[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$f3iqm7t5ptd7me":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":40,"label_statements":48,"drug_classes":70,"specialties":76,"medical_conditions":77,"animal_species":78},1827,"ulld20k9gmx5u07mvepnpx3r","tildipirosin",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],{"id":29,"dose_text":30,"species":31,"administration_route":32,"limitation":33,"source_label":34},13463,"Inject subcutaneously as a single dose in the neck at a dosage of 4 mg\u002Fkg (1 mL\u002F100 lb)\nbody weight (BW).","Cattle","Subcutaneous","Federal law restricts this drug to use by or on the order of a licensed veterinarian. For subcutaneous injection in beef and non-lactating dairy cattle only.\nNot for use in female dairy cattle 20 months of age or older or in calves to be processed for veal.\nDO NOT USE ZUPREVO 18% IN SWINE. Fatal adverse events have been reported following the use of tildipirosin in swine.\nNOT FOR USE IN CHICKENS OR TURKEYS.","Zuprevo™",{"id":36,"dose_text":37,"species":10,"administration_route":38,"limitation":10,"source_label":39},13464,"DOSAGE AND ADMINISTRATION: Inject subcutaneously as a single dose in the neck at a dosage of 4 mg\u002Fkg (1 mL\u002F100 lb) body weight (BW). Do not inject more than 10 mL per injection site. Do not puncture the stopper of the respective vial size more than the tested number of punctures, shown in Table 1.\nClinical field studies indicate that administration of Zuprevo™ 18% (tildipirosin) Injectable Solution is effective for the control of respiratory disease in beef and non-lactating dairy cattle at \"high risk\" of developing BRD. Calves at high risk of developing BRD typically experience one or more of the following risk factors:\nCommingling from multiple sale barns\u002Fsources\nExtended transport times and shrink\nExposure to wet or cold weather conditions or wide temperature swings\nStressful arrival processing procedures (such as castration, dehorning, or branding)\nRecent weaning and poor vaccination history\nTable 1 Number of punctures tested in the in-use study for the respective vial sizes\nVial size [mL]\nNumber of punctures tested in the in-use study\n100\n8\n250\n16","SUBCUTANEOUS","ZUPREVO™ 18% (Tildipirosin) Injectable Solution for Cattle",[41,45],{"id":42,"strength_text":43,"dosage_form":44,"proprietary_name":34,"species":31,"source_label":34},11717,"Each milliliter of solution contains 180 milligrams (mg) tildipirosin.","Injectable Solution",{"id":46,"strength_text":47,"dosage_form":10,"proprietary_name":10,"species":10,"source_label":39},11718,"180 mg \u002F 1 mL",[49,53,56,59,63,66],{"id":50,"kind":51,"statement":52,"species":31,"limitation":33,"source_label":34},19758,"indication","For the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.",{"id":54,"kind":51,"statement":55,"species":31,"limitation":33,"source_label":34},19759,"For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.",{"id":57,"kind":51,"statement":58,"species":10,"limitation":10,"source_label":39},19760,"INDICATIONS: Zuprevo™18% is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and and non-lactating dairy cattle, and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.",{"id":60,"kind":61,"statement":62,"species":10,"limitation":10,"source_label":39},19761,"warning","WARNINGS: FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. TO AVOID ACCIDENTAL INJECTION, DO NOT USE IN AUTOMATICALLY POWERED SYRINGES WHICH HAVE NO ADDITIONAL PROTECTION SYSTEM. IN CASE OF HUMAN INJECTION, SEEK MEDICAL ADVICE IMMEDIATELY AND SHOW THE PACKAGE INSERT OR LABEL TO THE PHYSICIAN.\nAvoid direct contact with skin and eyes. If accidental eye exposure occurs, rinse eyes with clean water. If accidental skin exposure occurs, wash the skin immediately with soap and water. Tildipirosin may cause sensitization by skin contact.