Selaspot

Description

SelaSpot (selamectin) Topical Parasiticide is presented as a colorless to yellow, ready-to-use solution contained in single-dose tubes, intended for topical (dermal) application in dogs and cats. Each tube is formulated to deliver 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.

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 following purposes: it kills adult fleas and prevents flea eggs from hatching for one month, thereby aiding in the prevention and control of flea infestations caused by Ctenocephalides felis. Additionally, it is indicated for the prevention of heartworm disease caused by Dirofilaria immitis, as well as for the treatment and control of ear mite infestations due to Otodectes cynotis. The drug also provides treatment and control of sarcoptic mange caused by Sarcoptes scabiei and controls tick infestations due to Dermacentor variabilis.

In cats, the drug is similarly indicated for killing adult fleas and preventing flea eggs from hatching for one month, thus assisting in the prevention and control of flea infestations caused by Ctenocephalides felis. It is also indicated for the prevention of heartworm disease caused by Dirofilaria immitis, treatment and control of ear mite infestations due to Otodectes cynotis, as well as for the treatment and control of roundworm infections caused by Toxocara cati and intestinal hookworm infections due to Ancylostoma tubaeforme.

Limitations of use include the specific age restrictions for dogs and cats as noted above.

Dosage and Administration

The recommended minimum dose of SelaSpot is 2.7 mg selamectin per pound (6 mg/kg) of body weight. Prior to the first use, a veterinarian or veterinary technician should demonstrate or instruct the pet owner on the appropriate technique for applying SelaSpot topically to dogs and cats.

To administer SelaSpot, the hair on the back of the animal should be parted 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 tube should be squeezed 3 or 4 times to empty its entire contents onto the skin in one spot. It is important not to massage the product into the skin.

For the prevention and control of flea infestations, SelaSpot should be administered at monthly intervals throughout the flea season, starting one month before fleas become active. For the prevention of heartworm disease, SelaSpot must be administered on a monthly basis. It may be given year-round or at least within one month after the animal's first exposure to mosquitoes, continuing monthly until the end of the mosquito season.

For the treatment of ear mite infestations in dogs and cats, SelaSpot should be administered once as a single topical dose. A second monthly dose may be required in some dogs. Similarly, for the treatment of sarcoptic mange in dogs, SelaSpot should be administered once as a single topical dose, with a second monthly dose potentially needed in some cases.

For the control of tick infestations in dogs, SelaSpot should be administered monthly. In cases of heavy tick infestations, an additional dose may be given two weeks after the previous dose, with monthly dosing continued thereafter. For the treatment and control of intestinal hookworm and roundworm infections, SelaSpot should be applied once as a single topical dose.

Contraindications

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

Application should not occur on broken skin or when the haircoat is wet. The product must not be massaged into the skin, and contact between the product and fingers should be avoided. In humans, SelaSpot may cause skin and eye irritation; therefore, individuals with known hypersensitivity to SelaSpot should exercise caution or consult a healthcare professional prior to use. In the event of human ingestion, immediate medical attention should be sought.

Warnings and Precautions

Not for human use; SelaSpot must be kept out of the reach of children. In humans, SelaSpot may cause skin and eye irritation. Reports of reactions such as hives, itching, and skin redness have been documented. Individuals with known hypersensitivity to SelaSpot should exercise caution or consult a healthcare professional prior to use.

SelaSpot contains isopropyl alcohol and the preservative butylated hydroxytoluene (BHT). It is imperative 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 essential 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.

Ingestion of SelaSpot by a human necessitates immediate contact with a physician. The product is flammable; therefore, it should be kept away from heat, sparks, open flames, or any other sources of ignition.

For animal safety, SelaSpot should not be administered to sick, debilitated, or underweight animals. No specific general precautions or laboratory tests have been identified for this product.

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, transient localized alopecia, with or without inflammation at or near the site of application, was noted in approximately 1% of subjects. Other adverse reactions were reported 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 experiences have revealed additional adverse reactions in both dogs and cats. In dogs, common reactions included lethargy, vomiting, diarrhea, anorexia, generalized pruritus, and application site reactions such as alopecia, lesions, erythema, pruritus, and inflammation. Serious adverse events reported in dogs also included seizures, tremors, ataxia, dermatitis, and in rare cases, death.

In cats, application site reactions were similarly noted, including alopecia, lesions, erythema, pruritus, inflammation, vesicles, blisters, and excoriations. Other adverse reactions reported in cats included 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, SelaSpot may cause skin and eye irritation, and reactions such as hives, itching, and skin redness have been reported. Individuals with known hypersensitivity to SelaSpot should exercise caution or consult a healthcare professional before use. Additionally, the product should not be administered to sick, debilitated, or underweight animals. Hypersensitivity reactions have not been observed in dogs with patent heartworm infections administered selamectin.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

SelaSpot (selamectin) is indicated for use in dogs six weeks of age and older and cats eight weeks of age and older. The recommended minimum dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight. It is contraindicated for administration to dogs younger than six weeks of age or cats younger than eight weeks of age.

In safety studies involving six-week-old puppies, selamectin was administered at doses of 1, 3, 5, and 10 times the recommended dose, with no adverse reactions observed. Similarly, in studies with six-week-old kittens, selamectin was applied at the same multiples of the recommended dose without any reported adverse effects.

