Senergy

Description

SENERGY (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-arabinohexopyranosyl)-5-demethoxy-25-de(1-methylpropyl)-22,23-dihydro-5-hydroxyiminoavermectin A1a.

Uses and Indications

This drug is indicated for the prevention and control of flea infestations (Ctenocephalides felis) and the prevention of heartworm disease caused by Dirofilaria immitis in dogs six weeks of age or older. Additionally, it is indicated for the treatment and control of ear mite infestations (Otodectes cynotis) and sarcoptic mange (Sarcoptes scabiei), as well as the control of tick infestations due to Dermacentor variabilis.

In cats eight weeks of age or older, this drug is indicated for the prevention and control of flea infestations (Ctenocephalides felis) and the prevention of heartworm disease caused by Dirofilaria immitis. It is also indicated for the treatment and control of ear mite infestations (Otodectes cynotis), roundworm (Toxocara cati) infections, and intestinal hookworm (Ancylostoma tubaeforme) infections.

For optimal efficacy, this drug should be administered once a month to prevent heartworm disease and to prevent and control flea infestations.

Dosage and Administration

The recommended minimum dose of selamectin is 2.7 mg per pound (6 mg/kg) of body weight. SENERGY 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, the dosing is as follows:

• For cats weighing up to 5 lbs, administer 15 mg (Mauve package) as 0.25 mL.

• For cats weighing 5.1–15 lbs, administer 45 mg (Blue package) as 0.75 mL.

• For cats weighing 15.1–22 lbs, administer 60 mg (Taupe package) as 1.0 mL.

• For cats over 22 lbs, use the appropriate combination of tubes to achieve the required dosage.

For dogs, the dosing is as follows:

• For dogs weighing up to 5 lbs, administer 15 mg (Mauve package) as 0.25 mL.

• For dogs weighing 5.1–10 lbs, administer 30 mg (Lavender package) as 0.25 mL.

• For dogs weighing 10.1–20 lbs, administer 60 mg (Brown package) as 0.5 mL.

• For dogs weighing 20.1–40 lbs, administer 120 mg (Red package) as 1.0 mL.

• For dogs weighing 40.1–85 lbs, administer 240 mg (Teal package) as 2.0 mL.

• For dogs weighing 85.1–130 lbs, administer 360 mg (Plum package) as 3.0 mL.

• For dogs over 130 lbs, use the appropriate combination of tubes to achieve the required dosage.

SENERGY is recommended for use in dogs 6 weeks of age and older and in cats 8 weeks of age and older.

Contraindications

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

Application is not recommended when the haircoat is wet, as this may affect product efficacy. Additionally, the product should not be applied to broken skin due to the presence of alcohol in SENERGY, which may cause irritation. It is also contraindicated to massage SENERGY into the skin, as this may alter the intended use and effectiveness of the product.

Warnings and Precautions

Not for human use, SENERGY must be kept out of the reach of children to prevent accidental exposure. In humans, SENERGY may cause irritation to the skin and eyes. Rare instances of adverse reactions, including hives, itching, and skin redness, have been reported. Individuals with known hypersensitivity to SENERGY should exercise caution or consult a healthcare professional prior to use.

SENERGY 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.

In cases of ingestion by a human, immediate medical attention should be sought by contacting a physician. SENERGY is flammable; therefore, it should be kept away from heat sources, sparks, open flames, or any other potential sources of ignition. Additionally, SENERGY should not be administered to sick, debilitated, or underweight animals to ensure their safety and well-being.

Side Effects

Adverse reactions associated with SENERGY 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 reactions were reported rarely, occurring in ≤0.5% of 1,743 treated cats and dogs. These included vomiting, loose stool or diarrhea (with or without blood), anorexia, lethargy, salivation, tachypnea, and muscle tremors.

Post-approval experience has revealed additional clinical signs, including pruritus, urticaria, erythema, ataxia, and fever. Rare reports have also indicated serious adverse reactions such as death and seizures in dogs.

It is important to note that SENERGY is not intended for human use, and precautions should be taken to keep it out of the reach of children. In humans, SENERGY may cause skin and eye irritation, with rare instances of reactions such as hives, itching, and skin redness reported. Individuals with known hypersensitivity to SENERGY should exercise caution or consult a healthcare professional prior to use. The formulation contains isopropyl alcohol and the preservative butylated hydroxytoluene (BHT). Users are advised to wash hands after application and to remove any product that comes into contact with the skin immediately using soap and water. In the event of eye contact, it is recommended to flush the eyes copiously with water. If ingested by a human, immediate medical attention should be sought.

