PetArmor FastCaps description, usages, side effects, indications, overdosage, supplying and lots more!

PetArmor FastCaps

Sergeant's Pet Care Products Inc.
Novartis Animal Health US, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
PetArmor FastCaps



FULL PRESCRIBING INFORMATION

PETARMOR®
FASTCAPS
(nitenpyram)

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

FASTCAPS™ Tablets contain 11.4 or 57.0 mg of nitenpyram, which belongs to the chemical class of neonicotinoids. Nitenpyram kills adult fleas.

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

FASTCAPS™ 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 FASTCAPS™ 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 FASTCAPS™ 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.

FASTCAPS™ 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

Pre-approval laboratory and clinical studies showed that FASTCAPS™ 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).

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 suspected adverse drug events, contact Sergeant’s Pet Care Products, Inc., at 1-855-451-FAST (3278) 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 Sergeant’s Pet Care Products, Inc. at 1-855-451-FAST (3278)

FASTCAPS™ Tablets begin working within 30 minutes. In studies, FASTCAPS™ achieved greater than 90% effectiveness against adult fleas on dogs within 4 hours and cats within 6 hours.

FASTCAPS™ 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.

FASTCAPS™ Tablets kill adult fleas that cause flea allergy dermatitis (FAD).

FASTCAPS™ Tablets may be used together with other products, including heartworm preventives, corticosteroids, antibiotics, vaccines, de-worming medications, shampoos and other flea products.

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.

FASTCAPS™ 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 FASTCAPS™ Tablets work:

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 FASTCAPS™ 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.

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

For questions, comments, technical assistance or to report a suspected adverse event please call 1-855-451-FAST (3278)

Visit our web site at www.petarmor.com

Manufactured For: Sergeant’s Pet Care Products, Inc., Omaha, NE 68138

NADA #141-175, Approved by FDA.
NAH/SER-PA/11.4-57CF/PI/1

P059070
RRRC

PetArmor
FastCaps
(
Nitenpyram )
11.4 mg

6 tablets

For Dogs & Cats

2-25 lbs.
 

Pet Armor
FastCaps
(
Nitenpyram )
57.0 mg

6 tablets

For Dogs

Over
25 lbs.  

PetArmor FastCaps

nitenpyram TABLET

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:21091-871
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
NITENPYRAM NITENPYRAM 11.4 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (to light yellow) 6 mm RB;CG ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:21091-871-01 1 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141175 2014-03-17


PetArmor FastCaps

nitenpyram TABLET

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:21091-870
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
NITENPYRAM NITENPYRAM 57.0 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
WHITE (to light yellow) 11 mm HIH;CG ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:21091-870-01 1 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141175 2014-03-17


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Be sure to consult your doctor before taking any medication!
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