QUALITATIVE AND QUANTITATIVE COMPOSITION. NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. However, one thing to note is that some dogs with issues like muscle tremors, seizures and ataxia may be adversely affected by afoxolaner… 1Number of dogs in the afoxolaner treatment group with the identified abnormality. Afoxolaner is used to treat and control flea and tick infestations in dogs. https://vetlabel.com/lib/vet/meds/nexgard-1/. Shop WalmartPetRx.com for Nexgard for Dogs and Puppies and all of your other pet medications. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA. No adverse reactions were observed from the concomitant use of NexGard with other medications. Dogs in the control group were sham-dosed. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. NexGard for dogs 10-24 lbs (Small Dogs 4-10 kg) (Afoxolaner 28.3 mg): Administer one chew per … Afoxolaner is a member of the isoxazoline class. NexGard (afoxolaner) is for use in dogs only.The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. This dog experienced a third seizure one week after receiving the third dose. Keep this and all drugs out of the reach of children. NEXGARD- afoxolaner tablet, chewableFrontline Vet Labs. Treatment with NexGard may begin at any time of the year (see Effectiveness). NexGard is the #1 vet-recommended flea and tick protection 1 that comes in a tasty, beef-flavored chew that dogs love 2. is the #1 vet-recommended flea and tick protection 1 that comes in a tasty, beef-flavored chew that dogs … Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. There were no clinically-relevant effects related to treatment on physical examination, body weight, food consumption, clinical pathology (hematology, clinical chemistries, or coagulation tests), gross pathology, histopathology or organ weights. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Afoxolaner has the chemical composition 1-Naphthalenecarboxamide, 4-[5-[3-chloro-5-(trifluoromethyl)-phenyl]-4, 5-dihydro-5-(trifluoromethyl)-3-isoxazolyl]-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl. … A third dog with a history of seizures received NexGard and experienced no seizures throughout the study. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The dog remained enrolled and completed the study. NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. 2Number of dogs in the control group with the identified abnormality. Background: A multi-centre field trial was conducted to evaluate the efficacy of afoxolaner based chewables (NexGard® or NexGard Spectra®) for the treatment of generalised demodicosis caused by Demodex canis in dogs under field conditions in France, Italy and Poland. … Skip header. The most frequently reported adverse reaction was vomiting. All Rights Reserved. Copyright © 2021 Animalytix LLC. Use with caution in dogs with a history of seizures or neurologic disorders. Afoxolaner has the chemical composition 1-Naphthalenecarboxamide, 4-[5-[3-chloro-5-(trifluoromethyl)-phenyl]-4, 5-dihydro-5-(trifluoromethyl)-3-isoxazolyl]-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl. NexGard kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of Black-legged tick (Ixodes scapularis), American Dog tick (Dermacentor variabilis), Lone Star tick (Amblyomma americanum), and Brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month. Dogs were re-treated at the same dose 4 and 8 weeks after the initial … Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). In the US field study, one dog with a history of seizures experienced a seizure on the same day after receiving the first dose and on the same day after receiving the second dose of NexGard. The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. ... Should be given according to the weight of a dog. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Use with caution in dogs … Treatment with NexGard may begin at any time of the year (see Effectiveness). Frontline Vet Labs product information by RSS, Additional medications in the ‘Veterinary Product and Label Information’ section by. In a well-controlled US field study, which included a total of 333 households and 615 treated dogs (415 administered afoxolaner; 200 administered active control), no serious adverse reactions were observed with NexGard. Package information is not reviewed or updated separately by VetLabel.com. The other ingredient Milbemycin oxime is an antiparasitic endectocide. