Download The RIMADYL RewARDs PRogRAM

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Document related concepts
Transcript
The RIMADYL
Rewards Program:
Program Overview
• The program begins at initial diagnosis of osteoarthritis, when the veterinarian provides the dog
owner RIMADYL® (carprofen) for trial use as well as a coupon for a $10 rebate off their first purchase
- exclusively at the veterinary hospital.
• A s owners continue to take care of their dogs with RIMADYL, the #1 pain medication prescribed
by veterinarians,1 they’ll accumulate Reward Points based on the amount of RIMADYL purchased.
• These Reward Points translate into dollar amounts on a debit card they can spend exclusively at your
veterinary hospital to help pay for diagnostic tests, annual exams, additional RIMADYL, or any
other hospital expense.
• Includes reminders to dog owners to continue treatment and return to hospital.
• Addresses all components of compliance from recommendation to acceptance and follow through.
RIMADYL REWARDS PROGRAM:
We take care of the program administration so you can take care of your patients!
The RIMADYL® (carprofen) Rewards Program provides incentives and multiple opportunities to educate and
encourage dog owners to continue their use of RIMADYL as prescribed, and to return to the hospital for
follow-through over the long term.
3400
Suite
1750
3060 Peachtree
Peachtree Road
Road,NE,
Suite
2000
Atlanta,
Atlanta, GA
GA 30326
30305
RIMADYL
Kim Novick
81 Kirkwood Dr.
2ND Address line here
Newtown, PA 18940-1791
Coupon
Check
enclosed!
INITIATE: Recommendation > Receive > Rebate
BAR CODE AREA
October 2, 2008
Dear Kim Novick:
We’re so excited that you’ve joined the RimaDog™ Community — if we had tails we’d b
wagging them. Please find the enclosed RIMADYL® (carprofen) coupon check that you
Recommendation
Receive
Rebate
What to do now:
• Veterinarian diagnoses
dog with osteoarthritis
and recommends RIMADYL
• Dog owner accepts
veterinarian’s
recommendation
• Veterinarian provides
dog owner with RIMADYL
sample and coupon for
$10 rebate
• Dog owner registers at
rimadog.com
• Dog
owner
receives
letter
16 million
tail-waggers
can’t be wrong
encouraging them to
return to hospital along
with
One final$10
trick rebate check
made payable to hospital
requested. Be sure to visit the RimaDog Community regularly for other perks and incen
— Take the enclosed coupon check to the veterinary clinic listed on the check
— Receive an instant $10 savings toward your next RIMADYL purchase
— Turn your dog into a RimaDog with proper use of RIMADYL
— Continue talking to your veterinarian and checking back with the RimaDog
Community at Rimadyl.com for additional promotions and community benefits
1
We’re happy that you and your veterinarian decided to help get your pooch back to Rim
1
form with RIMADYL — the number one NSAID for pain relief . Be sure to continue usin
RIMADYL exactly as your doctor prescribes and take comfort in the fact that RIMADYL
helped over 16 million dogs manage pain.
Redeem the enclosed coupon check at your veterinarian’s clinic and you will automatic
receive an additional $5 savings towards your next RIMADYL purchase!
Sincerely,
The RIMADYL Team
1.
Market Dynamics Inc. (MDI), 2006
All brands are the property of Pfizer Inc., its affiliates, and/or its licensors. © 2009 Pfizer Inc. All rights reserved.
1750
2000
Suite
Suite
NE,
Road,
ree Road
Peacht 30305
3400 , GA 30326
3060
Atlanta
YL
RIMAD
Coupon
Checked!
enclos
BAR
RIM0907126
1750
Suite
2000
Suite
Road NE,
Peachtree Road,
3400
3060 Peachtree
GA 30326
30305
Atlanta,
Atlanta, GA
k
Novic
Kim
ood Dr. here
81 Kirkw ss line -1791
Addre
A
2ND wn, PA 18940
E ARE
Newto
COD
Kim Novick
Dr.
to
ns Kirkwood
81
RIMADYL
Rimadyl is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease),
as safety has not been established in dogs
with these disorders. The safe use of Rimadyl in animals less than 6 weeks of age, in pregnant dogs,
dogs used for breeding purposes, or in
lactating bitches has not been established. Safety has not been established for IV or IM administration.