However, caution is warranted as a case was reported involving a kitten estimated to be 5–6 weeks old (0.3 kg) that 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. 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.

Geriatric Use

Elderly patients, particularly those over the age of 65, should be approached with caution when considering the use of SelaSpot. It is important to note that SelaSpot is contraindicated in sick, debilitated, or underweight animals, which may include some geriatric patients.

For dogs, it is essential to conduct heartworm disease testing prior to administration of SelaSpot. In cases where a dog tests positive for adult heartworms, veterinarians can recommend appropriate treatment options. Notably, dogs that are already infected with adult heartworms can safely receive SelaSpot to prevent further infections.

In the case of cats, if the patient is older than six months, veterinarians may opt to test for heartworm disease before prescribing SelaSpot. Similar to dogs, cats that are infected with adult heartworms can also be administered SelaSpot to prevent additional infections.

Healthcare providers should ensure careful monitoring and consider these factors when prescribing SelaSpot to geriatric patients.

Pregnancy

Selamectin 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. Clinical studies indicate that selamectin can be administered to dogs infected with adult heartworms without adverse effects. Similarly, cats infected with adult heartworms may receive selamectin to prevent further infections.

However, caution is warranted based on a reported case involving a kitten, estimated to be 5–6 weeks old, 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 benefits against potential risks when considering selamectin for use in pregnant patients or in the treatment of young or compromised animals.

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, lactating mothers may consider the use of selamectin, particularly in the context of treating pets with heartworm infections. Dogs infected with adult heartworms can safely be given SelaSpot, and similarly, cats infected with adult heartworms can be treated with SelaSpot to prevent further infections. Caution is advised, and healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of selamectin in 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory depression, or other neurological manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or toxicology specialist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

Nonclinical Toxicology

No teratogenic effects were observed in studies involving selamectin. The compound has been tested 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 reported. Additionally, the safety of selamectin was evaluated in cases of accidental oral ingestion. Oral administration of selamectin at the recommended topical dose in 5- to 8-month-old beagles did not result in any adverse reactions. In a pre-clinical study involving ivermectin-sensitive collies, oral administration of 2.5, 10, and 15 mg/kg did not cause any adverse reactions; however, one 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.

A topical safety study conducted with avermectin-sensitive collies at 1, 3, and 5 times the recommended dose of selamectin noted salivation 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 observed. 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 noted.

The safety of selamectin was further assessed in cases of accidental oral ingestion in cats, where administration of the recommended topical dose resulted in salivation and intermittent vomiting. Selamectin was also applied at 4 times the recommended dose to patent heartworm-infected cats, with no adverse reactions reported.

Postmarketing Experience

Post-approval adverse drug experience reporting for selamectin has identified several adverse events. It is important to note that not all adverse events are reported to the FDA/CVM, and it may not be possible to reliably estimate the frequency of these events or establish a causal relationship to product exposure.

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 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 (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.

Patient Counseling

Healthcare providers should instruct pet owners on the proper technique for applying SelaSpot topically to dogs and cats prior to its first use. A veterinarian or veterinary technician should demonstrate this technique to ensure correct application.

To prepare the SelaSpot tube for use, advise pet owners to firmly press the cap down to puncture the seal, which will produce a clicking sound indicating successful puncture. After removing the cap, they should check that the tip of the tube is open.

When administering the product, pet owners 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. They should place the tip of the tube directly on the skin and squeeze the tube 3 or 4 times to empty its entire contents onto the skin in one spot. It is important to instruct them to keep the tube squeezed while dragging it away from the liquid and lifting it to remove. They should also check the tube to ensure it is empty. Emphasize that the product should not be massaged into the skin.

Due to the alcohol content, SelaSpot should not be applied to broken skin, and contact between the product and fingers should be avoided. Additionally, it should not be applied when the haircoat is wet. Inform pet owners that bathing or shampooing the dog 2 or more hours after treatment will not reduce the effectiveness of SelaSpot against fleas or heartworm. For cats, bathing or shampooing 2 hours after treatment will not reduce effectiveness against fleas, while bathing or shampooing 24 hours after treatment will not affect effectiveness against heartworm.

Pet owners may observe stiff hair, clumping of hair, hair discoloration, or a slight powdery residue at the treatment site in some animals. These effects are temporary and do not impact the safety or effectiveness of the product. Advise them to discard empty tubes in ordinary household refuse.

If a monthly dose of SelaSpot is forgotten, pet owners should apply it immediately, resume monthly applications, and notify their veterinarian. They should contact their veterinarian if they administer more than the prescribed amount of SelaSpot.

Instruct pet owners to avoid contact with the application site when it is wet, but they may hold or play with their pet once the area is dry. It is crucial to inform them that SelaSpot is not for use in humans and should be kept out of reach of children. In humans, SelaSpot may cause skin and eye irritation, and reactions such as hives, itching, and skin redness have been reported. Individuals with known hypersensitivity to SelaSpot should use the product with caution or consult a healthcare professional.

Pet owners should wash their hands after use and immediately wash off any product that comes into contact with their 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 25°C (77°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 any compromise to the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View veterinary label (PDF)