[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$f3eww118xoz4tj":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":19,"available_strengths":49,"label_statements":60,"drug_classes":104,"specialties":115,"medical_conditions":116,"animal_species":122},1807,"kwwddah1n7nra9gjng1kw9ss","spinosad",null,[],[13],{"source":14,"licence":15,"source_url":16,"harvested_by":17,"retrieved_at":18},"FDA Green Book","US public domain","https:\u002F\u002Fanimaldrugsatfda.fda.gov\u002Fadafda\u002Fapp\u002Fsearch\u002Fpublic\u002FingredientsInformationExcel\u002FSection2ActiveIngredients","load-reference-corpus.cjs","2026-09-07",[20,27,31,37,42,45],{"id":21,"dose_text":22,"species":23,"administration_route":24,"limitation":25,"source_label":26},13199,"Administer tablets once a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per kilogram) of body weight.","Dogs","Oral","Federal law restricts this drug to use by or on the order of a licensed veterinarian.","Comfortis®",{"id":28,"dose_text":29,"species":30,"administration_route":24,"limitation":25,"source_label":26},13200,"Administer tablets once a month at the minimum dosage of 22.5 mg per pound (50 mg per kilogram) of body weight.","Cats",{"id":32,"dose_text":33,"species":34,"administration_route":24,"limitation":35,"source_label":36},13201,"Given orally, once a month at a minimum dosage of 13.5 mg\u002Flb (30 mg\u002Fkg) spinosad and 0.2 mg\u002Flb (0.5 mg\u002Fkg) milbemycin oxime body weight.","Dogs and Puppies (8 Weeks and Older and 5 Lbs or Greater)","Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.\nTreatment with fewer than 3 monthly doses after the last exposure to mosquitos may not provide complete heartworm prevention.\nUse with caution in breeding females. The safe use of TRIFEXIS in breeding males has not been evaluated.\nUse with caution in dogs with pre-existing epilepsy.","Trifexis™",{"id":38,"dose_text":39,"species":10,"administration_route":40,"limitation":10,"source_label":41},13202,"COMFORTIS is given orally once a month, at the recommended minimum dosage of 13.5 mg\u002Flb (30 mg\u002Fkg).\nDo not use the dosing schedule below when administering COMFORTIS to cats, as it can result in an underdosage.\nDosage Schedule for Dogs:\n* Dogs over 120 lbs should be administered the appropriate combination of tablets.\nBody Weight of Dog\nSpinosad Per Tablet\n(mg)\nTablets\nAdministered\n5 to 10 lbs\n140\nOne\n10.1 to 20 lbs\n270\nOne\n20.1 to 40 lbs\n560\nOne\n40.1 to 60 lbs\n810\nOne\n60.1 to 120* lbs\n1620\nOne\nAdminister COMFORTIS with food for maximum effectiveness.\nCOMFORTIS is a chewable tablet and is readily consumed by dogs when offered by the owner just prior to feeding. Alternatively, COMFORTIS may be offered in food or administered like other tablet medications. COMFORTIS should be administered at monthly intervals.\nIf vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed, administer COMFORTIS with food and resume a monthly dosing schedule.\nTreatment with COMFORTIS may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment with COMFORTIS should continue the entire year without interruption.\nTo minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea protection product.","ORAL","Comfortis™ (spinosad)",{"id":43,"dose_text":44,"species":10,"administration_route":40,"limitation":10,"source_label":41},13203,"COMFORTIS is given orally once a month, at the minimum dosage of 22.5 mg\u002Flb (50 mg\u002Fkg).\nDo not use the dosing schedule below when administering COMFORTIS to dogs, as it can result in an overdosage.\nDosage Schedule for Cats:\n*Cats over 24 lbs should be administered the appropriate combination of tablets.\nBody Weight of Cat\nSpinosad Per Tablet\n(mg)\nTablets Administered\n4.1 to 6 lbs\n140\nOne\n6.1 to 12 lbs\n270\nOne\n12.1 to 24* lbs\n560\nOne\nAdminister COMFORTIS with food for maximum effectiveness.