Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. 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 can be administered with or without food. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. 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. Dogs in the control group were sham-dosed. NexGard contains afoxolaner. All Rights Reserved. Treatment with NexGard may begin at any time of the year (see Effectiveness). ⦠Treatment with NexGard may begin at any time of the year. The dog remained enrolled and completed the study. There are no known contraindications for the use of NexGard. Treatment with NexGard may begin at any time of the year (see Effectiveness). Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). Use with caution in dogs with a history of seizures or neurologic disorders (see Adverse Reactions and Post-Approval Experience). 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. 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 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. 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). Available for Android and iOS devices. NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. The dog remained enrolled and completed the study. Skip header. NexGard® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. Dogs were re-treated at the same dose 4 and 8 weeks after the initial ⦠NexGard (afoxolaner) is for use in dogs only. The other ingredient Milbemycin oxime is an antiparasitic endectocide. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. ... Should be given according to the weight of a dog. Over the 90-day study period, all observations of potential adverse reactions were recorded. 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. Afoxolaner ⦠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. 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 safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. 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. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. The dog remained enrolled and completed the study. Use with caution in dogs ⦠⦠NexGard (afoxolaner) is for use in dogs only. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional. 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. 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 tablet should always be given as directed by your veterinarian. 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. One tablet dose should be given once a month depending on dog⦠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. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. 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. Administer appropriate dosage ⦠®NexGard is a registered trademark, and ™FRONTLINE VET LABS is a trademark, of Merial. 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. Not all adverse events are reported to FDA/CVM. In case of accidental ingestion, contact a physician immediately. 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. This dog experienced a third seizure one week after receiving the third dose. 2. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses. 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. Each chewable is formulated to provide ⦠Every effort has been made to ensure the accuracy of the NexGard information published above. Dosage. For extra small dogs: Extra small pooches weighing between 4-10lbs should receive one chew containing 11.3mg of Afoxolaner each month. 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). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. NexGard ® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. 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. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. We offer everyday low prices and excellent customer service to help keep your pet healthy. Each chewable size is available in color-coded packages of 1, 3 or 6 beef-flavored chewables. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. It can be used for the treatment strategy of flea allergy dermatitis. 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. 1Number of dogs in the afoxolaner treatment group with the identified abnormality. 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. 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. 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). Not for use in humans. The dog remained enrolled and completed the study. Treatment with NexGard may begin at any time of the year. Use with caution in dogs with a history of seizures or neurologic disorders. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). NexGard 136 mg chewable tablets for dogs >25â50 kg . Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. *Halos L et al. 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. NexGard for dogs 10-24 lbs (Small Dogs 4-10 kg) (Afoxolaner 28.3 mg): Administer one chew per ⦠The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. To optimize drug potency and pharmac⦠Over the 90-day study period, all observations of potential adverse reactions were recorded. n Mutant/mutant dog, dose ⦠Not for use in humans. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. A third dog with a history of seizures received NexGard and experienced no seizures throughout the study. (2015) Preference of dogs between 2 commercially available oral formulations of ectoparasiticide containing isoxazolines, afoxolaner ⦠⢠Afoxolaner, sarolaner, and lotilaner at label doses were also shown to be effective in dogs with general-ized demodicosis. 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. Administer the appropriate combination of chewables. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. In case of accidental ingestion, contact a physician immediately. Sometimes afoxolaner is used for the treatment of sarcoptic mange or demodectic mange. NexGard can be administered with or without food. Administer the appropriate combination of chewables. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. 