[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$f1bktmccmtrzfx":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":61,"label_statements":87,"drug_classes":149,"specialties":155,"medical_conditions":156,"animal_species":157},1816,"gkaogu2pd8fvqp7k6t5f9vm8","terbinafine",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",[28,35,40,44,48,53,57],{"id":29,"dose_text":30,"species":31,"administration_route":32,"limitation":33,"source_label":34},13341,"Administer one dose (1 dropperette) per affected ear. The duration of effect should last 30 days.","Dogs","Otic","For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.","CLARO™",{"id":36,"dose_text":37,"species":31,"administration_route":32,"limitation":38,"source_label":39},13342,"Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.","Federal law restricts this drug to use by or on the order of a licensed veterinarian.","Osurnia™",{"id":41,"dose_text":42,"species":31,"administration_route":32,"limitation":10,"source_label":43},13343,"Administer one dose (1 dropperette) per affected ear.","SIMPLERA™",{"id":45,"dose_text":46,"species":31,"administration_route":32,"limitation":10,"source_label":47},13344,"Administer one dose (1 tube) per affected ear once.","Otiserene®",{"id":49,"dose_text":50,"species":10,"administration_route":51,"limitation":10,"source_label":52},13345,"SIMPLERA should be administered by veterinary personnel.\nWear eye protection when administering SIMPLERA. (see\nHuman Warnings, PRECAUTIONS, POST-APPROVAL EXPERIENCE\n).\nSplatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure.\nShake before use.\nVerify the tympanic membrane is intact prior to administration. (see\nCONTRAINDICATIONS,\nPRECAUTIONS, POST-APPROVAL EXPERIENCE\n).\nAdminister one dose (1 dropperette) per affected ear.\n1.Clean and dry the external ear canal before administering the product.\n2.Verify the tympanic membrane is intact prior to administration.\n3.Remove single dose dropperette from the package.\n4.While holding the dropperette in an upright position, remove the cap from the dropperette.\n5.Turn the cap over and push the other end of the cap onto the tip of the dropperette.\n6.Twist the cap to break the seal and then remove cap from the dropperette.\n7.Screw the applicator nozzle onto the dropperette.\n8.Insert the tapered tip of the dropperette into the affected external ear canal and squeeze to instill the entire contents (1 mL) into the affected ear.\n9.Gently massage the base of the ear to allow distribution of the solution. Restrain the dog to minimize post application head shaking to reduce potential for splatter of product and accidental eye exposure in people and dogs (see\nPOST-APPROVAL EXPERIENCE\n).\n10.Repeat with other ear as prescribed.\n11.The duration of effect should last 30 days. Cleaning the ear after dosing may affect product effectiveness.","AURICULAR (OTIC)","SIMPLERA™ (florfenicol, terbinafine, mometasone furoate)",{"id":54,"dose_text":55,"species":10,"administration_route":51,"limitation":10,"source_label":56},13346,"DuOtic™ should be administered by a veterinary professional. Wear eye protection when administering DuOtic™ (see\nHuman Safety Warnings, Precautions, Post-approval Experience, and\nTarget Animal Safety\n).\nSplatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure.\nClean and dry the external ear canal before administering the initial dose of the product.\nVerify the tympanic membrane is intact prior to each administration (see\nPrecautions, Contraindications, Target Animal Safety\nand\nPost-approval Experience\n).\nAdminister one dose (1 tube) per affected ear. Repeat administration in 7 days.\nOpen tube by twisting the soft tip. Insert the flexible tip in the affected external ear canal and squeeze entire tube contents into the external ear canal. After application, gently massage the base of the ear to allow the gel to penetrate the lower part of the ear canal.\nRestrain dog to minimize post-application head shaking to reduce potential for splatter of product, and accidental eye exposure in people and dogs (see\nPost-Approval Experience\nand\nTarget Animal Safety\n).\nDo not clean the ear canal for 45 days after the initial administration to allow contact of the gel with the ear canal. Cleaning the ear may affect product effectiveness (see\nEffectiveness\n). If alternative otic therapies are required, it is recommended to clean the ear(s) before application of those therapies.","DuOtic™(terbinafine and betamethasone acetate otic gel)",{"id":58,"dose_text":59,"species":10,"administration_route":51,"limitation":10,"source_label":60},13347,"Klentz should be administered by veterinary personnel.\nWear eye protection when administering Klentz. (see\nHuman Warnings, Precautions, Post-Approval Experience\n).\nSplatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure.\nShake before use.\nVerify the tympanic membrane is intact prior to administration. (see\nContraindications, Precautions, Post-Approval Experience\n).\nAdminister one dose (1 dropperette) per affected ear.\n1. Clean and dry the external ear canal before administering the product.