Advantage Multi For Dogs: Product Information (Page 2 of 5)

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, includinghemorrhagic

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%)

PulmonaryHemorrhage

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 1-800-422-9874.

Post-Approval Experience

The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions 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 in dogs are listed in decreasing order of reporting frequency: depression/lethargy, vomiting, pruritus, diarrhea, anorexia, hyperactivity, ataxia, trembling, hypersalivation, application site reactions (alopecia, pruritus, lesions, and erythema), seizures, and anaphylaxis/anaphylactic reactions (hives, urticaria, facial swelling, edema of the head).

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.

To report suspected adverse events and/or obtain a copy of the SDS or for technical assistance, call Bayer Animal Heath at 1-800-422-9874.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2021. All Rights Reserved.