Bravecto Plus was not effective when administered more than 2 months prior to infection. Keep this and all drugs out of the reach of children. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. These cats also had mild elevations of aspartate aminotransferase (AST) (less than twice the upper reference range of 100 IU/L). & Articles, All In foreign market experience reports for Bravecto Plus, one veterinarian experienced tingling and numbness of the fingers, hand, and arm, and swelling of the hand and arm after getting Bravecto Plus on her fingers. Discount flea, tick, heartworm and intestinal worm treatments by PetBucket. Avoid oral ingestion (see Animal Safety). Additional signs, including blurred vision and disorientation, occurred after taking an antihistamine. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. 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. Peak fluralaner concentrations are achieved between 3 and 21 days following topical administration and the elimination half-life ranges between 11 and 18 days. PLUS SPOT-ON - 3 months flea and tick protection for cats, PLUS worm treatment, in one spot-on. One cat exhibited transient lacrimation from one eye during the first 15 minutes after dosing. 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. 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). Each tube is packaged individually in a pouch. *ALT was greater than twice the upper reference range of 100 IU/L. Do not eat, drink or smoke while handling the product. 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/reportanimalae. If contact with eyes occurs, then flush eyes slo… 0061-5998-02, The cap is designed to stay on the tube for dosing and should not be removed. For topical use only. Select one or more newsletters to continue. 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. The effectiveness of Bravecto Plus to prevent heartworm disease after bathing or water immersion has not been evaluated. Avoid contact with skin and eyes. Reg. A veterinarian or veterinary technician should demonstrate or instruct the pet owner regarding the appropriate technique for applying Bravecto Plus topically to cats prior to first use. Citations, PRINCIPAL DISPLAY PANEL - 112.5 mg/5.6 mg Tube Pouch Carton, PRINCIPAL DISPLAY PANEL - 250 mg/12.5 mg Tube Pouch Carton, PRINCIPAL DISPLAY PANEL - 500 mg/25 mg Tube Pouch Carton, (What Do not contact or allow children to contact the application site until 2 hours post application. Moxidectin is for systemic use and is a semisynthetic derivative of nemadectin, belonging to the milbemycin group of macrocyclic lactones. Additional information can be found at www.bravecto.com. As I opened the packaging I split some on my hands. When replacing a monthly heartworm preventative product, the first dose of Bravecto Plus should be given within one month of the last dose of the former medication. It is exclusively indicated when use against ticks or fleas and one or more of the other target parasites is indicated at the same time. per page. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The mode of action of fluralaner is the antagonism of the ligand-gated chloride channels (gamma-aminobutyric acid (GABA)-receptor and glutamate-receptor). Treated kittens had reduced food consumption on the day of treatment. The cap is designed to stay on the tube for dosing and should not be removed. Additional information can be found at www.bravecto.com. Do not contact or allow children to contact the application site until 2 hours post application. The effectiveness of Bravecto Plus to prevent heartworm disease after bathing or water immersion has not been evaluated. Put on gloves. 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. November 2, 2020. 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 product is highly flammable. Copy the URL below and paste it into your RSS Reader application. Show. Updated Part the fur at the administration site. Fluralaner is for systemic use and belongs to the class of isoxazoline-substituted benzamide derivatives. One treated kitten experienced vomiting 2 hours after administration and another 8 hours after treatment. 0061-5996-02, Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide, acetone, butylhydroxytoluene. For cats, Bravecto® flea treatment is available as a topical solution, which is applied to your cat’s skin on the back of their neck. 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. Files, All Mapping Fluralaner, one of the ingredients in Bravecto Plus, is a member of the isoxazoline class. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. In addition, three treated cats (2/8 cats in the 1× group and 1/8 cats in the 3× group) developed adverse neurologic signs during the study and were euthanized due to quality-of-life concerns. 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). The cats in the control group (0×) received mineral oil topically. Add to Cart. Avoid oral ingestion (see Animal Safety). Biochemical Data Summary. Every effort has been made to ensure the accuracy of the Bravecto Plus (fluralaner and moxidectin topical solution) for Cats information published above. 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. Field Safety Study: In a well-controlled field study, Bravecto Plus was used concurrently with other medications, such as vaccines, anthelmintics, antibiotics and steroids. Compare. Step 2: The cat should be standing or lying with its back horizontal during application. SAVE MORE WITH BRAVECTO ®. Oral Safety Studies: In an oral safety study, one dose of Bravecto Plus was administered orally to 4- to 9-month-old kittens at the maximum labeled dose of 93.0 mg fluralaner/kg and 4.7 mg moxidectin/kg. * Cats over 27.5 lb should be administered the appropriate combination of tubes. this version. Once administered, the formula spreads throughout the body and results starts to show only within 48 hours. Kills fleas, ticks, roundworms, hookworms and prevents heartworm disease for 2 months. 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. Bravecto PLUS Flea,Tick & Worm Spot-On for Cats Large (6.25-12.5kg) Special Price $49.90 $65.00. Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide, acetone, butylhydroxytoluene. Cosmetic changes at the application site included matting/clumping/spiking of hair, wetness, or a greasy appearance. When fleas and ticks bite, they ingest the solution and die within 8 hours. should be administered the appropriate combination of tubes. Available for Android and iOS devices. 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). The seal was broken on the first pack of Bravecto Plus for cats I purchased. BRAVECTO PLUS- fluralaner and moxidectin solution. When replacing a monthly heartworm preventative product, the first dose of Bravecto Plus should be given within one month of the last dose of the former medication. Avoid contact with skin and eyes. FDA Safety Recalls (Animal Drug), Clinical Trials, Set Descending Direction. Bravecto Plus to us is the pick of what is available if you are after flea and worm free cats - and applying four times over the year works for our household..one cat appears to get mild irritation at application area while the other cat has no issues. For Large Cats . The cap should be rotated clockwise or counter clockwise one full turn. Part the hair and apply directly to the skin. is a systemic insecticide and Place the tube tip vertically against the skin at the base of the skull of the cat. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. There are no known contraindications for the use of the product. Specifically designed for the challenges of treating cats, BRAVECTO PLUS delivers everything that you expect from BRAVECTO and more. Peak fluralaner concentrations are achieved between 3 and 21 days following topical administration and the elimination half-life ranges between 11 and 18 days. Wash hands and contacted skin thoroughly with soap and water immediately after use of the product. 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. Peak moxidectin concentrations are achieved between 1 and 5 days following topical administration and the elimination half-life ranges between 20 and 30 days. Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Compared to other products which must be given every month. Additional signs, including blurred vision and disorientation, occurred after taking an antihistamine. A second cat in the 1× group had neurologic signs that included ataxia, paresis, and muscle tremors 25 days after dosing. The pouch should only be opened immediately prior to use. 0061-5997-02, 0061-5998-01, Use with caution in cats that are heartworm positive (see Animal Safety). (fluralaner and moxidectin topical solution) for Cats. Put on gloves. Bravecto Plus should be administered topically as a single dose every 2 months according to the Dosage Schedule below to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin. A second cat in the 1X group had neurologic signs that included ataxia, paresis, and muscle tremors 25 days after dosing. Clinical signs in one cat in the 1X group included vomiting, depression, vocalization, and ataxia 38 days after dosing. For prevention of heartworm disease, Bravecto Plus should be administered at 2-month intervals. The cap should be rotated clockwise or counter clockwise one full turn. In a pilot oral safety study, adult cats orally administered 0.5X or 1X the maximum labeled dose of Bravecto Plus had foaming hypersalivation for up to five minutes and reduced food consumption on the day of dosing. 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. Bravecto Plus has not been shown to be effective in kittens less than 6 months of age. Keep the product in the original packaging until use in order to prevent children from getting direct access to the product. 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. In foreign market experience reports for Bravecto Plus, one veterinarian experienced tingling and numbness of the fingers, hand, and arm, and swelling of the hand and arm after getting Bravecto Plus on her fingers. 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. 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). Cosmetic changes at the application site included matting/clumping/spiking of hair, wetness, or a greasy appearance. Do not store above 77°F (25°C). Hold the tube at the crimped end with the cap in an upright position (tip up). Use with caution in cats with a history of neurologic disorders. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=d9d5ebde-7ff7-4864-b393-fbe77d7a112f, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Step 3: Squeeze the tube and gently apply the entire contents of Bravecto Plus directly to the skin at the base of the skull of the cat. Two untreated cats were found dead prior to dosing. Bravecto Plus - How it works? Keep away from heat, sparks, open flame or other sources of ignition. Store in the original package in order to protect from moisture. The mode of action of fluralaner is the antagonism of the ligand-gated chloride channels (gamma-aminobutyric acid (GABA)-receptor and glutamate-receptor). Each milliliter contains 280 mg of fluralaner and 14 mg of moxidectin. One cat within 4 hours of use developed ataxia involving loss of use of back legs, head tremor and has had to go into the Vet for overnight observation in case she developed fits. If you are a consumer or patient please visit Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. How to use Bravecto Plus for Cats Ensure the animal's back is horizontal. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. Field Safety Study: In a well-controlled field study, Bravecto Plus was used concurrently with other medications, such as vaccines, anthelmintics, antibiotics and steroids. Peak moxidectin concentrations are achieved between 1 and 5 days following topical administration and the elimination half-life ranges between 20 and 30 days. Major brands including Nexgard, Frontine, Bravecto, Advantage, Advantix, Drontal and Revolution. 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. PubMed, Fluralaner is an inhibitor of the arthropod nervous system. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert. Avoid contact with skin and eyes. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. PLEASE NOTE: Rebate levels are based on the number of doses of the same product. Product may be supplied in 1 or 2 tubes per carton. 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