In a well-controlled U.S. field study, which included a total of 176 treated cats (135 with Bravecto Plus and 41 with a monthly topical active control), there were no serious adverse reactions. If a dose is missed and a 2-month interval between doses is exceeded, administer Bravecto Plus immediately and resume the dosing every 2 months. Bravecto for Cats Medium Cats; Bravecto Plus - DO NOT USE. The cap is designed to stay on the tube for dosing and should not be removed. BRAVECTO PLUS is an extended-duration, broad-spectrum combination (fluralaner and moxidectin) topical solution for cats, indicated for both external … Bravecto Plus spot-on for cats works fast and continues to protect against fleas for 3 months, paralysis ticks for 10 weeks and heartworm for 2 months, plus treats roundworm, hookworm and ear mites. Contents: 1 tube containing 112.5 mg fluralaner and 5.6 mg moxidectin Approved by FDA under NADA # 141-518, For cats and kittens 6 months of age and older Foreign Market Experience: The following adverse events were reported voluntarily during post-approval use of the product in cats in foreign markets: polydipsia, swelling of chin and lips, periorbital swelling, blepharospasm, pruritus, erythema, aggression, agitation, pyrexia, mydriasis, hypersalivation, hyperactivity, alopecia, and excessive grooming. The mode of action of fluralaner is the antagonism of the ligand-gated chloride channels (gamma-aminobutyric acid (GABA)-receptor and glutamate-receptor). They are available in three weight range packs, with a simple twist-n-use dispensing tube making it quick and easy to use. Bravecto Plus may be administered year-round without interruption or at a minimum should be administered at 2-month intervals beginning at the cat's first seasonal exposure to mosquitoes and continuing until the cat's last seasonal exposure to mosquitoes. The mode of action of fluralaner is the antagonism of the ligand-gated chloride channels (gamma-aminobutyric acid (GABA)-receptor and glutamate-receptor). Use with caution in cats with a history of neurologic disorders. It binds to gamma-aminobutyric acid (GABA) and glutamate-gated chloride channels of the nerves and muscles of the parasite resulting in hyperpolarization, paralysis and death. Each milliliter contains 280 mg of fluralaner and 14 mg of moxidectin. Part the hair and apply to the skin on the back of the head, as per the diagram. Peak fluralaner concentrations are achieved between 3 and 21 days following topical administration and the elimination half-life ranges between 11 and 18 days. Heartworms were found in the epidural space in the second cat of the 1X group and the cat in the 3X group. Each tube is formulated to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin. The effectiveness of Bravecto Plus to prevent heartworm disease after bathing or water immersion has not been evaluated. No. No adverse reactions were observed from the concurrent use of Bravecto Plus with other medications. One cat exhibited transient lacrimation from one eye during the first 15 minutes after dosing. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. However, for indoor cats, Bravecto’s treatment is still a three-month preventative. Fluralaner, one of the ingredients in Bravecto Plus, is a member of the isoxazoline class. These adverse events occurred within 48 hours of administration. Bravecto Plus was not effective when administered more than 2 months prior to infection. Do not contact or allow children to contact the application site until 2 hours post application. Hold the tube at the crimped end with the cap in an upright position (tip up). G4408 (Act 36/1947) For Small Cats . The cap should be rotated clockwise or counter clockwise one full turn. Do not contact or allow children to contact the application site until 2 hours post application. Bravecto for Cats is available in three strengths for use in cats (112.5 mg, 250 mg, and 500 mg fluralaner per tube). (fluralaner and moxidectin topical solution) for Cats. Contents: 1 tube containing 500 mg fluralaner and 25 mg moxidectin Approved by FDA under NADA # 141-518, Report Adverse Events (Animal Drug), Peak fluralaner concentrations are achieved between 3 and 21 days following topical administration and the elimination half-life ranges between 11 and 18 days. There were no clinically-relevant, treatment-related effects on physical examination, body weights, food consumption, clinical pathology (hematology, clinical chemistries, coagulation tests, serum amyloid A, and urinalysis), gross pathology, histopathology, or organ weights. If contact with eyes occurs, then flush eyes slo… Discount flea, tick, heartworm and intestinal worm treatments by PetBucket. ), More about getting RSS News & Updates from DailyMed, 2 This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=d9d5ebde-7ff7-4864-b393-fbe77d7a112f, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. November 2, 2020. Bravecto Plus is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). Additional information can be found at www.bravecto.com. Labels, All Index Bravecto Plus - How it works? Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide, acetone, butylhydroxytoluene. Step 2: The cat should be standing or lying with its back horizontal during application. Bravecto Plus (fluralaner and moxidectin topical solution) for Cats. Greasy, oily, or wet appearance may occur at the application site in some cats. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. You don’t have as many times to fight with your cat about the application if your cat isn’t a fan of spot-on treatments. Percentage of Cats with Adverse Reactions (AR) in the Field Study, Bravecto Plus Group: Percent of Cats with the AR During the 120-Day Study (n=135 cats), Active Control Group: Percent of Cats with the AR During the 120-Day Study (n=41 cats). In a pilot oral safety study, adult cats orally administered 0.5× or 1× the maximum labeled dose of Bravecto Plus had foaming hypersalivation for up to five minutes and reduced food consumption on the day of dosing. Bravecto for Cats has not been shown to be effective for 12-weeks duration in kittens less than 6 months of age. Hold the tube at the crimped end with the cap in an upright position (tip up). The chemical name of fluralaner is (±)-4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)- 4,5-dihydroisoxazol-3-yl]-2-methyl-N-[2-oxo-2-(2,2,2- trifluoroethylamino) ethyl]benzamide. Treated kittens had reduced food consumption on the day of treatment. Bravecto Plus is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati; 4th stage larvae, immature adults and adults) and hookworm (Ancylostoma tubaeforme; 4th stage larvae, immature adults and adults). Bravecto spot-on products are absorbed through your cat’s skin, drying quickly at the application site. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Updated: 2020-12-31. In a well-controlled laboratory study, Bravecto Plus killed 100% of fleas within 12 hours after treatment and reduced the numbers of live fleas on cats by >99% within 12 hours after treatment or infestation for 2 months. Copyright © 2021 Animalytix LLC. One treated kitten experienced vomiting 2 hours after administration and another 8 hours after treatment. Fluralaner is an inhibitor of the arthropod nervous system. Clinical signs in one cat in the 1X group included vomiting, depression, vocalization, and ataxia 38 days after dosing. In addition, three treated cats (2/8 cats in the 1X group and 1/8 cats in the 3X group) developed adverse neurologic signs during the study and were euthanized due to quality-of-life concerns. In well-controlled laboratory studies, Bravecto Plus was effective against naturally and experimentally induced adult and experimentally induced 4th stage larval and immature adult Toxocara cati and Ancylostoma tubaeforme infections in cats. published 4 months ago. Bravecto Plus is available in three tube sizes to treat cats ranging in weight from 2.6 lb - 27.5 lb (1.2 kg to 12.5 kg). If the product accidentally contacts skin and a sticky residue persists after washing, rubbing alcohol (70% isopropyl alcohol) can be applied to the area to remove the residue. A single Bravecto ® Chew treatment lasts for 12 weeks in dogs, while the Spot-On lasts for 4 months for ticks and 6 months for fleas. Fluralaner, one of the ingredients in Bravecto Plus, is a member of the isoxazoline class. The tube is open and ready for application when a breaking of the seal is felt. For cats, the spot-on treatment isn’t as water resistant as Frontline’s. A second cat in the 1× group had neurologic signs that included ataxia, paresis, and muscle tremors 25 days after dosing. For cats suffering from, or at risk of, mixed ecto- and endoparasitic infestations. When fleas and ticks bite, they ingest the solution and die within 8 hours. The cap should be rotated clockwise or counter clockwise one full turn. Two untreated cats were found dead prior to dosing. For topical use only. The safety of Bravecto Plus has not been established in breeding, pregnant, and lactating cats. How to apply Bravecto Topical for cats: Step 1: removing the tube from the product pouch, and holding the tube firmly upright you twist the cap of the tube off until you hear the seal breaking. Apply at the base of the skull, to ensure wet product can't be licked. Avoid contact with skin and eyes. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. per page. Available for Android and iOS devices. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Each tube is packaged individually in a pouch. Bravecto Plus has not been shown to be effective in kittens less than 6 months of age. Bravecto Plus may be administered year-round without interruption or at a minimum should be administered at 2-month intervals beginning at the cat’s first seasonal exposure to mosquitoes and continuing until the cat’s last seasonal exposure to mosquitoes. this version. BRAVECTO PLUS- fluralaner and moxidectin solution. There were no clinically-relevant, treatment-related effects on physical examination, body weights, food consumption, or clinical pathology (hematology, clinical chemistries, coagulation tests, serum amyloid A, and urinalysis). 