Rx Trifexis 40.1-60 lbs (Blue) x 6 tablet

Trifexis Trifexis monthly heartworm medication for dogs also kills fleas and controls adult hookworms, roundworms and whipworms. Chewable tablet safe for dogs and puppies 8 weeks of age or older and 5 lbs of body weight or more. Begins killing fleas within 30 minutes. Trifexis kills fleas before they can lay eggs. Prescription items are NON-RETURNABLE and NON-REFUNDABLE. - CAUTIONS/WARNINGS:Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Warnings: Not for human use. Keep this and all drugs out of the reach of children. Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad alone, a component of Trifexis (see ADVERSE REACTIONS). Precautions: Treatment with fewer than 3 monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention (see EFFECTIVENESS). Prior to administration of Trifexis, dogs should be tested for existing heartworm infection. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. Trifexis is not effective against adult D. immitis. While the number of circulating microfilariae may decrease following treatment, Trifexis is not indicated for microfilariae clearance (see ANIMAL SAFETY). Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some dogs treated with milbemycin oxime carrying a high number of circulating microfilariae. These reactions are presumably caused by release of protein from dead or dying microfilariae. Use with caution in breeding females (see ANIMAL SAFETY). The safe use of Trifexis in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy (see ADVERSE REACTIONS). Puppies less than 14 weeks of age may experience a higher rate of vomiting (see ANIMAL SAFETY). Adverse Reactions: In a well-controlled US field study, which included a total of 352 dogs (176 treated with Trifexis and 176 treated with an active control), no serious adverse reactions were attributed to administration of Trifexis. All reactions were regarded as mild. Over the 180-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence >1% (average monthly rate) within any of the 6 months of observation are presented in the following table. The most frequently reported adverse reaction in dogs in the Trifexis group was vomiting. Average Monthly Rate (%) of Dogs With Adverse Reactions Adverse Reaction Trifexis Chewable Tablets&ordf* Active Control Tablets&ordf* Vomiting 6.13 3.08 Pruritus 4.00 4.91 Lethargy 2.63 1.54 Diarrhea 2.25 1.54 Dermatitis 1.47 1.45 Skin Reddening 1.37 1.26 Decreased appetite 1.27 1.35 Pinnal Reddening 1.18 0.87 &ordf*=176 dogs In the US field study, one dog administered Trifexis experienced a single mild seizure 2 1/2 hours after receiving the second monthly dose. The dog remained enrolled and received four additional monthly doses after the event and completed the study without further incident. Following concomitant extra-label use of ivermectin with spinosad alone, a component of Trifexis, some dogs have experienced the following clinical signs: trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation. Spinosad alone has been shown to be safe when administered concurrently with heartworm preventatives at label directions. In US and European field studies, no dogs experienced seizures when dosed with spinosad alone at the therapeutic dose range of 13.5-27.3 mg/lb (30-60 mg/kg), including 4 dogs with pre-existing epilepsy. Four epileptic dogs that received higher than the maximum recommended dose of 27.3 mg/lb (60 mg/kg) experienced at least one seizure within the week following the second dose of spinosad, but no seizures following the first and third doses. The cause of the seizures observed in the field studies could not be determined. For technical assistance or to report a suspected adverse drug reaction, contact Elanco Animal Health at 1-888-545-5973. Additional information can be found at www.trifexis.com. Alternatively, suspected adverse drug reactions may be reported to FDA at 1-800-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm - DIRECTIONS:Dosage and Administration: Trifexis is given orally, once a month at the minimum dosage of 13.5 mg/lb (30 mg/kg) spinosad and 0.2 mg/lb (0.5 mg/kg) milbemycin oxime body weight. For heartworm prevention, give once monthly for at least 3 months after exposure to mosquitoes (see Effectivness). Dosage Schedule: Body Weight Spinosad Per Tablet (mg) Milbemycin oxime Per Tablet (mg) Tablets Administered 5 to 10 lbs 140 2.3 One 10.1 to 20 lbs 270 4.5 One 20.1 to 40 lbs 560 9.3 One 40.1 to 60 lbs 810 13.5 One 60.1 to 120 lbs 1620 27 One Over 120 lbs Administer the appropriate combination of tablets Administer Trifexis with food for maximum effectiveness. If a dose is missed and a monthly interval between doses is exceeded, then immediate administration of Trifexis with food and resumption of monthly dosing will minimize the opportunity for the development of adult heartworm infections and flea reinfestations. If vomiting occurs within an hour of administration, redose with another full dose. Heartworm Prevention: Trifexis should be administered at monthly intervals beginning within 1 month of the dog's first seasonal exposure and continuing until at least 3 months after the dog's last seasonal exposure to mosquitoes (see EFFECTIVENESS). Trifexis may be administered year round without interruption. When replacing another heartworm preventative product, the first dose of TRIFEXIS should be given within a month of the last dose of the former medication. Flea Treatment and Prevention: Treatment with Trifexis may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment with TRIFEXIS should continue the entire year without interruption. To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea protection product. Intestinal Nematode Treatment and Control: Trifexis also provides treatment and control of roundworms (T. canis, T. leonina), hookworms (A. caninum) and whipworms (T. vulpis). Dogs may be exposed to and can become infected with roundworms, whipworms and hookworms throughout the year, regardless of season or climate. Clients should be advised of measures to be taken to prevent reinfection with intestinal parasites. Contraindications: There are no known contraindications to the use of Trifexis. - INGREDIENTS:How Supplied: Trifexis is available in five tablet sizes. Each tablet size is available in color-coded packages of 6 tablets. 5-10 lbs (140 mg spinosad and 2.3 mg milbemycin oxime) 10.1-20 lbs (270 mg spinosad and 4.5 mg milbemycin oxime) 20.1-40 lbs (560 mg spinosad and 9.3 mg milbemycin oxime) 40.1-60 lbs (810 mg spinosad and 13.5 mg milbemycin oxime) 60.1-120 lbs (1620 mg spinosad and 27 mg milbemycin oxime) - STORAGE/DISPOSAL REQ:Store at 20-25C (68-77F) excursions permitted between 15-30C (59-86F). - HEIGHT(INCHES): 1.000 - WIDTH(INCHES):1.000 - LENGTH(INCHES):1.000