Studies to determine the activity of Rimadyl
when administered concomitantly with other protein-bound or similarly metabolized drugs have not been
conducted. Drug compatibility should be
monitored closely in patients requiring additional therapy. Such drugs commonly used include cardiac,
anticonvulsant and behavioral medications.
It has been suggested that treatment with carprofen may reduce the level of inhalant anesthetics needed.15
It is suggested to use different sites for
additional injections. If additional pain medication is warranted after administration of the total daily dose
of Rimadyl,
here
reaso 2ND
Caplet/Chewable Tablets
atAddress line
Coupon
More
Stay
PA 18940-1791
Check anddyl.cNewtown,
om
For oral use in dogs only
alternative analgesia should
Sit
be considered. The use of another NSAID is not recommended.
Sterile AREA
Injectable Solution 50 mg/mL
and we
Due to the palatable nature of Rimadyl chewable tablets, store out of reach of dogs in a secured location.
For subcutaneous use in dogs only
Severe adverse reactions may occur if
ofen),
g enclosed!
BAR CODE
large quantities of tablets are ingested. If you suspect your dog has consumed Rimadyl chewable tablets
® (carpr
above the labeled dose, please call your
Non-steroidal, anti-inflammatory drug
excitin
veterinarian for immediate assistance and notify Pfizer Animal Health (1-800-366-5288).
DYL
some
INFORMATION FOR DOG OWNERS:
RIMA
made
Rimadyl, like other drugs of its class, is not free from adverse reactions. Owners should be advised of
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
with
the potential for adverse reactions and
be informed of the clinical signs associated with drug intolerance. Adverse reactions may include decreased
to a $10
m and
pain
DESCRIPTION: Rimadyl (carprofen) is a non-steroidal anti-inflammatory drug (NSAID) of the propionic
appetite, vomiting, diarrhea, dark
acid class that includes ibuprofen,
or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing
g you
naproxen, and ketoprofen. Carprofen is the nonproprietary designation for a substituted carbazole, 6-chloro-α-methyl-9H-carbazole-2-acetic
of gums, skin or white of the eye due to
dog’s
progra
jaundice, lethargy, incoordination, seizure, or behavioral changes.
acid.
The empirical formula is C15H12ClNO2 and the molecular weight 273.72. The chemical structure of carprofen
DYL
treatin
is shown above. Carprofen is a white,
ge your
Serious adverse reactions associated with this drug class can occur without warning and in rare situations
crystalline compound. It is freely soluble in ethanol, but practically insoluble in water at 25°C.
RIMA
s Rimadyl
result in death (see Adverse
mana
rt, we’re
Reactions). Owners should be advised to discontinue Rimadyl therapy and contact their veterinarian
2008
Injectable is a sterile solution containing carprofen. Each mL of Rimadyl Injectable contains 50.0 mg carprofen,
immediately if signs of intolerance are
k:
help
ped the
to
30.0 mg arginine, 88.5 mg
observed.
October 2,
glycocholic acid, 169.0 mg lecithin, 10.0 mg benzyl alcohol, 6.17 mg sodium hydroxide, with additional
Novic
promotion needed
reasons
ued suppo
sodium hydroxide and hydrochloric
revam
acid as
ued to
you.
More
The vast majority of patients with drug-related adverse reactions have recovered when the signs are recognized,
to adjust pH, and water for injection.
Kim
the drug is withdrawn, and veterinary
contin
contin
s like
We’ve
care, if at
tails we’d be
appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all dogs during
Product
Dear
DYL.
had
CLINICAL PHARMACOLOGY: Carprofen is a non-narcotic,
administration of any NSAID.
your
non-steroidal anti-inflammatory agent with characteristic analgesic and antipyretic your tail
— if we
owner
you’ve
RIMA
wag
WARNINGS: Keep out of reach of children. Not for human use. Consult a physician in cases of accidental
activity approximately equipotent to indomethacin
for you!
in animal models.
value
ingestion by humans. For use in dogs
Community
glad
Kim Novick:
only. Do not use in cats.
that you
ase of
news
ted dog
Dearing
The mechanism of action of carprofen, like that of other NSAIDs,
check
se we
RimaDog™
includ
is believed to be associated with the inhibition of cyclooxygenase activity. Two
We’re
coupon
purch
All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy.