\n2. Verify the tympanic membrane is intact prior to administration.\n3. Remove single dose dropperette from the package.\n4. While holding the dropperette in an upright position, twist the cap to open the dropperette. The cap does not come off the dropperette.\n5. Insert the tapered tip of the dropperette into the affected external ear canal and squeeze to instill the entire contents (1 mL) into the affected ear.\n6. Gently massage the base of the ear to allow distribution of the solution.\nRestrain the dog to minimize post application head shaking to reduce potential for splatter of product and accidental eye exposure in people and dogs (see\nPost-Approval Experience\n).\n7. Repeat with other ear as prescribed.\n8. The duration of the effect should last 30 days. Cleaning the ear after dosing may affect product effectiveness.","Klentz™ (florfenicol, terbinafine, mometasone furoate)",[62,66,70,73,77,81,84],{"id":63,"strength_text":64,"dosage_form":65,"proprietary_name":34,"species":31,"source_label":34},11574,"16.6 mg\u002FmL florfenicol, 14.8 mg\u002FmL terbinafine (equivalent to 16.6 mg\u002FmL terbinafine hydrochloride), 2.2 mg\u002FmL mometasone furoate","Solution",{"id":67,"strength_text":68,"dosage_form":69,"proprietary_name":39,"species":31,"source_label":39},11575,"10 mg florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate per mL","Gel",{"id":71,"strength_text":72,"dosage_form":65,"proprietary_name":43,"species":31,"source_label":43},11576,"16.6 mg\u002FmL florfenicol, 14.8 mg\u002FmL terbinafine (equivalent to 16.6 mg\u002FmL terbinafine hydrochloride) and 2.2 mg\u002FmL mometasone furoate",{"id":74,"strength_text":75,"dosage_form":69,"proprietary_name":76,"species":31,"source_label":76},11577,"10 mg terbinafine and 1 mg betamethasone acetate per mL","DuOtic®",{"id":78,"strength_text":79,"dosage_form":80,"proprietary_name":47,"species":31,"source_label":47},11578,"15.1 mg marbofloxacin, 22.7 mg terbinafine, 2.01 mg dexamethasone per tube","Otic Suspension",{"id":82,"strength_text":72,"dosage_form":65,"proprietary_name":83,"species":31,"source_label":83},11579,"Klentz™",{"id":85,"strength_text":72,"dosage_form":65,"proprietary_name":86,"species":31,"source_label":86},11580,"Florfinasone™ Otic",[88,92,95,98,101,104,108,111,115,118,121,125,128,132,135,138,142,146],{"id":89,"kind":90,"statement":91,"species":31,"limitation":10,"source_label":86},19596,"indication","Florfinasone™ Otic is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).",{"id":93,"kind":90,"statement":94,"species":31,"limitation":38,"source_label":39},19597,"For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).",{"id":96,"kind":90,"statement":97,"species":31,"limitation":10,"source_label":47},19598,"For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius) in dogs.",{"id":99,"kind":90,"statement":100,"species":31,"limitation":10,"source_label":76},19599,"For the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).",{"id":102,"kind":90,"statement":103,"species":10,"limitation":10,"source_label":52},19600,"SIMPLERA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).",{"id":105,"kind":90,"statement":106,"species":10,"limitation":10,"source_label":107},19601,"OSURNIA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).","Osurnia® (florfenicol, terbinafine, betamethasone acetate)",{"id":109,"kind":90,"statement":110,"species":10,"limitation":10,"source_label":56},19602,"DuOtic™ is indicated for the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).",{"id":112,"kind":113,"statement":114,"species":10,"limitation":10,"source_label":52},19603,"contraindication","Do not use in dogs with known tympanic membrane perforation (see\nPRECAUTIONS\n).\nSIMPLERA is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.",{"id":116,"kind":113,"statement":117,"species":10,"limitation":10,"source_label":60},19604,"Do not use in dogs with known tympanic membrane perforation (see\nPrecautions\n).\nKlentz is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.",{"id":119,"kind":113,"statement":120,"species":10,"limitation":10,"source_label":107},19605,"Do not use in dogs with known tympanic perforation (see\nPrecautions\n). Do not use in dogs with a hypersensitivity to florfenicol, terbinafine or corticosteroids.",{"id":122,"kind":123,"statement":124,"species":10,"limitation":10,"source_label":60},19606,"warning","Human Warnings:\nKlentz\nmay cause eye injury and irritation (see\nPrecautions, Post-Approval Experience\n).\nIf contact with eyes occurs, flush copiously with water for at least 15 minutes. If irritation persists, contact a physician.\nHumans with known hypersensitivity to any of the active ingredients in Klentz should not handle this product.