Revolt

Description

Revolt (selamectin) Topical Parasiticide is presented as a colorless to yellow, ready-to-use solution contained in single-dose tubes, designed for topical (dermal) application in dogs six weeks of age and older, and cats eight weeks of age and older. Each tube is formulated to deliver a minimum dosage of 2.7 mg/lb (6 mg/kg) of body weight of selamectin. The chemical structure of selamectin is defined as (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.

Uses and Indications

This drug is indicated for use in dogs six weeks of age or older and in cats eight weeks of age and older.

In dogs, the drug is indicated for the prevention and control of flea infestations caused by Ctenocephalides felis, prevention of heartworm disease due to Dirofilaria immitis, treatment and control of ear mite infestations caused by Otodectes cynotis, treatment and control of sarcoptic mange due to Sarcoptes scabiei, and control of tick infestations caused by Dermacentor variabilis.

In cats, the drug is indicated for the prevention and control of flea infestations caused by Ctenocephalides felis, prevention of heartworm disease due to Dirofilaria immitis, treatment and control of ear mite infestations caused by Otodectes cynotis, treatment and control of roundworm infections due to Toxocara cati, and treatment and control of intestinal hookworm infections caused by Ancylostoma tubaeforme.

Limitations of use include the specific age requirements for dogs and cats as stated above.

Dosage and Administration

The recommended minimum dose of selamectin is 2.7 mg per pound (6 mg/kg) of body weight. The entire contents of a single dose tube should be administered topically, or two tubes may be used in combination for dogs weighing over 130 pounds.

For Cats:

• For cats weighing up to 5 lbs, use the rose-colored package containing 15 mg of selamectin, with an administered volume of 0.25 mL.

• For cats weighing 5.1 to 15 lbs, use the blue package containing 45 mg of selamectin, with an administered volume of 0.75 mL.

• For cats weighing 15.1 to 22 lbs, use the taupe package containing 60 mg of selamectin, with an administered volume of 1.0 mL.

• For cats over 22 lbs, the appropriate combination of tubes should be used.

For Dogs:

• For dogs weighing up to 5 lbs, use the rose-colored package containing 15 mg of selamectin, with an administered volume of 0.25 mL.

• For dogs weighing 5.1 to 10 lbs, use the purple package containing 30 mg of selamectin, with an administered volume of 0.25 mL.

• For dogs weighing 10.1 to 20 lbs, use the brown package containing 60 mg of selamectin, with an administered volume of 0.5 mL.

• For dogs weighing 20.1 to 40 lbs, use the maroon package containing 120 mg of selamectin, with an administered volume of 1.0 mL.

• For dogs weighing 40.1 to 85 lbs, use the teal package containing 240 mg of selamectin, with an administered volume of 2.0 mL.

• For dogs weighing 85.1 to 130 lbs, use the plum package containing 360 mg of selamectin, with an administered volume of 3.0 mL.

• For dogs over 130 lbs, the appropriate combination of tubes should be used.

Revolt is recommended for use in dogs 6 weeks of age and older and in cats 8 weeks of age and older. A veterinarian or veterinary technician should demonstrate or instruct the pet owner on the appropriate technique for applying Revolt topically to dogs and cats prior to first use.

To administer, 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. It is important not to massage the product into the skin.

Contraindications

Use of this product is contraindicated in sick, debilitated, or underweight animals. Application should not occur on broken skin due to the presence of alcohol in the formulation. Additionally, the product should not be massaged into the skin, applied when the haircoat is wet, or used in any manner that may expose it to children. This product is not intended for human use.

Warnings and Precautions

User safety is paramount when handling Revolt. This product is strictly not for human use and must be kept out of the reach of children. In humans, Revolt may cause irritation to the skin and eyes. Reports of adverse reactions, including hives, itching, and skin redness, have been documented. Individuals with known hypersensitivity to Revolt should exercise caution or consult a healthcare professional prior to use.

