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It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. Skip header. To optimize drug potency and pharmacâ¦ NexGard ® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. Not for use in humans. 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. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. On Day 28, NexGard was 81.1% effective 12 hours post-infestation. ®NexGard is a registered trademark, and ™FRONTLINE VET LABS is a trademark, of Merial. NexGard can be administered with or without food. 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. 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. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. If a dose is missed, administer NexGard and resume a monthly dosing schedule. NexGard is available in four sizes of beef-flavored soft chewables: 11.3, 28.3, 68 or 136 mg afoxolaner. In case of accidental ingestion, contact a physician immediately. 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. 26-29 â¢ 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 â¦ Each chewable is formulated to provide â¦ QUALITATIVE AND QUANTITATIVE COMPOSITION. 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 tablet, chewableFrontline Vet Labs. 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). 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. 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. 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. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. One tablet dose should be given once a month depending on dogâ¦ There are no known contraindications for the use of NexGard. The dog remained enrolled and completed the study. 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. It can be used for the treatment strategy of flea allergy dermatitis. NexGard for dogs 10-24 lbs (Small Dogs 4-10 kg) (Afoxolaner 28.3 mg): Administer one chew per â¦ NexGard (afoxolaner) is for use in dogs only. Administer the appropriate combination of chewables. The most frequently reported adverse reaction was vomiting. Keep this and all drugs out of the reach of children. NexGard 136mg for Dogs 25.1-50kg NexGard 136mg for Dogs 25.1-50kg may be available in the countries listed below. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated.Use with caution in dogs â¦ The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. n Mutant/mutant dog, dose â¦ 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. 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 most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional. Use with caution in dogs â¦ Store at or below 30°C (86°F) with excursions permitted up to 40°C (104°F). 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. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. 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. NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). Methods: Client-owned dogsâ¦ 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. 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. No adverse reactions were observed from the concomitant use of NexGard with other medications. 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. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. 2Number of dogs in the control group with the identified abnormality. Terms of Use | Copyright © 2021. Administer the appropriate combination of chewables. Every effort has been made to ensure the accuracy of the NexGard information published above. Afoxolaner is used to treat and control flea and tick infestations in dogs. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. ... Should be given according to the weight of a dog. 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. 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. *Halos L et al. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The dog remained enrolled and completed the study. The dog remained enrolled and completed the study. NexGard contains afoxolaner. Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. 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. â¢ Afoxolaner, sarolaner, and lotilaner at label doses were also shown to be effective in dogs with general-ized demodicosis. Sometimes afoxolaner is used for the treatment of sarcoptic mange or demodectic mange. CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. In a 90-day field study, 415 dogs were administered afoxolaner â¦ Keep NexGard in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. Available for Android and iOS devices. This dog experienced a third seizure one week after receiving the third dose. Updated: 2020-12-31. 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 other ingredient Milbemycin oxime is an antiparasitic endectocide. 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. Copyright © 2021 Animalytix LLC. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). Over the 90-day study period, all observations of potential adverse reactions were recorded. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. For extra small dogs: Extra small pooches weighing between 4-10lbs should receive one chew containing 11.3mg of Afoxolaner each month. Over the 90-day study period, all observations of potential adverse reactions were recorded. Administer appropriate dosage â¦ Administer appropriate dosage â¦ 1Number of dogs in the afoxolaner treatment group with the identified abnormality. 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. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). We offer everyday low prices and excellent customer service to help keep your pet healthy. In a well-controlled laboratory study, NexGard began to kill fleas four hours after initial administration and demonstrated >99% effectiveness at eight hours. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. NexGard ® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. There are no known contraindications for the use of NexGard. 