good
ct
joined theh tipsunique cyclooxygenases
have been described
in mammals. The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for
® (carprofen)
Appropriate laboratory tests to establish
for dedica is in dogs
hematological and serum biochemical baseline data prior to, and periodically during, administration of
normal gastrointestinal
rs, becau your next
incentives.
that you’ve
and renal function. The inducible cyclooxygenase,
some
COX-2,
generates prostaglandins involved in inflammation. Inhibition
, produ
and
any NSAID should be considered. Owners
healt RIMADYL
ically
perks
should be advised to observe for signs of potential drug toxicity (see Information for Dog Owners, Adverse
of COX-1 is thought to be associated with gastrointestinal
starte
s
have
and renal toxicity while inhibition of COX-2 provides anti-inflammatory activity. The
arthrit
other
Reactions, Animal Safety and PostWe’re so excited
onials
forversus
theieenclosed
Approval Experience).
specificity of a particular
NSAID for COX-2
COX-1 may vary from species to species. In an in vitro study using canine cell cultures,
regularly
toward
Dogg
es. For
testim
the them.r Please find
ped specif ation about
carprofen demonstrated selective inhibition of COX-2 versus COX-1. Clinical relevance of these data
ADVERSE REACTIONS: During investigational studies for the caplet formulation with twice daily administration
Community
has not been shown. Carprofen has also
good
chang
have
of 1 mg/lb, no clinically significant
been shown to inhibit the release of several prostaglandins in two inflammatory cell systems: rat polymorphonuclear
owner
develo
adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which
leukocytes (PMN) and human
were similar for carprofen caplet- and
inform
even wagging
tips,
visit the RimaDog
rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system)
to registe
n check
unity
placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea
inflammatory reactions.
(4%), changes in appetite (3%), lethargy
Be sure to
s studies have demonstrated that carprofen has modulatory effects on both humoral and cellular immune
latest
health
(1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control.
coupo
Several
comm
er, you’ll so be sure
requested.
responses. Data also indicate
onial
es the
that carprofen inhibits the production of osteoclast-activating factor (OAF), PGE1, and PGE2 by its inhibitory
canine
There were no serious adverse events reported during clinical field studies with once daily administration
effect in prostaglandin biosynthesis.
d a new
a memb
of 2 mg/lb. The following categories of
DYL,
testim
provid
ines,
abnormal
health
Based upon comparison with data obtained from intravenous administration,
observations
r
were
reported. The product vehicle served as control.
check
carprofen is rapidly and nearly completely absorbed (more than 90%
create
you’re
unity
bioavailable) when administered orally. Peak blood plasma
of RIMA
Owne
concentrations are achieved in 1–3 hours after oral administration of 1, 5, and 25 mg/
also
listed on the
nt guidel
clinic
promotionsPercentage of Dogs with Abnormal Health Observations Reported in Clinical Field Study (2 mg/lb once daily)
kg to dogs. The mean terminal
Comm
half-life of carprofen is approximately 8 hours (range 4.5–9.8 hours) after single oral doses varying from
its. Once purchases
1–35 mg/kg
geme
We’ve
Product
veterinary
of body
weight. After a 100 mg single intravenous bolus dose, the mean elimination half-life was approximately
og™
Observation
11.7 hours in the dog. Rimadyl is
Rimadyl (n=129)
mana
Placebo (n=132)
more than 99% bound to plasma protein and exhibits
check to the
er benef
purchase
a very small volume of distribution.
RimaD
future
Inappetence
1.6
RIMADYL
The
1.5
Comparison of anext
single 25 mg
s on
dose in Beagle dogs after subcutaneous and oral administration demonstrated that the dorsoscapular
enclosed coupon
and pain nal memb
Vomiting
your results
subcutaneous
3.1
3.8
administration
mingwithin
in a slower rate of drug input (as reflected by mean peak observed concentrations) but comparable total
— Take the
saving
Diarrhea/Soft stool
r care
drug absorption
3.1
savings
4.5
a 12 hour dosing interval (as reflected by area under the curve from hours zero to 12 postdose).
