Selamectin
Topical Parasiticide For Dogs
and Cats
Revolution is recommended for
use in dogs six weeks of age or older and cats eight weeks of age and older
for the following parasites and indications:
Dogs:
Revolution kills adult fleas
and prevents flea eggs from hatching for one month and is indicated for the
prevention and control of flea infestations (Ctenocephalides
felis), prevention of heartworm disease caused by
Dirofilaria immitis, and the treatment and control of ear mite
(Otodectes cynotis) infestations. Revolution also
is indicated for the treatment and control of sarcoptic mange
(Sarcoptes scabiei) and for the control of tick
infestations due to (Dermacentor variabilis).
Cats:
Revolution kills adult fleas
and prevents flea eggs from hatching for one month and is indicated for the
prevention and control of flea infestations (Ctenocephalides
felis), prevention of heartworm disease caused by
Dirofilaria immitis, and the treatment and control of ear mite
(Otodectes cynotis) infestations. Revolution is
also indicated for the treatment and control of roundworm
(Toxocara cati) and intestinal hookworm
(Ancylostoma tubaeforme) infections in cats.
WARNINGS
Not for human
use. Keep out of the reach of children.
In humans,
Revolution may be irritating to skin and eyes. Reactions such as hives,
itching and skin redness have been reported in humans in rare instances.
Individuals with known hypersensitivity to Revolution should use the product
with caution or consult a health care professional. Revolution contains
isopropyl alcohol and the preservative butylated hydroxytoluene (BHT). 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. In case of ingestion by a human, contact a
physician immediately. The material safety data sheet (MSDS) provides more
detailed occupational safety information. For a copy of the MSDS or to
report adverse reactions attributable to exposure to this product, call
1-800-366-5288.
Flammable - Keep away from
heat, sparks, open flames or other sources of ignition.
Do not use in
sick, debilitated or underweight animals (see SAFETY).
PRECAUTIONS:
Prior to administration of
Revolution, dogs should be tested for existing heartworm infections. At the
discretion of the veterinarian, infected dogs should be treated to remove
adult heartworms. Revolution is not effective against adult
D. immitis and, while the number of circulating
microfilariae may decrease following treatment, Revolution is not effective
for microfilariae clearance.
Hypersensitivity reactions
have not been observed in dogs with patent heartworm infections administered
three times the recommended dose of Revolution. Higher doses were not
tested.
ADVERSE
REACTIONS:
Pre-approval clinical trials:
Following treatment with
Revolution, transient localized alopecia with or without inflammation at or
near the site of application was observed in approximately 1% of 691 treated
cats. Other signs observed rarely (≤0.5% of 1743 treated cats and dogs)
included vomiting, loose stool or diarrhea with or without blood, anorexia,
lethargy, salivation, tachypnea, and muscle tremors.
Post-approval experience:
In addition to the
aforementioned clinical signs that were reported in pre-approval clinical
trials, there have been reports of pruritus, urticaria, erythema, ataxia,
fever, and rare reports of death. There have also been rare reports of
seizures in dogs (see WARNINGS).
DOSAGE:
The recommended minimum
dose is 2.7 mg selamectin per pound (6 mg/kg) of body weight.
Administer the entire
contents of a single dose tube (or two tubes used in combination for dogs
weighing over 130 pounds) of Revolution topically in accordance with the
following tables. (see ADMINISTRATION for the recommended treatment
intervals).
|
Cats
(lb) |
Package color |
mg
per tube |
Potency
(mg/mL) |
Administered volume (mL) |
|
Up to 5 |
Mauve |
15 mg |
60 |
0.25 |
|
5.1-15 |
Blue |
45 mg |
60 |
0.75 |
For cats over 15 lbs use the
appropriate combination of tubes.
|
Dogs
(lb) |
Package color |
mg
per tube |
Potency
(mg/mL) |
Administered volume (mL) |
|
Up to 5 |
Mauve |
15 mg |
60 |
0.25 |
|
5.1-10 |
Purple |
30 mg |
120 |
0.25 |
|
10.1-20 |
Brown |
60 mg |
120 |
0.5 |
|
20.1-40 |
Red |
120 mg |
120 |
1.0 |
|
40.1-85 |
Teal |
240 mg |
120 |
2.0 |
|
85.1-130 |
Plum |
360 mg |
120 |
3.0 |
For dogs over 130 lbs use the
appropriate combination of tubes.