\nFor technical assistance or to report a suspected adverse reaction, call: 1-800-219-9286.\nFor customer service or to request a Material Safety Data Sheet (MSDS), call: 1-800-211-3573.\nFor additional Zuprevo™18% information go to www.zuprevo.com.\nFor a complete listing of adverse reactions for Zuprevo™18% reported to CVM see: http:\u002F\u002Fwww.fda.gov\u002FAnimalVeterinary\u002FSafetyHealth.\nDO NOT USE ZUPREVO 18% IN SWINE. Fatal adverse events have been reported following the use of tildipirosin in swine. NOT FOR USE IN CHICKENS OR TURKEYS.",{"id":64,"kind":61,"statement":65,"species":10,"limitation":10,"source_label":39},19762,"RESIDUE WARNING: Cattle intended for human consumption must not be slaughtered within 21 days of the last treatment. Do not use in female dairy cattle 20 months of age or older. Use of this drug product in these cattle may cause milk residues. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.",{"id":67,"kind":68,"statement":69,"species":10,"limitation":10,"source_label":39},19763,"mechanism_of_action","CLINICAL PHARMACOLOGY: Similar to other macrolides, tildipirosin inhibits essential bacterial protein biosynthesis with selective binding to ribosomal subunits in a bacteriostatic and time-dependent manner. Tildipirosin may be bactericidal against certain isolates of Mannheimia haemolytica and Pasteurella multocida.\nThe following plasma pharmacokinetic (PK) properties of tildipirosin have been observed following a subcutaneous injection at a dose of 4 mg\u002Fkg body weight in the neck:\nTable 2 Summary of pharmacokinetic characterization of tildipirosin administered subcutaneously to calves at a dose of 4 mg\u002Fkg BW.\nParameter\nAverage\nSD\nCmax: maximum observed plasma concentration\nTmax: Time at which Cmax was observed\nAUC0-last: Area under the plasma concentration versus time curve measured from time zero to the last sample with tildipirosin concentrations exceeding the limit of quantification of the analytical method\nAUC0-inf: AUC estimated from time zero to time infinity\nt1\u002F2: Terminal elimination half life\nCmax (ng\u002FmL)\n767Value based on all 14 animals\n284\nTmax (hr)\n0.75\n0.43\nAUC0-last (hr∙ng\u002FmL)\n21017Value based on 8 animals that were slaughtered at 504 hr post-treatment.\n3499\nAUC0-inf (hr∙ng\u002FmL)\n24934\n3508\nt1\u002F2 (hr)\n210\n53\nDue to the extensive partitioning of macrolides into tissues and because of their multi-fold greater concentrations in bronchial fluid relative to that observed in the blood, plasma drug concentrations underestimate concentrations at the site of actionNightingale, C.H. (1997) Pharmacokinetics and pharmacodynamics of newer macrolides. The Pediatric Infectious Disease Journal, 16, 438-443.. This is shown for tildipirosin in the following table, where bronchial fluid samples were collected in live, healthy calves, and compared to the concentrations in plasma observed in these same animals:\nTable 3 Bronchial fluid-to-plasma ratio of tildipirosin in non-anesthetized cattle following a subcutaneous injection at a dose of 4 mg\u002Fkg body weight in the neck\nTime\n(hours)\nBronchial fluid (BF) concentration (ng\u002Fg)\nPlasma (P) concentration (ng\u002FmL)\nBF\u002FP Ratio\nAverage\nSD\nAverage\nSD\n4\n1543\n895\n297\n81.8\n5.20\n10\n2975\n1279\n242\n96.7\n12.3\n24\n3448\n1433\n136\n53.9\n25.4\n72\n3489\n1712\n70.7\n29.0\n49.3\n96\n1644\n2024\n60.2\n29.0\n27.3\n120\n1619\n1629\n52.3\n19.9\n30.9\n240\n1937\n1416\n27.1\n10.8\n71.5\n336\n1225\n1682\n26.1\n9.2\n47.0\n504\n935\n1032\n16.8\n1.7\n55.6\nTildipirosin concentrations in bronchial fluid collected in vivo from non-anesthetized cattle reflect the bacterial exposure to drug concentrations at the site of action.",[71],{"id":72,"documentId":73,"slug":74,"name":75},760,"bxs4f046yrei7h9opsuizhsz","macrolides","Macrolides",[],[],[]]