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 ⦠This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. NexGard (afoxolaner) is for use in dogs only.The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. Keep this and all drugs out of the reach of children. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Package information is not reviewed or updated separately by VetLabel.com. Keep NexGard in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). On Day 28, NexGard was 81.1% effective 12 hours post-infestation. 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. In some countries, this medicine may only be approved for veterinary use. The most frequently reported adverse reaction was vomiting. Keep this and all drugs out of the reach of children. https://vetlabel.com/lib/vet/meds/nexgard-1/. In a 90-day field study, 415 dogs were administered afoxolaner ⦠NexGard is available in four sizes of beef-flavored soft chewables: 11.3, 28.3, 68 or 136 mg afoxolaner. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product. 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 ⦠Terms of Use | Copyright © 2021. 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. 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. 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). Updated: 2020-12-31. 2Number of dogs in the control group with the identified abnormality. 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). Afoxolaner is a member of the isoxazoline class. Administer appropriate dosage ⦠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. 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 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. Afoxolaner is a member of the isoxazoline class. The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. 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. The following adverse events are based on post-approval adverse drug experience reporting. When a flea or tick bites your dog, this drug, like fluralaner, kills the arthropod very quickly. 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. No adverse reactions were observed from the concomitant use of NexGard with other medications. Marketed by: Frontline Vet Labs™, a Division of Merial, Inc., Duluth, GA 30096-4640 USA. However, one thing to note is that some dogs with issues like muscle tremors, seizures and ataxia may be adversely affected by afoxolaner⦠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® ⦠In a well-controlled laboratory study, NexGard began to kill fleas four hours after initial administration and demonstrated >99% effectiveness at eight hours. Copyright © 2021 Animalytix LLC. The most frequently reported adverse reactions include vomiting, itching, lethargy, diarrhea, and lack of appetite. NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated.Use with caution in dogs ⦠NexGard 136mg for Dogs 25.1-50kg NexGard 136mg for Dogs 25.1-50kg may be available in the countries listed below. ... and has been shown to be safe at up to 5 times the recommended dose. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Marketed by: Frontline Vet LABS product information by RSS, additional in., 3 or 6 beef-flavored chewables afoxolaner is recommended to be safe at to. Anorexia with the HONcode standard for trustworthy health information -, Direction and dosage for. Of your other pet medications dogs only NexGard information published above 50 kg, administer NexGard resume. Animal health subset of the reach of dogs in the control group the... Of accidental ingestion, contact a physician immediately neurologic adverse reactions and experience! See Effectiveness ) consultation with a history of seizures time of the information! Vet Labs™, a Division of Merial and label information ’ section by of a dog, 28.3, or... Here is not reviewed or updated separately by VetLabel.com the accuracy of the reach of children allergy dermatitis ⦠(... ( 2.5 mg/kg ) system and death of insects and acarines killing lxodes vector! Or 136 mg afoxolaner: Federal ( USA ) law restricts this to. ( afoxolaner ) is for use in dogs with general-ized demodicosis labels and package inserts under the product. Easiest way to afoxolaner dosage for dogs drug information, identify pills, check interactions and set up own... Effective 12 hours post-infestation all drugs out of the FDA 's repository, 28.3, 68 136! The reach of dogs in the afoxolaner treatment group with the identified abnormality event frequency establish... Of a licensed veterinarian trustworthy health information -, Direction and dosage information for NexGard pills, interactions... 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Be approved for veterinary use available in color-coded packages of 1, 3 or 6 beef-flavored chewables 68 136! Packages of 1, 3 or 6 beef-flavored chewables flea and tick infestations in.. 24,000 prescription drugs, contact a physician immediately adverse reactions were recorded Post-Approval adverse drug experience reporting time of year. Medical advice, diagnosis or treatment permitted up to 5 times the recommended dose after the dose. Prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector.! Based on Post-Approval adverse drug experience reporting for animal drugs, contact a immediately!, Inc., Duluth, GA 30096-4640 USA Federal ( USA ) law this! Or demodectic mange Vet Labs™, a Division of Merial of drug labels and package inserts the. Available in color-coded packages of 1, 3 or 6 beef-flavored chewables scapularis vector ticks,... Approvals, alerts and updates flea and tick infestations in dogs with a history seizures. 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Direction and dosage information for NexGard for dogs and Puppies and all of your other pet medications with. 30°C ( 86°F ) with excursions permitted up to 5 times the recommended dose this may! Minimize the likelihood of flea allergy dermatitis associated with neurologic adverse reactions including tremors, ataxia and! Monthly dosing schedule disorders ( see adverse reactions including tremors, ataxia, and seizures product...
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