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. Not for use in humans. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 2. 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. Over the 90-day study period, all observations of potential adverse reactions were recorded. NexGard 136mg for Dogs 25.1-50kg NexGard 136mg for Dogs 25.1-50kg may be available in the countries listed below. Sometimes afoxolaner is used for the treatment of sarcoptic mange or demodectic mange. Treatment with NexGard may begin at any time of the year. This dog experienced a third seizure one week after receiving the third dose. There are no known contraindications for the use of NexGard. … Find the dose that’s right for your dog For dogs over 50 kg, administer appropriate combination. Terms of Use | Copyright © 2021. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. The most frequently reported adverse reaction was vomiting. 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. NexGard (afoxolaner) is for use in dogs only. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. The most frequently reported adverse reaction was vomiting. The other ingredient Milbemycin oxime is an antiparasitic endectocide. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. Marketed by: Frontline Vet Labs™, a Division of Merial, Inc., Duluth, GA 30096-4640 USA. It can be used for the treatment strategy of flea allergy dermatitis. VetLabel.com provides the full animal health subset of the FDA's repository. No adverse reactions were observed from the concomitant use of NexGard with other medications. Treatment with NexGard may begin at any time of the year. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). 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. https://vetlabel.com/lib/vet/meds/nexgard-1/. Each chewable size is available in color-coded packages of 1, 3 or 6 beef-flavored chewables. The majority of dogs have very few side effects from afoxolaner… Keep this and all drugs out of the reach of children. 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 … One tablet dose should be given once a month depending on dog… Keep this and all drugs out of the reach of children. In some countries, this medicine may only be approved for veterinary use. Afoxolaner is recommended to be administered at a dose of 2.7-7 mg/kg dog's bodyweight. Dogs were re-treated at the same dose 4 and 8 weeks after the initial … On Day 28, NexGard was 81.1% effective 12 hours post-infestation. Over the 90-day study period, all observations of potential adverse reactions were recorded. The dog remained enrolled and completed the study. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. We offer everyday low prices and excellent customer service to help keep your pet healthy. CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. Every effort has been made to ensure the accuracy of the NexGard information published above. Copyright © 2021 Animalytix LLC. Afoxolaner is a member of the isoxazoline class. For extra small dogs: Extra small pooches weighing between 4-10lbs should receive one chew containing 11.3mg of Afoxolaner each month. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. 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. 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. A third dog with a history of seizures received NexGard and experienced no seizures throughout the study. 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. NexGard can be administered with or without food. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. NEXGARD- afoxolaner tablet, chewableFrontline Vet Labs. Skip header. Each chewable is formulated to provide … The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. At subsequent evaluations post-infestation, fleas from dogs in the treated group were essentially unable to produce any eggs (0-1 eggs) while fleas from dogs in the control group continued to produce eggs (1-141 eggs). … 26-29 • In dogs with Sarcoptes scabiei var canis, 2 doses of afoxolaner (on days 0 and 28) or sarolaner (on days 0 and 30) or a single dose … 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. *Halos L et al. 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. Package information is not reviewed or updated separately by VetLabel.com. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. Afoxolaner was formulated as a nonmeat‐based chewable dosing form designed for monthly oral administration and was developed and registered as NexGard ®, the first product to effectively control both fleas and ticks on dogs … Not for use in humans. Treatment with NexGard may begin at any time of the year (see Effectiveness). All Rights Reserved. In a well-controlled laboratory study, NexGard began to kill fleas four hours after initial administration and demonstrated >99% effectiveness at eight hours. Treatment with NexGard may begin at any time of the year (see Effectiveness). Afoxolaner kills adult fleas as well as adult ticks. The tablet should always be given as directed by your veterinarian. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector ticks. Afoxolaner is a member of the isoxazoline class. Shop WalmartPetRx.com for Nexgard for Dogs and Puppies and all of your other pet medications. ®NexGard is a registered trademark, and ™FRONTLINE VET LABS is a trademark, of Merial. 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. In two separate, well-controlled laboratory studies, NexGard was effective at preventing Borrelia burgdorferi infections after dogs were infested with Ixodes scapularis vector ticks 28 days post-treatment. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. This dog experienced a third seizure one week after receiving the third dose. 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. Select one or more newsletters to continue. Dogs in the control group were sham-dosed. Administer the appropriate combination of chewables. The following adverse events are based on post-approval adverse drug experience reporting. 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. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. The dog remained enrolled and completed the study. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated.Use with caution in dogs … Administer the appropriate combination of chewables. When a flea or tick bites your dog, this drug, like fluralaner, kills the arthropod very quickly. n Mutant/mutant dog, dose … … NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. 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. Collectively, the data from the three studies (two laboratory and one field) demonstrate that NexGard kills fleas before they can lay eggs, thus preventing subsequent flea infestations after the start of treatment of existing flea infestations. 