Upcotoward
Behavior change
prope
s use ofin theRIMADYL
0.8
and additio additional
0.8
and other instant $10
Carprofen is eliminated
Dermatitis tips
dog primarily by biotransformation in the liver followed by rapid excretion of the resulting metabolites
0.8
st
tions
proper
0.8
Receive an
(the ester
—ry,
DYL
withevent
glucuronide of carprofen and the ether glucuronides ofRimaDog
PU/PD
2 phenolic metabolites, 7-hydroxy carprofen and 8-hydroxy carprofen) in the feces
0.8
Doggie health
–
promo
RimaDog
is, surge
(70–80%) and urine (10–20%). Some enterohepatic
SAP increase
to reque .
circulation of the drug is observed.
7.8
back with the
8.3
RimaDog and
But RIMA dog into a
ALT increase
tunity
benefits
checking
5.4
INDICATIONS:
Rimadyl is indicated for the relief of pain and inflammation
ly, arthrit nality.
4.5
associated with osteoarthritis and for the control of postoperative pain
— Turn your
yl.com
AST increase
oppor
2.3
associated with soft tissue and orthopedic
and community
surgeries in dogs.
0.8
unate
BUN increase
and regain
g to your veterinarian DOSAGE
3.1
promotions
1.5
its perso
at Rimad
AND ADMINISTRATION: Always provide Client Information Sheet with prescription. The recommended
talking
Bilirubinuria
dosage for oral administration
16.3
12.1
ge pain
s it. Unfort even
for additional
Continuerevivin
to dogs is!2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be administered as 2 mg/lb
today
Ketonuria
of body
14.7
s
and
9.1
mana — toward
administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of postoperative pain, administer approximately weight once daily or divided and
at Rimadyl.com
2 hours before the procedure.
1 dogs
ess,
and mean
Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical
Rimadyl tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be
Owner testimonial
judgement is necessary to determine clinical
halved by placing the tablet on a hard
And more
first stepCommunity
relevance.
surface and pressing down on both sides of the score. Rimadyl chewable tablets are palatable and willingly
his tail
consumed by most dogs when offered
joy, happin 16 million take the
to toRimaDog
by the owner. Therefore, they may be fed by hand or placed on food. Care should
wags
During investigational studies of surgical pain for the caplet formulation, no clinically significant adverse
be taken
back
ensure that the dog consumes the complete dose.
reactions were reported. The product
dog’s
over
who
vehicle served as control.
your topooch
The recommended dosage for subcutaneous
administration
get
dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may
you’ll
1
your
be administered as either 2to
a dog
mg/lbhelp
of body weight once daily or divided and administered asusing
Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with
decided
away
Caplets (2 mg/lb once daily)
has helpedCommunity,
postoperative
to continue 1 mg/lb (2.2 mg/kg) twice daily. For control of
pain, administer approximately12 hours before
og is
the procedure.
take
. Be sure
DYL
your veterinarian
relief
og
has
PALATABILITY: A controlled
Observation*
palatability
study was conducted which demonstrated that Rimadyl chewable
Rimadyl (n=148)
pain
A RimaD pain can
Placebo (n=149)
RIMA
Upcoming
that you and
consumed
on firstfor
offering by a majority of dogs.
that RIMADYL tablets were readily accepted and
NSAID
Vomiting
oneEFFECTIVENESS:
10.1
We’re happy
s of
In fact
the RimaD
13.4
in the fact
Diarrhea/Soft stool
Confirmation ofcomfort
the effectiveness of Rimadyl for the relief of pain and inflammation associated with osteoarthritis, and
6.1
— the number
cause
6.0
for the
l pain.
events
control of postoperative
joining
Ocular disease
pain associated with soft tissue and orthopedic surgeries, was demonstrated in 7 placebo-controlled,
and take
2.7
masked studies RimaDog
0
og.
examining the anti-inflammatory and analgesic effectiveness of Rimadyl caplets in various breeds of
prescribes
contro
Inappetence
form with RIMADYL
1.4
les. By
dogs.
0
your doctor
Dermatitis/Skin lesion
RimaD
helps
2.0
Separate placebo-controlled, masked, multicenter field studies confirmed the anti-inflammatory and analgesic
lifesty
1.3
exactly as
effectiveness of Rimadyl caplets
Dysrhythmia
your
pain.
0.7
when dosed at 2 mg/lb once daily or when divided and administered at 1 mg/lb twice daily. In these 2
0
RIMADYL
active
field studies, dogs diagnosed with
Apnea
within
1.4
osteoarthritis showed statistically significant overall improvement based on lameness evaluations by
07126
dogs manage when
0
their
the veterinarian and owner observations
Oral/Periodontal disease
1.4
spirit
administered Rimadyl at labeled doses.
