[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$fw0gbiudfoyj4":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":74,"label_statements":104,"drug_classes":168,"specialties":179,"medical_conditions":180,"animal_species":181},1750,"quvok0svm4opigr8st62hyex","mometasone",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",[28,35,39,44,48,53,57,62,66,70],{"id":29,"dose_text":30,"species":31,"administration_route":32,"limitation":33,"source_label":34},12581,"For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (2 drops from the 215 g bottle) once daily in the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (4 drops from the 215 g bottle) once daily in the ear canal. Therapy should continue for 7 consecutive days.","Dogs","Otic","Federal law restricts this drug to use by or on the order of a licensed veterinarian.","Mometavet®",{"id":36,"dose_text":37,"species":31,"administration_route":32,"limitation":33,"source_label":38},12582,"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.","Posatex® Otic Suspension",{"id":40,"dose_text":41,"species":31,"administration_route":42,"limitation":33,"source_label":43},12583,"For dogs weighing less than 30 lbs, instill 4\ndrops from the 7.5g, 15g, or 30g bottle into the\near canal (2 drops from the 215g bottle) or, for\ndogs weighing 30 lbs or more, instill 8 drops\nfrom the 7.5g, 15g or 30g bottle into the ear\ncanal (4 drops from the 215g bottle), once\ndaily for 7 days.","Topical","Mometamax™ Otic Suspension",{"id":45,"dose_text":46,"species":31,"administration_route":32,"limitation":10,"source_label":47},12584,"Mometamax Single™ should be administered by veterinary personnel. The dose volume is 0.8 mL per affected ear. Verify the tympanic membrane is intact prior to administration.","Mometamax Single™",{"id":49,"dose_text":50,"species":31,"administration_route":32,"limitation":51,"source_label":52},12585,"Administer one dose (1 dropperette) per affected ear. The duration of effect should last 30 days.","For otic use in dogs only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.","CLARO™",{"id":54,"dose_text":55,"species":31,"administration_route":32,"limitation":10,"source_label":56},12586,"Administer one dose (1 dropperette) per affected ear.","SIMPLERA™",{"id":58,"dose_text":59,"species":10,"administration_route":60,"limitation":10,"source_label":61},12587,"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":63,"dose_text":64,"species":10,"administration_route":60,"limitation":10,"source_label":65},12588,"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)",{"id":67,"dose_text":68,"species":10,"administration_route":60,"limitation":10,"source_label":69},12589,"DOS\nAGE\nAN\nD ADMINISTRATION:\nThe external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (2 drops from the 215 g bottle) of Mometavet™ Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g tubes and bottles, 15 g tubes and bottles, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.","MOMETAVETTM (gentamicin sulfate, mometasone furoate anhydrous, and clotriamzole Otic Suspension)",{"id":71,"dose_text":72,"species":10,"administration_route":60,"limitation":10,"source_label":73},12590,"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.","Posatex® Otic Suspension (Orbifloxacin, Mometasone Furoate Monohydrate and Posaconazole, Suspension)",[75,79,83,87,91,94,98,101],{"id":76,"strength_text":77,"dosage_form":78,"proprietary_name":43,"species":31,"source_label":43},10856,"Each gram contains 3 mg gentamicin base; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 10 mg clotrimazole, in a mineral oil-based system containing a plasticized hydrocarbon gel.","Liquid (Suspension)",{"id":80,"strength_text":81,"dosage_form":82,"proprietary_name":38,"species":31,"source_label":38},10857,"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":86,"proprietary_name":52,"species":31,"source_label":52},10858,"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":88,"strength_text":89,"dosage_form":90,"proprietary_name":34,"species":31,"source_label":34},10859,"Each gram contains gentamicin sulfate, USP equivalent to 3 mg gentamicin base; mometasone furoate anhydrous, USP equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP.","Suspension",{"id":92,"strength_text":93,"dosage_form":86,"proprietary_name":56,"species":31,"source_label":56},10860,"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":95,"strength_text":96,"dosage_form":97,"proprietary_name":47,"species":31,"source_label":47},10861,"A 0.8 mL dose delivers 6.88 mg gentamicin, 2.08 mg posaconazole, and 1.68 mg mometasone furoate.","Otic Suspension",{"id":99,"strength_text":93,"dosage_form":86,"proprietary_name":100,"species":31,"source_label":100},10862,"Klentz™",{"id":102,"strength_text":93,"dosage_form":86,"proprietary_name":103,"species":31,"source_label":103},10863,"Florfinasone™ Otic",[105,109,112,115,118,121,124,127,131,134,137,140,144,147,150,154,157,160,164],{"id":106,"kind":107,"statement":108,"species":31,"limitation":33,"source_label":34},18423,"indication","For the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase- positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).",{"id":110,"kind":107,"statement":111,"species":31,"limitation":33,"source_label":38},18424,"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":113,"kind":107,"statement":114,"species":31,"limitation":10,"source_label":103},18425,"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":116,"kind":107,"statement":117,"species":31,"limitation":10,"source_label":47},18426,"For the treatment of otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius and Pseudomonas aeruginosa) in dogs.",{"id":119,"kind":107,"statement":120,"species":10,"limitation":10,"source_label":69},18427,"INDICATIONS: Mometavet™ Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P\n. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).",{"id":122,"kind":107,"statement":123,"species":10,"limitation":10,"source_label":73},18428,"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":125,"kind":107,"statement":126,"species":10,"limitation":10,"source_label":61},18429,"SIMPLERA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).",{"id":128,"kind":129,"statement":130,"species":10,"limitation":10,"source_label":69},18430,"contraindication","CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.",{"id":132,"kind":129,"statement":133,"species":10,"limitation":10,"source_label":73},18431,"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":135,"kind":129,"statement":136,"species":10,"limitation":10,"source_label":61},18432,"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":138,"kind":129,"statement":139,"species":10,"limitation":10,"source_label":65},18433,"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":141,"kind":142,"statement":143,"species":10,"limitation":10,"source_label":69},18434,"warning","WARNINGS: The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (e.g, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Mometavet™ Otic Suspension immediately and flush the ear canal thoroughly with a non-toxic solution.\nCorticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy. Field and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.\nP\nRE\nC\nAUTIONS:\nBefore instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.\nAdministration of recommended doses of Mometavet™ Otic Suspension beyond 7 days may result in delayed wound healing.\nIf overgrowth of non-susceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.\nAvoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and\u002For polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.\nUse of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.",{"id":145,"kind":142,"statement":146,"species":10,"limitation":10,"source_label":65},18435,"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":148,"kind":142,"statement":149,"species":10,"limitation":10,"source_label":61},18436,"CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.",{"id":151,"kind":152,"statement":153,"species":10,"limitation":10,"source_label":69},18437,"adverse_reaction","A\nD\nVE\nR\nS\nE\nR\nE\nACTIONS:\nGe\nn\ntam\ni\nci\nn\n:\nWhile aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.\nM\no\nm\ne\nt\na\ns\no\nn\ne\n: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and\u002For prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.\nClo\nt\nrima\nz\no\nl\ne\n: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.\nMometavet™ Otic Suspension:\nIn field studies following once-daily treatment with gentamicin, mometasone, and clotrimazole otic suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with gentamicin, mometasone, and clotrimazole otic suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.\nTo report suspected adverse drug events, for technical assistance, or to obtain a Safety Data Sheet (SDS), contact Dechra at (866) 933-2472. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http:\u002F\u002Fwww.fda.gov\u002Freportanimalae",{"id":155,"kind":152,"statement":156,"species":10,"limitation":10,"source_label":73},18438,"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":158,"kind":152,"statement":159,"species":10,"limitation":10,"source_label":65},18439,"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":161,"kind":152,"statement":162,"species":10,"limitation":10,"source_label":163},18440,"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":165,"kind":166,"statement":167,"species":10,"limitation":10,"source_label":69},18441,"mechanism_of_action","PHARMACOLOGY:\nGentamicin: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive bacteria. In vitro tests have determined that gentamicin is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, gentamicin was shown to have a range of activity against the following organisms commonly isolated from infected canine ears: Pseudomonas spp. (including P. aeruginosa), coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.\nMometasone: Mometasone furoate anhydrous is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.\nSystemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.\nThe extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.\nClotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms.\nI\nn vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with M\nalassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor and swelling.\nIn studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.\nG\ne\nn\nt\nam\ni\ncin-\nM\no\nm\ne\nt\na\ns\no\nn\ne\n-\nClo\nt\nri\nm\na\nz\no\nl\ne\n: By virtue of its three active ingredients, gentamicin, mometasone, and clotrimazole otic suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, gentamicin, mometasone, and clotrimazole otic suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Gentamicin, mometasone, and clotrimazole otic suspension reduced discomfort, redness, swelling, exudate, and odor.",[169,174],{"id":170,"documentId":171,"slug":172,"name":173},822,"w6ha1c9jm6bdr9mrj7mg5l95","glucocorticoid-receptor-agonists","Glucocorticoid Receptor Agonists",{"id":175,"documentId":176,"slug":177,"name":178},856,"dcdetq8zlaxge6js44km7uqm","corticosteroid-hormone-receptor-agonists","Corticosteroid Hormone Receptor Agonists",[],[],[]]