REVOLUTION PLUS: Product Information (Page 2 of 3)

Ear Mite Treatment and Control

For the treatment of ear mite (Otodectes cynotis) infestations, REVOLUTION PLUS should be administered once as a single topical dose. Do not administer into the ear canal. Monthly use of REVOLUTION PLUS will control any subsequent ear mite infestations. Cleansing of the infested ears is recommended to remove debris.

Nematode Treatment and Control

For the treatment of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections, REVOLUTION PLUS should be applied once as a single topical dose. Monthly use of REVOLUTION PLUS will control any subsequent roundworm and intestinal hookworm infections.

CONTRAINDICATIONS:

There are no known contraindications for the use of REVOLUTION PLUS.

WARNINGS:

Human warnings:

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

Do not come into contact with or allow children to contact the application site until 4 hours post application.

In humans, REVOLUTION PLUS may be irritating to skin and eyes. REVOLUTION PLUS and selamectin topical solution contain isopropyl alcohol and the preservative butylated hydroxytoluene (BHT). Reactions such as hives, itching and skin redness have been reported in humans after accidental dermal contact with selamectin topical solution. Individuals with known hypersensitivity to selamectin topical solution should use caution or consult a health care professional before applying this product on a cat. Wash hands after use and wash off any product in contact with the skin immediately with soap and water.
If contact with eyes occurs, then flush eyes copiously with water; if wearing contact lenses, rinse the eyes first then remove contact lenses and continue to rinse for 5 – 10 minutes and seek medical attention. In case of ingestion by a human, contact a physician immediately. The safety data sheet (SDS) provides more detailed occupational safety information. For a copy of the SDS or to report a suspected adverse reaction, call Zoetis at 1-888-963-8471.
Flammable — Keep away from heat, sparks, open flames or other sources of ignition.

PRECAUTIONS:

Sarolaner, one of the ingredients in REVOLUTION PLUS, is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders.

The safe use of REVOLUTION PLUS has not been evaluated in kittens less than 8 weeks of age. The safe use of REVOLUTION PLUS has not been evaluated in breeding, pregnant, or lactating cats.

ADVERSE REACTIONS:

In a field safety and effectiveness study, REVOLUTION PLUS was administered to cats with fleas. The study included a total of 430 cats (282 treated with REVOLUTION PLUS and 148 treated with imidacloprid + moxidectin once monthly for three treatments). Over the 90-day study period, all observations of potential adverse reactions were recorded. Reactions reported in the REVOLUTION PLUS group included those presented in the following table.Adverse Reactions by Treatment Group

Adverse Reaction

REVOLUTION PLUS(n = 282)

Imidacloprid + moxidectin(n =148)
Lethargy 12 (4.3%) 1 (0.7%)
Skin lesions* 10 (3.5%) 3 (2.0%)
Anorexia 9 (3.2%) 3 (2.0%)
Pruritus 7 (2.5%) 3 (2.0%)
Conjunctivitis 7 (2.5%) 1 (0.7%)
Sneezing 6 (2.1%) 1 (0.7%)
Administration site hair changes (alopecia) 5 (1.8%) 0 (0.0%)
Administration site lesions (scabbing) 2 (0.7%) 0 (0.0%)

*Lesions not associated with application site.
In a second field safety and effectiveness study, REVOLUTION PLUS was administered to 124 cats with ear mites. Adverse reactions in cats treated with REVOLUTION PLUS included emesis, dermatitis and eczema, and pruritus.

In a third field safety and effectiveness study, REVOLUTION PLUS was administered to 70 cats with hookworms. Adverse reactions in cats treated with REVOLUTION PLUS included diarrhea, anorexia, emesis, and lethargy.

Post-Approval Experience (2022)
The following adverse events are based on post-approval adverse drug experience reporting forREVOLUTION PLUS. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the exposure using these data.
The following adverse events reported in cats are listed in decreasing order of reporting frequency:
Application site reactions (including alopecia, lesions, erythema, and pruritus), lethargy, anorexia, vomiting, generalized pruritus, behavioral disorders (including hiding, hyperactivity, and vocalization), ataxia, muscle tremor, diarrhea, generalized alopecia, and seizure.
Contact Information
To report adverse reactions call Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

CLINICAL PHARMACOLOGY:

Following topical administration of REVOLUTION PLUS both selamectin and sarolaner are well absorbed with mean absolute bioavailability of 40.5% and 57.9%, respectively, and distribute systemically. In cats, selamectin and sarolaner are low clearance compounds with a long half-life of 12.5 days and 41.5 days following topical administration, respectively. Following IV dose, the total body clearance for selamectin was 10.2 mL/kg/hr and for sarolaner was 3.41 mL/kg/hr. The volume of distribution at steady state was 1.26 L/kg for selamectin and 3.87 L/kg for sarolaner. The primary route of elimination for both drugs is hepatobiliary excretion (approximately 50% of dose excreted in feces).