Recommended for use in dogs 6
weeks of age and older and in cats 8 weeks of age and older.
ADMINISTRATION:
A veterinarian or veterinary
technician should demonstrate or instruct the pet owner regarding the
appropriate technique for applying Revolution topically to dogs and cats
prior to first use.
Firmly press the cap down to
puncture the seal on the Revolution 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
onto 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 haircoat is wet. Bathing or shampooing the animal 2 or more hours
after treatment will not reduce the effectiveness of Revolution. Stiff hair,
clumping of hair, hair discoloration, or a slight powdery residue may be
observed at the treatment site in some animals. These effects are temporary
and do not affect the safety or effectiveness of the product. Discard empty
tubes in your ordinary household refuse.
Flea Control
in Dogs and Cats
For the prevention and control
of flea infestations, Revolution should be administered at monthly intervals
throughout the flea season, starting one month before fleas become active.
In controlled laboratory studies >98% of fleas were killed within 36 hours.
Results of clinical field studies using Revolution monthly demonstrated >90%
control of flea infestations within 30 days of the first dose. Dogs and cats
treated with Revolution, including those with pre-existing flea allergy
dermatitis, showed improvement in clinical signs associated with fleas as a
direct result of eliminating the fleas from the animals and their
environment.
If the dog or cat is already
infested with fleas when the first dose of Revolution is administered, adult
fleas on the animal are killed and no viable fleas hatch from eggs after the
first administration. However, an environmental infestation of fleas may
persist for a short time after beginning treatment with Revolution because
of the emergence of adult fleas from pupae.
Heartworm
Prevention in Dogs and Cats
For the prevention of
heartworm disease, Revolution must be administered on a monthly basis.
Revolution may 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 and resumption of monthly dosing will minimize the opportunity
for the development of adult heartworms. When replacing another heartworm
preventive product in a heartworm disease prevention program, the first dose
of Revolution must be given within a month of the last dose of the former
medication.
Selamectin, the active
ingredient in Revolution, is a macrocyclic lactone compound. These compounds
effectively prevent the development of adult heartworms when administered to
dogs and cats within one month of exposure to infective (L3)
Dirofilaria immitis larvae. Efficacy of macrocyclic
lactones decreases below 100% in dogs, however, if first administered >2
months after exposure to infective larvae. Thus, in heartworm endemic
regions, delaying initiation of heartworm prevention using Revolution beyond
2 months of first exposure to infective larvae (e.g., starting puppies and
kittens at >8 weeks of age), or gaps of >2 months in the administration of
Revolution during periods of heartworm transmission, increases the risk of
the animal acquiring heartworms. Animals with unknown heartworm history that
test negative for heartworms prior to the initiation of Revolution may be
harboring pre-patent infections at the time Revolution was started. Testing
such animals 3-4 months after initiation of Revolution 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.
Cats already infected with adult heartworms can be given Revolution monthly
to prevent further infections.
Ear Mite
Treatment in Dogs and Cats
For the treatment of ear mite
(O. cynotis) infestations in dogs and cats,
Revolution should be administered once as a single topical dose. A second
monthly dose may be required in some dogs. Monthly use of Revolution will
control any subsequent ear mite infestations. In the clinical field trials
ears were not cleaned, and many animals still had debris in their ears after
the second dose. Cleansing of the infested ears is recommended to remove the
debris.
