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SENTINEL® (milbemycin oxime - lufenuron)

By: Novartis Animal Health

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This palatable once-a-month prescription tablet prevents heartworm disease and flea populations in dogs and puppies. SENTINEL Flavor Tabs also control flea populations and adult hookworms, and remove and control adult roundworm and whipworm infections in dogs and puppies.

Caution

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

Description

SENTINEL Flavor Tabs are available in four tablet sizes in color-coded packages for oral administration to dogs and puppies according to their weight (See Dosage section). Each tablet is formulated to provide a minimum of 0.23 mg/pound (0.5 mg/kg) of milbemycin oxime and 4.55 mg/pound (10 mg/kg) body weight of lufenuron. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C32H45NO7, MW 555.71) and 20% A3 (C31H43NO7, MW 541.68). Milbemycin oxime is classified as a macrocyclic anthelmintic. Lufenuron is a benzoylphenylurea derivative with the following chemical composition: N-[2,5-dichloro-4-(1,1,2,3,3,3, - hexafluoropropoxy)-phenylaminocarbonyl] 2,6- difluorobenzamide (C17H8CI2F8N2O3, MW 511.15). Benzoylphenylurea compounds, including lufenuron, are classified as insect development inhibitors (IDIs).

Mode of Action

Milbemycin oxime, one active ingredient in SENTINEL Flavor Tabs, is a macrocyclic anthelmintic which is believed to act by interfering with invertebrate neurotransmission. Milbemycin oxime eliminates the tissue stage of heartworm larvae and the adult stage of hookworm (Ancylostoma caninum), roundworm (Toxocara canis and Toxascaris leonina) and whipworm (Trichuris vulpis) infestations when administered orally according to the recommended dosage schedule.

Lufenuron, the other active ingredient in SENTINEL Flavor Tabs, 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 the adult flea. After biting a lufenuron-treated dog, the female flea ingests a blood meal containing lufenuron which is subsequently deposited in her eggs. Lufenuron prevents most flea eggs from hatching or maturing into adults and thus prevents and controls flea populations by breaking the life cycle (See Efficacy).

Indications

SENTINEL Flavor Tabs are indicated for use in dogs and puppies, four weeks of age and older, and two pounds body weight or greater. SENTINEL Flavor Tabs are also indicated for the prevention of heartworm disease caused by Dirofilaria immitis, for the prevention and control of flea populations, the control of adult hookworm (Ancylostoma caninum), and the removal and control of adult roundworm (Toxocara canis and Toxascaris leonina) and whipworm (Trichuris vulpis) infections. 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

Do not use in puppies less than four weeks of age or less than two pounds in body weight. Prior to administration of SENTINEL Flavor Tabs, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilaria prior to initiating treatment with SENTINEL Flavor Tabs. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy have been noted in some treated dogs carrying a high number of circulating microfilaria. These reactions are presumably caused by release of protein from dead or dying microfilaria.

SENTINEL Flavor Tabs immediately break the flea life cycle by inhibiting egg development. However, pre-existing flea populations may continue to develop and emerge after treatment with SENTINEL Flavor Tabs. 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. The concurrent use of conventional pesticidal products may be employed depending on the severity of the infestation.

If a SENTINEL Flavor Tabs-treated dog comes in contact with a flea-infested environment, adult fleas may infest the treated animal. These adult fleas are unable to produce viable offspring. Depending on the severity of infestation, the temporary use of conventional adulticides in an integrated flea control program may be necessary to control these adult fleas.

Adequate flea control may not be achieved in dogs that have repeated exposure to flea infested animals or environments.

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