Capstar (nitenpyram 11.4 mg) Dailymed
Generic: nitenpyram
IMPRINT: RB CG
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COLOR: white
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nitenpyram 57 mg - cg hih round white
nitenpyram 11.4 mg - rb cg round white
capstar (nitenpyram) capsule - cg rb round white
capstar (nitenpyram) capsule - rb cg round white
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capstar (nitenpyram) capsule - cg hih round white
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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
Other Information
CAPSTAR (nitenpyram) Tablets begin working within 30 minutes. In studies, CAPSTAR achieved greater than 90% effectiveness against adult fleas on dogs within 4 hours and cats within 6 hours.
CAPSTAR Tablets are safe for pregnant or nursing dogs and cats (See Post-Approval Experience section).
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 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 And Cats
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 and miliary dermatitis in the cat. 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.
The following diagram illustrates the flea's life cycle and where CAPSTAR Tablets work:
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.
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.
Storage Conditions
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
Elancoâ„¢
Principal Display Panel - 11.4 Mg Carton Label
Capstarâ„¢
(nitenpyram)
11.4 mg
6 Tablets
(11.4 mg nitenpyram each)
For Dogs and Cats
2–25 lbs.
For treatment of flea infestations on dogs and cats.
For Oral Use.
NADA #141-175
Approved by FDA
Product # 604152
Elanco
Principal Display Panel - 11.4 Mg Carton Label
Capstarâ„¢
(nitenpyram)
11.4 mg
60 Tablets
(11.4 mg nitenpyram each)
For Dogs and Cats
2–25 lbs.
For treatment of flea infestations on dogs and cats.
For Oral Use.
NADA #141-175
Approved by FDA
Product # 604152
Elanco
Principal Display Panel - 11.4 Mg Dog Carton Label
CAPSTARâ„¢
(nitenpyram)
11.4 mg
Treatment of fleainfestations on dogs
For oral use
Beings workingwithin 30 minutes
For dogs 2-25 lbs | 6 tablets (11.4 mg each)
Keep this and all drugs out of reach of children
[NADA #141-174 Approved by FDA]
Elancoâ„¢
Principal Display Panel - 11.4 Mg Cat Box Label
CAPSTARâ„¢
(nitenpyram)
11.4 mg
Treatment of fleainfestations on cats
For oral use
Begins workingwithin 30 minutes
For cats 2-25 lbs | 60 tablets
[NADA #141-175 Approved by FDA]
Elancoâ„¢
Principal Display Panel - 11.4 Mg Cat Carton Label
CAPSTARâ„¢
(nitenpyram)
11.4 mg
Treatment of fleainfestations on cats
For oral use
Beings workingwithin 30 minutes
For cats 2-25 lbs | 6 tablets (11.4 mg each)
Keep this and all drugs out of reach of children
[NADA #141-174 Approved by FDA]
Elancoâ„¢
Principal Display Panel - 57.0 Mg Dog Box Label
CAPSTARâ„¢
(nitenpyram)
57.0 mg
Treatment of fleainfestations on dogs
For oral use
Begins workingwithin 30 minutes
for dogs over 25lbs | 60 tablets
[NADA #141-175 Approved by FDA]
Elancoâ„¢
Principal Display Panel - 57.0 Mg Dog Box Label
CAPSTARâ„¢
(nitenpyram)
57.0 mg
Treatment offlea infestationson dogs
For oral use
60 tablets
(57.0 mg nitenpyram each)
Beginsworking within 30 minutes
Principal Display Panel - 57.0 Mg Dog Carton Label
CAPSTARâ„¢
(nitenpyram)
57.0 mg
Treatment of fleainfestations on cats
For oral use
Beings workingwithin 30 minutes
For dogs over 25 lbs | 6 tablets (57.0 mg each)
Keep this and all drugs out of reach of children
[NADA #141-174 Approved by FDA]
Elancoâ„¢
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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