Revolt: Product Information (Page 2 of 3)

SAFETY:

Selamectin has been tested safe in over 100 different pure and mixed breeds of healthy dogs and over 15 different pure and mixed breeds of healthy cats, including pregnant and lactating females, breeding males and females, puppies six weeks of age and older, kittens eight weeks of age and older, and avermectin-sensitive collies. A kitten, estimated to be 5–6 weeks old (0.3 kg), died 8 1/2 hours after receiving a single treatment of selamectin at the recommended dosage. The kitten displayed clinical signs which included muscle spasms, salivation and neurological signs. The kitten was a stray with an unknown history and was malnourished and underweight (see WARNINGS).

DOGS: In safety studies, selamectin was administered at 1, 3, 5, and 10 times the recommended dose to six-week-old puppies, and no adverse reactions were observed. The safety of selamectin administered orally also was tested in case of accidental oral ingestion. Oral administration of selamectin at the recommended topical dose in 5- to 8-month-old beagles did not cause any adverse reactions. In a pre-clinical study selamectin was dosed orally to ivermectin-sensitive collies. Oral administration of 2.5, 10, and 15 mg/kg in this dose escalating study did not cause any adverse reactions; however, eight hours after receiving 5 mg/kg orally, one avermectin-sensitive collie became ataxic for several hours, but did not show any other adverse reactions after receiving subsequent doses of 10 and 15 mg/kg orally. In a topical safety study conducted with avermectin-sensitive collies at 1, 3 and 5 times the recommended dose of selamectin, salivation was observed in all treatment groups, including the vehicle control. Selamectin also was administered at 3 times the recommended dose to heartworm infected dogs, and no adverse effects were observed.

CATS: In safety studies, selamectin was applied at 1, 3, 5, and 10 times the recommended dose to six-week-old kittens. No adverse reactions were observed. The safety of selamectin administered orally also was tested in case of accidental oral ingestion. Oral administration of the recommended topical dose of selamectin to cats caused salivation and intermittent vomiting. Selamectin also was applied at 4 times the recommended dose to patent heartworm infected cats, and no adverse reactions were observed.

In well-controlled clinical studies, selamectin was used safely in animals receiving other frequently used veterinary products such as vaccines, anthelmintics, antiparasitics, antibiotics, steroids, collars, shampoos and dips.

STORAGE CONDITIONS:

Store below 30°C (86°F).

HOW SUPPLIED:

Available in eight separate dose strengths for dogs and cats of different weights (see DOSAGE). Revolt for puppies and kittens is available in cartons containing 3 single dose tubes. Revolt for cats and dogs is available in cartons containing 3 or 6 single dose tubes.

Approved by FDA under ANADA # 200-673

Revolt™ (selamectin)

Manufactured By:

Aurora Pharmaceutical, Inc.

NORTHFIELD, MN 55057

www.aurorapharmaceutical.com

aurora pharmaceutical®

Manufactured In U.S.A

Client Information About Revolt™ (selamectin) Revolt (pronounced “Re-volt”) Generic name: selamectin (“sel-a-mec-tin”)

This summary contains important information about Revolt. You should read this information before you start using Revolt on your dog or cat and review it each time your prescription is refilled. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or if you want to know more about Revolt.

What is Revolt?
Revolt is a topical parasiticide that is applied to the skin of dogs six weeks of age and older and cats eight weeks of age and older to kill adult fleas and prevent flea eggs from hatching, prevent heartworm disease and protect your pet against other parasites (see below).

Why has my veterinarian prescribed Revolt?
Revolt has been prescribed by your veterinarian to treat, prevent and/or control the following parasites in your dog or cat:

Dog Parasites:

• Control and prevention of flea infestation (Ctenocephalides felis)
• Prevention of heartworm disease (Dirofilaria immitis)
• Treatment and control of ear mite infestation (Otodectes cynotis)
• Treatment and control of sarcoptic mange (Sarcoptes scabiei)
• Control of the American Dog Tick (Dermacentor variabilis)

Cat Parasites:

• Control and prevention of flea infestation (Ctenocephalides felis)
• Prevention of heartworm disease (Dirofilaria immitis)
• Treatment and control of ear mite infestation (Otodectes cynotis)
• Treatment and control of intestinal worms — Roundworm (Toxocara cati), Hookworm (Ancylostoma tubaeforme)

What should I discuss with my veterinarian before Revolt is prescribed?
Your veterinarian is best suited to discuss and recommend appropriate medications for your dog or cat. It is important to discuss your pet’s health history with your veterinarian so he/she can decide if Revolt is right for your animal.

Revolt should not be used in sick, debilitated or underweight animals.

Dogs should be tested for heartworm disease prior to giving Revolt. If your dog tests positive for adult heartworms, your veterinarian can recommend appropriate treatment. Dogs infected with adult heartworms can safely be given Revolt.

