Advantix for Dogs

The recommended minimum dose is 4.5 mg/lb (10 mg/kg) Imidacloprid (Advantix for Dogs) and 1.1 mg/lb (2.5 mg/kg) Moxidectin (Advantix for Dogs), once a month, by topical administration.

Do not apply to irritated skin.

1. Remove one dose applicator tube (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.

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 for30 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.

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 Advantix for Dogs in the prevention of heartworm disease.

Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of Advantix 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, Advantix for Dogs should be administered at one-month intervals. Advantix 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 AdvantageMulti for Dogs immediately and resume the monthly dosing schedule. When replacing another heartworm preventative product in a heartworm prevention program, the first treatment with Advantix for Dogs should be given within one month of the last dose of the former medication.

Flea Treatment: For the treatment of flea infestations, Advantix for Dogs should be administered at one-month intervals. If the dog is already infested with fleas when the first dose of Advantix 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 (Advantix for Dogs), including those with preexisting 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 Uncinariastenocephala (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), Advantix for Dogs should be administered once as a single topical dose.

Do not administer this product orally.

Do not use this product (containing 2.5% Moxidectin (Advantix for Dogs)) on cats.

Field Studies: Following treatment with Advantage Multifor Dogs or an active control, dog owners reported the following post-treatment reactions:

During a field study using 61 dogs with pre-existing flea allergy dermatitis, one (1.6%) dog experienced localized pruritus immediately after Imidacloprid (Advantix for Dogs) application, and one investigator noted hyperkeratosis at the application site of one dog (1.6%).

Laboratory Effectiveness Studies: One dog in a laboratory effectiveness study experienced weakness, depression, and unsteadiness between 6 and 9 days after application with Advantix 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 (Advantix for Dogs), which vary between dogs, and occur between 1 and 21 days after application of Advantix for Dogs.

The following clinical observations also occurred in laboratory effectiveness studies following application with Advantix 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.

Foreign Market Experience: Because the following events were reported voluntarily during post-approval use of the product in foreign markets, it is not always possible to reliably establish a causal relationship to drug exposure. The following adverse events were reported in humans: eye irritation, allergic reactions, skin irritation, skin tingling, sore throat, and chemical odor. Adverse events reported in dogs topically treated with Imidacloprid (Advantix for Dogs) + Moxidectin (Advantix for Dogs) for dogs included: vomiting, diarrhea, bloody diarrhea, salivation, poor appetite, lethargy, weakness, restlessness, agitation, disorientation, ataxia, muscle tremors, seizures, panting, labored breathing, acute pulmonary edema, hives, rash, swollen face and ears, pruritus, erythema, alopecia, hot spots, local discomfort, and discoloration of the hair at the application site. Accidental oral ingestion in dogs caused salivation, vomiting, muscle tremor, seizures, mydriasis, ataxia, lethargy, disorientation, agitation, and poor appetite. Adverse reactions reported in cats treated topically with Imidacloprid (Advantix for Dogs) + Moxidectin (Advantix for Dogs) for dogs included application site and skin reactions, vomiting, lethargy, agitation, and neurologic signs.

To report a suspected adverse reaction, call 1-800-422-9874.