0
. RIM09 over 16 million
Pyrexia
0.7
helped
1.3
active
Based
upon the blood level comparison between subcutaneous and oral administration, Rimadyl effectiveness
reserved
Urinary tract disease
for osteoarthritis after
the
1.4
rights
1.3
dorsoscapular subcutaneous and oral administration should be similar, although there may be a slight
Wound more!
drainage
And
delay in the onset of relief after
automatically
1.4
Inc. All
0
subcutaneous injection.
and you will
Pfizer
clinic
* A single dog may have experienced more than one occurrence of an event.
Separate placebo-controlled, masked, multicenter
field studies confirmed the effectiveness of Rimadyl caplets for the control of postoperative pain
. © 2009
when
at 2 veterinarian’s
mg/lb once daily in various breeds of dogs. In these studies, dogs presented for ovariohysterectomy,
During investigational studies for the chewable tablet formulation, gastrointestinal signs were observed
your
rely,
at dosed
cruciate repair and aural
in some dogs. These signs included
checksurgeries
its licensors
purchase!
were administered Rimadyl preoperatively and
vomiting and soft stools.
for a maximum of 3 days (soft tissue) or 4 days (orthopedic) postoperatively. In general,
Since
your significant
RIMADYL
and/or
YL Team
dogs administered Rimadyl
2006
hstatistically
showed
reduction in pain scores compared to controls.
enclosed coupon
There were no serious adverse events reported during clinical field studies for the injectable formulation.
your next
The following categories of abnormal
throug
ANIMAL SAFETY STUDIES:
towards
Redeem the
Laboratory studies in unanesthetized dogs and clinical field studies have demonstrated that Rimadyl
its affiliates,
health observations were reported. The product vehicle served as control.
is
ea,
well
The RIMAD ics Inc. (MDI),
savings
Inc.,
tolerated in
dogs after oral administration.
iption
Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Studies with the
diarrh
additional $5
of Pfizer
Dynam
Injectable
In target animal safety studies,
Rimadyl was administered
orally to healthy Beagle dogs at 1, 3, and 5 mg/lb twice daily (1, 3 and 5 times the
receive an
g and,
by prescr
ngdailyand
recommended total
dose) for 42 consecutive days with no significant adverse reactions. Serum albumin for a single female
1. Market are the property
Observation*
receiving 5
Rimadyl (n=168)
warnin
Placebo (n=163)
lt returned to the pre-treatment value (2.6 g/dL) after 4 weeks ofdog
mg/lbvomiti
twice daily decreased to 2.1 tg/dL
ble only loss,
after 2 weeks of treatment,
treatment, and
Vomiting
was 2.3 g/dL at the final
All brands
10.1
6-week evaluation. Over the
consu
withou
6-week treatment period, black or bloody stools were observed in 1 dog (1 incident) treated
availa
9.2
ite with
Diarrhea/soft stool
and treated
1 mg/lb
twice daily and in 1 dog (2yincidents)
2.4
with 3 mg/lb twice daily. Redness of the colonic mucosa was observed in 1 male that
occur
3.7
ation
Dermatitis
received 3 mg/lb twice daily.
e appet
0.6
may
1.2
medic
Sincerely,
Dysrhythmia
yl10therap
0.6
includ
0.6
Two of 8 dogs receiving
mg/lb orally twice daily (10 times the recommended total daily dose) for 14 days exhibited hypoalbuminemia.
atory
effects albumin
Swelling
The mean
may
RIM0907126
0
Team
Rimad
1.2
level in the dogs receiving this dose was lower (2.38 g/dL) than each
side
of 2 placebo control groups (2.88 and 2.93 g/dL, respectively). Three
Dehiscence
flamm The RIMADYL
rights reserved.
