[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$fnfceejo54gk7":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":52,"label_statements":64,"drug_classes":118,"specialties":124,"medical_conditions":125,"animal_species":131},1876,"dwkdl2k0sanaxfzy1hi7jibb","sarolaner",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",[28,34,38,44,48],{"id":29,"dose_text":30,"species":31,"administration_route":32,"limitation":10,"source_label":33},13826,"SimparicaTRIO® is given orally, once a month, at the recommended minimum dose of 0.54 mg\u002Flb (1.2 mg\u002Fkg) sarolaner, 0.011 mg\u002Flb (24 µg\u002Fkg) moxidectin, and 2.27 mg\u002Flb (5 mg\u002Fkg) pyrantel (as pamoate salt).","Dogs","Oral","Simparica TRIO®",{"id":35,"dose_text":36,"species":31,"administration_route":32,"limitation":10,"source_label":37},13827,"0.91 mg\u002Flb (2 mg\u002Fkg body weight), one per month.","SIMPARICA®",{"id":39,"dose_text":40,"species":41,"administration_route":42,"limitation":10,"source_label":43},13828,"The recommended minimum dosage is 2.7 mg selamectin per pound (6.0 mg\u002Fkg) of body weight in combination with 0.45 mg sarolaner per pound (1.0 mg\u002Fkg) of body weight administered monthly.","Cats","Topical","revolution® PLUS",{"id":45,"dose_text":46,"species":10,"administration_route":47,"limitation":10,"source_label":33},13829,"SIMPARICA TRIO is given orally once a month, at the recommended minimum dose of 0.54 mg\u002Flb (1.2 mg\u002Fkg) sarolaner, 0.011 mg\u002Flb (24 μg\u002Fkg) moxidectin, and 2.27 mg\u002Flb (5 mg\u002Fkg) pyrantel (as pamoate salt).\nDosage Schedule\nBody Weight\n(lbs)\nSarolaner per\nTablet\n(mg)\nMoxidectin\nper Tablet\n(mg)\nPyrantel\nper\nTablet\n(mg)\nNumber\nof Tablets\nAdministered\n2.8 to 5.5\n3\n0.06\n12.5\nOne\n5.6 to 11.0\n6\n0.12\n25\nOne\n11.1 to 22.0\n12\n0.24\n50\nOne\n22.1 to 44.0\n24\n0.48\n100\nOne\n44.1 to 88.0\n48\n0.96\n200\nOne\n88.1 to 132.0\n72\n1.44\n300\nOne\n>132.0\nAdminister the appropriate combination of tablets\nSIMPARICA TRIO can be offered to the dog with or without food.\nCare should be taken to ensure that the dog consumes the complete dose and that part of the dose is not lost or refused. If a dose is missed, give SIMPARICA TRIO immediately and resume monthly dosing.\nHeartworm Prevention:\nSIMPARICA TRIO should be administered at monthly intervals year‑round or at least within one month of the animal’s first seasonal exposure to mosquitoes and continuing until at least 1 month after the dog’s last seasonal exposure. If a dose is missed, give SIMPARICA TRIO immediately and resume monthly dosing. When replacing a monthly heartworm preventive product, SIMPARICA TRIO should be given within one month of the last dose of the former medication.\nFlea Treatment and Prevention:\nTreatment with SIMPARICA TRIO may begin at any time of the year. SIMPARICA TRIO should be administered year‑round at monthly intervals or started at least one month before fleas become active.\nTo minimize the likelihood of flea re‑infestation, it is important to treat all dogs and cats within a household with a flea control product.\nTapeworm Prevention:\nTreatment with SIMPARICA TRIO may begin at any time of the year. SIMPARICA TRIO should be administered year-round at monthly intervals or started at least one month before fleas become active.\nSIMPARICA TRIO will only prevent D. caninum infections by killing the fleas on the treated dog. Dogs may also become infected with D. caninum by ingesting fleas from untreated animals, it is therefore recommended that all pets in a household are treated for fleas.\nTick Treatment and Control:\nTreatment with SIMPARICA TRIO can begin at any time of the year. SIMPARICA TRIO should be administered year‑round at monthly intervals or started at least one month before ticks become active.\nIntestinal Nematode Treatment and Control:\nFor the treatment of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections, SIMPARICA TRIO should be administered once as a single dose. Monthly use of SIMPARICA TRIO will control any subsequent infections.","ORAL",{"id":49,"dose_text":50,"species":10,"administration_route":47,"limitation":10,"source_label":51},13830,"SIMPARICA is given orally once a month at the recommended minimum dosage of 0.91 mg\u002Flb (2 mg\u002Fkg).