COMFORTIS chewable tablets (spinosad) are available in five chewable flavored tablet sizes for oral administration to dogs and puppies according to their weight. Each chewable tablet is formulated to provide a minimum spinosad dosage of 13.5 mg/lb (30 mg/kg) to reduce flea symptoms in dogs.
This dog flea medicine works rapidly to kill fleas before they are able to lay eggs and are effective for one month. The convenient, chewable tablets for dogs come in a tasty, beef flavor for easy administration. Comfortis is dispensed with the package inserts and instructions but does not include the box.
This flea medicine for dogs manufactured by Elanco Animal Health is easy to administer.
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Dogs and puppies 14 weeks and older
- Once-a-month, convenient tablet
- Safe for dogs and puppies 14 weeks and older
- Kills fleas before they are able to lay eggs
- Effective against flea infestation in dogs for a month
- Chewable tablets for dogs in a tasty, beef flavor for easy administration
Federal (USA) law restricts this dog flea medicine to use by or on the order of a licensed veterinarian.
COMFORTIS chewable tablets kill fleas and are indicated for the prevention and treatment of flea infestations in dogs for one month.
Dosage and Administration:
COMFORTIS chewable tablets are given orally once a month, at the recommended minimum dosage of 13.5 mg/lb (30 mg/kg).
Recommended Dosage Schedule:
|Body Weight||Spinosad Per Tablet (mg)||Tablets Administered|
|5 to 10 lbs||140||One|
|10.1 to 20 lbs||270||One|
|20.1 to 40 lbs||560||One|
|240.1 to 60 lbs||810||One|
|60.1 to 120* lbs||1620||One|
* Dogs over 120 lbs should be administered the appropriate combination of tablets.
Administer COMFORTIS chewable tablets with food for maximum effectiveness.
COMFORTIS is a chewable tablet and is readily consumed by dogs when offered by the owner just prior to feeding. Alternatively, this flea medicine may be offered in food or administered like other tablet medications. COMFORTIS flea medicine for dogs should be administered at monthly intervals.
If vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed, administer COMFORTIS flea medicine for pets with food and resume a monthly dosing schedule.
Treatment with COMFORTIS chewable tablets for dogs may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment with COMFORTIS chewable tablets for dogs should continue the entire year without interruption.
To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved dog flea medicine protection product.
There are no known contraindications for the use of COMFORTIS chewable tablets.
Not for human use. Keep this and all veterinary drugs out of the reach of children.
Serious adverse reactions have been reported following concomitant extra label use of ivermectin with COMFORTIS.
COMFORTIS chewable tablets are for use in dogs and puppies 14 weeks of age and older.
Use with caution in breeding females. Use with caution in dogs with pre-existing epilepsy. The safe use of COMFORTIS flea medicine for dogs in breeding males has not been evaluated.
In a well-controlled US field study, which included a total of 470 dogs (330 dogs treated with COMFORTIS chewable tablet for dogs and 140 dogs treated with an active control), no serious adverse reactions were observed with COMFORTIS flea medicine for dogs. 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 dog flea medicine and active control groups was vomiting. The occurrence of vomiting, most commonly within 48 hours after treatment, decreased with repeated doses of COMFORTIS flea medicine for dogs.
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)|
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 for dogs 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 (60mg/kg) experienced at least one seizure within the week following the second dose of COMFORTIS dog flea medication, but no seizures following the first and third doses. The cause of the seizures observed in the field studies could not be determined.
Post Approval Experience (June 2009):
The following adverse reactions are based on post-approval adverse drug event reporting. The adverse reactions are listed in decreasing order of frequency: vomiting, depression/lethargy, anorexia, ataxia, diarrhea, pruritus, trembling, hyper salivation and seizures.
Following concomitant extra label use of ivermectin with COMFORTIS, some dogs have experienced the following clinical signs: trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Post approval experience continues to support the safety of this dog flea medicine when used concurrently with heartworm preventatives according to label directions.
For technical assistance or to report an adverse drug reaction, call 1-888-545-5973. Additional information can be found at www.comfortis4dogs.com.
For a complete listing of adverse reactions for spinosad reported to the CVM see http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetylnformation/ucm055394htm
Mode of Action:
The primary target of action of COMFORTIS, flea treatment for dogs in insects is an activation of nicotinic acetylcholine receptors (nAChRs). Insects treated with spinosad show involuntary muscle contractions and tremors resulting from activation of motor neurons. Prolonged spinosad-induced hyper excitation results in prostration, paralysis, and flea death.