1.2
ance
All of
tinue
0
incidents of black or bloody stool were observed
in 1Inc.
dog. Five
8 dogs exhibited reddened areas of duodenal mucosa on gross pathologic
Pfizer
WBC increase
these
13.7
© 2009
6.7
Histologic exam of these
al anti-in
areas revealed no evidence of ulceration, but did show minimal congestion of the lamina propria in 2 of
discon 5examination.
yl intoler Some of Inc. (MDI), 2006
the
and/or its licensors.
dogs.
teroid
* A single dog may have experienced more than one occurrence of an event.
ation.
its affiliates,
s. Dynamics ofoccur,
Rimad 1. Market
In separate safety studies lasting 13 and 52 weeks, respectively, dogs were administered orally up to
signs Pfizer Inc.,inform total
a non-s signs of
Post-Approval Experience:
11.4 mg/lb/day (5.7 times the recommended
are the property
daily dose of 2 mg/lb) of carprofen. In both studies, the drug was well tolerated clinically by all of the
or kidney
yl is
,
Although not all adverse reactions are reported, the following adverse reactions are based on voluntary
animals. No gross or histologic
All brands
662
post-approval adverse drug experience
liver
changes were seen in any of the treated animals. In both studies,
. If these prescribing
ations
Rimad
reporting. The categories of adverse reactions are listed by body system.
00084 dogs receiving the highest doses had average increases in serum L-alanine
aminotransferase (ALT) of approximately 20 IU.
full
Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal
medic
ation:
ive tract, even death
ulceration, gastrointestinal bleeding,
In the 52-week study, minor dermatologic changes occurred in dogs in each of the treatment groups
pancreatitis.
-class
but not in the control dogs. The changes were
digest
n of the
Inform
on or
described as slight redness or rash and were diagnosed as66-21
Hepatic: Inappetence, vomiting, jaundice,your
acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia,
non-specific dermatitis. The possibility exists that these mild lesions were treatment
NSAID
ing the
related, but no dose relationship was observed.
bilirubinuria, hypoalbuminemia.
through
alizati
Safety
Approximately one-fourth of hepatic reports were in Labrador Retrievers.
rs” sectio
530
other
Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation.
tant
involv
hospit
by prescription
Clinical field studies were conducted with 549 dogs of different breeds at the recommended oral doses
Owne
only
for 14 days (297 dogs were included
Urinary: Hematuria, polyuria, polydipsia,
in
urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities
Impor
ng in
As with
a study evaluating 1 mg/lb twice daily and 252 dogs were included in a separate study evaluating 2 mg/lb
effects
available
and diarrhea,
once daily). In
both studies the drug
including
for Dog
acute tubular necrosis,
renal tubular acidosis, glucosuria.
was clinically well tolerated and the incidence of clinical adverse reactions for Rimadyl-treated
vomiting
arian.
tory medication
animals was no higher than placebo-treated
te side
loss,
s, resulti
Behavioral: Sedation, lethargy, hyperactivity, restlessness,
ation
and,
aggressiveness.
animals (placebo contained inactive ingredients found in Rimadyl). For animals receiving 1 mg/lb twice
appetite
veterin
daily, the mean
anti-inflamma
post-treatment
indica
serum
Hematologic: Immune-mediated hemolytic
anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis.
include
ALT values were 11 IU greater and 9 IU less than pre-treatment
without warning
may
values for dogs receiving Rimadyl and placebo,
be seriou rtant Inform
respectively. Differences were not
Dermatologic:
occur
non-steroidal
Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis,
could
a animals
statistically significant.
is For
may
receiving 2 mg/lb once daily, the mean post-treatment
intolerance
ventral ecchymosis.
serum ALT values were 4.5 IU greater and 0.9 IU effects
In rare situations, injection site reactionsand
consult
Rimadyl
including
necrosis, abscess and seroma formation, and granulomas have been reported with the
than
pre-treatment values for dogs receiving Rimadyl and placebo,
which
side less
ons may the “Impo
of Rimadyl
respectively. In the latter study, 3 Rimadyl-treated
dogs developed a 3-fold or
injectable formulation. therapy
signs
of these
2008 greater
increase in (ALT) and/or (AST) during the
ZERO
course of therapy. One placebo-treated
situati
dog hadSome
Rimadyl
a greater than 2-fold increase in ALT. None of
Safety Information:
Immunologic
See
or hypersensitivity: Facial swelling, hives, erythema.
ZERO
medications,
these animals showed
clinical signs associated with laboratory
or kidneys.
value changes.