\nDosage Schedule:\nBody Weight\nSAROLANER per Tablet (mg)\nNumber of Tablets Administered\n2.8 to 5.5 lbs\n5\nOne\n5.6 to 11 lbs\n10\nOne\n11.1 to 22 lbs\n20\nOne\n22.1 to 44 lbs\n40\nOne\n44.1 to 88 lbs\n80\nOne\n88.1 to 132 lbs\n120\nOne\n>132.1 lbs\nAdminister the appropriate combination of tablets\nSIMPARICA can be offered by hand, in the food, or administered like other tablet medications.\nCare should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If a dose is missed, administer SIMPARICA and resume a monthly dosing schedule.\nSIMPARICA should be administered at monthly intervals.\nFlea Treatment and Prevention:\nTreatment with SIMPARICA may begin at any time of the year. In areas where fleas are common year-round, monthly treatment with SIMPARICA can continue the entire year without interruption.\nTo minimize the likelihood of flea re-infestation, it is important to treat all dogs and cats within a household with an approved flea control product.\nTick Treatment and Control:\nTreatment with SIMPARICA can begin at any time of the year (see Effectiveness).","Simparica®",[53,57,61],{"id":54,"strength_text":55,"dosage_form":56,"proprietary_name":37,"species":31,"source_label":37},12016,"5 mg, 10 mg, 20 mg, 40 mg, 80 mg, and 120 mg","Chewable Tablets",{"id":58,"strength_text":59,"dosage_form":60,"proprietary_name":43,"species":41,"source_label":43},12017,"60 mg\u002FmL selamectin; 10 mg\u002FmL sarolaner","Topical Solution",{"id":62,"strength_text":63,"dosage_form":56,"proprietary_name":33,"species":31,"source_label":33},12018,"Each chewable tablet contains either: 3.0 mg sarolaner \u002F 0.06 mg moxidectin \u002F 12.5 mg pyrantel (as pamoate salt), 6.0 mg sarolaner \u002F 0.12 mg moxidectin \u002F 25.0 mg pyrantel (as pamoate salt), 12.0 mg sarolaner \u002F 0.24 mg moxidectin \u002F 50.0 mg pyrantel (as pamoate salt), 24.0 mg sarolaner \u002F 0.48 mg moxidectin \u002F 100 mg pyrantel (as pamoate salt), 48.0 mg sarolaner \u002F 0.96 mg moxidectin \u002F 200 mg pyrantel (as pamoate salt) or 72.0 mg sarolaner \u002F 1.44 mg moxidectin \u002F 300 mg pyrantel (as pamoate salt)",[65,69,72,75,78,81,84,88,92,95,98,102,105,108,112,115],{"id":66,"kind":67,"statement":68,"species":31,"limitation":10,"source_label":33},20341,"indication","Simparica TRIO® is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. Simparica TRIO® kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. Simparica TR O® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.",{"id":70,"kind":67,"statement":71,"species":31,"limitation":10,"source_label":37},20342,"SIMPARICA® kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus\nsanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA® is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.",{"id":73,"kind":67,"statement":74,"species":41,"limitation":10,"source_label":43},20343,"revolution® PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis, the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections, and the treatment and control of ear mite (Otodectes cynotis) infestations. revolution® PLUS kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated cat, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), and Ixodes scapularis (black-legged tick) for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater.",{"id":76,"kind":67,"statement":77,"species":10,"limitation":10,"source_label":33},20344,"SIMPARICA TRIO is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and hookworm (L4, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala) infections. SIMPARICA TRIO kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated dog, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma\nmaculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick) for one month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater. SIMPARICA TRIO is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.",{"id":79,"kind":67,"statement":80,"species":10,"limitation":10,"source_label":43},20345,"REVOLUTION PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis, the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections, and the treatment and control of ear mite (Otodectes cynotis) infestations.