Imidacloprid and moxidectin

Indications

Advantage Multi for Dogs is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. Advantage Multi for Dogs kills adult fleas and is indicated for the treatment of flea infestations ( Ctenocephalides felis ). Advantage Multi for Dogs is indicated for the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis. Advantage Multi for Dogs is also indicated for the treatment and control of the following intestinal parasites: Intestinal Parasite Intestinal Stage Adult Immature Adult Fourth Stage Larvae Hookworm Species Ancylostoma caninum X X X Uncinaria stenocephala X X X Roundworm Species Toxocara canis X X Toxascaris leonina X Whipworm Trichuris vulpis X

Dosage and Administration

The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month, by topical administration. Do not apply to irritated skin. 1. Remove one dose applicator tube from the package. As specified in the following table, administer the entire contents of the Advantage Multi for Dogs tube that correctly corresponds with the body weight of the dog. * Dogs over 110 lbs. should be treated with the appropriate combination of Advantage Multi for Dogs tubes. Dog (lbs.) Advantage Multi For Dogs Volume (mL) Imidacloprid (mg) Moxidectin (mg) 3–9 Advantage Multi 9 0.4 40 10 9.1–20 Advantage Multi 20 1.0 100 25 20.1–55 Advantage Multi 55 2.5 250 62.5 55.1–88 Advantage Multi 88 4.0 400 100 88.1–110* Advantage Multi 110 5.0 500 125 2. While holding the tube in an upright position, remove the cap from the tube. 3. Turn the cap over and push the other end of cap onto the tip of the tube. 4. Twist the cap to break the seal and then remove cap from the tube. 5. The dog should be standing for application. Part the hair on the back of the dog between the shoulder blades until the skin is visible. For dogs weighing 20 lbs. or less, place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at one spot between the shoulder blades. For dogs weighing more than 20 lbs., place the tip of the tube on the skin and apply the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog. Do not let this product get in your dog's mouth or eyes. Do not allow the dog to lick any of the application sites for 30 minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes after application to prevent licking the application sites. (See WARNINGS .) Contact with eyes can lead to eye irritation and corneal ulceration. If contact with eyes occurs, hold the dog’s eyelids open, flush thoroughly with water, and contact your veterinarian. Stiff hair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some animals. This is temporary and does not affect the safety and effectiveness of the product. Shampooing 90 minutes after treatment does not reduce the effectiveness of Advantage Multi for Dogs in the prevention of heartworm disease. Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of Advantage Multi for Dogs in the treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against fleas. Heartworm Prevention: For prevention of heartworm disease, Advantage Multi for Dogs should be administered at one-month intervals. Advantage Multi for Dogs may be administered year-round or at a minimum should start one month before the first expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. If a dose is missed and a 30-day interval between doses is exceeded, administer Advantage Multi for Dogs immediately and resume the monthly dosing schedule. When replacing another heartworm preventative product in a heartworm prevention program, the first treatment with Advantage Multi for Dogs should be given within one month of the last dose of the former medication. Treatment of Circulating Microfilaria: For the treatment of circulating D. immitis microfilaria in heartworm-positive dogs, Advantage Multi for Dogs should be administered at one-month intervals. Treatment with an approved adulticide therapy is recommended because Advantage Multi for Dogs is not effective for the treatment of adult D. immitis . (See PRECAUTIONS .) Flea Treatment: For the treatment of flea infestations, Advantage Multi for Dog s should be administered at one-month intervals. If the dog is already infested with fleas when the first dose of Advantage Multi for Dogs is administered, adult fleas on the dog will be killed. However, reinfestation from the emergence of pre-existing pupae in the environment may continue to occur for six weeks or longer after treatment is initiated. Dogs treated with imidacloprid, including those with pre-existing flea allergy dermatitis have shown clinical improvement as a direct result of elimination of fleas from the dog. Treatment and Control of Intestinal Nematode Infections: For the treatment and control of intestinal hookworm infections caused by Ancylostoma caninum and Uncinaria stenocephala (adults, immature adults and fourth stage larvae) and roundworm infections caused by Toxocara canis (adults and fourth stage larvae), and Toxascaris leonina (adults), and whipworm infections caused by Trichuris vulpis (adults), Advantage Multi for Dogs should be administered once as a single topical dose. Treatment and Control of Sarcoptic Mange: For the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis , Advantage Multi for Dogs should be administered as a single topical dose. A second monthly dose may be administered if necessary. Figure Figure2

Contraindications

Do not administer this product orally. (See WARNINGS .) Do not use this product (containing 2.5 % moxidectin) on cats.