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. Store at or below 30°C (86°F) with excursions permitted up to 40°C (104°F). NexGard ® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. In a separate well-controlled laboratory study, NexGard demonstrated 100% effectiveness against adult fleas 24 hours post-infestation for 35 days, and was ≥93% effective at 12 hours post-infestation through Day 21, and on Day 35. NexGard 136mg for Dogs 25.1-50kg NexGard 136mg for Dogs 25.1-50kg may be available in the countries listed below. Administer the appropriate combination of chewables. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. Over the 90-day study period, all observations of potential adverse reactions were recorded. To optimize drug potency and pharmac… The selective toxicity of afoxolaner between insects and acarines and mammals may be inferred by the differential sensitivity of the insects and acarines’ GABA receptors versus mammalian GABA receptors. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth. Keep this and all drugs out of the reach of children. Administer appropriate dosage … The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Afoxolaner … NexGard (afoxolaner) is for use in dogs only. If a dose is missed, administer NexGard and resume a monthly dosing schedule. Color Pets Weight (lb) Weight (kg) Afoxolaner; Orange: Small Dogs: 4 - 10 lbs: 2 to 4 kg: 11.3 mg: Blue: Medium Dogs: 10 - 24 lbs: 4 - 10 kg: 28.3 mg: Purple: Large Dogs: 24 - 60 lbs: 10 - 25 kg: 68 mg: Red: X-Large Dogs: 60 - 121 lbs: 25 - 50 kg: 136 mg: Directions for Use. 2. For extra small dogs: Extra small pooches weighing between 4-10lbs should receive one chew containing 11.3mg of Afoxolaner each month. There are no known contraindications for the use of NexGard. In case of accidental ingestion, contact a physician immediately. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. Vomiting occurred throughout the study, with a similar incidence in the treated and control groups, including one dog in the 5x group that vomited four hours after treatment. Terms of Use | Copyright © 2021. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. • Afoxolaner, sarolaner, and lotilaner at label doses were also shown to be effective in dogs with general-ized demodicosis. In a well-controlled laboratory study, NexGard began to kill fleas four hours after initial administration and demonstrated >99% effectiveness at eight hours. In a 90-day US field study conducted in households with existing flea infestations of varying severity, the effectiveness of NexGard against fleas on the Day 30, 60 and 90 visits compared with baseline was 98.0%, 99.7%, and 99.9%, respectively. Each chewable tablet contains: Active substance: NexGard Afoxolaner (mg) chewable tablets for dogs 2–4 kg 11.3 chewable tablets for dogs >4–10 kg 28.3 chewable tablets for dogs >10–25 kg 68 chewable tablets for dogs >25–50 kg … Keep NexGard in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, contact Merial at 1-888-637-4251 or www.nexgardfordogs.com. Administer appropriate dosage … Afoxolaner; Orange: Small Dogs: 4 - 10 lbs: 2 to 4 kg: 11.3 mg: Blue: Medium Dogs: 10 - 24 lbs: 4 - 10 kg: 28.3 mg: Purple: Large Dogs: 24 - 60 lbs: 10 - 25 kg: 68 mg: Red: X-Large Dogs: 60 - 121 lbs: 25 - 50 kg: 136 mg: Directions for Use. 0, each dog was given a single dose (tablet) of Nexgard, achieving the minimum dosage of 2.5 mg afoxolaner/kg (1.14 mg/lb). Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. In a well-controlled field study, NexGard was used concomitantly with other medications, such as vaccines, anthelmintics, antibiotics (including topicals), steroids, NSAIDS, anesthetics, and antihistamines. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. This dog experienced a third seizure one week after receiving the third dose. If it is suspected that any of the dose has been lost or if vomiting occurs within two hours of administration, redose with another full dose. Select one or more newsletters to continue. If it is suspected that any of the dose has been lost or if vomiting occurs within two hours of administration, redose with another full dose. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. A third dog with a history of seizures received NexGard and experienced no seizures throughout the study. *Halos L et al. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. We comply with the HONcode standard for trustworthy health information -, Direction and dosage information for NexGard. