Information for Dosing Dogs

The flavored once-a-month tablet that prevents and controls flea populations in dogs.

Introduction

Novartis Animal Health encourages you to take the time to read this package insert which describes the use of PROGRAM (lufenuron) Flavor Tabs 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 Flavor Tabs, flea control, or medical problems associated with flea infestations, consult your veterinarian, who is your pet's healthcare expert.

Administration

TO ENSURE ADEQUATE ABSORPTION, ALWAYS ADMINISTER PROGRAM FLAVOR TABS TO DOGS IMMEDIATELY AFTER OR IN CONJUNCTION WITH A NORMAL MEAL.

Be certain the dog consumes the entire tablet or tablets. As an alternative to direct dosing, tablets may be offered in food. 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.

PROGRAM Flavor Tabs must be administered monthly, preferably on the same date each month in conjunction with a normal meal. Treatment with PROGRAM Flavor Tabs may begin at any time of year. In geographic areas where flea infestations are seasonal, the treatment schedule should begin several weeks prior to the expected onset of infestations. Treatments 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 Flavor Tabs, it is important to treat all dogs within a household. All cats within the household should be treated with lufenuron suspension or tablets. Fleas can reproduce on untreated dogs and cats and allow infestations to persist.

Description

PROGRAM Flavor Tabs are available in four sizes for oral administration to dogs and puppies according to their weight (see Dosage section). The active ingredient of PROGRAM Flavor Tabs 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. Benzoylphenylurea compounds, including lufenuron, are classified as insect development inhibitors (IDIs).

As an insect development inhibitor, PROGRAM Flavor Tabs do not kill adult fleas but effectively and safely control flea populations on your pet through a mode of action which breaks the flea's life cycle at the egg stage.

Indications

PROGRAM Flavor Tabs are labeled for use in dogs and puppies, six weeks of age and older, for the prevention and control of flea populations.

Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of pesticides may be necessary for adequate control of adult fleas.

Precautions

PROGRAM Flavor Tabs have no effect on adult fleas but act to immediately break the flea life cycle by preventing eggs from developing into adults. However, pre-existing immature fleas in the dog's environment may continue to develop and emerge as adults after treatment with PROGRAM Flavor Tabs. 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 Flavor Tabs, 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 Flavor Tabs, depending on the severity of the infestation.

If a PROGRAM Flavor Tabs-treated dog comes in contact with a flea-infested environment, adult fleas may infest the treated animal. However, these adult fleas will be unable to reproduce. Depending on the number of adult fleas, the temporary use of conventional adulticidal pesticides 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 Flavor Tabs, you must administer the tablet or tablets once a month in conjunction with a normal meal. If you miss the 30-day interval, give PROGRAM Flavor Tabs immediately and resume your monthly dosing schedule. It is important to treat all dogs within the household. All cats within the household should be treated with lufenuron suspension or tablets. Fleas can reproduce on untreated dogs and cats and allow infestations to persist.

The active ingredient in PROGRAM Flavor Tabs is excreted in high concentrations in the milk; however, no resulting adverse effects have been recognized.