[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$fnhaux74f4k44":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":39,"label_statements":47,"drug_classes":71,"specialties":87,"medical_conditions":88,"animal_species":89},1749,"nvqc2wmngstm1al3n380cc08","mirtazapine",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",[28,34],{"id":29,"dose_text":30,"species":31,"administration_route":32,"limitation":10,"source_label":33},12579,"Administer topically by applying a 1.5-inch ribbon of ointment (approximately 2 mg\u002Fcat) on the inner pinna of the cat’s ear once daily for 14 days.","Cats","Topical (transdermal)","Mirataz®",{"id":35,"dose_text":36,"species":10,"administration_route":37,"limitation":10,"source_label":38},12580,"DOSAGE AND ADMINISTRATION:\nAdminister topically by applying a 1.5-inch ribbon of ointment (approximately 2 mg\u002Fcat) on the inner pinna of the cat's ear once daily for 14 days (see Diagrams below).\nWear disposable gloves when applying Mirataz. Dispose of used gloves after each application.\nAlternate the daily application of Mirataz between the left and right inner pinna of the ears. Do not administer into the external ear canal. If desired, the inner pinna of the cat's ear may be cleaned by wiping with a dry tissue or cloth immediately prior to the next scheduled dose. If a dose is missed, apply Mirataz the following day and resume daily dosing.\nTo demonstrate the method of administering the dose, the veterinarian or trained personnel at the clinic should apply the first dose in the presence of the owner.\nThis ruler measures 1.5 inches. Use this ruler to measure the 1.5 inch ribbon of ointment to be applied.\nTo apply Mirataz:\nStep 1: Wear disposable gloves. Twist cap on tube counterclockwise to open.\nStep 2: Apply even pressure on tube and squeeze a 1.5-inch line of ointment onto your gloved finger using the measured line on the carton or in this package insert.\nStep 3: Using your gloved finger, gently rub ribbon of ointment on inside pinna of the cat's ear spreading it evenly over the surface. Dispose of used gloves after each application. If contact with your skin occurs wash thoroughly with soap and warm water.","TOPICAL","Mirataz® (mirtazapine transdermal ointment)",[40,44],{"id":41,"strength_text":42,"dosage_form":43,"proprietary_name":33,"species":31,"source_label":33},10854,"Each 1 g of Mirataz™ contains 20 mg of mirtazapine (2%).","Transdermal ointment",{"id":45,"strength_text":46,"dosage_form":10,"proprietary_name":10,"species":10,"source_label":38},10855,"20 mg \u002F 1 g",[48,52,55,59,63,67],{"id":49,"kind":50,"statement":51,"species":31,"limitation":10,"source_label":33},18417,"indication","For body weight gain in cats with a history of weight loss.",{"id":53,"kind":50,"statement":54,"species":10,"limitation":10,"source_label":38},18418,"INDICATION:\nMirataz is indicated for body weight gain in cats with a history of weight loss.",{"id":56,"kind":57,"statement":58,"species":10,"limitation":10,"source_label":38},18419,"contraindication","CONTRAINDICATIONS:\nMirataz is contraindicated in cats with a known hypersensitivity to mirtazapine or to any of the excipients.\nMirataz should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor (MAOI) [e.g. selegiline hydrochloride (L-deprenyl), amitraz], as there may be an increased risk of serotonin syndrome.",{"id":60,"kind":61,"statement":62,"species":10,"limitation":10,"source_label":38},18420,"warning","HUMAN WARNINGS:\nNot for human use. Keep out of reach of children.\nWear disposable gloves when handling or applying Mirataz to prevent accidental topical exposure.\nAfter application, dispose of used gloves and wash hands with soap and water. After application, care should be taken that people or other animals in the household do not come in contact with the treated cat for 2 hours because mirtazapine can be absorbed transdermally and orally.\nHowever, negligible residues are present at the application site and the body of the cat at 2 hours after dosing.