If your cat is older than six months of age, your veterinarian may decide to test him/her for heartworm disease before prescribing Revolt. Cats infected with adult heartworms can be given Revolt to prevent further infections.

What dose of Revolt do I use on my dog or cat?
Your veterinarian will recommend the appropriate dose for your dog or cat based on your animal’s body weight. You should not administer Revolt to dogs younger than 6 weeks of age or cats younger than 8 weeks of age. Revolt is available in eight separate dose strengths for dogs and cats of different weights.

What should I do if I do not give Revolt on time or miss a dose?
If you forget to apply a monthly dose of Revolt, immediately apply Revolt, resume monthly applications, and notify your veterinarian.

What if I administer more than the prescribed amount of Revolt to my dog or cat? Contact your veterinarian if you administer more than the prescribed amount of Revolt.

How should Revolt be applied?

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1. Remove the Revolt tube from its protective package.

2. While holding the tube in an upright position, twist the cap to break the seal. The cap will remain on the tube.

3. 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.

4. Apply the tip of the Revolt tube directly to the skin. Squeeze the tube firmly 3 to 4 times in one spot until empty. Keep the tube compressed on the final squeeze to avoid drawing liquid back into tube. Avoid contact between Revolt and your fingers.

5. While keeping tube squeezed, drag it away from liquid and lift up to remove.

6. Ensure tube is empty.

Do not massage Revolt into the skin.

Do not apply when the haircoat is wet.

Do not apply to broken skin – Revolt contains alcohol.

Stiff hair, clumping of hair, hair discoloration, or a slight powdery residue may be observed at the site in some animals. These effects are usually temporary and do not affect the safety or effectiveness of the product.

Can I give my pet a bath after applying Revolt? Yes. 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.

When can I play with my pet following treatment with Revolt?

You should avoid contact with application site when wet. You may hold or play with your pet any time after the area on which Revolt was applied is dry.

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I see fleas on my dog or cat. Is Revolt working?
Revolt kills adult fleas and prevents flea eggs from hatching. You may occasionally see a few fleas on dogs or cats treated with Revolt but more than 98% of adult fleas are killed within 36 hours.

Immature stages of the flea called pupae may be present in your pets’ environment (yard, flooring, carpet, bedding, etc.). These pupae are not killed by parasiticides (including Revolt) and as such may emerge as adult fleas. These adult fleas may hop onto your pet at any time. They must be exposed to Revolt on your dog or cat before being killed. It can take from 3 to 5 weeks (or longer depending on environmental conditions) for most fleas to complete their 4-stage life cycle (egg, larvae, pupae, and adult) and reach the adult stage before being seen on your pet. Due to the presence of immature flea stages in infested environments it can take up to 2 to 3 monthly applications for Revolt to maximally control the infestation of fleas in the environment. Once the flea population is controlled you will be less likely to see fleas.

I see ticks on my dog. Is Revolt working?
Revolt controls tick infestations only due to the American Dog Tick (Dermacentor variabilis), a tick commonly found on dogs. There are other common species of ticks that are not killed or controlled by Revolt. Your veterinarian can recommend appropriate products to control or kill ticks common to your area. For the control of the American Dog Tick, Revolt should be applied once a month; however, your veterinarian may recommend a second administration applied 14 days after the first dose if your dog has a heavy tick infestation and/or recommend additional tick control methods. It may take up to 5 days to kill the majority of ticks on your dog.

What are the possible side effects of Revolt?
Like all medicines, Revolt has some side effects. The most common is hair loss at the site of application with or without inflammation (redness, flaking) in cats. Other side effects reported in cats and dogs include vomiting, diarrhea with or without blood, anorexia (decreased appetite), lethargy (sluggishness), salivation, rapid breathing, pruritus (itching), urticaria (welts, hives), erythema (skin redness), ataxia (incoordination), fever and rare instances of death. There have also been rare reports of seizures in dogs.

If you have additional questions about possible side effects, talk to your veterinarian.

Can Revolt be given with other medicines?
In well-controlled clinical studies, selamectin was used safely in dogs and cats receiving other veterinary products such as vaccines, anthelmintics, antiparasitics, antibiotics, steroids, collars, shampoos and dips.

Tell your veterinarian about all medicines you have given your dog or cat in the past, and any medicines that you are planning to use with Revolt. This should include other medicines that you can get without a prescription. Your veterinarian may want to check that all of your dog’s or cat’s medicines can be given together.

How should Revolt be stored?
Revolt is flammable – Keep away from heat, sparks, open flames or other sources of ignition. Store below 30°C (86°F). After application, empty tubes can be placed in your normal household refuse for disposal.

What else should I know about Revolt?
Revolt is not for use in humans. Revolt should be kept out of 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. In case of human ingestion contact a doctor immediately.

Revised: 02/2020

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