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. Afoxolaner kills adult fleas as well as adult ticks. 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. NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. 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. NexGard can be administered with or without food. Over the 90-day study period, all observations of potential adverse reactions were recorded. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. At 72 hours post-infestation, NexGard demonstrated >97% effectiveness against Amblyomma americanum for 30 days. Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. 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 … Not for use in humans. This dog experienced a third seizure one week after receiving the third dose. Each chewable is formulated to provide … Keep this and all drugs out of the reach of children. n Mutant/mutant dog, dose … Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated.Use with caution in dogs … NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. Keep this and all drugs out of the reach of children. 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. Copyright © 2021 Animalytix LLC. 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. Afoxolaner is recommended to be administered at a dose of 2.7-7 mg/kg dog's bodyweight. NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). Sometimes afoxolaner is used for the treatment of sarcoptic mange or demodectic mange. Over the 90-day study period, all observations of potential adverse reactions were recorded. 2. NEXGARD- afoxolaner tablet, chewableFrontline Vet Labs. Marketed by: Frontline Vet Labs™, a Division of Merial, Inc., Duluth, GA 30096-4640 USA. The most frequently reported adverse reaction was vomiting. The tablet should always be given as directed by your veterinarian. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. Package information is not reviewed or updated separately by VetLabel.com. 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® … NexGard ® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. 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). NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). 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). NexGard (afoxolaner) is for use in dogs only.The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. 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. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of 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. 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. Not for use in humans. 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. There are no known contraindications for the use of NexGard. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. 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. Dogs in the control group were sham-dosed. 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. NexGard 136 mg chewable tablets for dogs >25–50 kg . 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. … (2015) Preference of dogs between 2 commercially available oral formulations of ectoparasiticide containing isoxazolines, afoxolaner … If a dose is missed, administer NexGard and resume a monthly dosing schedule. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. Use with caution in dogs … The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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). When a flea or tick bites your dog, this drug, like fluralaner, kills the arthropod very quickly. QUALITATIVE AND QUANTITATIVE COMPOSITION. 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 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. Administer the appropriate combination of chewables. Keep NexGard in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. This class has been associated with neurologic adverse reactions including tremors, ataxia, and 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. 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). NexGard for dogs 10-24 lbs (Small Dogs 4-10 kg) (Afoxolaner 28.3 mg): Administer one chew per … The dog remained enrolled and completed the study. 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 … 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 136mg for Dogs 25.1-50kg NexGard 136mg for Dogs 25.1-50kg may be available in the countries listed below. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. NexGard contains afoxolaner. In a well-controlled laboratory study, NexGard began to kill fleas four hours after initial administration and demonstrated >99% effectiveness at eight hours. 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. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. Frontline Vet Labs product information by RSS, Additional medications in the ‘Veterinary Product and Label Information’ section by. 1Number of dogs in the afoxolaner treatment group with the identified abnormality. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Administer the appropriate combination of chewables. Each chewable size is available in color-coded packages of 1, 3 or 6 beef-flavored chewables. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. 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. It can be used for the treatment strategy of flea allergy dermatitis. 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. https://vetlabel.com/lib/vet/meds/nexgard-1/. Treatment with NexGard may begin at any time of the year. 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. 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. The following adverse events are based on post-approval adverse drug experience reporting. • Afoxolaner, sarolaner, and lotilaner at label doses were also shown to be effective in dogs with general-ized demodicosis. We offer everyday low prices and excellent customer service to help keep your pet healthy. The other ingredient Milbemycin oxime is an antiparasitic endectocide. 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. ®NexGard is a registered trademark, and ™FRONTLINE VET LABS is a trademark, of Merial. 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. Administer appropriate dosage … Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. Select one or more newsletters to continue. 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