Capstar (nitenpyram 11.4 mg) Dailymed

PA101598X

CAPSTAR is an oral tablet for dogs, puppies, cats and kittens 2 pounds of body weight or greater and 4 weeks of age and older.

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.

Warnings

Not for human use. Keep this and all drugs out of the reach of children.

Directions

CAPSTAR Tablets kill adult fleas and are indicated for the treatment of flea infestations on dogs, puppies, cats and kittens 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
Species	Body Weight	Dose	Nitenpyram Per Tablet
Dog or Cat	2-25 lbs.	One tablet	11.4 mg
Dog	25.1-125 lbs.	One tablet	57.0 mg

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. 2011):

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 uled in decreasing order of reporting frequency.

CATS: hyperactivity, panting, lethargy, itching, vocalization, vomiting, fever, decreased appetite, nervousness, diarrhea, difficulty breathing, salivation, incoordination, seizures, pupil dilation, increased heart rate, and trembling.

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.

To report adverse effects, access medical information, or obtain additional product information call 1-888-545-5973. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

For a complete uling of adverse reactions for nitenpyram reported to the CVM see:

http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation

For technical assistance call Elanco US Inc. at 1-888-545-5973

Store at controlled room temperature, between 59° and 77°F (15°-25°C).

Questions? Comments? Please Call 1-888-545-5973

For technical assistance or to report a suspected adverse event please call 1-888-545-5973

Visit our web site at www.capstarpet.com

Manufactured for: Elanco US Inc.Greenfield, IN 46140, USA

Approved by FDA under NADA # 141-175

Capstar, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

Revision date: January 2020

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