Revolt contains isopropyl alcohol and the preservative butylated hydroxytoluene (BHT). It is essential to wash hands thoroughly after use and to immediately cleanse any product that comes into contact with the skin using soap and water. In the event of eye contact, it is critical to flush the eyes copiously with water. If contact lenses are being worn, they should be removed after rinsing the eyes for 5-10 minutes, followed by seeking medical attention. Should ingestion occur, immediate consultation with a physician is necessary. Additionally, Revolt is flammable; therefore, it must be kept away from heat, sparks, open flames, or any other sources of ignition.

For animal safety, Revolt should not be administered to sick, debilitated, or underweight animals.

Side Effects

Patients receiving treatment may experience a range of adverse reactions. In pre-approval clinical trials involving 691 treated cats, approximately 1% exhibited transient localized alopecia, with or without inflammation, at or near the site of application. Other adverse reactions were observed in ≤0.5% of 1,743 treated cats and dogs, including vomiting, loose stool or diarrhea (with or without blood), anorexia, lethargy, salivation, tachypnea, and muscle tremors.

Post-approval experience data from 2021 indicates that dogs reported adverse reactions in the following order of frequency: lethargy, vomiting, diarrhea, anorexia, generalized pruritus, seizures, application site reactions (which included alopecia, lesions, erythema, pruritus, and inflammation), tremors, ataxia, death, and dermatitis.

In cats, the most frequently reported adverse reactions included application site reactions (such as alopecia, lesions, erythema, pruritus, inflammation, vesicles, blisters, and excoriations), lethargy, anorexia, vomiting, death, generalized pruritus, diarrhea, ataxia, fever, generalized alopecia, tremors, hypersalivation, dermatitis, and seizures.

It is important to note that the product is not for human use and should be kept out of the reach of children. In humans, the product may cause skin and eye irritation, with reports of reactions such as hives, itching, and skin redness. Individuals with known hypersensitivity to the product should use it with caution or consult a healthcare professional. Additionally, the product should not be used in sick, debilitated, or underweight animals.

Drug Interactions

Selamectin, the active ingredient in Revolt, is a macrocyclic lactone compound that exhibits specific interactions relevant to heartworm prevention and treatment.

When transitioning from another heartworm preventive product to Revolt, it is essential that the first dose of Revolt is administered within one month of the last dose of the previous medication to ensure continued efficacy in heartworm prevention.

For animals with an unknown heartworm history, it is important to note that those testing negative for heartworms prior to starting Revolt may still harbor pre-patent infections. To confirm their heartworm status, retesting should be conducted 3 to 4 months after the initiation of Revolt. Additionally, at the veterinarian's discretion, cats aged 6 months or older may be tested for existing heartworm infections before commencing treatment with Revolt.

Selamectin has demonstrated a favorable safety profile and can be used concurrently with other commonly utilized veterinary products, including vaccines, anthelmintics, antiparasitics, antibiotics, steroids, collars, shampoos, and dips, without significant interactions.

Packaging & NDC

The table below lists each NDC Code for Revolt (selamectin) veterinary formulations. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Revolt (selamectin) is indicated for use in dogs six weeks of age and older and in cats eight weeks of age and older. The recommended minimum dosage is 2.7 mg selamectin per pound (6 mg/kg) of body weight.

For dogs, treatment should be administered to those weighing six weeks of age and older. For cats, treatment is appropriate for those weighing eight weeks of age and older. Prior to the first application, a veterinarian or veterinary technician should demonstrate or instruct the pet owner on the correct technique for topical application of Revolt.

Safety studies have demonstrated that selamectin can be administered at 1, 3, 5, and 10 times the recommended dose to six-week-old puppies and kittens without observing any adverse reactions. However, it is recommended that dogs be tested for heartworm disease before administration of Revolt, particularly in those six weeks of age or older. Additionally, cats six months of age and older may be tested for existing heartworm infections prior to initiating treatment with Revolt.

