Animal NDC 21091-178-03 Capstar
Nitenpyram

Animal Product Information

Field Name Field Value
Animal NDC Code 21091-178-03
Proprietary Name Capstar What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Nitenpyram What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Sergeant's Pet Care Products Llc
Product Type Otc Animal Drug
Usage Information
    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.DosageCAPSTAR 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
Active Ingredient(s)
  • Nitenpyram
Inactive Ingredient(s)
  • LACTOSE MONOHYDRATE (EWQ57Q8I5X)
  • CELLULOSE, MICROCRYSTALLINE (OP1R32D61U)
  • STARCH, CORN (O8232NY3SJ)
  • SILICON DIOXIDE (ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (70097M6I30)
  • LACTOSE MONOHYDRATE (EWQ57Q8I5X)
  • CELLULOSE, MICROCRYSTALLINE (OP1R32D61U)
  • STARCH, CORN (O8232NY3SJ)
  • SILICON DIOXIDE (ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (70097M6I30)
  • LACTOSE MONOHYDRATE (EWQ57Q8I5X)
  • CELLULOSE, MICROCRYSTALLINE (OP1R32D61U)
  • STARCH, CORN (O8232NY3SJ)
  • SILICON DIOXIDE (ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (70097M6I30)
  • LACTOSE MONOHYDRATE (EWQ57Q8I5X)
  • CELLULOSE, MICROCRYSTALLINE (OP1R32D61U)
  • STARCH, CORN (O8232NY3SJ)
  • SILICON DIOXIDE (ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (70097M6I30)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141175 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Capstar Images

Capstar Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



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 Ingredient



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 listed 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 1-800-781-4738. 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 listing of adverse reactions for nitenpyram reported to the CVM see: 

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

For technical assistance call 1-800-781-4738.


Other Information



CAPSTAR 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 1-800-781-4738

For technical assistance or to report a suspected adverse event please call 1-800-781-4738

Visit our web site at www.capstarpet.com

Approved by FDA under NADA # 141-175

PETIQ


G002477 Capstar For Dogs 2-25 Lbs. 6Ct Carton





* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.