Revolution

Description

Revolution (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 indications include 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 caused by Toxocara cati, and treatment and control of intestinal hookworm infections due to Ancylostoma tubaeforme.

Limitations of use have not been specified.

Dosage and Administration

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

For Cats:

• For cats weighing up to 5 lbs, use the mauve 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 to achieve the required dosage.

For Dogs:

• For dogs weighing up to 5 lbs, use the mauve 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 red 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 to achieve the required dosage.

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

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.

Contraindications

Use of this product is contraindicated in sick, debilitated, or underweight animals.

This product is not intended for human use and should be kept out of reach of children. It must not be applied to broken skin, and contact between the product and fingers should be avoided. Additionally, application is contraindicated when the haircoat is wet.

Warnings and Precautions

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

Revolution 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, and medical attention should be sought. Should ingestion occur, contacting a physician immediately is advised. Additionally, this product is flammable; therefore, it must be kept away from heat, sparks, open flames, or other sources of ignition.

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

Side Effects

Adverse reactions associated with the use of the product have been observed in both pre-approval clinical trials and post-approval experiences.

In pre-approval clinical trials involving 691 treated cats, approximately 1% of participants experienced transient localized alopecia, with or without inflammation, at or near the site of application. Other adverse signs were noted 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 revealed additional adverse reactions reported in dogs and cats, listed in decreasing order of frequency. In dogs, the most commonly reported reactions included lethargy, vomiting, diarrhea, anorexia, generalized pruritus, seizures, and application site reactions (which encompassed alopecia, lesions, erythema, pruritus, and inflammation). Less frequently reported reactions included tremors, ataxia, dermatitis, and in rare cases, death.

In cats, application site reactions were also frequently reported, including alopecia, lesions, erythema, pruritus, inflammation, vesicles, blisters, and excoriations. Other notable adverse reactions included lethargy, anorexia, vomiting, death, generalized pruritus, diarrhea, ataxia, fever, generalized alopecia, tremors, hypersalivation, dermatitis, and seizures.

It is important to note that while hypersensitivity reactions have not been observed in dogs with patent heartworm infections administered the product, caution should be exercised in individuals with known hypersensitivity to Revolution. Additionally, the product is not intended for human use, and users should keep it out of reach of children. In humans, Revolution may cause skin and eye irritation, and reactions such as hives, itching, and skin redness have been reported. Individuals experiencing such reactions should consult a healthcare professional.

Drug Interactions

Revolution is contraindicated in sick, debilitated, or underweight animals. Prior to the administration of Revolution, it is essential for dogs to be tested for existing heartworm infections. If a dog is found to be infected, the veterinarian may choose to treat the animal to eliminate adult heartworms, as Revolution is not effective against adult Dirofilaria immitis. While treatment may reduce the number of circulating microfilariae, Revolution does not facilitate the clearance of microfilariae.

For animals with an unknown heartworm history that test negative prior to starting Revolution, there is a possibility that they may harbor pre-patent infections at the time of initiation. To confirm their heartworm status, retesting should be conducted 3 to 4 months after the commencement of Revolution.

In cats aged 6 months or older, it is advisable to test for existing heartworm infections before initiating treatment with Revolution. Cats that are already infected with adult heartworms may still receive Revolution on a monthly basis to prevent further infections.

In well-controlled clinical studies, Revolution has been demonstrated to be safe for use in conjunction with other commonly used veterinary products, including vaccines, anthelmintics, antiparasitics, antibiotics, steroids, collars, shampoos, and dips. No specific dosage adjustments or additional monitoring are indicated when used alongside these products, as the combination has been shown to be effective and safe.

Packaging & NDC

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

Pediatric Use

Revolution (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. Safety studies have demonstrated that Revolution is safe for use in puppies and kittens at the recommended dosage, with no adverse reactions observed when applied at 1, 3, 5, and 10 times the recommended dose in six-week-old animals.

