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 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 cats and 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 cats, puppies and kittens 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
