"limitation":50,"source_label":40},13806,"Administer 3.4 mg\u002Flb (7.5 mg\u002Fkg) of body weight once daily.","Cats","Do not exceed 3.4 mg\u002Flb (7.5 mg\u002Fkg) 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.",{"id":52,"dose_text":43,"species":49,"administration_route":38,"limitation":44,"source_label":45},13807,{"id":54,"dose_text":55,"species":10,"administration_route":56,"limitation":10,"source_label":57},13808,"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.\nThe dose of ORBAX® Oral Suspension in the dog is 1.1 to 3.4 mg\u002Flb (2.5 to 7.5 mg\u002Fkg) 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.\nFor 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",{"id":59,"dose_text":60,"species":10,"administration_route":56,"limitation":10,"source_label":57},13809,"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.\nIn the cat, ORBAX® Oral Suspension and ORBAX® (orbifloxacin) Tablets are not bioequivalent. On a mg\u002Fkg 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\u002Flb (7.5 mg\u002Fkg) of body weight administered once daily. DO NOT EXCEED 3.4 mg\u002Flb (7.5 mg\u002Fkg) 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.\nAntibiotic 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.",{"id":62,"dose_text":63,"species":10,"administration_route":64,"limitation":10,"source_label":65},13810,"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)",[67,71,73,77,79,83],{"id":68,"strength_text":69,"dosage_form":70,"proprietary_name":45,"species":31,"source_label":45},11993,"Each tablet contains 22.7, or 68 milligrams of orbifloxacin.","Tablet",{"id":72,"strength_text":69,"dosage_form":70,"proprietary_name":45,"species":49,"source_label":45},11994,{"id":74,"strength_text":75,"dosage_form":76,"proprietary_name":40,"species":49,"source_label":40},11995,"Each mL of oral suspension contains 30 mg of orbifloxacin.","Liquid (Suspension)",{"id":78,"strength_text":75,"dosage_form":76,"proprietary_name":40,"species":31,"source_label":40},11996,{"id":80,"strength_text":81,"dosage_form":82,"proprietary_name":34,"species":31,"source_label":34},11997,"Each gram of POSATEX Otic Suspension contains 10 mg orbifloxacin; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 1 mg posaconazole in a mineral oil based system containing a plasticized hydrocarbon gel.","Topical Suspension",{"id":84,"strength_text":85,"dosage_form":10,"proprietary_name":10,"species":10,"source_label":57},11998,"30 mg \u002F 1 mL",[87,91,94,97,100,102,105,108,111,115,118,122,126,129,132],{"id":88,"kind":89,"statement":90,"species":31,"limitation":39,"source_label":40},20289,"indication","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.",{"id":92,"kind":89,"statement":93,"species":31,"limitation":33,"source_label":34},20290,"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).",{"id":95,"kind":89,"statement":96,"species":31,"limitation":44,"source_label":45},20291,"ORBAX® (orbifloxacin) Tablets are indicated for the management of\ndiseases in dogs and cats associated with bacteria susceptible to orbifloxacin.",{"id":98,"kind":89,"statement":99,"species":49,"limitation":50,"source_label":40},20292,"For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Staphylococcus aureus, Escherichia coli, and Pasteurella multocida.",{"id":101,"kind":89,"statement":96,"species":49,"limitation":44,"source_label":45},20293,{"id":103,"kind":89,"statement":104,"species":10,"limitation":10,"source_label":57},20294,"INDICATIONS: ORBAX® Oral Suspension is indicated for the treatment of urinary tract infections (cystitis) in dogs caused by susceptible strains of Staphylococcus pseudintermedius,\nProteus mirabilis,\nEscherichia 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,\nStaphylococcus aureus, coagulase positive staphylococci, Pasteurella multocida,\nProteus mirabilis,\nPseudomonas spp., Klebsiella pneumoniae,\nEscherichia coli,\nEnterobacter spp., Citrobacter spp., Enterococcus faecalis, β-hemolytic streptococci (Group G) and Streptococcus equisimilis.",{"id":106,"kind":89,"statement":107,"species":10,"limitation":10,"source_label":65},20295,"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).",{"id":109,"kind":89,"statement":110,"species":10,"limitation":10,"source_label":57},20296,"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.",{"id":112,"kind":113,"statement":114,"species":10,"limitation":10,"source_label":57},20297,"contraindication","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).\nOrbifloxacin is contraindicated in dogs known to be hypersensitive to quinolones.",{"id":116,"kind":113,"statement":117,"species":10,"limitation":10,"source_label":65},20298,"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\nPRECAUTIONS\n).",{"id":119,"kind":120,"statement":121,"species":10,"limitation":10,"source_label":57},20299,"warning","HUMAN WARNING: For use in animals only. Keep out of the reach of children.\nIndividuals 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.\nAvoid 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.",{"id":123,"kind":124,"statement":125,"species":10,"limitation":10,"source_label":57},20300,"adverse_reaction","ADVERSE REACTIONS: In a field study, when the tablet formulation of orbifloxacin was administered at 2.5 mg\u002Fkg\u002Fday, no drug-related adverse reactions were reported. In a foreign field study using the oral suspension at 7.5 mg\u002Fkg\u002Fday, vomiting was reported for ORBAX® Oral Suspension and the comparator.\nPost 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:\nCAT: Blindness, mydriasis, anorexia, ataxia, depression\u002Flethargy, vomiting, convulsions, abnormal retina, hypersalivation. In some cases, blindness has been temporary.\nFor a complete listing of adverse reactions for ORBAX® (orbifloxacin) Tablets reported to the CVM see:\nhttp:\u002F\u002Fwww.fda.gov\u002Freportanimalae\nFor technical assistance or to report a suspected adverse reaction call 1-800-224-5318.",{"id":127,"kind":124,"statement":128,"species":10,"limitation":10,"source_label":57},20301,"ADVERSE REACTIONS: In a field study, when the tablet formulation of orbifloxacin was administered at 2.5 mg\u002Fkg\u002Fday, no drug-related adverse reactions were reported. In a foreign field study using the oral suspension at 7.5 mg\u002Fkg\u002Fday, vomiting was reported for ORBAX® Oral Suspension and the comparator.\nPost 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:\nDOG: Vomiting, convulsions, depression\u002Flethargy, anorexia\nFor a complete listing of adverse reactions for ORBAX® (orbifloxacin) Tablets reported to the CVM see:\nhttp:\u002F\u002Fwww.fda.gov\u002Freportanimalae\nFor technical assistance or to report a suspected adverse reaction call 1-800-224-5318.",{"id":130,"kind":124,"statement":131,"species":10,"limitation":10,"source_label":65},20302,"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.\nTo report suspected adverse reactions, call 1-800-224-5318.\nFor a copy of the Material Safety Data Sheet (MSDS) call 1-800-770-8878.",{"id":133,"kind":134,"statement":135,"species":10,"limitation":10,"source_label":57},20303,"mechanism_of_action","CLINICAL PHARMACOLOGY:",[137],{"id":138,"documentId":139,"slug":140,"name":141},1000,"bf43cz32i9noskdm3trobgt0","otologicals","Otologicals",[],[144,149],{"id":145,"documentId":146,"slug":147,"title":148},115,"qsinaxvmzakywujz5lx1hjzp","cystitis","Cystitis",{"id":150,"documentId":151,"slug":152,"title":153},197,"kvl4hf3ri3woskokfd2sluaq","urinary-tract-infection","Urinary tract infection",[]]