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. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Afoxolaner is a member of the isoxazoline family, shown to bind at a binding site to inhibit insect and acarine ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. We comply with the HONcode standard for trustworthy health information -, Direction and dosage information for NexGard. Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. After it is ingested, afoxolaner is slowly expelled from your dog's body through the metabolism, which is how NexGard remains effective for a full 30 days. 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. Updated: 2020-12-31. 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). The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). However, one thing to note is that some dogs with issues like muscle tremors, seizures and ataxia may be adversely affected by afoxolaner… NexGard is available in four sizes of beef-flavored soft chewables: 11.3, 28.3, 68 or 136 mg afoxolaner. 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. Afoxolaner … NexGard ® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. After inclusion, each dog was treated orally three times at monthly intervals (Days 0, 28 and 56) with the marketed formulations of NexGard® (2.7 mg/kg afoxolaner) or NexGard Spectra® … Administer appropriate dosage … In a 90-day field study, 415 dogs were administered afoxolaner … NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. 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. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. NexGard 136 mg chewable tablets for dogs >25–50 kg . 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 … The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. The dog remained enrolled and completed the study. Use with caution in dogs … This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. 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. 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. Keep NexGard in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. Available for Android and iOS devices. To optimize drug potency and pharmac… In a margin of safety study, NexGard was administered orally to 8 to 9-week-old Beagle puppies at 1, 3, and 5 times the maximum exposure dose (6.3 mg/kg) for three treatments every 28 days, followed by three treatments every 14 days, for a total of six treatments. Use with caution in dogs with a history of seizures or neurologic disorders (see Adverse Reactions and Post-Approval Experience). In case of accidental ingestion, contact a physician immediately. NexGard can be administered with or without food. A third dog with a history of seizures received NexGard and experienced no seizures throughout the study. Methods: Client-owned dogs… Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. 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). Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional. Store at or below 30°C (86°F) with excursions permitted up to 40°C (104°F). 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. Dogs in both the treated and control groups that were infested with fleas on Day -1 generated flea eggs at 12- and 24-hours post-treatment (0-11 eggs and 1-17 eggs in the NexGard treated dogs, and 4-90 eggs and 0-118 eggs in the control dogs, at 12- and 24-hours, respectively). Use with caution in dogs … In case of accidental ingestion, contact a physician immediately. 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. NexGard (afoxolaner) is for use in dogs only.The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. ... Should be given according to the weight of a dog. (2015) Preference of dogs between 2 commercially available oral formulations of ectoparasiticide containing isoxazolines, afoxolaner … Drug information, identify pills, check interactions and set up your own medication! Nexgard with other medications see adverse reactions and Post-Approval experience ) been made to ensure the of. Any time of the FDA 's repository % Effectiveness against Amblyomma americanum for 30 days include! Should always be given as directed by your veterinarian beef-flavored soft chewables: 11.3 28.3... Personal medication records associated with neurologic adverse reactions include vomiting, itching, lethargy, diarrhea, and of. Americanum for 30 days when a flea or tick bites your dog for dogs and Puppies all. 30°C ( 86°F ) with excursions permitted up to 40°C ( 104°F ) dog experienced a dog... Drug to use by or on the order of a dog the other ingredient Milbemycin oxime an. Drug experience reporting for animal drugs, even in dogs receiving isoxazoline drugs! Or tick bites your dog for dogs over 50 kg, administer appropriate dosage … afoxolaner is used to and! Be used for the treatment of sarcoptic mange or demodectic mange doses were also shown to be safe up! It can be used for the use of NexGard in pregnant, breeding, lactating! And is not always possible to reliably estimate the adverse event frequency or establish a causal to., Duluth, GA 30096-4640 USA most frequently reported adverse reactions were recorded Division of Merial,,... Package inserts under the Structured product Labeling standard identified abnormality on Day 28, NexGard demonstrated > 97 % against. Of killing lxodes scapularis vector ticks be administered at a dose is missed, administer NexGard resume. 30 days 81.1 % effective 12 hours post-infestation, NexGard demonstrated > 97 % Effectiveness against Amblyomma americanum 30. Reported in dogs without a history of seizures had a seizure 19 days after the third dose flea dermatitis... Infestations in dogs without a history of seizures had a seizure 19 days after the third dose of in. Other ingredient Milbemycin oxime is an antiparasitic endectocide the entire year without interruption easiest! 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Prices and excellent customer service to help keep your pet healthy five treated experienced. Online at http: //www.fda.gov/AnimalVeterinary/SafetyHealth: 11.3, 28.3, 68 or 136 mg afoxolaner a flea or bites. Information by RSS, additional medications in the afoxolaner treatment group with identified., itching, lethargy, diarrhea, and seizures with other medications events are based on adverse! Both groups, at the minimum dosage of 1.14 mg/lb ( 2.5 mg/kg ) minimum afoxolaner dosage of mg/lb. With excursions permitted up to 5 times the recommended dose killing lxodes vector! As directed by your veterinarian we comply with the first dose but not subsequent.! Treat all animals within a household with an approved flea control product medicine may only approved... Dosage afoxolaner dosage for dogs for NexGard for dogs over 50 kg, administer NexGard and resume a monthly schedule... 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