Following repeated monthly doses of REVOLUTION PLUS, there was a less than dose proportional increase in the Cmax and AUC of sarolaner and selamectin. The accumulation of both sarolaner and selamectin was observed with Cmax plateauing after the 6th dose for sarolaner and the 3rd dose for selamectin.

MODE OF ACTION:

REVOLUTION PLUS contains two active pharmaceutical ingredients, selamectin and sarolaner. Selamectin is a semi-synthetic compound of the avermectin class. Selamectin paralyzes and/or kills a wide range of invertebrate parasites through interference with their chloride channel conductance causing disruption of normal neurotransmission. This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods leading to their paralysis and/or death. Sarolaner is an acaricide and insecticide belonging to the isoxazoline family. The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors). Sarolaner blocks GABA- and glutamate-gated chloride channels in the nervous system of insects and acarines. Disruption of these receptors by sarolaner prevents the uptake of chloride ions by GABA and glutamate ion channels, thus resulting in increased nerve stimulation and death of the target parasite. Sarolaner exhibits higher functional potency to block insect/acarine receptors compared to mammalian receptors.

EFFECTIVENESS:

Flea Treatment and Prevention

In a well-controlled laboratory study, REVOLUTION PLUS started to kill fleas within 12 hours of treatment and killed >98% of fleas within 24 hours. During subsequent weekly infestations, REVOLUTION PLUS started to kill fleas within 6 hours and killed ≥93.8% of fleas within 12 hours through Day 28.
In a 90-day multi-center field study in the United States, conducted in households with existing flea infestations, the effectiveness of REVOLUTION PLUS against fleas was 97.2%, 99.5%, and 99.8% when assessed on Days 30, 60, and 90, respectively. Cats with signs of flea allergy dermatitis showed improvement in alopecia, dermatitis/pyodermatitis, pruritus, erythema, and papules, and scaling, as a direct result of eliminating fleas.
In two additional well-controlled laboratory studies, there was a 100% reduction in adult flea count against an existing infestation and weekly re-infestation for at least 35 days. In one of these studies in which flea egg laying was examined, no flea eggs were recovered from cats treated with REVOLUTION PLUS through Day 22, and on Day 36. Four flea eggs were recovered from one cat on Day 29, but none of these four eggs hatched and developed into adult fleas. Fleas on control cats continued to produce eggs throughout the study, with counts ranging from 110 — 1,256 eggs per cat.
Collectively, the data from the four studies (three laboratory and one field) demonstrate that REVOLUTION PLUS kills fleas before they can lay eggs, thus preventing further flea infestations from developing once treatment of the existing flea infestation has been initiated.
Tick Treatment and Control

In well-controlled laboratory studies, REVOLUTION PLUS began to kill Ixodes scapularis ticks within 24 hours of administration and demonstrated ≥93.3% effectiveness 48 hours post re-infestation for a month. REVOLUTION PLUS demonstrated ≥91.6% effectiveness against Amblyomma maculatum 48 hours post-infestation for a month. At 72 hours post-infestation, REVOLUTION PLUS demonstrated ≥93.5% effectiveness against Dermacentor variabilis for a month.
Heartworm Prevention

In two well-controlled laboratory studies, a single topical dose of REVOLUTION PLUS was 100% effective in preventing the development of heartworms in cats inoculated with infective larvae of Dirofilaria immitis 30 days prior to treatment.
Ear Mite Treatment and Control

In a well-controlled laboratory study, a single topical dose of REVOLUTION PLUS resulted in > 99% effectiveness against an existing Otodectes cynotis infestation at 30 days post treatment. In a multi-center field study conducted in households with existing Otodectes cynotis infestations, 94.4% of cats in the group treated with REVOLUTION PLUS were negative for ear mites at Day 30.
Nematode Treatment and Control

Elimination of intestinal hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections was demonstrated in well-controlled laboratory studies.

In a 60-day multi-center field study, the effectiveness of REVOLUTION PLUS in reducing Ancylostoma tubaeforme fecal egg counts was 99.4% and 99.7% on Days 30 and 60, respectively.

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