PARASEDGE Multi For Dogs 3 – 9 Lbs: Product Information

PARASEDGE MULTI FOR DOGS 3 — 9 LBS- imidacloprid and moxidectin solution
PARASEDGE MULTI FOR DOGS 9.1 — 20 LBS- imidacloprid and moxidectin solution
PARASEDGE MULTI FOR DOGS 20.1 — 55 LBS- imidacloprid and moxidectin solution
PARASEDGE MULTI FOR DOGS 55.1 — 88 LBS- imidacloprid and moxidectin solution
PARASEDGE MULTI FOR DOGS 88.1 — 110 LBS- imidacloprid and moxidectin solution
Virbac AH, Inc

Once-a-month topical solution for the prevention of heartworm disease, the treatment of circulating microfilariae, kills adult fleas, is indicated for the treatment of flea infestations, the treatment and control of sarcoptic mange, as well as the treatment and control of intestinal parasite infections in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 lbs.

CAUTION:

Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

PARASEDGE™ 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-O-Demethyl-28-deoxy-25-(1,3-dimethyl-1-butenyl)-6,28-epoxy-23-(methoxyimino) milbemycin B.

INDICATIONS:

PARASEDGE™ 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. PARASEDGE™ Multi for Dogs kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis).PARASEDGE™ Multi for Dogs is indicated for the treatment and control of sarcoptic mange caused by Sarcoptes scabiei var. canis.PARASEDGE™ Multi for Dogs is also indicated for the treatment and control of the following intestinal parasites:

CONTRAINDICATIONS:

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

WARNINGS:

For the first 30 minutes after application:

Ensure that dogs cannot lick the product from application sites on themselves or other treated dogs.

Separate treated dogs from one another and from other pets to reduce the risk of accidental ingestion.

Ingestion of this product by dogs may cause serious adverse reactions including depression, salivation, dilated pupils, incoordination, panting, and generalized muscle tremors.

In avermectin sensitive dogs,^a the signs may be more severe and may include coma and death.^b

^a Some dogs are more sensitive to avermectins due to a mutation in the MDR1 gene. Dogs with this mutation may develop signs of severe avermectin toxicity if they ingest this product. The most common breeds associated with this mutation include Collies and Collie crosses.

^b Although there is no specific antagonist for avermectin toxicity, even severely affected dogs have completely recovered from avermectin toxicity with intensive veterinary supportive care.

HUMAN WARNINGS:

Not for human use. Keep out of the reach of children.

Children should not come in contact with application sites for two (2) hours after application.

Causes eye irritation. Harmful if swallowed. Do not get in eyes or on clothing. Avoid contact with skin. Exposure to the product has been reported to cause headache; dizziness; and redness, burning, tingling, or numbness of the skin. Wash hands thoroughly with soap and warm water after handling.

If contact with eyes occurs, hold eyelids open and flush with copious amounts of water for 15 minutes. If eye irritation develops or persists, contact a physician. If swallowed, call poison control center or physician immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or physician. People with known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In case of allergic reaction, contact a physician. If contact with skin or clothing occurs, take off contaminated clothing. Wash skin immediately with plenty of soap and water. Call a poison control center or physician for treatment advice.

The safety data sheet (SDS) provides additional occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

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 PARASEDGE™ Multi for Dogs has not been established in breeding, pregnant, or lactating dogs. The safe use of PARASEDGE™ 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 PARASEDGE™ 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 PARASEDGE™ Multi for Dogs has not been evaluated when administered on the same day as an adulticide. PARASEDGE™ 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 PARASEDGE™ Multi for Dogs, the microfilaria count in some heartworm-positive dogs may increase or remain unchanged following treatment with PARASEDGE™ Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride.
(See ADVERSE REACTIONS and ANIMAL SAFETY — Safety Study in Heartworm-Positive Dogs.)

PARASEDGE™ 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 imidacloprid and moxidectin topical solution 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 application, and one investigator noted hyperkeratosis at the application site of one dog (1.6%).

In a field safety and effectiveness study, imidacloprid and moxidectin topical solution 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 imidacloprid and moxidectin topical solution 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 imidacloprid and moxidectin topical solution. 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 imidacloprid and moxidectin topical solution.

The following clinical observations also occurred in laboratory effectiveness studies following application with imidacloprid and moxidectin topical solution 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 imidacloprid and moxidectin topical solution 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 imidacloprid and moxidectin topical solution alone or in a dosing regimen with melarsomine dihydrochloride.

Following treatment with imidacloprid and moxidectin topical solution alone or in a dosing regimen with melarsomine dihydrochloride, the following adverse reactions were observed:

Three dogs treated with imidacloprid and moxidectin topical solution ina dosing regimen with melarsomine dihydrochloride died of pulmonary embolism from dead and dying heartworms. One dog, treated with imidacloprid and moxidectin topical solution and melarsomine dihydrochloride, experienced pulmonary hemorrhage and responded to supportive medical treatment. Following the first treatment with imidacloprid and moxidectin topical solution alone, two dogs experienced adverse reactions (coughing, vomiting, and dyspnea) that required hospitalization. In both groups, there were more adverse reactions to imidacloprid and moxidectin topical solution following the first treatment than the second treatment.

To report a suspected adverse reaction, call 1-800-338-3659.

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 VIRBAC AH, Inc. at 1-800-338-3659.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/reportanimalae.