US Federal law restricts the use of this drug to licensed veterinarians or under their order.

Drug Interactions

Selamectin has been evaluated in well-controlled clinical studies and has demonstrated a favorable safety profile when administered concurrently with various veterinary products.

Pharmacodynamic Interactions Selamectin can be safely used alongside vaccines, anthelmintics, antiparasitics, antibiotics, steroids, collars, shampoos, and dips in both dogs and cats. No specific dosage adjustments or enhanced monitoring requirements have been identified for these combinations, indicating that selamectin does not adversely affect the efficacy or safety of these concurrent treatments.

Veterinarians may consider this information when developing treatment plans that involve selamectin and other veterinary products, ensuring a comprehensive approach to animal health management.

Packaging & NDC

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

Pediatric Use

SENERGY (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 dose for both species is 2.7 mg selamectin per pound (6 mg/kg) of body weight. SENERGY is available in various dose strengths tailored for dogs and cats of different weights.

Safety studies have demonstrated that selamectin can be administered to six-week-old puppies and kittens at doses of 1, 3, 5, and 10 times the recommended amount without adverse reactions. However, SENERGY should not be used in sick, debilitated, or underweight animals. Prior to administration, dogs should be tested for heartworm disease; if positive for adult heartworms, SENERGY can still be given. For cats older than six months, heartworm testing may be considered before prescribing SENERGY.

It is important to note that SENERGY is not intended for human use and should be kept out of reach of children.

Geriatric Use

Elderly patients, particularly those aged 65 and older, should be approached with caution when considering the use of SENERGY. It is important to note that SENERGY should not be administered to sick, debilitated, or underweight animals, as these conditions may exacerbate potential adverse effects.

Prior to initiating treatment with SENERGY, dogs must be tested for heartworm disease. In cases where a dog tests positive for adult heartworms, veterinarians are advised to recommend appropriate treatment before proceeding with SENERGY administration. For cats aged 6 months and older, testing for existing heartworm infections may also be considered at the veterinarian's discretion prior to treatment.

Selamectin, the active ingredient in SENERGY, has been evaluated for safety across a variety of healthy dog and cat breeds, including pregnant and lactating females, as well as breeding males and females. Safety studies have demonstrated that selamectin can be administered at doses up to ten times the recommended level in six-week-old puppies and kittens without any observed adverse reactions. Additionally, the safety of selamectin has been confirmed in cases of accidental oral ingestion in both dogs and cats, with no adverse effects reported.

While higher doses of selamectin have not been specifically tested in dogs with patent heartworm infections, hypersensitivity reactions have not been noted in dogs receiving three times the recommended dose. Therefore, careful monitoring and consideration of individual patient conditions are essential when treating geriatric patients with SENERGY.

Pregnancy

Selamectin has been tested in pregnant and lactating females, demonstrating a favorable safety profile. Clinical studies indicate that selamectin can be administered during pregnancy without adverse effects. There are no specific contraindications for the use of selamectin in pregnant patients. Therefore, healthcare professionals may consider the use of selamectin in this population, as the available data supports its safety during pregnancy.

Lactation

Selamectin has been tested safe in lactating females, and its safety has been established in both pregnant and lactating populations, indicating that it can be used in these groups without significant risk. However, there is a potential for excretion of selamectin in breast milk, although specific data on the levels and effects on nursing infants are not provided. Therefore, caution is advised when administering selamectin to nursing mothers, as the effects on the nursing infant are not fully understood.

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 to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 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.

Recommended Actions Upon ingestion by a human, the first step is to contact a physician without delay. This action is crucial to ensure that appropriate medical intervention can be initiated promptly.

Potential Symptoms While specific symptoms of overdosage may vary depending on the substance involved, it is essential for healthcare providers to monitor the patient closely for any signs of adverse reactions or complications that may arise from the overdose.

Management Procedures Management of an overdosage should be guided by the physician's assessment and may include supportive care, symptomatic treatment, and, if necessary, specific antidotes. Continuous monitoring of the patient's vital signs and overall condition is recommended to facilitate timely interventions.

Nonclinical Toxicology

Selamectin has been evaluated for its safety and efficacy in various nonclinical studies involving a wide range of animal breeds. In these studies, no increase in fetal malformations was observed, indicating a lack of teratogenic effects. Furthermore, hypersensitivity reactions were not noted in dogs with patent heartworm infections when administered three times the recommended dose of selamectin, although higher doses were not tested.