Geriatric Use

Elderly patients, particularly those aged 65 and older, may require special consideration when administering Revolt. It is not recommended for use in sick, debilitated, or underweight animals, which may include some geriatric patients. Prior to the administration of Revolt, it is essential that dogs be tested for existing heartworm infections. At the veterinarian's discretion, infected dogs should be treated to remove adult heartworms before initiating therapy.

The safety of selamectin, the active ingredient in Revolt, has been evaluated in over 100 different pure and mixed breeds of healthy dogs, as well as in 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, and kittens eight weeks of age and older. However, caution is warranted, as a case was reported involving a malnourished and underweight kitten, estimated to be 5–6 weeks old (0.3 kg), which died 8.5 hours after receiving a single treatment of selamectin at the recommended dosage. The kitten exhibited clinical signs such as muscle spasms, salivation, and neurological symptoms, highlighting the importance of assessing the overall health and nutritional status of geriatric patients prior to treatment.

In safety studies, selamectin was administered at 1, 3, 5, and 10 times the recommended dose to six-week-old puppies without any adverse reactions observed. Additionally, the safety of selamectin administered orally was tested in cases of accidental ingestion, with no adverse reactions noted in 5- to 8-month-old beagles receiving the recommended topical dose. However, in a topical safety study involving avermectin-sensitive collies, salivation was observed across all treatment groups, including the vehicle control, indicating a potential sensitivity that may be relevant in geriatric patients.

Selamectin was also applied at four times the recommended dose to patent heartworm-infected cats, with no adverse reactions reported. Furthermore, hypersensitivity reactions have not been observed in dogs with patent heartworm infections administered selamectin. Given these findings, careful monitoring and consideration of individual patient health status are advised when treating geriatric patients with Revolt.

Pregnancy

Selamectin has been evaluated for safety in over 100 different pure and mixed breeds of healthy dogs and more than 15 different pure and mixed breeds of healthy cats, including pregnant and lactating females. Clinical studies indicate that dogs infected with adult heartworms can safely receive selamectin, as can cats infected with adult heartworms to prevent further infections.

However, caution is warranted based on a reported case involving a kitten, estimated to be 5–6 weeks old and weighing 0.3 kg, which died 8 1/2 hours after receiving a single treatment of selamectin at the recommended dosage. The kitten exhibited clinical signs such as muscle spasms, salivation, and neurological symptoms. It is important to note that this kitten was a stray with an unknown history and was malnourished and underweight at the time of treatment.

Healthcare professionals should weigh the potential benefits against the risks when considering selamectin for use in pregnant patients or in animals with compromised health. Further studies may be necessary to fully understand the implications of selamectin use in these populations.

Lactation

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. There is no specific data available regarding the excretion of selamectin in human breast milk or its effects on breastfed infants. However, given the safety profile observed in lactating animals, it may be considered for use in lactating mothers when clinically indicated.

Lactating mothers should consult with their healthcare provider to weigh the potential benefits and risks before using selamectin while breastfeeding.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution and consider the overall clinical context when prescribing this medication to patients with hepatic impairment, as individual responses may vary.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare professionals should be alerted to any instances of ingestion by a human, as prompt intervention is crucial for patient safety.

Upon recognition of an overdose, the following steps are recommended:

1. Immediate Action: Contact a physician or poison control center without delay. This ensures that the patient receives appropriate guidance and management based on the specific circumstances of the overdose.

2. Monitoring Symptoms: Healthcare providers should be vigilant for potential symptoms associated with the overdose. While specific symptoms are not detailed in the provided information, general signs of overdose may include altered mental status, respiratory distress, or cardiovascular instability.

3. Management Procedures: The management of an overdose may involve supportive care, symptomatic treatment, and, if applicable, the administration of antidotes. The specific approach will depend on the substance involved and the clinical presentation of the patient.

