CAPSTAR- nitenpyram tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Nitenpyram (UNII: 3A837VZ81Y) (Nitenpyram - UNII:3A837VZ81Y)

Available from:

Elanco US Inc.

Administration route:

ORAL

Prescription type:

OTC

Authorization status:

New Animal Drug Application

Summary of Product characteristics

CAPSTAR- NITENPYRAM TABLET
ELANCO US INC.
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CAPSTAR™
(NITENPYRAM)
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 o