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PROGRAM® (Lufenuron) 6 Month Injectable for Cats

By: Novartis Animal Health

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The flea is a tormenter of cats. Fleabites are annoying and painful. Proteins in flea saliva can lead to an allergic reaction in the skin (flea allergy dermatitis). Fleas can spread from cats to dogs and back again. Fleas also transmit one of the common feline and canine tapeworms. PROGRAM 6 Month Injectable for Cats controls fleas by disrupting the life cycle of this insect. Developed by Novartis Animal Health, PROGRAM 6 Month Injectable for Cats is clean, safe, and effective.

Safe

Over half a million doses of PROGRAM 6 Month Injectable for Cats have been administered. It has undergone testing and is held to high FDA standards (NADA #141-105, approved by the FDA), so you know it's safe for your cat. The following side effects may occur in treated cats: injection site reactions, gastrointestinal reactions, inactivity, and loss of appetite.

Effective

PROGRAM® (lufenuron) 6 Month Injectable for Cats works like birth control for fleas by preventing eggs from developing. It provides extremely effective flea protection. In a university study, from day 14 through the rest of the 6 months, PROGRAM 6 Month Injectable for Cats demonstrated 97.7% effectiveness. What's more, PROGRAM 6 Month Injectable for Cats can't fall off like a collar or be groomed off by your cat like topical pesticides.

It is a six-month injection that controls flea populations in cats.

Caution: U.S. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

PROGRAM (lufenuron) 6 Month Injectable for Cats is available in two syringe sizes for subcutaneous administration to cats and kittens according to their weight. (See Dosage.) Each preloaded syringe is formulated to provide 4.54 mg/pound (10 mg/kg) body weight of lufenuron. The active ingredient of PROGRAM 6 Month Injectable for Cats is lufenuron, a benzoylphenyl-urea derivative with the following chemical composition: N-[2,5-dichloro-4-(1,1,2,3,3,3,-hexafluoropropoxy)-phenyl-aminocarbonyl]-2, 6-difluorobenzamide. Benzoylphenyl-urea compounds, including lufenuron, are classified as insect development inhibitors (IDIs).

Mode of Action

Lufenuron, the active ingredient of PROGRAM 6 Month Injectable for Cats, is an insect development inhibitor which breaks the flea life cycle by inhibiting egg development. Lufenuron's mode of action is interference with chitin synthesis, polymerization and deposition. Lufenuron has no effect on adult fleas.

After biting a lufenuron-treated cat, the female flea ingests a blood meal containing lufenuron which is subsequently deposited in her eggs. Lufenuron prevents flea eggs from hatching and developing into adults and thus controls flea populations by breaking the life cycle (See Efficacy).

Indications

PROGRAM 6 Month Injectable for Cats is indicated for use in cats, six weeks of age and older, for the 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.

Warning

Do not use in dogs. A severe local reaction may occur in dogs that is not seen in cats.

Precautions

The safety of PROGRAM 6 Month Injectable for Cats in reproducing animals has not been established.

PROGRAM 6 Month Injectable for Cats breaks the flea life cycle by inhibiting egg development. However, pre-existing flea populations may continue to develop and emerge after treatment with PROGRAM 6 Month Injectable for Cats. Based on results of clinical studies, this emergence generally occurs during the first 30-60 days. Therefore, noticeable control may not be observed until several weeks after dosing when a pre-existing infestation is present. Cooler geographic areas may have longer lag periods due to a prolonged flea life cycle. Pesticides may be used concurrently depending on the severity of the infestation.

Safety

PROGRAM 6 Month Injectable for Cats has been used and tested safely in over 16 breeds of cats, including females, males and kittens. In well-controlled clinical trials, 294 cats were treated with lufenuron. PROGRAM 6 Month Injectable for Cats has also been safely used in cats receiving frequently used veterinary products such as vaccines, anthelmintics, antibiotics, steroids and pesticides.

The acute toxicity of injectable lufenuron was evaluated by administering 100 mg/kg bw, 10X the recommended 10 mg/kg bw dose rate, to adult cats. The potential cumulative toxicity of 1X and 3X the 10 mg/kg six-month use rate of lufenuron injectable in two-week-old kittens was evaluated over a two-month period. Other than injection site reactions (see below), no clinical signs of toxicity were reported in these studies.

Cumulative toxicity of injectable lufenuron in 2-month-old cats was evaluated by administering 1X, 3X or 5X the six-month dose three times during the six-month study. This equates to cumulative doses of 3X, 9X and 15X, respectively. Other than injection site reactions (see below), no clinical signs of toxicity were reported in these studies. Heinz body inclusions were present in all the control and treated cats; however, erythrocytes in the 50 mg/kg (15X cumulative dose) group had slightly elevated levels of Heinz bodies at 3-6 months.

The following injection site reactions were noted in these laboratory studies. Transient, minor discomfort was noted in some kittens and cats upon injection. Small raised areas at the injection sites, presumed to be deposits of lufenuron, were seen immediately after administration and persisted in some cases for the duration of the studies. This response at the injection site correlated microscopically with acute to granulomatous inflammation and fibrosis. Older injection sites showed less inflammation which indicates that these effects may resolve with time. No neoplastic transformations were found (See Adverse Reactions).

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