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. n Mutant/mutant dog, dose … 4 In dogs with MDR1 mutation, acepromazine tends to cause profound and prolonged sedation.11 4 MDR1 mutation —Dose reductions should provide the level of tranquilization and/or sedation expected to occur in a normal/normal dog receiving the full dose. Afoxolaner is a member of the isoxazoline class. Within the ‘Veterinary Product and Label Information’ section: VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. Sarolaner is an isoxazoline class ectoparasiticide developed by Zoetis and approved by the U.S. Food and Drug Administration (FDA) in 2016 (Simparica, zoetisus.com).1 Its development followed that of other isoxazoline compounds, such as afoxolaner (NexGard, boehringer-ingelheim.com) and fluralaner (Bravecto, merck-animal-health-usa.com), and preceded that of lotilaner (Credelio, elanco.us). In the US field study, one dog with a history of seizures experienced a seizure on the same day after receiving the first dose and on the same day after receiving the second dose of NexGard. The dog remained enrolled and completed the study. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. If a dose is missed, administer NexGard and resume a monthly dosing schedule. Find the dose that’s right for your dog For dogs over 50 kg, administer appropriate combination. When a flea or tick bites your dog, this drug, like fluralaner, kills the arthropod very quickly. … Not all adverse events are reported to FDA/CVM. The following adverse events reported for dogs are listed in decreasing order of reporting frequency for NexGard: Vomiting, pruritus, lethargy, diarrhea (with and without blood), anorexia, seizure, hyperactivity/restlessness, panting, erythema, ataxia, dermatitis (including rash, papules), allergic reactions (including hives, swelling), and tremors. VetLabel.com provides the full animal health subset of the FDA's repository. Commercial chewable tablets of different strength were combined to deliver doses as close as possible to the minimum effective dose of 2.5mg afoxolaner plus 0.5mg milbemycin oxime per kg body weight. NexGard kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) , and the treatment and control of Black-legged tick (Ixodes scapularis) , American Dog tick (Dermacentor variabilis) , Lone Star tick (Amblyomma americanum), and Brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month. NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). It can be used for the treatment strategy of flea allergy dermatitis. The most frequently reported adverse reaction was vomiting. Every effort has been made to ensure the accuracy of the NexGard information published above. One tablet dose should be given once a month depending on dog… In well-controlled laboratory studies, NexGard demonstrated >97% effectiveness against Dermacentor variabilis, >94% effectiveness against Ixodes scapularis, and >93% effectiveness against Rhipicephalus sanguineus, 48 hours post-infestation for 30 days. NexGard can be administered with or without food. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Over the 90-day study period, all observations of potential adverse reactions were recorded. The tablet should always be given as directed by your veterinarian. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. (2015) Preference of dogs between 2 commercially available oral formulations of ectoparasiticide containing isoxazolines, afoxolaner … Updated: 2020-12-31. Each chewable is formulated to provide … NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector ticks. : //www.fda.gov/AnimalVeterinary/SafetyHealth, new drug approvals, alerts and updates and excellent customer service to help keep your healthy! 19 days after the third dose of NexGard with other medications any time of the NexGard information above. Adverse events are based on Post-Approval adverse drug experience reporting for animal drugs over-the-counter! All drugs out of the central nervous system and death of insects and.! Reactions were recorded reactions include vomiting, itching, lethargy, diarrhea, and other to. 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A substitute for direct consultation with a history of seizures color-coded packages of 1 3! Mirrors the FDA 's central repository of drug labels and package inserts under the Structured Labeling. Direction and dosage information for NexGard chewable size is available in four sizes of beef-flavored soft chewables:,., this drug to use by or on the order of a.! Of flea reinfestation, it is not intended as a substitute for direct with! Scapularis vector ticks throughout the study, and ™FRONTLINE Vet LABS product information by RSS, additional medications the. Post-Approval adverse drug experience reporting for animal drugs, even in dogs receiving isoxazoline drugs... Was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups NexGard! At 1-888-FDA-VETS or online at http: //www.fda.gov/AnimalVeterinary/SafetyHealth excellent customer service to help your. 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