It is important to note that a case was reported where a kitten, estimated to be 5–6 weeks old and weighing 0.3 kg, died 8.5 hours after receiving a single treatment of Revolution at the recommended dosage. The kitten was malnourished and underweight, highlighting the need for careful assessment of the health status of pediatric patients prior to treatment.

Prior to administering Revolution, dogs should be tested for existing heartworm infections. At the veterinarian's discretion, infected dogs should be treated to remove adult heartworms. Additionally, cats six months of age and older may be tested for heartworm infections before initiating treatment with Revolution.

Geriatric Use

There is no specific geriatric use information provided for Revolution (selamectin). The prescribing information does not include any recommended age considerations, dosage adjustments, safety concerns, or special precautions specifically for elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this medication in geriatric patients, as individual patient factors may influence treatment decisions. Monitoring for efficacy and safety is advised, particularly in the absence of age-specific data.

Pregnancy

Revolution has been evaluated for safety 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. The data indicate that the use of Revolution in these populations does not pose significant risks. Additionally, it has been administered to breeding males and females, as well as puppies six weeks of age and older and kittens eight weeks of age and older, without adverse effects noted.

While specific risk categories for human pregnancy are not provided, the available animal studies suggest that Revolution can be used safely in pregnant and lactating animals. Healthcare professionals should consider the benefits of treatment against any potential risks when prescribing this medication to pregnant patients or those planning to become pregnant.

Lactation

Revolution has been tested for safety 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. The safety of Revolution administered orally was evaluated in cases of accidental oral ingestion in lactating females, and no adverse reactions were observed.

There is no specific data available regarding the excretion of Revolution in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should consider the potential benefits and risks when recommending this product to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical attention. Healthcare professionals should be alerted to the situation as soon as possible.

Upon ingestion by a human, the first recommended action is to contact a physician without delay. This prompt communication is crucial for assessing the severity of the overdosage and determining the appropriate course of action.

Potential symptoms of overdosage may vary depending on the substance involved and the amount ingested. Therefore, a thorough evaluation by a healthcare provider is essential to identify any adverse effects and initiate necessary management procedures.

Management of overdosage may include supportive care and symptomatic treatment, tailored to the specific clinical scenario presented. Continuous monitoring of the patient’s condition is advised to ensure timely intervention and mitigate any complications that may arise.

Nonclinical Toxicology

No teratogenic effects were observed in safety studies. However, a case involving a malnourished stray kitten, estimated to be 5–6 weeks old and weighing 0.3 kg, resulted in death 8 1⁄2 hours after receiving a single treatment of Revolution at the recommended dosage. The kitten exhibited clinical signs including muscle spasms, salivation, and neurological symptoms.

In safety studies, Revolution was administered at 1, 3, 5, and 10 times the recommended dose to six-week-old puppies, with no adverse reactions reported. The safety of Revolution was also evaluated in cases of accidental oral ingestion. Oral administration of Revolution at the recommended topical dose in 5- to 8-month-old beagles did not result in any adverse reactions. In a pre-clinical study, selamectin was dosed orally to ivermectin-sensitive collies. While oral administration of 2.5, 10, and 15 mg/kg did not cause adverse reactions, 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 with avermectin-sensitive collies, salivation was observed across all treatment groups, including the vehicle control, when Revolution was applied at 1, 3, and 5 times the recommended dose. Additionally, Revolution was administered at 3 times the recommended dose to heartworm-infected dogs without any observed adverse effects. Safety studies involving six-week-old kittens also showed no adverse reactions when Revolution was applied at 1, 3, 5, and 10 times the recommended dose. However, oral administration of the recommended topical dose of Revolution to cats resulted in salivation and intermittent vomiting. In heartworm-infected cats, Revolution was applied at 4 times the recommended dose without any adverse reactions.

Revolution has been tested for safety 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. In well-controlled clinical studies, Revolution was used safely in conjunction with other commonly used veterinary products, including vaccines, anthelmintics, antiparasitics, antibiotics, steroids, collars, shampoos, and dips.