Sarcoptic
Mange Treatment in Dogs
For the treatment of sarcoptic
mange (S. scabiei) in dogs, Revolution should be
administered once as a single topical dose. A second monthly dose may be
required in some dogs. Monthly use of Revolution will control any subsequent
sarcoptic mange mite infestations. Because of the difficulty in finding
sarcoptic mange mites on skin scrapings, effectiveness assessments also were
based on resolution of clinical signs. Resolution of the pruritus associated
with the mite infestations was observed in approximately 50% of the dogs 30
days after the first treatment and in approximately 90% of the dogs 30 days
after the second monthly treatment.
Tick Control
in Dogs
For the control of tick
(Dermacentor variabilis) infestations in dogs,
Revolution should be administered on a monthly basis. In heavy tick
infestations, complete efficacy may not be achieved after the first dose. In
these cases, one additional dose may be administered two weeks after the
previous dose, with monthly dosing continued thereafter.
Nematode
Treatment in Cats
For the treatment of
intestinal hookworm (A. tubaeforme) and roundworm
(T. cati) infections, Revolution should be applied
once as a single topical dose.
SAFETY:
Revolution has been tested
safe in over 100 different pure and mixed breeds of healthy dogs and over 15
different pure and mixed breeds of healthy cats, including pregnant and
lactating females, breeding males and females, puppies six weeks of age and
older, kittens eight weeks of age and older, and avermectin-sensitive
collies. A kitten, estimated to be 5-6 weeks old (0.3 kg), died 81/2 hours
after receiving a single treatment of Revolution at the recommended dosage.
The kitten displayed clinical signs which included muscle spasms, salivation
and neurological signs. The kitten was a stray with an unknown history and
was malnourished and underweight (see WARNINGS).
DOGS: In safety studies,
Revolution was administered at 1, 3, 5, and 10 times the recommended dose to
six-week-old puppies, and no adverse reactions were observed. The safety of
Revolution administered orally also was tested in case of accidental oral
ingestion. Oral administration of Revolution at the recommended topical dose
in 5- to 8-month-old beagles did not cause any adverse reactions. In a
pre-clinical study selamectin was dosed orally to ivermectin-sensitive
collies. Oral administration of 2.5, 10, and 15 mg/kg in this dose
escalating study did not cause any adverse reactions; however, eight hours
after receiving 5 mg/kg orally, one avermectin-sensitive collie became
ataxic for several hours, but did not show any other adverse reactions after
receiving subsequent doses of 10 and 15 mg/kg orally. In a topical safety
study conducted with avermectin-sensitive collies at 1, 3 and 5 times the
recommended dose of Revolution, salivation was observed in all treatment
groups, including the vehicle control. Revolution also was administered at 3
times the recommended dose to heartworm infected dogs, and no adverse
effects were observed.
CATS: In safety studies,
Revolution was applied at 1, 3, 5, and 10 times the recommended dose to
six-week-old kittens. No adverse reactions were observed. The safety of
Revolution administered orally also was tested in case of accidental oral
ingestion. Oral administration of the recommended topical dose of Revolution
to cats caused salivation and intermittent vomiting. Revolution also was
applied at 4 times the recommended dose to patent heartworm infected cats,
and no adverse reactions were observed.
In well-controlled clinical
studies, Revolution was used safely in animals receiving other frequently
used veterinary products such as vaccines, anthelmintics, antiparasitics,
antibiotics, steroids, collars, shampoos and dips.
DESCRIPTION:
Revolution (selamectin)
Topical Parasiticide is available as a colorless to yellow, ready to use
solution in single dose tubes for topical (dermal) treatment of dogs six
weeks of age and older and cats 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. The chemical composition of selamectin is (5Z,
25S)-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-hydroxyiminoavermectin A1a.
STORAGE
CONDITIONS: Store below 30°C (86°F).
HOW SUPPLIED:
Available in seven separate dose strengths for dogs and cats of
different weights (see Dosage). Revolution for puppies and kittens is
available in cartons containing 3 single dose tubes. Revolution for cats and
dogs is available in cartons containing 3 or 6 single dose tubes.
CAUTION:
US Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
Manufacturer:
Pfizer Animal Health