\nREVOLUTION PLUS kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the prevention of Dipylidium caninum (tapeworm) infections as a direct result of killing Ctenocephalides felis vector fleas on the treated cat, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), and Ixodes scapularis (black-legged tick) for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater.",{"id":82,"kind":67,"statement":83,"species":10,"limitation":10,"source_label":51},20346,"SIMPARICA kills adult fleas, and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor\nvariabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (Asian longhorned tick)] for one month in dogs 6 months of age or older and weighing 2.8 pounds or greater. SIMPARICA is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector ticks.",{"id":85,"kind":86,"statement":87,"species":10,"limitation":10,"source_label":33},20347,"contraindication","There are no known contraindications for the use of SIMPARICA TRIO.",{"id":89,"kind":90,"statement":91,"species":10,"limitation":10,"source_label":43},20348,"warning","Human warnings:\nNot for human use. Keep this and all drugs out of the reach of children.\nDo not come into contact with or allow children to contact the application site until 4 hours post application.\nIn humans, REVOLUTION PLUS may be irritating to skin and eyes. REVOLUTION PLUS and selamectin topical solution contain isopropyl alcohol and the preservative butylated hydroxytoluene (BHT). Reactions such as hives, itching and skin redness have been reported in humans after accidental dermal contact with selamectin topical solution. Individuals with known hypersensitivity to selamectin topical solution should use caution or consult a health care professional before applying this product on a cat. Wash hands after use and wash off any product in contact with the skin immediately with soap and water.\nIf contact with eyes occurs, then flush eyes copiously with water; if wearing contact lenses, rinse the eyes first then remove contact lenses and continue to rinse for 5 – 10 minutes and seek medical attention. In case of ingestion by a human, contact a physician immediately. The safety data sheet (SDS) provides more detailed occupational safety information. For a copy of the SDS or to report a suspected adverse reaction, call Zoetis at 1-888-963-8471.\nFlammable - Keep away from heat, sparks, open flames or other sources of ignition.",{"id":93,"kind":90,"statement":94,"species":10,"limitation":10,"source_label":51},20349,"Not for use in humans. Keep this and all drugs out of reach of children. For use in dogs only. Do not use SIMPARICA in cats.\nSIMPARICA should not be used in dogs less than 6 months of age (see Animal Safety).\nKeep SIMPARICA in a secure location out of reach of dogs, cats and other animals to prevent accidental ingestion or overdose.",{"id":96,"kind":90,"statement":97,"species":10,"limitation":10,"source_label":33},20350,"Not for use in humans. Keep this and all drugs out of reach of children.\nKeep SIMPARICA TRIO in a secure location out of reach of dogs, cats and other animals to prevent accidental ingestion or overdose.",{"id":99,"kind":100,"statement":101,"species":10,"limitation":10,"source_label":43},20351,"adverse_reaction","In a field safety and effectiveness study, REVOLUTION PLUS was administered to cats with fleas. The study included a total of 430 cats (282 treated with REVOLUTION PLUS and 148 treated with imidacloprid + moxidectin once monthly for three treatments). Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions reported in the REVOLUTION PLUS group included those presented in the following table.\nAdverse Reactions by Treatment Group\nAdverse Reaction\nREVOLUTION PLUS\n(n = 282)\nImidacloprid + moxidectin\n(n =148)\nLethargy\n12 (4.3%)\n1 (0.7%)\nSkin lesions*\n10 (3.5%)\n3 (2.0%)\nAnorexia\n9 (3.2%)\n3 (2.0%)\nPruritus\n7 (2.5%)\n3 (2.0%)\nConjunctivitis\n7 (2.5%)\n1 (0.7%)\nSneezing\n6 (2.1%)\n1 (0.7%)\nAdministration site hair changes (alopecia)\n5 (1.8%)\n0 (0.0%)\nAdministration site lesions (scabbing)\n2 (0.7%)\n0 (0.0%)\n*Lesions not associated with application site.