Revolt: Product Information

REVOLT- selamectin solution
Aurora Pharmaceutical, Inc.

CAUTION:

US Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Revolt (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. The chemical composition of selamectin is (5Z,25S)-25-cyclohexyl-4′-O -de(2,6-dideoxy-3-O -methyl-α -L-arabino -hexopyranosyl)-5-demethoxy-25-de(1-methylpropyl)-22,23-dihydro-5-hydroxyiminoavermectin A1a .

INDICATIONS:

Revolt is recommended for use in dogs six weeks of age or older and cats eight weeks of age and older for the following parasites and indications:


Dogs:
Revolt 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. Revolt 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:
Revolt 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. Revolt is also indicated for the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections in cats.

WARNINGS:

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

In humans, Revolt may be irritating to skin and eyes.

Reactions such as hives, itching and skin redness have been reported in humans in rare instances. Individuals with known hypersensitivity to Revolt should use the product with caution or consult a health care professional. Revolt contains isopropyl alcohol and the preservative butylated hydroxytoluene (BHT). Wash hands after use and wash off any product in contact with the skin immediately with soap and water. If contact with eyes occurs, then flush eyes copiously with water. In case of ingestion by a human, contact a physician immediately. The safety data sheet (SDS) provides more detailed occupational safety information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Aurora Pharmaceutical at 1-888-215-1256 or www.aurorapharmaceutical.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.

Flammable — Keep away from heat, sparks, open flames or other sources of ignition.

Do not use in sick, debilitated or underweight animals (see SAFETY).

PRECAUTIONS:

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

ADVERSE REACTIONS:

Pre-approval clinical trials:
Following treatment with selamectin, transient localized alopecia with or without inflammation at or near the site of application was observed in approximately 1% of 691 treated cats. Other signs observed rarely (≤0.5% of 1743 treated cats and dogs) included vomiting, loose stool or diarrhea with or without blood, anorexia, lethargy, salivation, tachypnea, and muscle tremors.


Post-approval experience: In addition to the aforementioned clinical signs that were reported in pre-approval clinical trials, there have been reports of pruritus, urticaria, erythema, ataxia, fever, and rare reports of death. There have also been rare reports of seizures in dogs (see WARNINGS).

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 Revolt topically in accordance with the following tables. (See ADMINISTRATION for the recommended treatment intervals.)

Cats (lb) Package Color mg per tube Potency (mg/mL) Administered volume (mL)
Up to 5 Rose 15 mg 60 0.25
5.1-15 Blue 45 mg 60 0.75
15.1-22 Taupe 60 mg 60 1.0

For cats over 22 lbs use the appropriate combination of tubes.

Dogs (lb) Package Color mg per tube Potency (mg/mL) Administered volume (mL)
Up to 5 Rose 15 mg 60 0.25
5.1-10 Purple 30 mg 120 0.25
10.1-20 Brown 60 mg 120 0.5
20.1-40 Maroon 120 mg 120 1.0
40.1-85 Teal 240 mg 120 2.0
85.1-130 Plum 360 mg 120 3.0

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 Revolt topically to dogs and cats prior to first use.

While holding the tube in an upright position, twist the cap to break the seal. The cap will remain on the tube. 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 dog 2 or more hours after treatment will not reduce the effectiveness of Revolt against fleas or heartworm. Bathing or shampooing the cat 2 hours after treatment will not reduce the effectiveness of Revolt against fleas. Bathing or shampooing the cat 24 hours after treatment will not reduce the effectiveness of Revolt against heartworm.

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, Revolt 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 selamectin monthly demonstrated >90% control of flea infestations within 30 days of the first dose. Dogs and cats treated with selamectin, 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 Revolt 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 Revolt because of the emergence of adult fleas from pupae.

Heartworm Prevention in Dogs and Cats
For the prevention of heartworm disease, Revolt must be administered on a monthly basis. Revolt 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 Revolt 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 Revolt must be given within a month of the last dose of the former medication.

Selamectin, the active ingredient in Revolt, 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 Revolt 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 Revolt 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 Revolt may be harboring pre-patent infections at the time Revolt was started. Testing such animals 3–4 months after initiation of Revolt 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 Revolt. Cats already infected with adult heartworms can be given Revolt 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, Revolt should be administered once as a single topical dose. A second monthly dose may be required in some dogs. Monthly use of Revolt 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, Revolt should be administered once as a single topical dose. A second monthly dose may be required in some dogs. Monthly use of Revolt 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, Revolt 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 and control of intestinal hookworm (A. tubaeforme) and roundworm (T. cati) infections, Revolt should be applied once as a single topical dose.

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