Comfortis for dogs chewable tablets kill fleas and are indicated for the prevention and treatment of flea infestations on dogs for one month. Comfortis for dogs and cats works.

Directions:
Comfortis for dogs chewable tablets should be dosed once a month, at the recommended minimum dosage of 13.5 mg/lb (30 mg/kg). Comfortis chewable tablets are available in five chewable flavored tablet sizes for oral administration to dogs and puppies according to their weight.
Comfortis chewable tablets should be given with food for maximum effectiveness. They are readily consumed when offered by hand prior to feeding but may also be given in food or by placing the tablet at the back of the tongue and encouraging the animal to swallow.
Treatment with Comfortis for dogs chewable tablets may begin at any time of the year, but should preferably begin one month before fleas become active and continue until the end of the flea season. In areas where fleas are common year-round, continue treatment with Comfortis throughout the year. In order to minimize the likelihood of flea reinfestation, all animals within a household should be treated with an approved flea protection product.

Warnings:
Comfortis chewable tablets are for use in dogs and puppies 14 weeks of age and older. They should be used with caution in breeding females, however the safe use of this product has not been studied in breeding males. Comfortis should also be used with caution in dogs with pre-existing epilepsy.
Vomiting has been seen on rare occasions in association with the administration of Comfortis. If vomiting occurs within an hour of administration, it is recommended that the animal is redosed with another full dose of the medication. On rare occasions, a reduced appetite, lethargy, diarrhea, a cough, increased drinking, reddened skin, salivation, hyperactivity, an increased appetite and vocalization have been seen in treated animals, most commonly in association with overdosing of the medication.
Comfortis for dogs chewable tablets have been safely administered in conjunction with other frequently used veterinary products, such as vaccines, anthelmintics, antibiotics, steroids, flea and tick control products, anesthetics, NSAIDs, antihistamines, alternative/herbal remedies, shampoos, and prescription diets. Not for human use. Keep this and all drugs out of the reach of children.

About Comfortis (spinosad)

Comfortis (spinosad) is the first FDA-approved, chewable, beef-flavored tablet that kills fleas and prevents flea infestations on dogs for a full month. Comfortis is:

• Convenient. Easy to give, with no messy applications
• Fast. Starts to kill fleas in 30 minutes before they can lay eggs
• Effective. Provides full flea protection for a full month

And Comfortis has been demonstrated to be safe for dogs and puppies 14 weeks and older.

View a brief video to learn more about Comfortis' many benefits from the perspective of veterinary professionals.

Proven flea protection, in a family-friendly form

Here are just a few of the features that make Comfortis an ideal choice for convenient, family-friendly flea protection:

• No need to isolate. With Comfortis, you can play with your dog immediately after treatment. No need to isolate from other household pets or children. Just treat and play.
• No staining residue. Unlike some other flea treatments, Comfortis won't stain carpeting, upholstery or clothing.
• No bath-time worries. Comfortis can't be washed, rubbed or shaken off while bathing or swimming.

Dog owners are most satisfied when using Comfortis, according to veterinarians.¹ View video testimonials about how convenient, and family-friendly Comfortis is for veterinary professionals and their clients.

How to Use Comfortis (spinosad)

Comfortis chewable tablets are one of the most convenient flea products on the market today.

Use the following as general guidelines for administering Comfortis. Ask your veterinarian about your dog's specific needs.

• Administer monthly.
• For best results, administer year-round without interruption.
• Administer with food for maximum effectiveness.
• Administer the correct dose as prescribed by your veterinarian.
• If you miss a dose, give Comfortis immediately and resume regular monthly dosing.

If necessary, you can administer Comfortis like you would other tablet medications.

View the Comfortis Comfortis product labelfor more detail.

Ask your veterinarian

Your veterinarian is your best source of advice about your dog's healthcare. That's why Comfortis (spinosad) is available through your veterinarian.

Your veterinarian can ensure the proper dosage of Comfortis and recommend other products that can help protect your dog's health. Consulting your veterinarian can help you avoid the costly and potentially dangerous trials-and-errors that pet owners could experience with over-the-counter products.

Your veterinarian can also make recommendations about flea treatment times and duration for your geographic area and specific household. For instance, to minimize the likelihood of flea reinfestation, it's advisable to treat all animals in your household with an approved flea product. Ask your veterinarian about Elanco flea-control products for your other pets.

Potential Side Effects And Adverse Reactions From Comfortis

It is important to know that some dog's have had adverse reactions and/or side effects from Comfortis including but not limited to vomiting, decreased appetite, lethargy, hyperactivity and increased salivation. In June 2008, the FDA released a warning that some dogs have had adverse reactions when taking Comfortis and Ivermectin concurrently. Ivermectin is a common ingredient in heartworm prevention medication including Heartgard products. Always discuss the use of any new product, including non-prescription meds, with your veterinarian before buying and administering them to your pet. Be sure to include all other food, supplements, meds and products your dog is currently receiving. For our pets, we often wait up to six to twelve months before trying a new pet health product just in case any unexpected problems with the product come to light that weren't discovered in the preliminary trial stages.

Adverse Reactions:

In a well-controlled US field study, which included a total of 470 dogs (330 dogs treated with COMFORTIS chewable tablets and 140 dogs treated with an active control), no serious adverse reactions were observed with COMFORTIS chewable tablets. All reactions were regarded as mild and did not result in any dog being removed from the study.

Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions that occurred at an incidence > 1% within any of the 3 months of observation are presented in the following table. The most frequently reported adverse reaction in dogs in the COMFORTIS chewable tablets and active control groups was vomiting. The occurrence of vomiting, most commonly within 48 hours after treatment, decreased with repeated doses of COMFORTIS chewable tablets.

Percentage of Dogs (%) with Adverse Reactions

	Month 1		Month 2		Month 3
	COMFORTIS Chewable Tablets (N=330)	Active Topical Control (N=139a)	COMFORTIS Chewable Tablets (N=282)	Active Topical Control (N=124)	COMFORTIS Chewable Tablets (N=260)	Active Topical Control (N=125)
Vomiting	12.7	12.2	7.8	3.2	5.8	4.8
Decreased Appetite	9.1	5.0	2.8	1.6	1.9	0.8
Lethargy	7.6	5.0	3.5	4.0	1.2	0.8
Diarrhea	6.7	5.0	4.3	0.8	1.2	0.0
Cough	3.9	5.0	0.4	2.4	0.0	0.0
Polydipsia	2.4	1.4	0.7	0.0	0.4	0.0
Vocalization	1.8	0.0	0.4	0.0	0.4	0.0
Increased Appetite	1.5	0.0	0.4	0.8	0.4	0.0
Erythema	1.5	0.0	0.4	0.0	0.4	0.0
Hyperactivity	1.2	1.4	0.0	0.0	0.4	0.0
Excessive Salivation	1.2	0.0	0.4	0.0	0.0	0.0

^a This number (n=139) is less than the total number of dogs in the safety population for the active control group (n=140) because one dog joined the study late and was only dosed at Month 3.

In US and European field studies, no dogs experienced seizures when dosed with COMFORTIS chewable tablets at the therapeutic dose range of 13.5-27.3 mg/lb (30-60 mg/kg), including 4 dogs with pre-existing epilepsy. Four epileptic dogs that received higher than the maximum recommended dose of 27.3 mg/lb (60 mg/kg) experienced at least one seizure within the week following the second dose of COMFORTIS chewable tablets, but no seizures following the first and third doses. The cause of the seizures observed in the field studies could not be determined.