\nIn a second field safety and effectiveness study, REVOLUTION PLUS was administered to 124 cats with ear mites. Adverse reactions in cats treated with REVOLUTION PLUS included emesis, dermatitis and eczema, and pruritus.\nIn a third field safety and effectiveness study, REVOLUTION PLUS was administered to 70 cats with hookworms. Adverse reactions in cats treated with REVOLUTION PLUS included diarrhea, anorexia, emesis, and lethargy.\nPost-Approval Experience (2022)\nThe following adverse events are based on post-approval adverse drug experience reporting forREVOLUTION PLUS. Not all adverse events are reported to FDA\u002FCVM. It is not always possible to reliably estimate the exposure using these data.\nThe following adverse events reported in cats are listed in decreasing order of reporting frequency:\nApplication site reactions (including alopecia, lesions, erythema, and pruritus), lethargy, anorexia, vomiting, generalized pruritus, behavioral disorders (including hiding, hyperactivity, and vocalization), ataxia, muscle tremor, diarrhea, generalized alopecia, and seizure.\nContact Information\nTo report adverse reactions call Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http:\u002F\u002Fwww.fda.gov\u002Freportanimalae.",{"id":103,"kind":100,"statement":104,"species":10,"limitation":10,"source_label":51},20352,"SIMPARICA was administered in a well-controlled US field study, which included a total of 479 dogs (315 dogs treated with SIMPARICA and 164 dogs treated with active control once monthly for three treatments).\nOver the 90-day study period, all observations of potential adverse reactions were recorded.\nTable 1. Dogs with adverse reactions\nAdverse reaction\nsarolaner\nsarolaner\nactive control\nactive control\nN\n%\n(n = 315)\nN\n#\n(n =164)\nVomiting\n3\n0.95%\n9\n5.50%\nDiarrhea\n2\n0.63%\n2\n1.20%\nLethargy\n1\n0.32%\n2\n1.20%\nInappetence\n0\n0%\n3\n1.80%\nAdditionally, one female dog aged 8.6 years exhibited lethargy, ataxia while posturing to eliminate, elevated third eyelids, and inappetence one day after receiving SIMPARICA concurrently with a heartworm preventative (ivermectin\u002Fpyrantel pamoate). The signs resolved one day later. After the day 14 visit, the owner elected to withdraw the dog from the study.\nAbnormal neurologic signs such as tremors, decreased conscious proprioception, ataxia, decreased or absent menace, and\u002For seizures were reported in dogs receiving SIMPARICA (see Animal Safety).\nPost Approval Experience (2019):\nThe following adverse events are based on post-approval adverse drug experience reporting for SIMPARICA. Not all adverse events 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 these data.\nThe following adverse events reported for dogs are listed in decreasing order of reporting frequency:\nVomiting, tremors, lethargy, seizure, diarrhea (with and without blood), anorexia, ataxia, pruritus, hypersalivation and hyperactivity.",{"id":106,"kind":100,"statement":107,"species":10,"limitation":10,"source_label":33},20353,"In a field safety and effectiveness study, SIMPARICA TRIO was administered to dogs for the prevention of heartworm disease. The study included a total of 410 dogs treated once monthly for 11 treatments (272 treated with SIMPARICA TRIO and 138 treated with an active control). Over the 330-day study period, all observations of potential adverse reactions were recorded. The most frequent reactions reported in the SIMPARICA TRIO group are presented in the following table.\nTable 1. Dogs with Adverse Reactions\nClinical Sign\nSIMPARICA TRIO\nn = 272\nActive Control\nn = 138\nVomiting\n14.3%\n10.9%\nDiarrhea\n13.2%\n8.0%\nLethargy\n8.5%\n6.5%\nAnorexia\n5.1%\n5.8%\nPolyuria\n3.7%\n3.6%\nHyperactivity\n2.2%\n0.7%\nPolydipsia\n2.2%\n2.9%\nIn a second field safety and effectiveness study, SIMPARICA TRIO was administered to 278 dogs with fleas. Adverse reactions in dogs treated with SIMPARICA TRIO included diarrhea.\nIn a third field safety and effectiveness study, SIMPARICA TRIO was administered to 120 dogs with roundworms. Adverse reactions in dogs treated with SIMPARICA TRIO included diarrhea and vomiting.