Changes in the clinical laboratory values (hematology and
Important
ber 2, NSAID-class
PERIOD
in rare
clinical
In rare situations, death has been associated with some of the adverse reactions listed above.
liver
arian.
chemistry) were not considered clinically significant.
occur, discontinue
tract,
ZERO
The 1 mg/lb twice daily course of therapy was repeated as
signs
needed at 2-week intervals in 244
Octo
To report a suspected adverse reaction call 1-800-366-5288.
ONE
digestive
dogs, some for as long as
As with other
5 years.
veterin
the
DOLLAR
2000
death. If these
involving
STORAGE: Store tablets at controlled room temperature 15°–30°C (59°–86°F). Store injectable under refrigeration
veterinarian.
information.
your
Clinical
or even
field studies were conducted in 297 dogs of different
nbreeds
2°–8°C (36°–46°F). Once
effects
l Health Suite
undergoing orthopedic or soft-tissue surgery.prescribing
broached, product may be stored at temperatures up to 25°C (77°F) for 28 days.
full Dogs were administered
2 mg/lb of Rimadyl two hours
prior
to surgery then once daily, as needed for 2 days (soft tissueof
hospitalizatio
the
indicate side
Animaree Road,
surgery)
in
or 3 days (orthopedic surgery). Rimadyl was
could
well tolerated
HOW SUPPLIED: Rimadyl caplets and chewable tablets are scored, and contain 25 mg, 75 mg, or 100 mg
when used in conjunction with a variety of anesthetic-related drugs.
resulting
which
The type and severity of abnormal health observation in RimadylPfizer
of carprofen per caplet or tablet. Each
Owners” section
and placebo-treated animals were approximately
caplet size is packaged in bottles containing 30, 60, or 180 caplets, or blister paks containing 4 caplets.
e
Peacht
Each chewable tablet size is packaged in
for Dog
may be serious,
was vomiting and was observed at approximately
bottles containing 7, 30, 60, or 180 tablets. Rimadyl
3060 , GA 30305
the same frequency in Rimadyl- and placebo-treated animals. Changes in clinicopathologic
Injectable is supplied in 20-mL, amber, glass, sterile, multi-dose vials.
00084662
Information
in rare situations
indices of hematopoetic,
renal, hepatic, and clotting function were not clinically significant. The mean post-treatment serum ALT
REFERENCES:
values were 7.3 IU
Atlanta
and 2.5 IU less than pre-treatment values for dogs receiving Rimadyl and placebo,
See the “Important
2, 2009
respectively. The mean post-treatment AST values were 3.1 IU
1. Baruth H, et al: In Anti-Inflammatory and Anti-Rheumatic Drugs, Vol. II, Newer Anti-Inflammatory Drugs,
ry2006
Rainsford KD, ed. CRC Press, Boca Raton, p. 33, 1986.
66-21
less for dogs receiving
Rimadyl and 0.2 IU greater
1Market
Dynamics
for dogs
receiving placebo.
Inc.
(MDI),
2. Vane JR, Botting RM: Mechanism of action of anti-inflammatory drugs. Scand J Rheumatol 25:102,
qual and few in number (see Adverse Reactions). The most frequent abnormal
your veterinarian.
pp. 9–21, 1996.
Janua
health observation
*****
Clinical field studies on the use of Rimadyl Injectable
3. Grossman CJ, Wiseman J, Lucas FS, et al: Inhibition of constitutive and inducible cyclooxygenase
d bywere conducted on 331 dogs undergoing orthopedic or soft tissue surgery. Dogs were
activity in human platelets and mononuclear cells by NSAIDs and COX530
administered 2 mg/lb of Rimadyl subcutaneously two hours prior to surgery and once daily thereafter,
ital
2 inhibitors. Inflammation Research 44:253–257, 1995.
as needed, for 2 days (soft tissue surgery) or
cashe
3 days (orthopedic surgery).be
4. Ricketts AP, Lundy KM, Seibel SB: Evaluation of selective inhibition of canine cyclooxygenase 1 and
Rimadyl was well tolerated when used in conjunction with a variety of anesthetic-related drugs. The
**********
2 by carprofen and other nonsteroidal anti-inflammatory drugs. Am J
type and severity
al Hosp
Health
of abnormal health
Vet Res 59:11, pp. 1441–1446, November 1998.
observations
in Rimadyl- and placebo-treated animals were approximately equal and few in number (see Adverse
must
Animal
Reactions).
