Medi-Vet - Sentinel Flea and Heartworm Protection Product Information

The palatable once-a-month prescription tablet that 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/lb (0.5 mg/kg) of milbemycin oxime and 4.55 mg/lb (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 (C₁₇ H₈ CI₂F₈N₂O₃ ,MW511.15). Benzoylphenylurea compounds, including lufenuron, are classified as insect development inhibitors (IDIs).

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 Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (round-worm) and Trichuris vulpis (whipworm) infections.

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

Precautions: Do not use in puppies less than four weeks of age and less than two pounds of 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 microfilariae 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 microfilariae. These reactions are pre-sumably caused by release of protein from dead or dying microfilariae.

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 insecticidal 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.

Dosage: SENTINEL Flavor Tabs are given orally, once a month, at the recommended minimum dosage of 0.23 mg/lb (0.5 mg/kg) milbemycin oxime and 4.55 mg/lb (10 mg/kg) lufenuron.

Recommended Dosage Schedule:


Body Weight	Milbemycin Oxime Per Tablet	Lufenuron Per Tablet

2 to 10 lbs.	2.3 mg	46 mg
11 to 25 lbs.	5.75 mg	115 mg
26 to 50 lbs.	11.5 mg	230 mg
51 to 100 lbs.	23.0 mg	460 mg

Dogs over 100 lbs. should receive the appropriate combination of tablets.

Administration: TO ENSURE ADEQUATE ABSORPTION, ALWAYS ADMINISTER SENTINEL Flavor Tabs TO DOGS IMMEDIATELY AFTER OR IN CONJUNCTION WITH A NORMAL MEAL.

SENTINEL Flavor Tabs are palatable and most dogs will consume the tablet when offered by the owner. As an alternative to direct dosing, the tablets can be hidden in food. Be certain the dog consumes the entire tablet or tablets. Administer SENTINEL Flavor Tabs to dogs, immediately after or in conjunction with a normal meal. Food is essential for adequate absorption of lufenuron. Watch the dog closely following administration to be sure the entire dose has been consumed. If it is not entirely consumed, redose with the full recommended dose as soon as possible.

SENTINEL Flavor Tabs must be administered monthly, preferably on the same date each month. Treatment with SENTINEL Flavor Tabs may begin at any time of year. In geographic areas where mosquitoes and fleas are seasonal, the treatment schedule should begin one month prior to the expected onset and should continue until the end of "mosquito and flea season." In areas with year-round infestations, treatment should continue through the entire year without interruption.

To ensure the greatest flea control from the use of SENTINEL Flavor Tabs, it is important to treat all dogs and cats within a household for fleas. All cats within the household should be treated with lufenuron suspension, injectable or tablets because untreated dogs and cats may develop infestations which could reduce the overall flea control within a household. (See Precautions.)

If a dose is missed and a 30-day interval between dosing is exceeded, administer SENTINEL Flavor Tabs immedi-ately and resume the monthly dosing schedule. If SENTINEL Flavor Tabs replace daily diethylcarbamazine (DEC) for heartworm prevention, the first dose must be given within 30 days after the last dose of DEC.

Adverse Reactions: The following adverse reactions have been reported in dogs after giving milbemycin oxime or lufenuron: vomiting, depression/lethargy, pruritus, urticaria, diarrhea, anorexia, skin congestion, ataxia, convul-sions, hypersalivation and weakness.

How Supplied: SENTINEL Flavor Tabs are available in four tablet sizes, formulated according to the weight of the dog. Each tablet size is available in color-coded packages of six tablets each, which are packaged 10 per display carton.

Storage Conditions: Store in a dry place at controlled room temperature, between 59 and 86°F (15-30°C).

SENTINEL^® Flavor Tabs^® / CAPSTAR^® FLEA MANAGEMENT SYSTEM

Indications

In dogs and puppies, the concurrent use of SENTINEL Flavor Tabs and CAPSTAR Tablets is indicated to kill adult fleas and prevent eggs from hatching. The effects of SENTINEL Flavor Tabs, which prevent and control flea populations, and CAPSTAR Tablets, which treat flea infestations, are combined to provide a FLEA MANAGEMENT SYSTEM.

