INTERCEPTOR
The palatable once-a-month tablet that prevents heartworm
disease, controls adult hookworm, and removes and controls
adult roundworm and whipworm infections in dogs and puppies.
Description
INTERCEPTOR (milbemycin oxime) Flavor Tabs are available
in four tablet sizes in color-coded packages for oral
administration to dogs and puppies. Each tablet is formulated
to provide a minimum of 0.23 mg/lb (0.5 mg/kg) body weight
of milbemycin oxime.
Brown 2.3 mg
Green 5.75 mg
Yellow 11.5 mg
White 23.0 mg
Indications
INTERCEPTOR Flavor Tabs are indicated for use in the prevention
of heartworm disease caused by Dirofilaria immitis, the
control of adult Ancylostoma caninum (hookworm), and the
removal and control of adult Toxocara canis and Toxascaris
leonina (roundworms) and Trichuris vulpis (whipworm) infections
in dogs and in puppies four weeks of age or greater, and
two pounds body weight or greater.
Dosage
INTERCEPTOR Flavor Tabs are given orally, once a month,
at the recommended minimum dosage rate of 0.23 mg milbemycin
oxime per pound of body weight (0.5 mg/kg).
Recommended
Dosage Schedule for Dogs
Body Weight INTERCEPTOR Flavor Tabs
2-10 lbs. One tablet (2.3 mg)
11-25 lbs. One tablet (5.75 mg)
26-50 lbs. One tablet (11.5 mg)
51-100 lbs. One tablet (23.0 mg)
Dogs over 100 lbs. are provided the appropriate combination
of tablets.
Administration
INTERCEPTOR Flavor Tabs are palatable and most dogs will
consume the tablet willingly when offered by the owner.
As an alternative, the dual-purpose tablet may be offered
in food or administered as other tablet medications. Watch
the dog closely following dosing to be sure the entire
dose has been consumed. If it is not entirely consumed,
redose once with the full recommended dose as soon as
possible.
INTERCEPTOR
Flavor Tabs must be administered monthly, preferably on
the same date each month. The first dose should be administered
within one month of the dog's first exposure to mosquitoes
and monthly thereafter until the end of the mosquito season.
If a dose is missed and a 30-day interval between dosing
is exceeded, administer INTERCEPTOR Flavor Tabs immediately
and resume the monthly dosing schedule.
If
INTERCEPTOR Flavor Tabs replaces diethylcarbamazine (DEC)
for heartworm prevention, the first dose must be given
within 30 days after the last dose of DEC.
Palatability
Palatability trials conducted in 244 dogs from 10 different
U.S. veterinary practices demonstrated that INTERCEPTOR
Flavor Tabs were willingly accepted from the owner by
over 95% of dogs. The trial was comprised of dogs representing
60 different breeds and both sexes, with weights ranging
from 2.1 lbs. to 143.3 lbs., and ages ranging from 8 weeks
to 15 years.
Precautions
Do not use in puppies less than four weeks of age and
less than two pounds of body weight. Prior to initiation
of the INTERCEPTOR Flavor Tabs treatment program, dogs
should be tested for existing heartworm infections. Infected
dogs should be treated to remove adult heartworms and
microfilariae prior to initiating treatment with INTERCEPTOR
Flavor Tabs. Mild, transient hypersensitivity reactions
manifested as labored respiration, vomiting, salivation
and lethargy, have been noted in some treated dogs carrying
a high num-ber of circulating microfilariae. These reactions
are presumably caused by release of protein from dead
or dying microfilariae.
Adverse
Reactions
The following adverse reactions have been reported following
the use of INTERCEPTOR: Depression/ lethargy, vomiting,
ataxia, anorexia, diarrhea, convulsions, weakness and
hypersalivation.
Efficacy
INTERCEPTOR Flavor Tabs eliminate the tissue stage of
heartworm larvae and the adult stage of hookworm (Ancylostoma
caninum), roundworms (Toxocara canis, Toxascaris leonina)
and whipworm (Trichuris vulpis) infestations when administered
orally according to the recommended dosage schedule. The
anthelmintic activity of milbemycin oxime is believed
to be a result of interference with invertebrate neurotransmission.
Safety
INTERCEPTOR has been tested safely in over 75 different
breeds of dogs, including collies, pregnant females, breeding
males and females, and puppies over two weeks of age.
In well-controlled clinical field studies, 786 dogs completed
treatment with milbemycin oxime. Milbemycin oxime was
used safely in animals receiving frequently used veterinary
products such as vaccines, anthelmintics, antibiotics,
steroids, flea collars, shampoos and dips.
Two
studies in heartworm-infected dogs were conducted which
demonstrated mild, transient hypersensitivity reactions
in treated dogs with high microfilaremia counts (see Precautions
for reactions observed). Safety studies in pregnant dogs
demonstrated that high doses (1.5 mg/kg = 3X) of milbemycin
oxime given in an exaggerated dosing regimen (daily from
mating through weaning), resulted in measurable concentrations
of the drug in milk. Puppies nursing these females which
received exaggerated dosing regimens demonstrated milbemycin-related
effects.These effects were directly attributable to the
exaggerated experimental dosing regimen. The product is
normally intended for once-a-month administration only.
Subsequent studies included using 3X daily from mating
to one week before weaning and demonstrated no effects
on the pregnant females or their litters. A second study
where pregnant females were dosed once at 3X the monthly
use rate either before, on the day of or shortly after
whelping resulted in no effects on the puppies.Some
nursing puppies, at 2, 4, and 6 weeks of age, given greatly
exaggerated oral INTERCEPTOR doses (9.6 mg/kg = 19X) exhibited
signs typified by tremors, vocalization and ataxia. These
effects were all transient and puppies returned to normal
within 24 to 48 hours. No effects were observed in puppies
given the recommended dose of INTERCEPTOR (0.5 mg/kg).
This product has not been tested in dogs less than 1 kg
weight.
Storage
Conditions
INTERCEPTOR Flavor Tabs should be stored at room temperature,
between 59° and 86°F (15-30°C).
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