Description:
PROGRAM® SUSPENSION
Novartis
(LUFENURON)
Suspension
The once-a-month
oral suspension that controls flea populations.
Introduction
Novartis Animal
Health encourages you to take the time to read this package insert which
describes the use of PROGRAM® (lufenuron) Suspension as a convenient
monthly flea control treatment. Controlling flea infestations is very important
to the health of your pet. After reading this insert, if you have any questions
about PROGRAM Suspension, flea control or medical problems associated with flea
infestations, consult your veterinarian, who is your pet’s healthcare expert.
Administration
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TO
ENSURE ADEQUATE ABSORPTION ALWAYS ADMINISTER PROGRAM SUSPENSION TO CATS
IN CONJUNCTION WITH A NORMAL MEAL. |
PROGRAM
Suspension is administered by mixing into food. If the dose is not entirely
consumed, redose once with the full recommended dose as soon as possible. In
multiple cat households, each cat should be treated separately to ensure
adequate dosing.
PROGRAM
Suspension must be administered monthly, preferably on the same date each month
in conjunction with a normal meal. To help you remember the monthly dosing, use
the enclosed reminder stickers on the appropriate dates on your calendar.
Treatment with PROGRAM Suspension may begin at any time of year. Treatment
should continue until the end of “flea season”. If there is risk of exposure to
fleas year-round, then treatment should continue the entire year without
interruption. Ask your veterinarian for details concerning your geographic area
and the most effective treatment schedule for your pet.
To maximize
benefits from the use of PROGRAM Suspension, it is important to treat all cats
within a household. All dogs within the household should be treated with PROGRAM
Tablets. Fleas can reproduce on untreated cats and dogs and allow infestations
to persist.
Directions For
Use
Mix the entire
contents of the appropriate size PROGRAM Suspension pack(s) with about two
tablespoons of the cat's food. Since PROGRAM Suspension is a liquid, it mixes
easily with wet food. You can make it a special treat for your cat by mixing it
with your cat's favorite wet food.
Observe the cat
closely to ensure the entire dose has been consumed and then provide its normal
meal. Always administer PROGRAM to cats in conjunction with a normal meal as
food is important for complete absorption of PROGRAM. If your cat does not
consume its meal following administration of PROGRAM, try withholding the cat's
food the night before to ensure it eats a meal with PROGRAM.
Some cats have
special dietary needs, so be sure to consult your veterinarian before giving
your cat any new foods or before withholding food overnight.
Description
PROGRAM
Suspension is available in two sizes of packs for oral administration to cats
and kittens according to their weight (see Dosage section). The active
ingredient of PROGRAM Suspension is lufenuron, a benzoylphenylurea derivative
with the following chemical composition:
N-[2,5-dichloro-4-(1,1,2,3,3,3,-hexafluoropropoxy)-phenylaminocarbonyl]-2,6-difluorobenzamide.
Benzoylphenyl-urea compounds, including lufenuron, are classified as insect
development inhibitors (IDIs).
As an insect
development inhibitor, PROGRAM does not kill adult fleas, but effectively and
safely controls flea populations on your pet through a mode of action which
breaks the flea's life cycle at the egg stage.
Indications
PROGRAM
Suspension is labeled for use in cats and kittens, six weeks of age and older,
for the control of flea populations.
Precautions
PROGRAM
Suspension has no effect on adult fleas but acts to immediately break the flea
life cycle by preventing eggs from developing into adults. However, pre-existing
immature fleas in the cat's environment may continue to develop and emerge as
adults after treatment with PROGRAM Suspension. Based on results of clinical
studies, this emergence generally occurs during the first 30-60 days. Therefore,
if your pet already has a flea infestation before starting PROGRAM, noticeable
results may not be observed until several weeks after dosing. In cooler
climates, immature fleas may take longer to complete the life cycle and emerge
as adults. To speed control, traditional products that kill adult fleas may be
used temporarily with PROGRAM, depending on the severity of the infestation.
If a
PROGRAM-treated cat comes in contact with a flea-infested environment, adult
fleas may infest the treated animal. However, these adult fleas will be unable
to reproduce and will soon die off. Depending on the number of adult fleas, the
temporary use of conventional adulticidal insecticides may be used to control
these adult fleas. Your veterinarian can recommend the most effective treatment
plan for your pet.
To ensure that
your pet gets the greatest benefit from PROGRAM Suspension, you must administer
the dose once a month in conjunction with a normal meal. If you miss the 30-day
interval, give PROGRAM Suspension to your cat immediately and resume your
monthly dosing schedule. It is important to treat all cats within the household.
All dogs within the household should be treated with PROGRAM Tablets. Fleas can
reproduce on untreated dogs and cats and allow infestations to persist.
The active
ingredient in PROGRAM is excreted in high concentrations in the milk, however,
no resulting adverse effects have been recognized.
Flea
Infestations on Cats
Although other
flea species may be found on cats, the cat flea (Ctenocephalides felis)
is the predominant flea associated with infestations on cats in the United
States. In addition to the common nuisance irritations associated with
infestations, fleas can be responsible for medical problems in your pet such as
miliary dermatitis, a skin reaction to flea bites. Also, fleas transmit other
parasites, including tapeworms. Controlling flea infestations is important to
your pet's health while also reducing the major and minor annoyances associated
with these parasites.
Lufenuron, the
active ingredient of PROGRAM Suspension does not kill adult fleas but
effectively breaks the flea's life cycle by inhibiting egg development.
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 cat and
subsequently lay eggs which drop off your cat's coat. Within days, larvae hatch
from the eggs and live undetected in your cat'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 cat to
continue the life cycle. After biting a PROGRAM-treated cat, the female flea
ingests lufenuron which is deposited in her eggs. Lufenuron prevents these eggs
from hatching or developing into mature adults. This safe and convenient
approach to flea control effectively breaks the flea's life cycle and controls
flea populations.
Dosage
PROGRAM
Suspension is given orally by mixing into food, once a month, at the recommended
minimum dosage of 13.6 mg lufenuron per pound (30 mg/kg) of body weight.
|
Recommended Dosage
Schedule: |
|
Body
Weight |
Pack Per
Month |
Lufenuron
Per Pack |
Pack
Color |
|
Up to 10
lbs |
1 Small |
135 mg |
Orange |
|
11 to 20
lbs |
1 Large |
270 mg |
Green |
Cats over 20 lbs
are provided the appropriate combination of packs.
Once A Month
PROGRAM
Suspension will safely and effectively control flea infestations only if
administered on a monthly dosing schedule. To help you remember the monthly
dosing, use the enclosed reminder stickers on the appropriate dates on your
calendar.
Adverse
Reactions
The following
adverse reactions have been reported in cats after giving PROGRAM: vomiting,
depression/lethargy, anorexia (loss of appetite), diarrhea, dyspnea (labored
breathing), pruritus (itchy, scratchy skin), and skin disorder.
How Supplied
PROGRAM
Suspension is available in two pack sizes (see Dosage and Administration
section), formulated and color-coded according to the weight of the cat. Both
pack sizes are available in color-coded packages of 6 packs per carton.
Storage
Conditions
PROGRAM
Suspension should be stored at room temperature between 59° and 86°F (15-30°C).
Keep out of the
reach of children.
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