\nCOMFORTIS is a chewable tablet that can be consumed by cats when offered by the owner just prior to or after feeding. Alternatively, COMFORTIS may be offered in food or administered like other tablet medications.\nCOMFORTIS should be administered at monthly intervals.\nIf vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed, administer COMFORTIS with food and resume a monthly dosing schedule.\nTreatment with COMFORTIS may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment with COMFORTIS should continue the entire year without interruption.\nTo minimize the likelihood of flea reinfestations, it is important to treat all animals within a household with an approved flea protection product.",{"id":46,"dose_text":47,"species":10,"administration_route":40,"limitation":10,"source_label":48},13204,"TRIFEXIS is given orally, once a month at the minimum dosage of 13.5 mg\u002Flb (30 mg\u002Fkg) spinosad and 0.2 mg\u002Flb (0.5 mg\u002Fkg) milbemycin oxime body weight. For heartworm prevention, give once monthly for at least 3 months after exposure to mosquitoes (see\nEFFECTIVENESS\n).\nDosage Schedule:\nBody Weight\nSpinosad\nPer Tablet (mg)\nMilbemycin oxime\nPer Tablet (mg)\nTablets\nAdministered\n5 to 10 lbs\n140\n2.3\nOne\n10.1 to 20 lbs\n270\n4.5\nOne\n20.1 to 40 lbs\n560\n9.3\nOne\n40.1 to 60 lbs\n810\n13.5\nOne\n60.1 to 120 lbs\n1620\n27\nOne\nOver 120 lbs\nAdminister the appropriate combination of tablets\nAdminister TRIFEXIS with food for maximum effectiveness. To ensure heartworm prevention, owners should observe the dog for one hour after dosing. If vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed and a monthly interval between doses is exceeded, then immediate administration of TRIFEXIS with food and resumption of monthly dosing will minimize the opportunity for the development of adult heartworm infections and flea reinfestations.","TRIFEXIS™",[50,54,56],{"id":51,"strength_text":52,"dosage_form":53,"proprietary_name":26,"species":23,"source_label":26},11417,"Each chewable tablet contains 140, 270, 560, 810, or 1620 milligrams (mg) spinosad.","Tablet (Chewable)",{"id":55,"strength_text":52,"dosage_form":53,"proprietary_name":26,"species":30,"source_label":26},11418,{"id":57,"strength_text":58,"dosage_form":59,"proprietary_name":36,"species":34,"source_label":36},11419,"The product is available in five tablet strengths:\n140 mg spinosad and 2.3 mg milbemycin oxime\n270 mg spinosad and 4.5 mg milbemycin oxime\n560 mg spinosad and 9.3 mg milbemycin oxime\n810 mg spinosad and 13.5 mg milbemycin oxime\n1620 mg spinosad and 27 mg milbemycin oxime","Chewable Tablets",[61,65,68,71,74,77,81,84,88,91,94,98,101],{"id":62,"kind":63,"statement":64,"species":23,"limitation":25,"source_label":26},19418,"indication","To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on dogs and puppies 14 weeks of age and older and 5.0 pounds or body weight or greater.",{"id":66,"kind":63,"statement":67,"species":30,"limitation":25,"source_label":26},19419,"To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis) for 1 month on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater.",{"id":69,"kind":63,"statement":70,"species":34,"limitation":35,"source_label":36},19420,"Trifexis™ Chewable Tablets kill fleas and are indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), and the treatment and control of adult hookworm (Ancylostoma caninum), adult roundworm (Toxocara canis and Toxascaris leonina) and adult whipworm (Trichuris vulpis) infections in dogs and puppies 8 weeks of age or older and 5 pounds of body weight or greater.",{"id":72,"kind":63,"statement":73,"species":34,"limitation":35,"source_label":36},19421,"Trifexis™Chewable Tablets are indicated for the prevention of heartworm disease (Dirofilaria immitis).",{"id":75,"kind":63,"statement":76,"species":10,"limitation":10,"source_label":41},19422,"COMFORTIS kills fleas and is indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), for one month, on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater.",{"id":78,"kind":79,"statement":80,"species":10,"limitation":10,"source_label":41},19423,"contraindication","There are no known contraindications for the use of COMFORTIS.",{"id":82,"kind":79,"statement":83,"species":10,"limitation":10,"source_label":48},19424,"There are no known contraindications to the use of TRIFEXIS.",{"id":85,"kind":86,"statement":87,"species":10,"limitation":10,"source_label":41},19425,"warning","Not for human use. Keep this and all drugs out of the reach of children.