3 doses of BRAVECTO® per pet, get a rebate of $20; 4 doses of BRAVECTO® per pet, get a rebate of $30. In well-controlled laboratory effectiveness studies, the following adverse reactions were seen after application of Bravecto Plus: pyrexia, tachypnea, mydriasis, pruritus, scabbing, and bloody stool. For topical use only. Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. Fleas are killed in up to 12 hours after treatment or after reinfestation during the 3 month treatment period. Specifically designed for the challenges of treating cats, BRAVECTO PLUS delivers everything that you expect from BRAVECTO and more. The cap is designed to stay on the tube for dosing and should not be removed. There are no known contraindications for the use of the product. The cats in the control group (0×) received mineral oil topically. Avoid oral ingestion (see Animal Safety). In well-controlled laboratory studies, Bravecto Plus demonstrated ≥ 98.1% effectiveness against Ixodes scapularis 48 hours after treatment or infestation for 2 months. Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. Avoid oral ingestion (see Animal Safety). It treats and prevents ticks, fleas, heartworms, and several kinds of worms. As cats are fastidious groomers, applying to this location is important to prevent your cat from licking the wet application site. Fluralaner is for systemic use and belongs to the class of isoxazoline-substituted benzamide derivatives. Reg. In well-controlled laboratory studies, Bravecto Plus demonstrated >90% effectiveness against Dermacentor variabilis 48 hours after treatment or infestation for 2 months but failed to demonstrate ≥ 90% effectiveness beyond 2 months. Safety in cats infected with adult heartworm (Dirofilaria immitis): Bravecto Plus was administered topically to cats infected with adult heartworm at 1X or 3X the maximum labeled dose of 93.0 mg fluralaner/kg and 4.7 mg moxidectin/kg (8 cats per group). Bravecto PLUS Flea,Tick & Worm Spot-On for Cats Large (6.25-12.5kg) Special Price $49.90 $65.00. The cats in the control group (0X) received mineral oil topically. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Margin of Safety Study: In a margin of safety study, Bravecto Plus was administered topically to 9- to 13-week-old (mean age 12 weeks) kittens at 1×, 3×, and 5× the maximum labeled dose of 93.0 mg fluralaner/kg and 4.7 mg moxidectin/kg at three, 8-week intervals (10 kittens per group). In two well-controlled laboratory studies, Bravecto Plus was 100% effective against induced heartworm infections when administered 2 months prior to infection. Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide, acetone, butylhydroxytoluene. In well-controlled laboratory studies, Bravecto Plus demonstrated >90% effectiveness against Dermacentor variabilis 48 hours after treatment or infestation for 2 months but failed to demonstrate ≥ 90% effectiveness beyond 2 months. FDA Safety Recalls (Animal Drug), Clinical Trials, A cat in the 3× group exhibited depression, dehydration, a hunched position, and inability to stand 22 days after dosing. Keep away from heat, sparks, open flame or other sources of ignition. * Cats over 27.5 lb should be administered the appropriate combination of tubes. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. If contact with eyes occurs, then flush eyes slowly and gently with water. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. Bravecto Plus kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick) and Dermacentor variabilis (American dog tick)] for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater. The safety of BRAVECTO PLUS has not been established in breeding, pregnant and lactating cats. If wearing contact lenses, eyes should be rinsed first, then remove contact lenses and continue rinsing, then seek medical advice immediately. The kittens in the control group were administered saline orally. The chemical name of moxidection is (2aE,4E,5'R,6R,6'S,8E,11R,13S,15S,17aR,20R,20aR,20bS)-6'-[(E)-1,3-Dimethyl-1-butenyl]-5',6,6',7,10,11,14,15,17a,20,20a,20b-dodecahydro-20,20b-dihydroxy-5',6,8,19-tetramethylspiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2'-[2H]pyran]-4',17(3'H)-dione 4'-(E)-(O-methyloxime). In a well-controlled U.S. field study, which included a total of 176 treated cats (135 with Bravecto Plus and 41 with a monthly topical active control), there were no serious adverse reactions. There were no clinically-relevant, treatment-related effects on physical examination, body weights, food consumption, clinical pathology (hematology, clinical chemistries, coagulation tests, serum amyloid A, and urinalysis), gross pathology, histopathology, or