Revolution Heartworm Preventive

(selamectin)

Topical Parasiticide For Dogs & Cats

Revolution Heartworm Preventive by Pfizer is a once-a-month topical treatment for heartworms and parasite protection. In Cats, Revolution protects against heartworms, roundworms, hookworms, fleas and ear mites. In Dogs, Revolution protects against heartworms, fleas, ticks, ear mites and sarcoptic mange. Recommended for use in dogs 6 weeks of age or older and cats 8 weeks of age and older.

Dogs:

Revolution kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. Revolution also is indicated for the treatment and control of sarcoptic mange (Sarcoptes scabiei) and for the control of tick infestations due to (Dermacentor variabilis).

Cats:

Revolution kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations. Revolution is also indicated for the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections in cats.

• Kills adult fleas (Ctenocephalides felis) and prevents flea eggs from hatching
• Prevents heartworm disease caused by Dirofilaria immitis
• Treats and controls ear mites (Otodectes cynotis)
• Treats and controls roundworms (Toxocara cati) and hookworms (Ancylostoma tubaeforme)

Description:

Revolution (selamectin) Topical Parasiticide is available as a colorless to yellow, ready to use solution in single dose tubes for topical (dermal) treatment of dogs six weeks of age and older and cats eight weeks of age and older. The content of each tube is formulated to provide a minimum of 2.7 mg/lb (6 mg/kg) of body weight of selamectin.

Precautions:

Prior to administration of Revolution, dogs should be tested for existing heartworm infections. At the discretion of the veterinarian, infected dogs should be treated to remove adult heartworms. Revolution is not effective against adult D. immitis and, while the number of circulating microfilariae may decrease following treatment, Revolution is not effective for microfilariae clearance.

Hypersensitivity reactions have not been observed in dogs with patent heartworm infections administered three times the recommended dose of Revolution. Higher doses were not tested.

Adverse Reactions:

Transient localized alopecia with or without inflammation at or near the site of application is is observed in approximately <1% of cases. Other signs observed rarely include vomiting, loose stool or diarrhea with or without blood, anorexia, lethargy, salivation, tachypnea, and muscle tremors.

Dosage:

The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight.

Administer the entire contents of a single dose tube (or two tubes used in combination for dogs weighing over 130 pounds) of Revolution topically in accordance with the following tables. (see ADMINISTRATION for the recommended treatment intervals).

For cats over 15 lbs use the appropriate combination of tubes.

For dogs over 130 lbs use the appropriate combination of tubes.

Recommended for use in dogs 6 weeks of age and older and in cats 8 weeks of age and older.

Administration:

A veterinarian or veterinary technician should demonstrate or instruct the pet owner regarding the appropriate technique for applying Revolution topically to dogs and cats prior to first use.

Firmly press the cap down to puncture the seal on the Revolution tube; a clicking sound will confirm that the cap has successfully punctured the seal. Remove the cap and check to ensure that the tip of the tube is open. To administer the product, part the hair on the back of the animal at the base of the neck in front of the shoulder blades until the skin is visible. Place the tip of the tube on the skin and squeeze the tube 3 or 4 times to empty its entire contents directly onto the skin in one spot. Keeping the tube squeezed, drag it away from the liquid and lift to remove. Check the tube to ensure that it is empty. Do not massage the product into the skin. Due to alcohol content, do not apply to broken skin. Avoid contact between the product and fingers. Do not apply when the haircoat is wet. Bathing or shampooing the animal 2 or more hours after treatment will not reduce the effectiveness of Revolution. Stiff hair, clumping of hair, hair discoloration, or a slight powdery residue may be observed at the treatment site in some animals. These effects are temporary and do not affect the safety or effectiveness of the product. Discard empty tubes in your ordinary household refuse.

Flea Control in Dogs and Cats

For the prevention and control of flea infestations, Revolution should be administered at monthly intervals throughout the flea season, starting one month before fleas become active. In controlled laboratory studies >98% of fleas were killed within 36 hours. Results of clinical field studies using Revolution monthly demonstrated >90% control of flea infestations within 30 days of the first dose. Dogs and cats treated with Revolution, including those with pre-existing flea allergy dermatitis, showed improvement in clinical signs associated with fleas as a direct result of eliminating the fleas from the animals and their environment.

If the dog or cat is already infested with fleas when the first dose of Revolution is administered, adult fleas on the animal are killed and no viable fleas hatch from eggs after the first administration. However, an environmental infestation of fleas may persist for a short time after beginning treatment with Revolution because of the emergence of adult fleas from pupae.

Heartworm Prevention in Dogs and Cats

For the prevention of heartworm disease, Revolution must be administered on a monthly basis. Revolution may be administered year-round or at least within one month after the animal's first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. The final dose must be given within one month after the last exposure to mosquitoes. If a dose is missed and a monthly interval between dosing is exceeded then immediate administration of Revolution and resumption of monthly dosing will minimize the opportunity for the development of adult heartworms. When replacing another heartworm preventive product in a heartworm disease prevention program, the first dose of Revolution must be given within a month of the last dose of the former medication.

Selamectin, the active ingredient in Revolution, is a macrocyclic lactone compound. These compounds effectively prevent the development of adult heartworms when administered to dogs and cats within one month of exposure to infective (L₃) Dirofilaria immitis larvae. Efficacy of macrocyclic lactones decreases below 100% in dogs, however, if first administered >2 months after exposure to infective larvae. Thus, in heartworm endemic regions, delaying initiation of heartworm prevention using Revolution beyond 2 months of first exposure to infective larvae (e.g., starting puppies and kittens at >8 weeks of age), or gaps of >2 months in the administration of Revolution during periods of heartworm transmission, increases the risk of the animal acquiring heartworms. Animals with unknown heartworm history that test negative for heartworms prior to the initiation of Revolution may be harboring pre-patent infections at the time Revolution was started. Testing such animals 3-4 months after initiation of Revolution would be necessary to confirm their negative heartworm status.

At the discretion of the veterinarian, cats ?6 months of age may be tested to determine the presence of existing heartworm infections before beginning treatment with Revolution. Cats already infected with adult heartworms can be given Revolution monthly to prevent further infections.

Ear Mite Treatment in Dogs and Cats

For the treatment of ear mite (O. cynotis) infestations in dogs and cats, Revolution should be administered once as a single topical dose. A second monthly dose may be required in some dogs. Monthly use of Revolution will control any subsequent ear mite infestations. In the clinical field trials ears were not cleaned, and many animals still had debris in their ears after the second dose. Cleansing of the infested ears is recommended to remove the debris.

Sarcoptic Mange Treatment in Dogs

For the treatment of sarcoptic mange (S. scabiei) in dogs, Revolution should be administered once as a single topical dose. A second monthly dose may be required in some dogs. Monthly use of Revolution will control any subsequent sarcoptic mange mite infestations. Because of the difficulty in finding sarcoptic mange mites on skin scrapings, effectiveness assessments also were based on resolution of clinical signs. Resolution of the pruritus associated with the mite infestations was observed in approximately 50% of the dogs 30 days after the first treatment and in approximately 90% of the dogs 30 days after the second monthly treatment.

Tick Control in Dogs

For the control of tick (Dermacentor variabilis) infestations in dogs, Revolution should be administered on a monthly basis. In heavy tick infestations, complete efficacy may not be achieved after the first dose. In these cases, one additional dose may be administered two weeks after the previous dose, with monthly dosing continued thereafter.

Nematode Treatment in Cats

For the treatment of intestinal hookworm (A. tubaeforme) and roundworm (T. cati) infections, Revolution should be applied once as a single topical dose.

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