\nIn case of accidental skin exposure, wash thoroughly with soap and warm water. In case of accidental eye exposure, flush eyes with water. If skin or eye irritation occurs seek medical attention.\nIn case of accidental ingestion, or if skin or eye irritation occurs, seek medical attention.",{"id":64,"kind":65,"statement":66,"species":10,"limitation":10,"source_label":38},18421,"adverse_reaction","ADVERSE REACTIONS:\nIn a randomized, double-masked, vehicle-controlled field study to assess the effectiveness and safety of mirtazapine for the management of weight loss in cats, 115 cats treated with Mirataz and 115 cats treated with vehicle control were evaluated for safety. The vehicle control was an ointment containing the same inert ingredients as Mirataz without mirtazapine. The most common adverse reactions included application site reactions, behavioral abnormalities (vocalization and hyperactivity), and vomiting. The adverse reactions observed in the study and number of cats experiencing each adverse reaction is summarized in Table 1 below.\nTable 1. Adverse Reactions Reported During the Field Study\nAdverse Reaction\nMirataz\nN=115 (%)\nVehicle Control\nN=115 (%)\nApplication site (Ear pinna)\nErythema\n12 (10.4%)\n20 (17.4%)\nCrust\u002FScab\n3 (2.6%)\n6 (5.2%)\nResidue\n3 (2.6%)\n8 (7.0%)\nScaling\u002FDryness\n3 (2.6%)\n3 (2.6%)\nDermatitis or irritation\n1 (0.9%)\n9 (7.8%)\nAlopecia\n1 (0.9%)\n2 (1.7%)\nPruritus\n1 (0.9%)\n4 (3.5%)\nBehavioral\nVocalization\n13 (11.3%)\n2 (1.7%)\nHyperactivity\n8 (7.0%)\n1 (0.9%)\nDisoriented state or ataxia\n4 (3.5%)\n2 (1.7%)\nLethargy\u002Fweakness\n4 (3.5%)\n9 (7.8%)\nAttention Seeking\n3 (2.6%)\n0\nAggression\n2 (1.7%)\n0\nPhysical Examination or Observational\nVomiting\n13 (11.3%)\n15 (13.0%)\nDehydration\n6 (5.2%)\n5 (4.3%)\nDiarrhea or soft stool\n6 (5.2%)\n7 (6.1%)\nHeart murmur\n5 (4.3%)\n7 (6.1%)\nInappetence\n5 (4.3%)\n5 (4.3%)\nRenal insufficiency One cat with renal insufficiency was reported with a serious adverse reaction of acute renal failure, hematuria, and pyuria at the Week 2 visit. The cat was enrolled with a history of chronic kidney disease. Euthanasia was elected and necropsy revealed hypertrophic cardiomyopathy, bilateral parathyroid hyperplasia, and mild to moderate renal disease.\n4 (3.5%)\n0\nEar infection\n3 (2.6%)\n0\nUrinary tract infection\n3 (2.6%)\n0\nClinical Pathology\nHematuria\n7 (6.1%)\n1 (0.9%)\nElevated BUN (without creatinine) At Week 2, blood urea nitrogen (BUN) values were significantly higher in the Mirataz group compared to the vehicle control group (p\u003C0.10). The BUN in the Mirataz group was 43.60 mg\u002FdL (reference range 16-37 mg\u002FdL) compared to 36.05 mg\u002FdL in the vehicle control group.\n6 (5.2%)\n0\nElevated creatinine and BUN\n5 (4.3%)\n1 (0.9%)\nHyperphosphatemia\n5 (4.3%)\n0\nHypokalemia\n5 (4.3%)\n2 (1.7%)\nPyuria\n5 (4.3%)\n0\nAnemia\n3 (2.6%)\n8 (7.0%)\nLow urine specific gravity\n3 (2.6%)\n1 (0.9%)\nMonocytosis\n3 (2.6%)\n2 (1.7%)\nNeutrophilia\n3 (2.6%)\n2 (1.7%)\nPost study, follow-up was done in 199 cats (103 in the Mirataz (mirtazapine transdermal ointment) group and 96 in the vehicle control group).\nFollowing cessation of Mirataz, four cats were reported as being less social or less restless, one cat was reported as more active, and one cat was reported with increased hissing and urinating out of the litter box.\nTo report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Dechra at (866) 933-2472.\nFor 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":68,"kind":69,"statement":70,"species":10,"limitation":10,"source_label":38},18422,"mechanism_of_action","CLINICAL PHARMACOLOGY:",[72,77,82],{"id":73,"documentId":74,"slug":75,"name":76},806,"x7n8gr0e4m7lex4kvru6nx6p","serotonin-5ht-3-antagonists","Serotonin 5HT-3 Antagonists",{"id":78,"documentId":79,"slug":80,"name":81},828,"f3t3mt2xr4xf5zzj1t19a8lk","histamine-h1-receptor-antagonists","Histamine H1 Receptor Antagonists",{"id":83,"documentId":84,"slug":85,"name":86},839,"g4y7fgmsn10wrfwd8l4coaye","adrenergic-alpha2-antagonists","Adrenergic alpha2-Antagonists",[],[],[]]