\nSerious adverse reactions have been reported following concomitant extra-label use of ivermectin with COMFORTIS (see\nPost Approval Experience).\nKeep COMFORTIS in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.",{"id":89,"kind":86,"statement":90,"species":10,"limitation":10,"source_label":48},19426,"Not for human use. Keep this and all drugs out of the reach of children.\nSerious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad alone, a component of TRIFEXIS (see\nADVERSE REACTIONS\n).",{"id":92,"kind":86,"statement":93,"species":10,"limitation":10,"source_label":41},19427,"Not for human use. Keep this and all drugs out of the reach of children.\nKeep COMFORTIS in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.",{"id":95,"kind":96,"statement":97,"species":10,"limitation":10,"source_label":48},19428,"adverse_reaction","In a well-controlled US field study, which included a total of 352 dogs (176 treated with TRIFEXIS and 176 treated with an active control), no serious adverse reactions were attributed to administration of TRIFEXIS. All reactions were regarded as mild.\nOver the 180-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence >1% (average monthly rate) within any of the 6 months of observation are presented in the following table. The most frequently reported adverse reaction in dogs in the TRIFEXIS group was vomiting.\nAverage Monthly Rate (%) of Dogs With Adverse Reactions\nan=176 dogs\nAdverse Reaction\nTRIFEXIS Chewable\nTabletsa\nActive Control\nTabletsa\nVomiting\n6.13\n3.08\nPruritus\n4.00\n4.91\nLethargy\n2.63\n1.54\nDiarrhea\n2.25\n1.54\nDermatitis\n1.47\n1.45\nSkin Reddening\n1.37\n1.26\nDecreased appetite\n1.27\n1.35\nPinnal Reddening\n1.18\n0.87\nIn the US field study, one dog administered TRIFEXIS experienced a single mild seizure 2 ½ hours after receiving the second monthly dose. The dog remained enrolled and received four additional monthly doses after the event and completed the study without further incident.\nFollowing concomitant extra-label use of ivermectin with spinosad alone, a component of TRIFEXIS, some dogs have experienced the following clinical signs: trembling\u002Ftwitching, salivation\u002Fdrooling, seizures, ataxia, mydriasis, blindness and disorientation. Spinosad alone has been shown to be safe when administered concurrently with heartworm preventatives at label directions.\nIn US and European field studies, no dogs experienced seizures when dosed with spinosad alone at the therapeutic dose range of 13.5-27.3 mg\u002Flb (30-60 mg\u002Fkg), including 4 dogs with pre-existing epilepsy. Four epileptic dogs that received higher than the maximum recommended dose of 27.3 mg\u002Flb (60 mg\u002Fkg) experienced at least one seizure within the week following the second dose of spinosad, but no seizures following the first and third doses. The cause of the seizures observed in the field studies could not be determined.\nFor technical assistance or to report suspected adverse drug events, contact Elanco US Inc. at 1-888-545-5973. 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":99,"kind":96,"statement":100,"species":10,"limitation":10,"source_label":41},19429,"In a well-controlled US field study, which included a total of 470 dogs (330 dogs treated with COMFORTIS and 140 dogs treated with an active control), no serious adverse reactions were observed with COMFORTIS. All reactions were regarded as mild and did not result in any dog being removed from the study.