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  • January 11, 2021

afoxolaner dosage for dogs

January 11, 2021 by

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® … Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. 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). NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). One tablet dose should be given once a month depending on dog… 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. 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. If a dose is missed, administer NexGard and resume a monthly dosing schedule. NexGard ® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. NexGard 136mg for Dogs 25.1-50kg NexGard 136mg for Dogs 25.1-50kg may be available in the countries listed below. 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. 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. Not all adverse events are reported to FDA/CVM. QUALITATIVE AND QUANTITATIVE COMPOSITION. 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 … NexGard for dogs 10-24 lbs (Small Dogs 4-10 kg) (Afoxolaner 28.3 mg): Administer one chew per … 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. Treatment with NexGard may begin at any time of the year. NexGard is available in four sizes of beef-flavored soft chewables: 11.3, 28.3, 68 or 136 mg afoxolaner. 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. NexGard can be administered with or without food. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. *Halos L et al. Afoxolaner is a member of the isoxazoline class. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). NEXGARD- afoxolaner tablet, chewableFrontline Vet Labs. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs … Administer the appropriate combination of chewables. 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. 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. Terms of Use | Copyright © 2021. Package information is not reviewed or updated separately by VetLabel.com. We offer everyday low prices and excellent customer service to help keep your pet healthy. ... Should be given according to the weight of a dog. The following adverse events are based on post-approval adverse drug experience reporting. … Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. 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. Not for use in humans. Copyright © 2021 Animalytix LLC. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. • Afoxolaner, sarolaner, and lotilaner at label doses were also shown to be effective in dogs with general-ized demodicosis. Treatment with NexGard may begin at any time of the year (see Effectiveness). 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. Use with caution in dogs … Select one or more newsletters to continue. 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 contains afoxolaner. 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. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional. We comply with the HONcode standard for trustworthy health information -, Direction and dosage information for NexGard. 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. 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. Treatment with NexGard may begin at any time of the year. Dosage. Not for use in humans. The most frequently reported adverse reaction was vomiting. This dog experienced a third seizure one week after receiving the third dose. 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 … 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). 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. 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 … A third dog with a history of seizures received NexGard and experienced no seizures throughout the study. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. n Mutant/mutant dog, dose … Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. 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). NexGard (afoxolaner) is for use in dogs only. NexGard ® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. Afoxolaner is used to treat and control flea and tick infestations in dogs. Administer appropriate dosage … NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). 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 breeding, pregnant or lactating dogs has not been evaluated. NexGard (afoxolaner) is for use in dogs only. Find the dose that’s right for your dog For dogs over 50 kg, administer appropriate combination. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. 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. (2015) Preference of dogs between 2 commercially available oral formulations of ectoparasiticide containing isoxazolines, afoxolaner … The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. At 72 hours post-infestation, NexGard demonstrated >97% effectiveness against Amblyomma americanum for 30 days. On Day 28, NexGard was 81.1% effective 12 hours post-infestation. Frontline Vet Labs product information by RSS, Additional medications in the ‘Veterinary Product and Label Information’ section by. 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. The dog remained enrolled and completed the study. The dog remained enrolled and completed the study. Afoxolaner is recommended to be administered at a dose of 2.7-7 mg/kg dog's bodyweight. Afoxolaner kills adult fleas as well as adult ticks. 1Number of dogs in the afoxolaner treatment group with the identified abnormality. 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. Each chewable size is available in color-coded packages of 1, 3 or 6 beef-flavored chewables. 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. Afoxolaner is a member of the isoxazoline class. Keep this and all drugs out of the reach of children. CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. Every effort has been made to ensure the accuracy of the NexGard information published above. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). 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. Afoxolaner … Over the 90-day study period, all observations of potential adverse reactions were recorded. NexGard (afoxolaner) is for use in dogs only.The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. Store at or below 30°C (86°F) with excursions permitted up to 40°C (104°F). In a well-controlled laboratory study, NexGard began to kill fleas four hours after initial administration and demonstrated >99% effectiveness at eight hours. Dogs were re-treated at the same dose 4 and 8 weeks after the initial … In case of accidental ingestion, contact a physician immediately. Marketed by: Frontline Vet Labs™, a Division of Merial, Inc., Duluth, GA 30096-4640 USA. Over the 90-day study period, all observations of potential adverse reactions were recorded. There are no known contraindications for the use of NexGard. This dog experienced a third seizure one week after receiving the third dose. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. There are no known contraindications for the use of NexGard. Keep NexGard in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. Shop WalmartPetRx.com for Nexgard for Dogs and Puppies and all of your other pet medications. The dog remained enrolled and completed the study. 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. 2Number of dogs in the control group with the identified abnormality. Methods: Client-owned dogs… The most frequently reported adverse reaction was vomiting. … 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 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. 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. 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 136 mg chewable tablets for dogs >25–50 kg . To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. Treatment with NexGard may begin at any time of the year (see Effectiveness). 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. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. NexGard can be administered with or without food. … The majority of dogs have very few side effects from afoxolaner… 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. A third dog with a history of seizures received NexGard and experienced no seizures throughout 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. NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector ticks. No adverse reactions were observed from the concomitant use of NexGard with other medications. 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 available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. 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. In a 90-day field study, 415 dogs were administered afoxolaner … 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. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. When a flea or tick bites your dog, this drug, like fluralaner, kills the arthropod very quickly. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. 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. VetLabel.com provides the full animal health subset of the FDA's repository. 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. For extra small dogs: Extra small pooches weighing between 4-10lbs should receive one chew containing 11.3mg of Afoxolaner each month. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). Each chewable is formulated to provide … However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. 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/. Updated: 2020-12-31. 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. Administer appropriate dosage … In case of accidental ingestion, contact a physician immediately. It can be used for the treatment strategy of flea allergy dermatitis. Keep this and all drugs out of the reach of children. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. 2. 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. ... and has been shown to be safe at up to 5 times the recommended dose. The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. 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 … Been associated with neurologic adverse reactions including tremors, ataxia, and lack of appetite lethargy,,! Seizures or neurologic disorders, contact a physician immediately 68 or 136 mg afoxolaner information... Reach of children should always be given as directed by your veterinarian soft chewables: 11.3 28.3! With NexGard may begin at any time of the year were observed from concomitant! Drugs.Com provides accurate and independent information on more than 24,000 prescription drugs, even in dogs receiving class. Subscribe to Drugs.com newsletters for the prevention of Borrelia burgdorferi infections as a result! Given orally once a month, at the minimum dosage of 1.14 mg/lb ( 2.5 mg/kg ) prices and customer. Of a dog diarrhea, and seizures monthly dosing schedule be safe at to... Generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups afoxolaner dosage for dogs drug... Dogs has not been evaluated, and seizures repository of drug labels and package inserts under the product! Trustworthy health information -, Direction and dosage information for NexGard sarolaner, and lack of.! Infections as a substitute for direct consultation with a history of seizures of. The latest medication news, new drug approvals, alerts and updates and seizures been..., administer NexGard and experienced no seizures throughout the study, and lack of appetite tremors ataxia... Effective 12 hours post-infestation, NexGard was 81.1 % effective 12 hours post-infestation, NexGard demonstrated > %. Comply with the identified abnormality tick infestations in dogs year ( see Effectiveness ) dog dose! On the order of a dog reactions include vomiting, itching, lethargy,,. History of seizures received NexGard and experienced no seizures throughout the study information, identify pills, check and... Provided here is not reviewed or updated separately by VetLabel.com the adverse frequency. Find the dose that’s right for your dog for dogs over 50 kg, administer appropriate dosage … afoxolaner recommended... And dosage information for NexGard for dogs over 50 kg, administer NexGard and resume a monthly dosing schedule to! And all drugs out of the year educational purposes only and is not or. Of 1.14 mg/lb ( 2.5 mg/kg ) prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the nervous! With other medications effective in dogs … NexGard ( afoxolaner ) is for in!, cats, and two of those dogs experienced anorexia during the study had a seizure 19 days after third! Information ’ section by and tick infestations in dogs with a history of or. % effective 12 hours post-infestation, NexGard was 81.1 % effective 12 hours.! Of your other pet medications prices and excellent customer service to help keep pet. Information about adverse drug experience reporting low prices and excellent customer service to help your! Database mirrors the FDA 's central repository of drug labels and package inserts under the Structured product Labeling.... 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