Interceptor (milbemycin oxime Rx) Heartworm Preventative for Dogs

Trade Names:

Interceptor® Flavor Tabs® for Dogs & Cats

General description of Interceptor:

A monthly pill which prevents heartworm and kills parasites such as hookworm, roundworm and whipworm. Flavored tablets are available for both dogs and cats in a 6 or 12 month supply.

What is Interceptor?

• Milbemycin is a strong drug able to interfere with a parasite's nerve transmission, causing death of many forms of parasites
• Milbemycin flavored tablets are given by mouth

Reasons for prescribing Interceptor:

• To prevent heartworm disease and roundworm, hookworm and whipworm infections in dogs
• To prevent heartworm disease and roundworm and hookworm infections in cats
• To treat certain types of mange

What dogs/cats should not take Interceptor?

• Puppies less than 4 weeks of age; kittens less than 6 weeks of age
• Dogs with a body weight less than 2 pounds; cats with a body weight less than 1.5 pounds
• Pets who have tested positive for heartworm
• Safe for all breeds of dogs and cats
• Safe for breeding, pregnant or nursing dogs, but safety has not been established in breeding, pregnant or nursing cats
• Pets known to have had an allergic reaction to milbemycin or like products

Directions:

Give as directed by your veterinarian. Your veterinarian will choose the package size appropriate to your pet's weight. Read and follow the label carefully.

This medication can be given as a treat or with a meal. Tablets may be broken for ease of administration.

Ensure your pet consumes the entire dose. If it is not entirely consumed, re-dose the full recommended dose as soon as possible.

Milbemycin is given once a month, preferably on the same day of each month. Administer within one month of the pet's first exposure to mosquitoes and monthly thereafter. The medication kills the parasites acquired during the previous month. Treatment may continue year-round or until the end of the mosquito season. Discuss this with your veterinarian.

If the animal vomits within 2 hours of the dose, and you feel it is unrelated to the medication, give another dose.

Missed doses reduce the effectiveness of therapy.

If this product replaces another type of heartworm preventive, the first dose must be given within 30 days after the last dose of the previous product.

What if a dose of Interceptor is missed?

If a dose is missed, give it as soon as you can. If it is time already for the next dose, skip the missed dose and go back to the normal schedule. Do not give two doses at the same time. If you miss more than 8 weeks in a row, give the drug as soon as you remember, but you should have your pet's blood tested for heartworms within 6 months (as infection may have occurred).

What to tell/ask veterinarian before giving Interceptor?

• What tests may need to be performed prior to treatment with this drug
• What are the risks and benefits of using this drug?
• If your pet has experienced side-effects on other drugs/products
• If your pet has experienced any other medical problems or allergies now or ever
• All medicines and supplements that you are giving your pet or plan to give your pet, including those you can get without a prescription. Your veterinarian may want to check that all of your pet's medicines can be given together.
• If you pet is pregnant or nursing or if you plan to breed your pet

Storage and Warnings:

Store at room temperature away from heat and direct sunlight.

Remove tablet from original pack only at time of administration.

Humans should maintain good personal hygiene as hookworm and roundworm infections could easily be contracted.

Do not allow pets to eat rodents or raw flesh or fish. Pet feces should be removed daily and the premises kept clean.

Keep this and all medication out of reach of children and pets. Call your physician immediately if you accidentally take this product.

Potential side effects of Interceptor:

• A mild, transient hypersensitivity reaction (labored breathing, vomiting, salivation and lethargy) has been noted in some dogs carrying a large number of circulating microfilariae (immature heartworm). These reactions are likely due to the parasites dying all at once.
• May also cause itchiness, hives and red skin, lethargy, depression, staggering, convulsions, weakness
• More serious side effects could occur in a dog with preexisting heartworm infection
• If you notice anything unusual, contact your veterinarian

Can Interceptor be given with other drugs?

• Yes, no known drug interactions have been noted.
• Do not give this product if your dog is already taking heartworm medication.
• If your pet experiences any unusual reactions when taking multiple medications, contact your veterinarian

Overdosing?

Contact your veterinarian immediately if pet consumes more than the prescribed amount.

What else should I know about Interceptor?

Notify your veterinarian if your animal's condition does not improve or worsens despite this treatment.

As with all prescribed medicines, milbemycin should only be given to the dog/cat for which it was prescribed. It should be given only for the condition for which it was prescribed.

This is just a summary of information about milbemycin. If you have any questions or concerns about milbemycin or the conditions for which it was prescribed, contact your veterinarian.

Every effort has been made to ensure the accuracy of the information published. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the USA product label or package insert.

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INTERCEPTOR^® FLAVOR TABS^® FOR DOGS & CATS

Novartis

(milbemycin oxime)

INFORMATION FOR DOSING DOGS

The palatable once-a-month tablet that prevents heartworm disease, controls adult hookworm, and removes and controls adult roundworm and whipworm infections in dogs and puppies.

Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Description: INTERCEPTOR (milbemycin oxime) Flavor Tabs are available in four tablet sizes in color-coded packages for oral administration to dogs and puppies. Each tablet is formulated to provide a minimum of 0.23 mg/lb (0.5 mg/kg) body weight of milbemycin oxime. 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).

Package color	Milbemycin oxime tablet
Brown	2.3 mg*
Green	5.75 mg
Yellow	11.5 mg
White	23.0 mg

*for dogs only

Indications: INTERCEPTOR Flavor Tabs are indicated for use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adultAncylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis(whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater.

Dosage: INTERCEPTOR Flavor Tabs are given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5 mg/kg).

Recommended Dosage Schedule for Dogs

Body Weight	INTERCEPTOR Flavor Tabs
2-10 lbs.	One tablet (2.3 mg)
11-25 lbs.	One tablet (5.75 mg)
26-50 lbs.	One tablet (11.5 mg)
51-100 lbs.	One tablet (23.0 mg)

Dogs over 100 lbs. are provided the appropriate combination of tablets.

Administration: INTERCEPTOR Flavor Tabs are palatable and most dogs will consume the tablet willingly when offered by the owner. As an alternative, the dual-purpose tablet may be offered in food or administered as other tablet medications. 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.

INTERCEPTOR Flavor Tabs must be administered monthly, preferably on the same date each month. The first dose should be administered within one month of the dog’s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. If a dose is missed and a 30-day interval between dosing is exceeded, administer INTERCEPTOR Flavor Tabs immediately and resume the monthly dosing schedule.

If INTERCEPTOR Flavor Tabs replaces diethylcarbamazine (DEC) for heartworm prevention, the first dose must be given within 30 days after the last dose of DEC.

Palatability: Palatability trials conducted in 244 dogs from 10 different U.S. veterinary practices demonstrated that INTERCEPTOR Flavor Tabs were willingly accepted from the owner by over 95% of dogs. The trial was comprised of dogs representing 60 different breeds and both sexes, with weights ranging from 2.1 lbs. to 143.3 lbs., and ages ranging from 8 weeks to 15 years.

Precautions: Do not use in puppies less than four weeks of age or less than two pounds of body weight. Prior to initiation of the INTERCEPTOR Flavor Tabs treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with INTERCEPTOR 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 presumably caused by release of protein from dead or dying microfilariae.

Adverse Reactions: The following adverse reactions have been reported following the use of INTERCEPTOR Flavor Tabs: Depression/lethargy, vomiting, ataxia, anorexia, diarrhea, convulsions, weakness and hypersalivation.

Efficacy: INTERCEPTOR Flavor Tabs eliminate the tissue stage of heartworm larvae and the adult stage of hookworm (Ancylostoma caninum),roundworms (Toxocara canis, Toxascaris leonina) and whipworm (Trichuris vulpis) infestations when administered orally according to the recommended dosage schedule. The anthelmintic activity of milbemycin oxime is believed to be a result of interference with invertebrate neurotransmission.

Safety: Milbemycin oxime has been tested safely in over 75 different breeds of dogs, including collies, pregnant females, breeding males and females, and puppies over two weeks of age. In well-controlled clinical field studies, 786 dogs completed treatment with milbemycin oxime. Milbemycin oxime was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, antibiotics, steroids, flea collars, shampoos and dips.

Two studies in heartworm-infected dogs were conducted which demonstrated mild, transient hypersensitivity reactions in treated dogs with high microfilaremia counts (see Precautions for reactions observed). Safety studies in pregnant dogs demonstrated that high doses (1.5 mg/kg = 3X) of milbemycin oxime given in an exaggerated dosing regimen (daily from mating through weaning), resulted in measurable concentrations of the drug in milk. Puppies nursing these females which received exaggerated dosing regimens demonstrated milbemycin-related effects. These effects were directly attributable to the exaggerated experimental dosing regimen. The product is normally intended for once-a-month administration only. Subsequent studies included using 3X daily from mating to one week before weaning and demonstrated no effects on the pregnant females or their litters. A second study where pregnant females were dosed once at 3X the monthly use rate either before, on the day of or shortly after whelping resulted in no effects on the puppies.

Some nursing puppies, at 2, 4, and 6 weeks of age, given greatly exaggerated oral milbemycin oxime doses (9.6 mg/kg = 19X) exhibited signs typified by tremors, vocalization and ataxia. These effects were all transient and puppies returned to normal within 24 to 48 hours. No effects were observed in puppies given the recommended dose of milbemycin oxime (0.5 mg/kg). This product has not been tested in dogs less than 1 kg weight.