\nIn one well-controlled laboratory study, one dog had a seizure 16 days after administration of SIMPARICA TRIO.",{"id":109,"kind":110,"statement":111,"species":10,"limitation":10,"source_label":33},20354,"mechanism_of_action","Following oral administration of SIMPARICA TRIO in Beagle dogs (13 to 15 months of age at the time of initial dosing), sarolaner and moxidectin were rapidly and well-absorbed. Following a single oral dose of SIMPARICA TRIO (sarolaner dose of 1.2 mg\u002Fkg), the sarolaner mean maximum plasma concentration (Cmax) was 523 ng\u002FmL with a mean time to maximum concentration (Tmax) of 3.5 hours and an absolute bioavailability of 88%. At a moxidectin dose of 0.024 mg\u002Fkg, the moxidectin mean Cmax was 13.1 ng\u002FmL with a mean Tmax of 2.4 hours and an absolute bioavailability of 67%.\nFollowing intravenous (IV) dosing of a combination solution of sarolaner and moxidectin, the sarolaner volume of distribution (Vss) was 2.4 L\u002Fkg and systemic clearance (CL) was 6.0 mL\u002Fkg\u002Fhr. For moxidectin the Vss was 7.65 L\u002Fkg and CL was 26.6 mL\u002Fkg\u002Fhr. The terminal half‑lives were similar after oral and IV dosing for both sarolaner (12 days) and moxidectin (11 days). The primary route of elimination of both sarolaner and moxidectin is biliary excretion with minimal metabolism.\nFollowing an oral dose of SIMPARICA TRIO containing 5 mg\u002Fkg pyrantel (as pamoate salt), pyrantel has measurable plasma concentrations, but they are low and highly variable. Pyrantel pamoate is intended to remain in the gastrointestinal tract allowing for delivery of effective concentrations to gastrointestinal nematodes.",{"id":113,"kind":110,"statement":114,"species":10,"limitation":10,"source_label":51},20355,"Sarolaner is rapidly and well absorbed following oral administration of SIMPARICA. In a study of 12 Beagle dogs the mean maximum plasma concentration (Cmax) was 1100 ng\u002FmL and the mean time to maximum concentration (Tmax) occurred at 3 hours following a single oral dose of 2 mg\u002Fkg to fasted animals. The mean oral bioavailability was 86% and 107% in fasted and fed dogs, respectively. The mean oral T1\u002F2 values for fasted and fed animals was 10 and 12 days respectively.\nSarolaner is distributed widely; the mean volume of distribution (Vdss) was 2.81 L\u002Fkg bodyweight following a 2 mg\u002Fkg intravenous dose of sarolaner. Sarolaner is highly bound (≥99.9%) to plasma proteins. The metabolism of sarolaner appears to be minimal in the dog. The primary route of sarolaner elimination from dogs is biliary excretion with elimination via the feces.\nFollowing repeat administration of SIMPARICA once every 28 days for 10 doses to Beagle dogs at 1X, 3X, and 5X the maximum intended clinical dose of 4 mg\u002Fkg, steady-state plasma concentrations were reached after the 6th dose. Following treatment at 1X, 3X, and 5X the maximum intended clinical dose of 4 mg\u002Fkg, sarolaner systemic exposure was dose proportional over the range 1X to 5X.",{"id":116,"kind":110,"statement":117,"species":10,"limitation":10,"source_label":43},20356,"Following topical administration of REVOLUTION PLUS both selamectin and sarolaner are well absorbed with mean absolute bioavailability of 40.5% and 57.9%, respectively, and distribute systemically. In cats, selamectin and sarolaner are low clearance compounds with a long half-life of 12.5 days and 41.5 days following topical administration, respectively. Following IV dose, the total body clearance for selamectin was 10.2 mL\u002Fkg\u002Fhr and for sarolaner was 3.41 mL\u002Fkg\u002Fhr. The volume of distribution at steady state was 1.26 L\u002Fkg for selamectin and 3.87 L\u002Fkg for sarolaner. The primary route of elimination for both drugs is hepatobiliary excretion (approximately 50% of dose excreted in feces).\nFollowing repeated monthly doses of REVOLUTION PLUS, there was a less than dose proportional increase in the Cmax and AUC of sarolaner and selamectin. The accumulation of both sarolaner and selamectin was observed with Cmax plateauing after the 6th dose for sarolaner and the 3rd dose for selamectin.",[119],{"id":120,"documentId":121,"slug":122,"name":123},978,"i07zfx5o5kzia7n1ub38jbuf","antiparasitics","Antiparasitics",[],[126],{"id":127,"documentId":128,"slug":129,"title":130},188,"xzg7actze4xw6lc9kyh513m6","flea-infestation","Flea infestation",[]]