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 â¦ This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Afoxolaner is recommended to be administered at a dose of 2.7-7 mg/kg dog's bodyweight. Keep this and all drugs out of the reach of children. Use with caution in dogs with a history of seizures or neurologic disorders (see Adverse Reactions and Post-Approval Experience). Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). In case of accidental ingestion, contact a physician immediately. â¦ A third dog with a history of seizures received NexGard and experienced no seizures throughout the study. Afoxolaner was formulated as a nonmeatâbased 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 â¦ 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. However, one thing to note is that some dogs with issues like muscle tremors, seizures and ataxia may be adversely affected by afoxolanerâ¦ 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® â¦ When a flea or tick bites your dog, this drug, like fluralaner, kills the arthropod very quickly. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Marketed by: Frontline Vet Labs™, a Division of Merial, Inc., Duluth, GA 30096-4640 USA. â¦ 4 In dogs with MDR1 mutation, acepromazine tends to cause profound and prolonged sedation.11 4 MDR1 mutation âDose reductions should provide the level of tranquilization and/or sedation expected to occur in a normal/normal dog receiving the full dose. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. The safety profile of afoxolaner, a new isoxazoline molecule, was evaluated following the regulatory requirements when administered six times orally in a soft chewable formulation at a dose of at least 1×, 3× or 5× the maximum exposure dose (6.3 mg/kg) in 8-week-old Beagle dogs. 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. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. 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. 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. Treatment with NexGard may begin at any time of the year (see Effectiveness). Treatment with NexGard may begin at any time of the year (see Effectiveness). Select one or more newsletters to continue. The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. The dog remained enrolled and completed the study. This dog experienced a third seizure one week after receiving the third dose. A third dog with a history of seizures received NexGard and experienced no seizures throughout the study. Package information is not reviewed or updated separately by VetLabel.com. All Rights Reserved. NexGard 136 mg chewable tablets for dogs >25â50 kg . Dogs in the control group were sham-dosed. We comply with the HONcode standard for trustworthy health information -, Direction and dosage information for NexGard. https://vetlabel.com/lib/vet/meds/nexgard-1/. NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector ticks. Use with caution in dogs with a history of seizures or neurologic disorders. â¦ 2. Afoxolaner is a member of the isoxazoline class. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. 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. NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). Shop WalmartPetRx.com for Nexgard for Dogs and Puppies and all of your other pet medications. The majority of dogs have very few side effects from afoxolanerâ¦ Dogs were re-treated at the same dose 4 and 8 weeks after the initial â¦ Use with caution in dogs â¦ 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. NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). 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. Dosage. 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 can be administered with or without food. Afoxolaner â¦ Treatment with NexGard may begin at any time of the year. If a dose is missed, administer NexGard and resume a monthly dosing schedule. 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. In some countries, this medicine may only be approved for veterinary use. Each chewable tablet contains: Active substance: NexGard Afoxolaner (mg) chewable tablets for dogs 2â4 kg 11.3 chewable tablets for dogs >4â10 kg 28.3 chewable tablets for dogs >10â25 kg 68 chewable tablets for dogs >25â50 kg â¦ The tablet should always be given as directed by your veterinarian. Afoxolaner is a member of the isoxazoline class. NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. 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 (afoxolaner) is for use in dogs only.The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. Not all adverse events are reported to FDA/CVM. 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. Treatment with NexGard may begin at any time of the year. 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. At 72 hours post-infestation, NexGard demonstrated >97% effectiveness against Amblyomma americanum for 30 days. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. VetLabel.com provides the full animal health subset of the FDA's repository. NexGard (afoxolaner) is for use in dogs only. Each chewable size is available in color-coded packages of 1, 3 or 6 beef-flavored chewables. 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). Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. ... and has been shown to be safe at up to 5 times the recommended dose. The most frequently reported adverse reaction was vomiting. 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® (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 are based on post-approval adverse drug experience reporting. Find the dose thatâs right for your dog For dogs over 50 kg, administer appropriate combination. Frontline Vet Labs product information by RSS, Additional medications in the ‘Veterinary Product and Label Information’ section by. Afoxolaner kills adult fleas as well as adult ticks. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. 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. 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 â¦

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