In a well-controlled laboratory study, COMFORTIS flea medicine for dogs began to kill fleas 30 minutes after administration and demonstrated 100% effectiveness within 4 hours.
COMFORTIS, dog flea medicine kills fleas before they can lay eggs. If a severe environmental infestation exists, fleas may persist for a period of time after dose administration due to the emergence of adult fleas from pupae already in the environment.
In field studies conducted in households with existing flea infestations of varying severity, flea reductions of 98.0% to 99.8% were observed over the course of 3 monthly treatments with COMFORTIS.
Dogs with signs of flea allergy dermatitis, one of the common flea symptoms in dogs showed improvement in erythema, papules, scaling, alopecia, dermatitis/pyodermatitis and pruritus as a direct result of eliminating the fleas.
COMFORTIS tablets for dogs were tested in pure and mixed breeds of healthy dogs in well-controlled clinical and laboratory studies. No dogs were withdrawn from the field studies due to treatment-related adverse reactions.
In a dose tolerance study, COMFORTIS flea medicine for dogs were administered orally to adult Beagle dogs at average doses of up to 100 mg/kg once daily for 10 consecutive days (16.7 times the maximum recommended monthly dose). Vomiting was seen in 5 of 6 treated dogs during the first 6 days of treatment, usually within 2.5 hours of dosing.
Treated females with this veterinary medication lost weight early in the treatment period, but their weights were similar to control dogs by the end of the 24-day study.
This flea medicine for dogs were not associated with any clinically significant changes in hematology, blood coagulation or urinalysis parameters; however, mild elevations in ALT occurred in all dogs treated with COMFORTIS, best flea treatment for dogs.
In a margin of safety study, COMFORTIS tablets for dog flea treatment were administered orally to 6-week-old Beagle puppies at average doses of 1.5, 4.4, and 7.4 times the maximum recommended dose at 28-day intervals over a 6-month period. Vomiting was observed across all groups, including the control. Increased vomiting was observed at elevated doses, usually within 1 hour following administration. Vomiting at all doses decreased over time and stabilized when puppies were 14 weeks of age. The average daily and total weight gains of treated dogs were smaller than control dogs and were dose dependent. COMFORTIS flea medicine for dogs was not associated with clinically significant changes in hematology, clinical chemistry, and coagulation or urinalysis parameters.
Treatment with COMFORTIS chewable tablets for dogs was not associated with any other clinically significant adverse clinical observations, gross necropsy or histopathological changes.
In a reproductive safety study, COMFORTIS dog flea medicine was administered orally to female Beagles at 1.3 and 4.4 times the maximum recommended therapeutic dose every 28 days prior to mating, during gestation, and during a six-week lactation period. No treatment-related adverse effects were noted for conception rates in the dams, or for mortality, body temperature, necropsy, or histopathology findings for the dams or puppies. One dam from each treatment group experienced early pregnancy loss and one additional high dose dam aborted late term. The treated dams experienced more vomiting, especially at one hour post-dose, than the control dams.
Puppies from dams treated at 1.3 times the maximum recommended therapeutic dose had lower body weights than puppies from control dams. Although puppy mortality between treated and control dams was not different, the puppies from the treated dams experienced more lethargy (4.4X group only), dehydration, weakness and felt cold to the touch (4.4X group only) than puppies from control dams.
A pilot study without a control group was conducted to analyze milk from three lactating dogs treated with an experimental formulation of spinosad at 1.5 times the maximum recommended dose of this dog flea medicine was administered at day 28 of gestation and 24 hours prior to parturition. The data demonstrated that spinosyn were excreted in the milk of these dogs. Mortality and morbidity were greatest in puppies from the dam with the highest spinosyn level in milk. The spinosad milk: reference plasma exposure ratio calculated from this study ranged from 2.2 to 3.5.
In well-controlled field studies, COMFORTIS flea medicine for dogs were administered safely in conjunction with other frequently used veterinary products, such as vaccines, anthelmintic, antibiotics, steroids, flea and tick control products, anesthetics, NSAIDs, antihistamines, alternative/herbal remedies, shampoos, and prescription diets. Changes in hematology, clinical chemistry and urinalysis values were compared pre- and post-study and were unremarkable.
Store these veterinary medications at 20-25°C (68-77°F), excursions permitted between 15 to 30°C (59 to 86°F).
COMFORTIS chewable tablets to treat flea infestation in dogs are available in five flavored tablet sizes: 140, 270, 560, 810 or 1620 mg. Each chewable tablet size is available in color-coded packages of 6 tablets.
Manufactured for Elanco Animal Health, A Division of Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285