Capstar for Dogs

Capstar Nitenpyram Capstar® is an oral tablet for dogs and puppies 2 pounds of body weight or greater and 4 weeks of age and older. Capstar Tablets begin working within 30 minutes. In studies, Capstar achieved greater than 90% effectiveness against adult fleas on dogs within 4 hours. Capstar Tablets are safe for pregnant or nursing dogs. Life Cycle of the Flea Fleas can be a problem because they reproduce so rapidly. A single female flea may produce up to 2,000 eggs over her lifetime. Eggs hatch and can develop into adults within only three weeks. Adult female fleas feed by ingesting blood from your pet and subsequently lay eggs, which drop off your pet’s coat. Within days, larvae hatch from the eggs and live undetected in your pet’s surroundings, such as the carpet, bedding and other protected areas. Flea larvae spin a cocoon, and, when appropriately stimulated, a young adult flea emerges and jumps onto your pet to continue the life cycle. When these new fleas are seen on your pet, treat with Capstar Tablets. Directions Capstar Tablets kill adult fleas and are indicated for the treatment of flea infestations on dogs and puppies 2 pounds of body weight or greater and 4 weeks of age and older. A single dose of Capstar should kill the adult fleas on your pet. If your pet gets re-infested with fleas, you can safely give another dose as often as once per day. To give Capstar Tablets, place the pill directly in your pet’s mouth or hide it in food. If you hide the pill in food, watch closely to make sure your pet swallows the pill. If you are not sure that your pet swallowed the pill, it is safe to give a second pill. Treat all infested pets in the household. Fleas can reproduce on untreated pets and allow infestations to persist. Dosage Capstar Tablets should be administered according to the following schedule. Weigh your pet prior to administration to ensure proper dosage. Do not administer to pets under 2 pounds. Recommended Dosage Schedule Dog, 2-25 lbs: One tablet, 11.4 mg Nitenpyram per Tablet Dog, 25.1-125 lbs: One tablet, 57.0 mg Nitenpyram per Tablet *Please see separate insert in this package for concurrent dosing of Capstar Tablets. Active Ingredients Capstar Tablets contain 11.4 or 57.0 mg of nitenpyram, which belongs to the chemical class of neonicotinoids. Nitenpyram kills adult fleas. Additional Information Warning: Not for human use. Keep this and all drugs out of the reach of children. When using this product, you may notice that your dog or cat will start scratching itself as fleas begin to die. The scratching behavior is temporary and is a reaction to the fleas, not the drug. In dogs, this may present as transient signs of hyperactivity, panting, vocalization and excessive grooming/licking. Capstar Tablets kill adult fleas that cause flea allergy dermatitis (FAD). Capstar Tablets may be used together with other products, including heartworm preventives, corticosteroids, antibiotics, vaccines, de-worming medications, shampoos and other flea products. Flea Infestations on Dogs In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in your pet such as flea allergy dermatitis (FAD) in the dog. Also, fleas transmit other parasites, including tapeworms. The control of flea infestations is important to your pet’s health and also reduces the problems associated with these parasites. Capstar Tablets do not have an effect on fleas in the pet’s environment. You may need to treat more than one time because immature fleas in and around the home will continue to develop into adults that can reinfest your pet. In addition to killing adult fleas with Capstar, you can treat your pet with an insect development inhibitor to prevent and control flea populations. Adverse Reactions Pre-approval laboratory and clinical studies showed that Capstar Tablets are safe for use in dogs and puppies 2 pounds of body weight or greater and 4 weeks of age and older. (See Post-Approval Experience section). Post-Approval Experience (Rev. 2010): The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are listed in decreasing order of reporting frequency. DOGS: lethargy/depression, vomiting, itching, decreased appetite, diarrhea, hyperactivity, incoordination, trembling, seizures, panting, allergic reactions including hives, vocalization, salivation, fever, and nervousness. The frequency of serious signs, including neurologic signs and death, was greater in animals under 2 pounds of body weight, less than 8 weeks of age, and/or reported to be in poor body condition. In some instances, birth defects and fetal/neonatal loss were reported after treatment of pregnant and/or lactating animals. After reading this insert, if you have any questions about flea control or medical problems associated with flea infestations, consult your veterinarian, who is your pet’s health care expert. To report suspected adverse drug events, contact Novartis Animal Health at 1-800-637-0281 or the FDA at 1-800-FDA-VETS or: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm For a complete listing of adverse reactions for nitenpyram reported to the CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055394.htm For technical assistance call Novartis Animal Health at 1-800-637-0281 Storage Conditions Store at controlled room temperature, between 59° and 77°F (15°-25°C). Questions? Comments? Please Call 1-800-332-2761 For technical assistance or to report a suspected adverse event please call 1-800-637-0281 Visit our web site at www.Capstarpet.com Manufactured for: Novartis Animal Health US, Inc., Greensboro, NC 27408 NADA #141-175, Approved by FDA. ©2011 Novartis Animal Health US, Inc. Capstar, PROGRAM, SENTINEL and Flavor Tabs are registered trademarks of Novartis AG. NAH/CAP-T/PI/5 01/11