Warnings

• DO NOT ADMINISTER THIS PRODUCT ORALLY • For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. • Children should not come in contact with application sites for two (2) hours after application. (See Contraindications , Warnings , Human Warnings , and Adverse Reactions , for more information)

Precautions

Do not dispense dose applicator tubes without complete safety and administration information. Use with caution in sick, debilitated, or underweight animals. The safety of Advantage Multi for Dogs has not been established in breeding, pregnant, or lactating dogs. The safe use of Advantage Multi for Dogs has not been established in puppies and dogs less than 7 weeks of age or less than 3 lbs. body weight. Prior to administration of Advantage Multi for Dogs , dogs should be tested for existing heartworm infection. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advantage Multi for Dogs has not been evaluated when administered on the same day as an adulticide. Advantage Multi for Dogs is not effective against adult D. immitis . Although the number of circulating microfilariae is substantially reduced in most dogs following treatment with Advantage Multi for Dogs , the microfilaria count in some heartworm-positive dogs may increase or remain unchanged following treatment with Advantage Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride. (See ADVERSE REACTIONS and ANIMAL SAFETY – Safety Study in Heartworm-Positive Dogs .) Advantage Multi for Dogs has not been evaluated in heartworm-positive dogs with Class 4 heartworm disease.

Adverse Reactions

Heartworm-Negative Dogs Field Studies: Following treatment with Advantage Multi for Dogs or an active control, dog owners reported the following post-treatment reactions: OBSERVATION Advantage Multi n = 128 Active Control n = 68 Pruritus 19 dogs (14.8 %) 7 dogs (10.3 %) Residue 9 dogs (7.0 %) 5 dogs (7.4 %) Medicinal Odor 5 dogs (3.9 %) None observed Lethargy 1 dog (0.8 %) 1 dog (1.5 %) Inappetence 1 dog (0.8 %) 1 dog (1.5 %) Hyperactivity 1 dog (0.8 %) None observed During a field study using 61 dogs with pre-existing flea allergy dermatitis, one (1.6 %) dog experienced localized pruritus immediately after imidacloprid application, and one investigator noted hyperkeratosis at the application site of one dog (1.6 %). In a field safety and effectiveness study, Advantage Multi for Dogs was administered to 92 client-owned dogs with sarcoptic mange. The dogs ranged in age from 2 months to 12.5 years and ranged in weight from 3 to 231.5 pounds. Adverse reactions in dogs treated with Advantage Multi for Dogs included hematochezia, diarrhea, vomiting, lethargy, inappetence, and pyoderma. Laboratory Effectiveness Studies: One dog in a laboratory effectiveness study experienced weakness, depression, and unsteadiness between 6 and 9 days after application with Advantage Multi for Dogs . The signs resolved without intervention by day 10 post-application. The signs in this dog may have been related to peak serum levels of moxidectin, which vary between dogs, and occur between 1 and 21 days after application of Advantage Multi for Dogs . The following clinical observations also occurred in laboratory effectiveness studies following application with Advantage Multi for Dogs and may be directly attributed to the drug or may be secondary to the intestinal parasite burden or other underlying conditions in the dogs: diarrhea, bloody stools, vomiting, anorexia, lethargy, coughing, ocular discharge and nasal discharge. Observations at the application sites included damp, stiff or greasy hair, the appearance of a white deposit on the hair, and mild erythema, which resolved without treatment within 2 to 48 hours. Heartworm-Positive Dogs Field Study: A 56-day field safety study was conducted in 214 D. immitis heartworm and microfilaria positive dogs with Class 1, 2 or 3 heartworm disease. All dogs received Advantage Multi for Dogs on Study Days 0 and 28; 108 dogs also received melarsomine dihydrochloride on Study Days – 14, 14, and 15. All dogs were hospitalized for a minimum of 12 hours following each treatment. Effectiveness against circulating D. immitis microfilariae was > 90 % at five of six sites; however, one site had an effectiveness of 73.3 %. The microfilaria count in some heartworm-positive dogs increased or remained unchanged following treatment with Advantage Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride. Following treatment with Advantage Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride, the following adverse reactions were observed: Adverse Reaction Dogs Treated with Advantage Multi for Dogs Only n = 106 Dogs Treated with Advantage Multi for Dogs + Melarsomine n = 108 Cough 24 (22.6 %) 25 (23.1 %) Lethargy 14 (13.2 %) 42 (38.9 %) Vomiting 11 (10.4 %) 18 (16.7 %) Diarrhea, including hemorrhagic 10 (9.4 %) 22 (20.4 %) Inappetence 7 (6.6 %) 19 (17.6 %) Dyspnea 6 (5.7 %) 10 (9.3 %) Tachypnea 1 (< 1 %) 7 (6.5 %) Pulmonary Hemorrhage 0 1 (< 1 %) Death 0 3 (2.8 %) Three dogs treated with Advantage Multi for Dogs in a dosing regimen with melarsomine dihydrochloride died of pulmonary embolism from dead and dying heartworms. One dog, treated with Advantage Multi for Dogs and melarsomine dihydrochloride, experienced pulmonary hemorrhage and responded to supportive medical treatment. Following the first treatment with Advantage Multi for Dogs alone, two dogs experienced adverse reactions (coughing, vomiting, and dyspnea) that required hospitalization. In both groups, there were more adverse reactions to Advantage Multi for Dogs following the first treatment than the second treatment. To report a suspected adverse reaction, call 888-545-5973. Post-Approval Experience (2022) The following adverse events are based on post-approval adverse drug experience reporting for Advantage Multi for Dogs . 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 this data. The following adverse events reported in dogs are listed in decreasing order of reporting frequency: depression/lethargy, pruritus, vomiting, diarrhea, anorexia, application site reactions (alopecia, pruritus, erythema, and lesions, including blisters), hyperactivity, ataxia, trembling, seizures, panting, hypersalivation, anaphylaxis/anaphylactic reactions (hives, facial swelling, edema of the head), and corneal ulceration. Serious reactions, including neurologic signs and death have been reported when cats have been exposed (orally and topically) to this product. In humans, nausea, numbness or tingling of the mouth/lips and throat, ocular and dermal irritation, pruritus, headache, vomiting, diarrhea, depression and dyspnea have been reported following exposure to this product.

