Description:
Revolution For Dogs 21-40 lbs, 6 Doses
REVOLUTION
Topical Parasiticide For Dogs and Cats
(selamectin)
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).
- Use in dogs 6 weeks of age or older against the following parasites:
adult fleas, flea eggs, heartworm, ear mites, sarcoptic mites, and
American dog tick
- Killing adult fleas and preventing flea eggs from hatching for one
month, and indicated for prevention and control of flea infestations (Ctenocephalides
felis)
- Prevention of heartworm disease caused by Dirofilaria immitis
- Treatment and control of ear mite (Otodectes cynotis)
infestations
- Treatment and control of sarcoptic mange (Sarcoptes scabiei)
- Control of tick (Dermacentor variabilis) infestations
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.
- Kills adult fleas (Ctenocephalides felis) and prevents flea eggs from
hatching
- Prevents heartworm disease caused by Dirofilaria immitis
- Treats and controls ear mites (Otodectes cynotis)
- Treats and controls roundworms (Toxocara cati) and hookworms (Ancylostoma
tubaeforme)
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.
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.
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
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