\nOver the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence > 1% within any of the 3 months of observation are presented in the following table. The most frequently reported adverse reaction in dogs in the COMFORTIS and active control groups was vomiting.\nThe occurrence of vomiting, most commonly within 48 hours after treatment, decreased with repeated doses of COMFORTIS.\nPercentage of Dogs (%) with Adverse Reactions\na This number (n=139) is less than the total number of dogs in the safety population for the active control group (n=140) because one dog joined the study late and was only dosed at Month 3.\nMonth 1\nMonth 2\nMonth 3\nCOMFORTIS\nChewable\nTablets\n(N=330)\nActive\nTopical\nControl\n(N=139a)\nCOMFORTIS\nChewable\nTablets\n(N=282)\nActive\nTopical\nControl\n(N=124)\nCOMFORTIS\nChewable\nTablets\n(N=260)\nActive\nTopical\nControl\n(N=125)\nVomiting\n12.7\n12.2\n7.8\n3.2\n5.8\n4.8\nDecreased Appetite\n9.1\n5.0\n2.8\n1.6\n1.9\n0.8\nLethargy\n7.6\n5.0\n3.5\n4.0\n1.2\n0.8\nDiarrhea\n6.7\n5.0\n4.3\n0.8\n1.2\n0.0\nCough\n3.9\n5.0\n0.4\n2.4\n0.0\n0.0\nPolydipsia\n2.4\n1.4\n0.7\n0.0\n0.4\n0.0\nVocalization\n1.8\n0.0\n0.4\n0.0\n0.4\n0.0\nIncreased Appetite\n1.5\n0.0\n0.4\n0.8\n0.4\n0.0\nErythema\n1.5\n0.0\n0.4\n0.0\n0.4\n0.0\nHyperactivity\n1.2\n1.4\n0.0\n0.0\n0.4\n0.0\nExcessive Salivation\n1.2\n0.0\n0.4\n0.0\n0.0\n0.0\nIn US and European field studies, no dogs experienced seizures when dosed with COMFORTIS at the therapeutic dose range of 13.5-27.3 mg\u002Flb (30-60 mg\u002Fkg), including 4 dogs with pre-existing epilepsy. Four epileptic dogs that received higher than the maximum recommended dose of 27.3 mg\u002Flb (60 mg\u002Fkg) experienced at least one seizure within the week following the second dose of COMFORTIS, but no seizures following the first and third doses.\nThe cause of the seizures observed in the field studies could not be determined.",{"id":102,"kind":96,"statement":103,"species":10,"limitation":10,"source_label":41},19430,"In a well-controlled US field study, which included a total of 211 cats (139 treated with COMFORTIS and 72 treated with an active topical control once a month for 3 treatments), no serious adverse reactions were attributed to the administration of COMFORTIS.\nOver the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence > 1% within any of the 3 months of observations are presented in the following table. The most frequently reported adverse reaction in cats was vomiting.\nPercentage of Cats (%) with Adverse Reactions\nMonth 1\nMonth 2\nMonth 3\nCOMFORTIS\n(n=139)\nActive\nTopical\nControl\n(n=72)\nCOMFORTIS\n(n=135)\nActive\nTopical\nControl\n(n=69)\nCOMFORTIS\n(n=132)\nActive\nTopical\nControl\n(n=67)\nVomiting\n14.4\n1.4\n14.8\n1.4\n13.6\n4.5\nLethargy\n3.6\n0.0\n0.7\n0.0\n1.5\n1.5\nAnorexia\n2.2\n0.0\n0.7\n0.0\n2.3\n1.5\nWeight Loss\n1.4\n0.0\n0.0\n0.0\n3.0\n0.0\nDiarrhea\n1.4\n1.4\n0.7\n2.9\n2.3\n1.5\nOver the 3-month (3-dose) study, vomiting occurred on the day of or the day after at least one dose in 28.1% (39\u002F139) of the cats treated with COMFORTIS and in 2.8% (2\u002F72) of the cats treated with the active topical control. Three of the 139 cats treated with COMFORTIS vomited on the day of or the day after all three doses.\nTwo cats that received extra-label topical otic ivermectin on Day -1 of the field study developed lethargy on Day 1 after COMFORTIS administration on Day 0.",[105,110],{"id":106,"documentId":107,"slug":108,"name":109},781,"b475siifec9n2hcp4yk23j6t","spinosyns","Spinosyns",{"id":111,"documentId":112,"slug":113,"name":114},900,"r8d1bfogv3gqysstllpwjykl","pediculicide","Pediculicide",[],[117],{"id":118,"documentId":119,"slug":120,"title":121},188,"xzg7actze4xw6lc9kyh513m6","flea-infestation","Flea infestation",[]]