A rising-dose safety study conducted in rough-coated collies, manifested a clinical reaction consisting of ataxia, pyrexia and periodic recumbency, in one of fourteen dogs treated with milbemycin oxime at 12.5 mg/kg (25X monthly use rate). Prior to receiving the 12.5 mg/kg dose (25X monthly use rate) on day 56 of the study, all animals had undergone an exaggerated dosing regimen consisting of 2.5 mg/kg milbemycin oxime (5X monthly use rate) on day 0, followed by 5.0 mg/kg (10X monthly use rate) on day 14 and 10.0 mg/kg (20X monthly use rate) on day 32. No adverse reactions were observed in any of the collies treated with this regimen up through the 10.0 mg/kg (20X monthly use rate) dose.

How supplied: INTERCEPTOR Flavor Tabs are available in four tablet sizes (see Dosage section), formulated according to the weight of the dog. Each tablet size is available in color-coded packages of 6 or 12 tablets each, which are packaged 10 per display carton.

Storage conditions: INTERCEPTOR Flavor Tabs should be stored at room temperature, between 59° and 77°F (15-25°C).

INFORMATION FOR DOSING CATS

The palatable once-a-month tablet that prevents heartworm disease and removes adult roundworms and hookworms in cats and kittens.

Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Description: INTERCEPTOR Flavor Tabs for Cats are available in three tablet sizes in color-coded packages for oral administration to cats and kittens. Each tablet is formulated to provide a minimum of 0.9 mg/lb (2.0 mg/kg) body weight of milbemycin oxime. 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).

Indications: INTERCEPTOR Flavor Tabs for Cats are indicated for use in the prevention of heartworm disease caused by Dirofilaria immitis, and the removal of adult Ancylostoma tubaeforme (hookworm) and Toxocara cati (roundworm) in cats and kittens six weeks of age or greater and 1.5 lbs. body weight or greater.

Dosage: INTERCEPTOR Flavor Tabs for Cats are given orally, once a month, at the recommended minimum dosage rate of 0.9 mg milbemycin oxime per pound of body weight (2.0 mg/kg).

Recommended Dosage Schedule for Cats

Body Weight	INTERCEPTOR Flavor Tab
1.5 to 6 lbs.	One tablet (5.75 mg)
6.1-12 lbs.	One tablet (11.5 mg)
12.1-25 lbs.	One tablet (23.0 mg)

Cats over 25 lbs. are provided the appropriate combination of tablets.

Administration: INTERCEPTOR Flavor Tabs for Cats are palatable and may be offered by the owner as a treat. As an alternative, the tablet may be offered in food or administered as other tablet medications. The tablets can be broken for ease of administration. Watch the cat 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.

INTERCEPTOR Flavor Tabs for Cats must be administered monthly, preferably on the same date each month. The first dose should be administered within one month of the cat’s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. If a dose is missed and a 30-day interval between dosing is exceeded, administer INTERCEPTOR Flavor Tabs for Cats immediately and resume the monthly dosing schedule. It is recommended that cats be tested for existing heartworm infection prior to starting treatment with Flavor Tabs for Cats (see Precautions).

Palatability: Palatability trials conducted in 72 cats demonstrated that INTERCEPTOR Flavor Tabs for Cats were successfully dosed by the owner when they either offered the tablet as a treat, placed the tablet in the cat’s mouth or placed the tablet in the cat’s food in 72% of cats. About 16% of the cats were manually dosed and 13% of the cats were not successfully dosed according to the protocol.

Precautions: Do not use in kittens less than six weeks of age or less than 1.5 lbs. body weight. Safety in heartworm-positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established.

Efficacy: INTERCEPTOR Flavor Tabs for Cats eliminate the tissue stage of heartworm larvae and hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections when administered orally according to the recommended dosage schedule. The anthelmintic activity of milbemycin oxime is believed to be a result of interference with invertebrate neurotransmission.

Safety: Milbemycin oxime has been tested safely in over 8 different breeds of cats. In well-controlled clinical field studies 141 cats completed treatment with milbemycin oxime. Milbemycin oxime was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, anesthetics, antibiotics, steroids, flea collars, shampoos and dips.

Safety studies were conducted in young cats and kittens and doses of 1X, 3X and 5X the minimum recommended dose of 2.0 mg/kg demonstrated no drug-related effects. Tolerability studies at exaggerated doses of 10X also demonstrated no drug-related adverse effects in kittens and young adult cats.

How supplied: INTERCEPTOR Flavor Tabs for Cats are available in three tablet sizes (see Dosage section), formulated according to the weight of the cat. Each tablet size is available in color-coded packages of 6 or 12 tablets each, which are packaged 10 per display carton.

Storage conditions: INTERCEPTOR Flavor Tabs for Cats should be stored at room temperature, between 59° and 77°F (15-25°C).

Manufactured for: Novartis Animal Health US, Inc., Greensboro, NC 27408, USA

NADA #140-915, Approved by FDA

©2010 Novartis

2006072

NAH/INT-FT/VI/4

10/09

INTERCEPTOR and Flavor Tabs are registered trademarks of Novartis AG.