Postmarketing Experience

Post-approval adverse drug experience reporting for Revolution has identified several adverse events associated with its use in dogs and cats. It is important to note that not all adverse events are reported to the FDA/CVM, and the frequency of these events cannot be reliably estimated, nor can a causal relationship to product exposure be established based on this data.

In dogs, the following adverse events have been reported in decreasing order of frequency: lethargy, vomiting, diarrhea, anorexia, generalized pruritus, seizures, application site reactions (which may include alopecia, lesions, erythema, pruritus, and inflammation), tremors, ataxia, death, and dermatitis.

For cats, the reported adverse events, also listed in decreasing order of frequency, include application site reactions (which may encompass 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.

Patient Counseling

Healthcare providers should instruct pet owners on the proper technique for applying Revolution topically to dogs and cats prior to its first use. It is essential that a veterinarian or veterinary technician demonstrates this application method to ensure correct usage.

Pet owners should be advised to firmly press the cap down to puncture the seal on the Revolution tube, noting that a clicking sound will confirm successful puncturing. After removing the cap, they should check to ensure that the tip of the tube is open. To administer the product, the owner should 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. The tip of the tube should be placed directly on the skin, and the owner should squeeze the tube 3 or 4 times to empty its entire contents onto the skin in one spot. It is important to keep the tube squeezed while dragging it away from the liquid and lifting it to remove. The owner should then check the tube to ensure that it is empty and must not massage the product into the skin.

Healthcare providers should caution pet owners against applying Revolution to broken skin due to its alcohol content and advise them to avoid contact between the product and their fingers. Additionally, it should not be applied when the haircoat is wet. Owners can be reassured that bathing or shampooing the dog 2 or more hours after treatment will not reduce the effectiveness of Revolution against fleas or heartworm. For cats, bathing or shampooing 2 hours after treatment will not diminish the effectiveness against fleas, while bathing or shampooing 24 hours after treatment will not affect its efficacy against heartworm.

Pet owners may observe temporary effects such as stiff hair, clumping of hair, hair discoloration, or a slight powdery residue at the treatment site; these do not impact the safety or effectiveness of the product. Empty tubes should be discarded in ordinary household refuse, and it is crucial to emphasize that Revolution is not for human use and should be kept out of reach of children.

Healthcare providers should inform pet owners that in humans, Revolution may cause skin and eye irritation, and reactions such as hives, itching, and skin redness have been reported. Individuals with known hypersensitivity to Revolution should use the product with caution or consult a healthcare professional. The product contains isopropyl alcohol and the preservative butylated hydroxytoluene (BHT).

After application, pet owners should wash their hands and remove any product that may have come into contact with their skin immediately using soap and water. In the event of contact with eyes, they should flush the eyes copiously with water; if wearing contact lenses, they should rinse the eyes first, remove the lenses, and continue rinsing for 5-10 minutes before seeking medical attention. If ingestion occurs, pet owners should contact a physician 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 must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent exposure to conditions that may compromise the product's quality.

Additional Clinical Information

Revolution should be administered topically, with the entire contents of a single dose tube used for dogs and cats, or two tubes for dogs weighing over 130 pounds. For effective flea control, it is recommended to apply Revolution monthly throughout the flea season, starting one month prior to flea activity. Monthly administration is also necessary for the prevention of heartworm disease and for controlling tick infestations in dogs. For ear mite infestations and sarcoptic mange in dogs, a single topical dose is sufficient. In cats, a single topical application is effective for treating and controlling intestinal hookworm and roundworm infections.

Clinicians should instruct pet owners on the proper application technique for Revolution prior to its first use. It is important for users to wash their hands after application and to remove any product from the skin immediately with soap and water. In the event of eye contact, the eyes should be flushed with water, and contact lenses should be removed. If ingested by a human, medical attention should be sought immediately. Postmarketing experience has revealed various adverse events in dogs, including lethargy, vomiting, and application site reactions, while cats have reported similar reactions along with additional symptoms such as hypersalivation and seizures.

Drug Information (PDF)

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

View veterinary label (PDF)