REVOLUTION PLUS: Product Information

REVOLUTION PLUS- sarolaner and selamectin solution
REVOLUTION PLUS- selamectin and sarolaner solution
Zoetis Inc.

CAUTION:

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

DESCRIPTION:

REVOLUTION PLUS (selamectin and sarolaner topical solution) for Cats is available as a colorless to yellow, ready to use solution in single dose tubes for topical (dermal) treatment of cats and kittens eight weeks of age and older. The content of each tube is formulated to provide a minimum of 2.7 mg/lb (6 mg/kg) of body weight of selamectin and 0.45 mg/lb (1.0 mg/kg) of body weight of sarolaner. Inactive ingredients: Dipropyleneglycol Monomethylether, Isopropyl Alcohol, Butylated Hydroxytoluene.

Selamectin is a member of the macrocyclic lactone class of parasiticides and the chemical name is 25-Cyclohexyl-4’-O-de(2,6-dideoxy-3-O-methyl-α-l-arabino-hexopyranosyl)-5-demethoxy-25-de(1-methylpropyl)-22,23-dihydro-5-(hydroxyimino)-avermectin A1a.

Sarolaner is a member of the isoxazoline class of parasiticides and the chemical name is 1(5’-((5S)-5-(3,5-Dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3’-H-spiro(azetidine-3,1’-(2)benzofuran)-1-yl)-2-(methylsulfonyl)ethanone. REVOLUTION PLUS contains the S-enantiomer of sarolaner.

INDICATIONS:

REVOLUTION PLUS is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. REVOLUTION PLUS kills adult fleas (Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, the treatment and control of tick infestations with Ixodes scapularis (black-legged tick), Amblyomma maculatum (Gulf Coast tick) and Dermacentor variabilis (American dog tick), the treatment and control of ear mite (Otodectes cynotis) infestations, and the treatment and control of roundworm (Toxocara cati) and intestinal hookworm (Ancylostoma tubaeforme) infections for one month in cats and kittens 8 weeks and older, and weighing 2.8 pounds or greater.

DOSAGE AND ADMINISTRATION:

The recommended minimum dosage is 2.7 mg selamectin per pound (6 mg/kg) of body weight and 0.45 mg sarolaner per pound (1 mg/kg) of body weight.

Administer the entire contents of a single tube (or two tubes in combination for cats weighing over 22 pounds) of REVOLUTION PLUS topically in accordance with the following table.

Body Weight (lbs) Tube Cap Color Tube Volume (mL) Tube Contents

Selamectin

(mg/tube)

Sarolaner

(mg/tube)

2.8 — 5.5

gold

0.25

152.5
5.6 — 11 orange 0.5305
11.1 — 22*green16010

* Cats over 22 lbs should be treated with the appropriate combination of tubes.Recommended for use in cats and kittens 8 weeks of age or older.

A veterinarian or veterinary technician should demonstrate or instruct the pet owner regarding the appropriate technique for applying REVOLUTION PLUS topically to cats and kittens prior to first use.

Dosage illustration
(click image for full-size original)

Firmly press the cap down to puncture the seal on the REVOLUTION PLUS tube; a clicking sound will confirm that the cap has successfully punctured the seal. Remove the cap and check to ensure that the tip of the tube is open. To administer the product, part the hair on the back of the animal at the base of the neck in front of the shoulder blades until the skin is visible. Place the tip of the tube on the skin and squeeze the tube 3 or 4 times to empty its entire contents directly on to the skin in one spot. Keeping the tube squeezed, drag it away from the liquid and lift to remove. Check the tube to ensure that it is empty.

Do not massage the product into the skin. Due to alcohol content, do not apply to broken skin. Avoid contact between the product and fingers. Do not apply when the hair coat is wet. Stiff hair, clumping of hair, hair discoloration, or a slight powdery residue may be observed at the treatment site in some cats. These effects are temporary and do not affect the safety or effectiveness of the product. Discard empty tubes in your ordinary household refuse.

The effectiveness of REVOLUTION PLUS against D. immitis after bathing has not been evaluated. Bathing or shampooing the cat 24 hours after treatment does not reduce the effectiveness of topical selamectin, one of the ingredients of REVOLUTION PLUS, against D. immitis.

Flea Treatment and Prevention
For the treatment and prevention of flea infestations, REVOLUTION PLUS may begin at any time of year. REVOLUTION PLUS should be administered year-round at monthly intervals or begin at least one month before fleas become active. If a cat is already infested with fleas when the first dose of REVOLUTION PLUS is administered, adult fleas on the animal are killed before they can lay eggs. However, an environmental infestation may persist for a short time after beginning treatment with REVOLUTION PLUS because of the development of adult fleas from eggs that were laid prior to the initiation of treatment.
Tick Treatment and Control
For the treatment and control of infestations with Ixodes scapularis , Amblyomma maculatum and Dermacentor variabilis , REVOLUTION PLUS may begin at any time of year. REVOLUTION PLUS should be administered year-round at monthly intervals or begin at least one month before the ticks become active.

Heartworm Prevention
For the prevention of heartworm disease, REVOLUTION PLUS must be administered on a monthly basis. REVOLUTION PLUS should be administered year-round or at least within one month after the animal’s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. The final dose must be given within one month after the last exposure to mosquitoes. If a dose is missed and a monthly interval between dosing is exceeded then immediate administration of REVOLUTION PLUS and resumption of monthly dosing will minimize the opportunity for the development of adult heartworms. When replacing another monthly heartworm preventive product in a heartworm disease prevention program, the first dose of REVOLUTION PLUS must be given within a month of the last dose of the former medication.
Selamectin, one of the active ingredients in REVOLUTION PLUS, is a macrocyclic lactone compound. These compounds effectively prevent the development of adult heartworms when administered to cats within one month of exposure to infective (L3) Dirofilaria immitis larvae. This product effectively eliminates the tissue stage of heartworm larvae for a month after infection. Cats with unknown heartworm history that test negative prior to the initiation of REVOLUTION PLUS may be harboring pre-patent infections at the time REVOLUTION PLUS was started. Testing such animals 3-4 months after initiation of REVOLUTION PLUS would be necessary to confirm their negative heartworm status. At the discretion of the veterinarian, cats ≥ 6 months of age may be tested to determine the presence of existing heartworm infections before beginning treatment with REVOLUTION PLUS. Cats already infected with adult heartworms can be given REVOLUTION PLUS monthly to prevent further infections.
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.

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