Step 1: Control

Give SENTINEL Flavor Tabs once per month to prevent and control flea populations. SENTINEL Flavor Tabs contain lufenuron. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. If a dog currently has a flea infestation, more rapid relief can be accomplished by adding CAPSTAR to the treatment as follows.

Step 2: Kill Adult Fleas

If your pet currently has a flea infestation, use CAPSTAR Tablets to kill adult fleas. CAPSTAR Tablets contain nitenpyram and are effective for the treatment of flea infestations. Nitenpyram starts killing adult fleas within 30 minutes of administration.

· Administer CAPSTAR Tablets once per week until adult fleas are no longer observed.

· For a severe flea infestation, administer CAPSTAR Tablets twice per week until adult fleas are no longer observed.

· Additional CAPSTAR Tablets may be administered as needed to kill the occasional adult flea picked up from infested environments.

· It is important to treat all cats and dogs in the household. All cats should be treated with approved products like lufenuron in combination with nitenpyram as needed. Fleas can reproduce on untreated pets and allow infestations to persist.

Dosage

The combination of SENTINEL Flavor Tabs and CAPSTAR Tablets should be administered according to the following schedule. Weigh your dog prior to administration to ensure proper dosage. Do not administer to dogs under 2 pounds.

Recommended Dosage Schedule
Body Weight	Dose	CAPSTAR Once or twice weekly (Nitenpyram per tablet)	SENTINEL Flavor Tabs once per month (Lufenuron per tablet)
2 to 10 lbs.	One Tablet	11.4 mg	46 mg
11 to 25 lbs.	One Tablet	11.4 mg	115 mg
26 to 50 lbs.	One Tablet	57.0 mg	230 mg
51 to 100 lbs.	One Tablet	57.0 mg	460 mg
101 to 125 lbs.	One Tablet	57.0 mg	**

* If adult fleas are seen

**Dogs over 100 lbs. are provided the appropriate combination of SENTINEL Flavor Tabs.

Precautions

The safety of the concurrent use of SENTINEL Flavor Tabs and CAPSTAR Tablets in pregnant or nursing dogs or in puppies less than 11 weeks of age has not been demonstrated.

Adverse Reactions

The following adverse reactions have been reported in dogs after giving SENTINEL Flavor Tabs: vomiting, depression/lethargy, pruritus, urticaria, diarrhea, anorexia, skin congestion, ataxia, convulsions, hypersalivation and weakness.

Effectiveness

Please refer to the labeling for SENTINEL Flavor Tabs and CAPSTAR Tablets for information about the effectiveness of each product. Studies testing the concurrent use of the two products demonstrated that each product remains effective for its labeled indication when both are administered concurrently. In a simulated home environment, the administration of SENTINEL Flavor Tabs monthly and CAPSTAR either once or twice weekly demonstrated a greater and more rapid reduction of established flea infestations than SENTINEL Flavor Tabs alone.

Animal Safety

The combination of nitenpyram, milbemycin oxime and lufenuron has been tested in a 90 day laboratory study. Administration of 5X the recommended use rate of CAPSTAR Tablets for 90 consecutive days, concurrently with administration of 5X the recommended use rate of SENTINEL Flavor Tabs every 2 weeks for 7 treatments was well tolerated.

Flea Infestations on Dogs

In addition to the common nuisance irritations associated with infestations, fleas can be responsible for skin conditions in the dog such as flea allergy dermatitis. Fleas also transmit other parasites, including tapeworms. The control of flea infestations reduces the problems associated with these parasites.

SENTINEL Flavor Tabs break the flea life cycle by inhibiting egg development. CAPSTAR Tablets rapidly kill adult fleas on the dog. The concurrent use of these two products provides an effective flea management system

The following diagram illustrates the flea's life cycle and where the combination of SENTINEL Flavor Tabs and CAPSTAR Tablets work:

Life Cycle of the Flea

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 the pet and subsequently lay eggs, which drop off the pet's coat. Within days, larvae hatch from the eggs and live undetected in the pet's surroundings, such as the carpet and bedding. Flea larvae spin a cocoon, and, when appropriately stimulated, a young adult flea emerges and jumps onto the pet to continue the life cycle.