\nNot for use in humans. Keep this and all drugs out of the reach of children. Avoid skin contact. In case of accidental ingestion by humans, contact a physician immediately.",{"id":126,"kind":123,"statement":127,"species":10,"limitation":10,"source_label":52},19607,"CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.",{"id":129,"kind":130,"statement":131,"species":10,"limitation":10,"source_label":107},19608,"adverse_reaction","The following adverse reactions were reported during the course of a US field study for treatment of otitis externa in dogs treated with OSURNIA with 1 tube per affected ear(s) and repeated after 7 days:\nFrequency of Adverse Reaction by Treatment\nAdverse Reaction\nOSURNIA (n=190)\nPlacebo (n=94)\nElevated Alkaline Phosphatase\n15 (7.9%)\n3 (3.2%)\nVomiting\n7 (3.7%)\n1 (1.1%)\nElevated AST, ALT, ALPAspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP). Two dogs with pre-existing elevations in ALP were reported to have an increase in liver enzymes (ALP, ALT and\u002For AST) at study exit. Subsequent clinical chemistries returned to pre-treatment levels in one dog, while no follow-up was performed for the second dog.\n2 (1.1%)\n0 (0.0%)\nWeight loss (>10% body weight)\n1 (0.53%)\n0 (0.0%)\nHearing Decrease\u002FLoss\n1 (0.53%)\n1 (1.1%)",{"id":133,"kind":130,"statement":134,"species":10,"limitation":10,"source_label":56},19609,"The following adverse reactions were reported during the course of a US field study for treatment of otitis externa in dogs treated with DuOtic™ with 1 tube per affected ear(s) and repeated after 7 days:\nNumber (%) of dogs with Adverse Reactions by Treatment\nAdverse Reaction\nDuOtic™\n(n=120)\nControl\n(n=119)\nElevated alanine aminotransferaseFour dogs were reported to have an increase in alanine aminotransferase at Study Exit. The levels reported in subsequent clinical chemistries returned to normal in three dogs, while no follow up was performed for the fourth dog.\n4 (3.3%)\n0 (0.0%)\nConjunctivitis\n1 (0.8%)\n0 (0.0%)\nOcular discharge\n1 (0.8%)\n2 (1.7%)\nEar discharge\n0 (0.0%)\n1 (0.8%)\nEar pruritus\n3 (2.5%)\n4 (3.4%)",{"id":136,"kind":130,"statement":137,"species":10,"limitation":10,"source_label":60},19610,"In a field study conducted in the United States (see\nEffectiveness\n), there were no directly attributable adverse reactions in 146 dogs administered florfenicol, terbinafine, and mometasone furoate otic solution.",{"id":139,"kind":130,"statement":140,"species":10,"limitation":10,"source_label":141},19611,"In a field study conducted in the United States (see\nEffectiveness\n), there were no directly attributable adverse reactions in 146 dogs administered CLARO.","CLARO™ Elanco TM (florfenicol, terbinafine, mometasone furoate)",{"id":143,"kind":144,"statement":145,"species":10,"limitation":10,"source_label":107},19612,"mechanism_of_action","OSURNIA is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal) and betamethasone acetate (steroidal anti-inflammatory). Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria. Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity.\nOSURNIA dissolves in ear wax and is slowly eliminated from the ear mechanically. Ear inflammation can increase the percutaneous absorption of active substances in OSURNIA.\nIn a laboratory study conducted in healthy dogs (see\nAnimal Safety\n), low plasma concentrations of florfenicol, terbinafine, and betamethasone acetate were measurable during the first 2-4 days after administration of 1× dose, and during the first 2-7 days after administration of 5× dose. No quantifiable plasma concentrations of any of the three active ingredients were observed in the pre-dose samples of most dogs prior to second and third administrations. Although total and peak exposure in the blood tended to be highly variable between dogs, systemic drug concentrations tended to increase in a less than dose-proportional manner as the administered dose increased from 1× to 5×.",{"id":147,"kind":144,"statement":148,"species":10,"limitation":10,"source_label":56},19613,"DuOtic™ is a fixed combination of two active ingredients: terbinafine (antifungal) and betamethasone acetate (steroidal anti-inflammatory). Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity.\nDuOtic™ dissolves in ear wax and is slowly eliminated from the ear mechanically. Ear inflammation can increase the percutaneous absorption of active substances in DuOtic™.\nIn a laboratory study conducted in healthy dogs administered Osurnia® (see\nTarget Animal Safety\n), low plasma concentrations of florfenicol, terbinafine, and betamethasone acetate were measurable during the first 2-4 days after administration of 1X dose, and during the first 2-7 days after administration of 5X dose. No quantifiable plasma concentrations of any of the three active ingredients were observed in the pre-dose samples of most dogs prior to second and third administrations. Although total and peak exposure in the blood tended to be highly variable between dogs, systemic drug concentrations tended to increase in a less than dose-proportional manner as the administered dose increased from 1X to 5X. The systemic exposure of terbinafine and betamethasone are not expected to be affected by the removal of florfenicol from the formulation.",[150],{"id":151,"documentId":152,"slug":153,"name":154},843,"fz5q3kb0a89c3m4grewa9a76","ergosterol-synthesis-inhibitors","Ergosterol Synthesis Inhibitors",[],[],[]]