Comfortis: Product Information

COMFORTIS- spinosad tablet, chewable
Elanco US Inc.

Chewable Tablets

COMFORTIS -Cats

(spinosad)

Chewable Tablets

Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

COMFORTIS (spinosad) is available in three sizes of chewable flavored tablets for oral administration to cats and kittens according to their weight. Each chewable flavored tablet is formulated to provide a minimum spinosad dosage of 22.5 mg/lb (50 mg/kg). Spinosad is a member of the spinosyns class of insecticides, which are non-antibacterial tetracyclic macrolides. Spinosad contains two major factors, spinosyn A and spinosyn D, derived from the naturally occurring bacterium, Saccharopolyspora spinosa. Spinosyn A and spinosyn D have the chemical compositions 2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]13-[[5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione and 2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[5-(dimethylamino)tetrahydro-6-methyl2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, respectively.

Indications:

COMFORTIS kills fleas and is indicated for the prevention and treatment of flea infestations (Ctenocephalides felis), for one month, on cats and kittens 14 weeks of age and older and 4.1 pounds of body weight or greater.

Dosage and Administration:

COMFORTIS is given orally once a month, at the minimum dosage of 22.5 mg/lb (50 mg/kg).

Do not use the dosing schedule below when administering COMFORTIS to dogs, as it can result in an overdosage.

Dosage Schedule:

*Cats over 24 lbs should be administered the appropriate combination of tablets.

Body Weight Spinosad Per Tablet(mg) Tablets Administered
4.1 to 6 lbs 140 One
6.1 to 12 lbs 270 One
12.1 to 24* lbs 560 One

Administer COMFORTIS with food for maximum effectiveness.

COMFORTIS is a chewable tablet that can be consumed by cats when offered by the owner just prior to or after feeding. Alternatively, COMFORTIS may be offered in food or administered like other tablet medications. COMFORTIS 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 with food and resume a monthly dosing schedule.

Treatment with COMFORTIS 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 should continue the entire year without interruption.

To minimize the likelihood of flea reinfestations, it is important to treat all animals within a household with an approved flea protection product.

Contraindications:

There are no known contraindications for the use of COMFORTIS.

Warnings:

Not for human use. Keep this and all drugs out of the reach of children.

Precautions:

Use with caution with concomitant extra-label use of ivermectin (see ADVERSE REACTIONS).

The safe use of COMFORTIS in breeding, pregnant, or lactating cats has not been evaluated.

Adverse Reactions:

In a well-controlled US field study, which included a total of 211 cats (139 treated with COMFORTIS and 72 treated with an active topical control once a month for 3 treatments), no serious adverse reactions were attributed to the administration of COMFORTIS.

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 observations are presented in the following table. The most frequently reported adverse reaction in cats was vomiting.

Percentage of Cats (%) with Adverse Reactions
Month 1 Month 2 Month 3
COMFORTIS(n=139) ActiveTopicalControl(n=72) COMFORTIS(n=135) ActiveTopicalControl(n=69) COMFORTIS(n=132) ActiveTopicalControl(n=67)
Vomiting 14.4 1.4 14.8 1.4 13.6 4.5
Lethargy 3.6 0.0 0.7 0.0 1.5 1.5
Anorexia 2.2 0.0 0.7 0.0 2.3 1.5
Weight Loss 1.4 0.0 0.0 0.0 3.0 0.0
Diarrhea 1.4 1.4 0.7 2.9 2.3 1.5

Over the 3-month (3-dose) study, vomiting occurred on the day of or the day after at least one dose in 28.1% (39/139) of the cats treated with COMFORTIS and in 2.8% (2/72) of the cats treated with the active topical control. Three of the 139 cats treated with COMFORTIS vomited on the day of or the day after all three doses.

Two cats that received extra-label topical otic ivermectin on Day -1 of the field study developed lethargy on Day 1 after COMFORTIS administration on Day 0.

For technical assistance or to report suspected adverse drug events, contact Elanco US Inc. at 1-888-545-5973.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

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