Description

Advantage Multi for Dogs (10 % imidacloprid + 2.5 % moxidectin) is a colorless to yellow ready-to-use solution packaged in single dose applicator tubes for topical treatment of dogs. The formulation and dosage schedule are designed to provide a minimum of 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin based on body weight. Imidacloprid is a chloronicotinyl nitroguanidine insecticide. The chemical name for imidacloprid is 1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine. Moxidectin is a semisynthetic macrocyclic lactone endectocide derived from the actinomycete Streptomycetes cyaneogriseus noncyanogenus . The chemical name for moxidectin is [6R, 23E, 25S(E)]-5-0- Demethyl-28-deoxy-25-(1,3-dimethyl-1-butenyl)-6,28-epoxy-23-(methoxyimino) milbemycin B.

Storage

Store at temperatures between 4 °C (39 °F) and 25 °C (77 °F), avoiding excess heat or cold.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• IMOXI™ Topical Solution for Dogs (imidacloprid + moxidectin), Vetoquinol USA, Inc.. Set id 5d21b656-c84b-4779-8e6e-e59138bbaee2.
• Midamox ® for Dogs (imidacloprid + moxidectin) Topical Solution, Norbrook Laboratories Limited. Set id 19f146c0-a788-4e70-86c3-c152a83dec63.
• VET one ® Midamox ® for Dogs (imidacloprid + moxidectin), MWI/VetOne. Set id 1b8ac0a1-afe3-41ff-a3d2-85d7f86806aa.
• Barrier ® for Dogs (imidacloprid+moxidectin) Topical Solution, Aurora Pharmaceutical, Inc.. Set id 2aca52b5-298f-427e-86d1-80a4eb1a771e.
• Elanco TM advantage multi™ for cats (imidacloprid+moxidectin) Topical Solution, Elanco US Inc.. Set id 4acea077-3f1a-4507-ab8c-2f65d9035c97.
• Barrier ® for Cats (imidacloprid+moxidectin) Topical Solution, Aurora Pharmaceutical, Inc. Set id 2e20c08c-87fe-404c-9f78-149951d30675.
• IMOXI™ Topical Solution for Cats (imidacloprid + moxidectin), Vetoquinol USA, Inc.. Set id e7b8b1c4-b1d2-48f8-9a85-9a9a17ccba69.
• VETone® Midamox ® for Cats (imidacloprid + moxidectin), MWI/VetOne. Set id a189b875-eb45-439b-9013-9449519e1dff.
• Midamox ® for Cats (imidacloprid + moxidectin) Topical Solution, Norbrook Laboratories Limited. Set id 4e3e11f4-e667-46bf-84cc-1a5dafd45a5a.
• PARASEDGE™ Multi for Dogs (imidacloprid + moxidectin) Topical Solution, Virbac AH, Inc. Set id f4a55d55-97e4-4468-a9f7-8ffe5ae22514.
• PARASEDGE™ Multi for Cats (imidacloprid + moxidectin) Topical Solution, Virbac AH, Inc. Set id f6c26118-53fd-44da-ada1-b37238cf1922.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming imidacloprid and moxidectin as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.