Advantage Multi For Cats: Product Information

ADVANTAGE MULTI FOR CATS- imidacloprid and moxidectin solution
Bayer HealthCare LLC Animal Health Division

Once-a-month topical solution for cats for the prevention of heartworm disease, kills adult fleas, is indicated for the treatment of flea infestations, as well as the treatment and control of ear mite infestations and intestinal parasite infections in cats and kittens 9 weeks of age and older and that weigh at least 2 lbs.

Once-a-month topical solution for ferrets for the prevention of heartworm disease, kills adult fleas, and is indicated for the treatment of flea infestations. Indicated for ferrets that weigh at least 2 lbs.

CAUTION:

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

DESCRIPTION:

Advantage Multi® for Cats (10 % imidacloprid + 1 % moxidectin) is a colorless to yellow ready-to-use solution packaged in single-dose applicator tubes for topical treatment of cats. The formulation and dosage schedule are designed to provide a minimum of 4.5 mg/lb (10.0 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin based on body weight.

Imidacloprid is a chloronicotinyl nitroguanidine insecticide. The chemical name of 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 of 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:

Advantage Multi for Cats is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. Advantage Multi for Cats kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations. Advantage Multi for Cats is also indicated for the treatment and control of ear mite (Otodectes cynotis) infestations and the following intestinal parasites:

Intestinal Parasite

Intestinal Stage

Adult

ImmatureAdult

Fourth Stage Larvae

Hookworm Species

Ancylostoma tubaeforme

X

X

X

Roundworm Species

Toxocara cati

X

X

WARNINGS:

Do not use on sick, debilitated, or underweight cats (see ADVERSE REACTIONS).

Do not use on cats less than 9 weeks of age or less than 2 lbs. body weight.

HUMAN WARNINGS:

Not for human use. Keep out of the reach of children.
Children should not come in contact with the application site for 30 minutes 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. For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call Bayer Veterinary Services at 1-800-422-9874. For consumer questions call 1-800-255-6826.

PRECAUTIONS:

Do not dispense dose applicator tubes without complete safety and administration information.

Avoid oral ingestion. Cats may experience hypersalivation, tremors, vomiting and decreased appetite if Advantage Multi for Cats is inadvertently administered orally or through grooming/licking of the application site.

The safety of Advantage Multi for Cats has not been established in breeding, pregnant, or lactating cats.

The effectiveness of Advantage Multi for Cats against heartworm infections (D. immitis) after bathing has not been evaluated in cats.

Use of this product in geriatric patients with subclinical conditions has not been adequately studied. Several otherwise healthy, thin geriatric cats experienced prolonged lethargy and sleepiness after using this drug.

(See ADVERSE REACTIONS.)

ADVERSE REACTIONS:

Field Study: Following treatment with Advantage Multi for Cats or an active control, cat owners reported the following post-treatment reactions:

*
These three cats were from the same household and included one 13-yr-old cat in good health, one 15-yr-old FIV positive cat in good health, and one 15-yr-old, underweight cat in fair health. Lethargy was noted for 24 to 36 hrs after the first treatment only; one cat was unsteady at 48 hrs. These cats were not on other medications.

OBSERVATION

Advantage Multi n = 113

Active Control n = 38

Lethargy (protracted sleeping, poorly responsive)

3 cats * (2.7%)

None observed

Behavioral changes (e.g., agitated, excessive grooming, hiding, pacing, spinning)

9 cats (8.0%)

1 cat (2.6%)

Discomfort (e.g., scratching, rubbing, head-shaking)

5 cats (4.4%)

None observed

Hypersalivation (within 1 hour after treatment)

3 cats (2.7%)

None observed

Polydipsia

3 cats (2.7%)

None observed

Coughing and gagging

1 cat (0.9%)

None observed

During another field study, a 16-year-old cat with renal disease slept in the same place without moving for two days following application. (See PRECAUTIONS.)

Laboratory Effectiveness Studies: Advantage Multi for Cats was administered at the recommended dose to 215 cats in 20 effectiveness studies. One random-sourced cat exhibited signs consistent with either moxidectin toxicity or viral respiratory disease and died 26 hours after product application; necropsy findings were inconclusive as to the cause of death. A second cat that became ill 3 days after application of Advantage Multi for Cats responded to treatment for respiratory infection and completed the study. A third cat became ill on day 3 and died with signs and lesions attributable to panleukopenia on day 7 after moxidectin application.

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 cats are listed in decreasing order of reporting frequency: hypersalivation, depression/lethargy, application site reactions (alopecia, pruritus, lesions, and erythema), decreased appetite, vomiting, hyperactivity, ataxia, trembling, and behavior disorder (hiding).

In some cases death has been reported.

In humans, ocular and dermal irritation, nausea, numbness or tingling of the mouth and lips, anaphylaxis, pruritus, vomiting, and tongue/taste abnormalities 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 Health 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.

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