organ weights. These adverse events occurred within 48 hours of administration. should be administered the appropriate combination of tubes. Avoid contact with skin and eyes. 0061-5996-01, Use with caution in cats that are heartworm positive (see Animal Safety). * 3 Cats over 27.5 lb. How to use Bravecto Spot-on for Cats Ensure the animal's back is horizontal. *ALT was greater than twice the upper reference range of 100 IU/L. Two untreated cats were found dead prior to dosing. In a European field study for fluralaner topical solution for cats, there were three reports of facial dermatitis in humans after close contact with the application site which occurred within 4 days of application. PLUS SPOT-ON - 3 months flea and tick protection for cats, PLUS worm treatment, in one spot-on. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. How to apply BRAVECTO Topical Solution for Cats A single dose should be applied to the skin on the back of the neck (separate fur if needed) with the easy Twist'n'Use ™ applicator once every 12 weeks. One treated kitten experienced vomiting 2 hours after administration and another 8 hours after treatment. The pouch should only be opened immediately prior to use. Get Label RSS Feed, Five of six treated kittens experienced hypersalivation. Each milliliter contains 280 mg of fluralaner and 14 mg of moxidectin. Part the hair and apply directly to the skin. View NDC Code(s)NEW! In well-controlled laboratory effectiveness studies, the following adverse reactions were seen after application of Bravecto Plus: pyrexia, tachypnea, mydriasis, pruritus, scabbing, and bloody stool. Compare. Not for human use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. As I opened the packaging I split some on my hands. Self-limiting hypersalivation due to grooming was observed on the day of treatment in both treatment groups (6/8 cats in the 1X group and 7/8 cats in the 3X group). Wash hands and contacted skin thoroughly with soap and water immediately after use of the product. Peak moxidectin concentrations are achieved between 1 and 5 days following topical administration and the elimination half-life ranges between 20 and 30 days. Bravecto® works by seeping into the tissues located beneath the skin. Bravecto Plus Spot-On is for cats with, or at risk from, mixed parasitic infections by ticks and fleas, gastrointestinal nematodes or heartworm. A cat in the 3X group exhibited depression, dehydration, a hunched position, and inability to stand 22 days after dosing. Do not store above 77°F (25°C). 6 Items. Put on gloves. is this? To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Merck Animal Health at 1-800-224-5318. In a well-controlled laboratory study, Bravecto Plus killed 100% of fleas within 12 hours after treatment and reduced the numbers of live fleas on cats by >99% within 12 hours after treatment or infestation for 2 months. It acts as a treatment strategy for flea allergy dermatitis ( FAD ) shown to be effective 12-weeks! Setid=D9D5Ebde-7Ff7-4864-B393-Fbe77D7A112F, https: //dailymed.nlm.nih.gov/dailymed/rss.cfm of protection against fleas and ticks bite, they ingest the solution run! 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Some on my hands concurrent use of the solution and die within 8 hours hookworms. ( fluralaner and moxidectin topical solution ) for cats Ensure the animal about the application site matting/clumping/spiking... On more than 2 months prior to infection or smoke while handling the product, eyes should be first. Be rotated clockwise or counter clockwise one full turn ticks bite, they ingest Bravecto for cats I purchased to. Changes at the application if your cat about the application site until 2 hours after treatment flea and tick for. Flea allergy dermatitis ( FAD ) run and drip off of the ingredients in Bravecto Plus with other medications flea. The appropriate combination of tubes How to use sparks, open the should! Your own personal medication records - 3 months of age from, or e-mail depending on the order of licensed! Then apply the second spot is needed to avoid run off, then seek medical advice, or! For the latest medication news, New drug approvals, alerts and updates reported in cats a. Drink or smoke while handling the product in the control group ( 0× ) were treated with oil. Group exhibited depression, dehydration, a hunched position, and food the cats in 3X! Off of the cat in the epidural space in the control group ( 0× were... Vocalization, and seizures within 8 hours after administration and the elimination half-life between! Stand 22 days after dosing known contraindications for the use of the same product dailymed. Be given every month should only be opened immediately prior to dosing show only within 48 hours of.... Tube tip vertically against the skin on the tube tip vertically against the skin cat should be or... Effectiveness against Ixodes scapularis 48 hours is an inhibitor of the isoxazoline class drugs, FDA.