In summary, immediate medical consultation is essential in cases of overdose to facilitate timely and effective management.

Nonclinical Toxicology

No teratogenic effects were reported in studies involving selamectin. However, a non-teratogenic effect was observed in a case involving a malnourished stray kitten, estimated to be 5–6 weeks old, which died 8.5 hours after receiving a single treatment of selamectin at the recommended dosage. The kitten exhibited clinical signs including muscle spasms, salivation, and neurological symptoms.

Selamectin has been evaluated for safety in over 100 different pure and mixed breeds of healthy dogs and more than 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. In safety studies, selamectin was administered at 1, 3, 5, and 10 times the recommended dose to six-week-old puppies, with no adverse reactions observed.

The safety of selamectin was also assessed in cases of accidental oral ingestion. In studies involving 5- to 8-month-old beagles, oral administration of selamectin at the recommended topical dose did not result in any adverse reactions. In a pre-clinical study, selamectin was dosed orally to ivermectin-sensitive collies. Administration of 2.5, 10, and 15 mg/kg in a dose-escalating study did not cause adverse reactions; however, one avermectin-sensitive collie became ataxic for several hours after receiving 5 mg/kg orally, but showed no further adverse reactions after subsequent doses of 10 and 15 mg/kg.

In a topical safety study conducted with avermectin-sensitive collies at 1, 3, and 5 times the recommended dose of selamectin, salivation was noted in all treatment groups, including the vehicle control. Selamectin was also administered at 3 times the recommended dose to heartworm-infected dogs, with no adverse effects reported. In safety studies involving six-week-old kittens, selamectin was applied at 1, 3, 5, and 10 times the recommended dose, and no adverse reactions were observed.

Oral administration of the recommended topical dose of selamectin to cats resulted in salivation and intermittent vomiting. Additionally, selamectin was applied at 4 times the recommended dose to heartworm-infected cats, with no adverse reactions noted. In well-controlled clinical studies, selamectin was safely used in conjunction with other commonly used veterinary products, including vaccines, anthelmintics, antiparasitics, antibiotics, steroids, collars, shampoos, and dips.

No specific details regarding animal pharmacology and toxicology beyond the aforementioned safety studies were provided.

Postmarketing Experience

Adverse events reported in the postmarketing experience for selamectin include a range of effects observed in both dogs and cats, with varying frequencies.

In dogs, the most frequently reported adverse events, listed in decreasing order of occurrence, are lethargy, vomiting, diarrhea, anorexia, generalized pruritus, seizures, and application site reactions, which encompass alopecia, lesions, erythema, pruritus, and inflammation. Additional events include tremors, ataxia, death, and dermatitis.

For cats, the adverse events reported, also in decreasing order of frequency, include application site reactions (such as alopecia, lesions, erythema, pruritus, inflammation, vesicles, blisters, and excoriations), lethargy, anorexia, vomiting, death, generalized pruritus, diarrhea, ataxia, fever, generalized alopecia, tremors, hypersalivation, dermatitis, and seizures.

Following treatment with selamectin, transient localized alopecia with or without inflammation at or near the site of application was noted in approximately 1% of 691 treated cats. Other signs observed in ≤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.

It is important to note that the post-approval experience data from 2021 reflects adverse drug experience reporting for selamectin. Not all adverse events are reported to the FDA/CVM, and it is not always feasible to reliably estimate the frequency of these events or establish a causal relationship to product exposure based on this data.

Patient Counseling

Healthcare providers should advise patients that Revolt (selamectin) is a topical parasiticide intended for use in dogs six weeks of age and older and cats eight weeks of age and older. It is effective in killing adult fleas, preventing flea eggs from hatching, preventing heartworm disease, and protecting against other parasites.