The safety profile of selamectin has been established 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 involving six-week-old puppies, selamectin was administered at doses of 1, 3, 5, and 10 times the recommended dose, with no adverse reactions reported. Similarly, in a topical safety study with avermectin-sensitive collies, salivation was observed across all treatment groups, including the vehicle control.

In a pre-clinical study, selamectin was dosed orally to ivermectin-sensitive collies. Administration of 2.5, 10, and 15 mg/kg did not result in adverse reactions; however, one collie exhibited ataxia for several hours after receiving 5 mg/kg, with no further adverse effects noted after subsequent doses. Additionally, selamectin was administered at three times the recommended dose to heartworm-infected dogs without any observed adverse effects.

In cases of accidental oral ingestion, the safety of selamectin was also assessed. Oral administration of the recommended topical dose to 5- to 8-month-old beagles did not cause adverse reactions, while in cats, it resulted in salivation and intermittent vomiting. Furthermore, selamectin was applied at four times the recommended dose to patent heartworm-infected cats, with no adverse reactions reported.

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, further supporting its safety profile in various clinical settings.

Postmarketing Experience

In addition to the clinical signs reported in pre-approval clinical trials, postmarketing experience has revealed additional adverse events. These include pruritus, urticaria, erythema, ataxia, and fever. Furthermore, there have been rare reports of death associated with the use of the product. Additionally, rare instances of seizures have been reported in dogs.

Patient Counseling

Healthcare providers should advise patients that SENERGY is a topical parasiticide designed for use in dogs six weeks of age and older and cats eight weeks of age and older. It effectively kills adult fleas, prevents flea eggs from hatching, and protects against heartworm disease and other parasites. It is essential for pet owners to discuss their pet’s health history with their veterinarian to determine if SENERGY is appropriate for their animal.

Patients should be informed that SENERGY should not be used in sick, debilitated, or underweight animals. For dogs, it is recommended to test for heartworm disease prior to administration. If a dog tests positive for adult heartworms, the veterinarian can suggest suitable treatment options. For cats older than six months, heartworm testing may also be advised before prescribing SENERGY. Cats infected with adult heartworms can safely receive SENERGY to prevent further infections.

The veterinarian will determine the appropriate dosage based on the pet's body weight. SENERGY should not be administered to dogs younger than six weeks or cats younger than eight weeks. It is available in eight different dose strengths tailored for various weights of dogs and cats. If a monthly dose is missed, patients should apply SENERGY immediately, resume the monthly schedule, and notify their veterinarian. In cases of administering more than the prescribed amount, patients should contact their veterinarian.

Patients should be instructed not to massage SENERGY into the skin, apply it when the haircoat is wet, or use it on broken skin, as SENERGY contains alcohol. They may observe temporary effects such as stiff hair, clumping, discoloration, or a slight powdery residue at the application site, which do not affect the product's safety or effectiveness. Bathing or shampooing the dog two or more hours after treatment will not diminish SENERGY's effectiveness against fleas or heartworm. For cats, bathing or shampooing two hours after treatment will not reduce effectiveness against fleas, while waiting 24 hours post-treatment will ensure effectiveness against heartworm.

Patients should avoid contact with the application site while it is wet and may hold or play with their pet once the area is dry. Although SENERGY 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. Immature flea stages, such as pupae, may still be present in the environment and can emerge as adult fleas, which will need to be exposed to SENERGY on the pet to be killed. It may take two to three monthly applications for SENERGY to effectively control flea infestations in the environment.

SENERGY is effective against the American Dog Tick (Dermacentor variabilis) but does not control other common tick species. For heavy tick infestations, the veterinarian may recommend a second application 14 days after the first dose or additional tick control methods. It may take up to five days to kill the majority of ticks on the dog.

Patients should be made aware 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, seizures or death. If patients have questions about side effects, they should consult their veterinarian.

It is important for patients to inform their veterinarian about all medications their pet has received in the past and any that they plan to use alongside SENERGY, including over-the-counter products. SENERGY is flammable and should be kept away from heat, sparks, and open flames, stored below 25°C (77°F), and disposed of properly after use.

Patients should be reminded that SENERGY is not intended for human use and should be kept out of reach of children. In humans, SENERGY may cause skin and eye irritation, and rare reactions such as hives and skin redness have been reported. Individuals with known hypersensitivity to SENERGY should use it cautiously or consult a healthcare professional. It is advisable to wash hands after application and to remove any product that comes into contact with the skin immediately with soap and water. In the event of human ingestion, patients should seek medical attention 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 exposure to conditions that may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View veterinary label (PDF)