It is crucial for patients to discuss their pet’s health history with their veterinarian to determine if Revolt is appropriate for their animal. Revolt should not be administered to sick, debilitated, or underweight animals. Prior to administering Revolt, dogs should be tested for heartworm disease. If a dog tests positive for adult heartworms, the veterinarian can recommend suitable treatment, as dogs infected with adult heartworms can safely receive Revolt. For cats older than six months, the veterinarian may also decide to test for heartworm disease before prescribing Revolt, which can be given to cats infected with adult heartworms to prevent further infections.

Patients should be instructed to apply Revolt monthly and to immediately apply a missed dose if they forget, while also notifying their veterinarian. It is important to contact the veterinarian if more than the prescribed amount of Revolt is administered. Patients should not massage the product into the skin, apply it when the haircoat is wet, or apply it to broken skin, as Revolt contains alcohol.

Some temporary effects may occur at the application site, such as stiff hair, clumping, discoloration, or a slight powdery residue, but these do not affect the product's safety or effectiveness. Bathing or shampooing the dog two or more hours after treatment will not diminish the effectiveness of Revolt against fleas or heartworm. For cats, bathing or shampooing two hours after treatment will not reduce effectiveness against fleas, while bathing 24 hours after treatment will not affect effectiveness against heartworm.

Patients should avoid contact with the application site when wet and may hold or play with their pet once the area is dry. While Revolt effectively kills adult fleas and prevents flea eggs from hatching, it is possible to see a few fleas on treated pets, as more than 98% of adult fleas are killed within 36 hours. Patients should be aware that immature flea stages, known as pupae, may still be present in the environment and can emerge as adult fleas.

Revolt controls tick infestations only for the American Dog Tick (Dermacentor variabilis) and does not affect other common tick species. Patients should be informed of potential side effects, which may include hair loss at the application site, vomiting, diarrhea (with or without blood), decreased appetite, lethargy, salivation, rapid breathing, itching, hives, skin redness, incoordination, fever, and in rare cases, death. If patients have questions about side effects, they should consult their veterinarian.

In well-controlled clinical studies, selamectin has been safely used in conjunction with other veterinary products, including vaccines and antiparasitics. Patients should be cautioned that Revolt is flammable and should be kept away from heat, sparks, open flames, or other ignition sources. It should be stored below 30°C (86°F), and empty tubes can be disposed of in normal household refuse.

Revolt is not intended for human use and should be kept out of reach of children. In humans, it may cause skin and eye irritation, with rare reports of hives, itching, and skin redness. Individuals with known hypersensitivity to Revolt should use it with caution or consult a healthcare professional. Patients should wash their hands after use and immediately wash off any product that comes into contact with the skin using soap and water. In the event of human ingestion, they should contact a doctor immediately.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at temperatures below 30°C (86°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to higher temperatures, which may compromise the product's quality.

Additional Clinical Information

Revolt should be administered topically, with the entire contents of a single dose tube used for dogs and two tubes for those weighing over 130 pounds. It is essential that a veterinarian or veterinary technician instructs pet owners on the proper application technique prior to the first use.

Patients should wash their hands after application and immediately cleanse any product that comes into contact with the skin using soap and water. In the event of eye contact, eyes should be flushed thoroughly with water, and contact lenses should be removed before continuing to rinse for 5-10 minutes, followed by seeking medical attention. If ingested by a human, a physician should be contacted immediately. Users should avoid contact between the product and fingers, and it should not be applied to broken skin. Temporary effects such as stiff hair, clumping, discoloration, or a slight powdery residue may occur at the treatment site but do not compromise the product's safety or effectiveness.

Postmarketing experience has revealed various adverse events. For dogs, the most frequently reported include lethargy, vomiting, diarrhea, anorexia, generalized pruritus, seizures, and application site reactions. In cats, common adverse events include application site reactions, lethargy, anorexia, and vomiting, among others.

Drug Information (PDF)

This document includes the full labeling information for Revolt, as submitted by Aurora Pharmaceutical, Inc. for veterinary use. It may include dosage by species, withdrawal periods, and administration instructions.

View veterinary label (PDF)