2000
The most frequent
5. Ceuppens JL, et al: Non-steroidal anti-inflammatory agents inhibit the synthesis of IgM rheumatoid
Pfizer
Anim
abnormal health observation
was vomiting and was observed at approximately the same frequency in Rimadylfactor in vitro. Lancet 1:528, 1982.
2,and2008
check Changes
Road, Suite
TS *****
placebotreated animals.
6. Ceuppens JL, et al: Endogenous prostaglandin E2 enhances polyclonal immunoglobulin production
in clinicopathologic indices of hematopoetic, renal, hepatic, and clotting function
October
Peachtree
by ionically inhibiting T suppressor cell activity. Cell Immunol 70:41, 1982.
This
were not clinically significant. The
y Land
3060
CEN
mean post-treatment serum ALT values were 8.4 IU and 7.0 IU less
7. Schleimer RP, et al: The effects of prostaglandin synthesis inhibition
Rima
er 2,
Octob
2008
Rimadyl.com
1
2
3
4
1
5–9
1
What to do now:
Your dog
deserves
RimaDog
to be a
10
rs can’t be wrong
16 million tail-wagge
Important Safety Information: Rimadyl is a non-steroidal anti-inflammatory medicatio
veterinarian. As with other NSAID-class medications, signs of Rimadyl intolerance may
One final trick
which could indicate side effects involving the digestive tract, liver or kidneys. Some of
. 00
$10
in rare situations may be serious,
resulting in hospitalization or even death. If these sign
your veterinarian. See the “Important Information
for Dog Owners” section of the full pre
$10 . 00
Happ
**********
TEN
**********
Fido
AND
00
k
Novic
Kim
od Dr
-1791
18940
81 Kirkwo
wn PA
Newto
than pre-treatment values for dogs receiving Rimadyl and placebo, respectively.
30305
The mean post-treatment
Atlanta, GA AST values were 1.5 IU and 0.7 IU greater for dogs receiving Rimadyl and placebo, respectively.
CONTRAINDICATIONS: Rimadyl should not be used in dogs exhibiting previous hypersensitivity to carprofen.
PRECAUTIONS: As a class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal,
renal and hepatic toxicity. Effects may
result from decreased prostaglandin production and inhibition of the enzyme cyclooxygenase which is
responsible for the formation of prostaglandins from arachidonic acid.11–14 When NSAIDs inhibit prostaglandins that cause inflammation they
may also inhibit those prostaglandins
which maintain normal homeostatic function.
These anti-prostaglandin effects may result in clinically significant disease in patients with
underlying or pre-existing disease
more often than in healthy patients. NSAID therapy could unmask occult disease which has previously
Hospital
been
undiagnosedAnimal
due to the absence of apparent clinical signs. Patients with underlying renal disease for example, may
experience exacerbation or
decompensation of their renal disease while on NSAID therapy.
Happy Land
The use of parenteral fluids during
surgery should be considered to reduce the
*********
potential risk of renal complications when using NSAIDs perioperatively.
12,14
11–14
TEN AND
00 CENTS
***********
Carprofen is an NSAID, and as with others in that class, adverse reactions may occur with its use. The
most frequently reported effects have been
gastrointestinal signs. Events involving suspected renal, hematologic, neurologic, dermatologic, and hepatic
effects have also been reported.
Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy,
or those with renal, cardiovascular, and/or
hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be approached
cautiously, with appropriate monitoring.
Since many NSAIDs possess the potential to induce gastrointestinal ulceration, concomitant use of Rimadyl
with
such as corticosteroids and NSAIDs, should be avoided or very closely monitored. Sensitivity to drug-associated other anti-inflammatory drugs,
the individual patient. For example, Rimadyl treatment was not associated with renal toxicity or gastrointestinal adverse reactions varies with
ulceration in well-controlled safety
studies of up to ten times the dose in dogs. As with any parenterally injected product, good hygienic procedures
should be used when administering
Rimadyl Injectable.
********************
This check
Kim Novick
Dr
81 Kirkwood
18940-1791
Newtown PA
on the immune response. Immunopharmacology 3:205, 1981.
8. Leung KH, et al: Modulation of the development of cell mediated immunity: Possible roles of the products
of cyclooxygenase and lipoxygenase pathways of arachidonic
acid metabolism. Int J Immunopharmacology 4:195, 1982.
9. Veit BC: Immunoregulatory activity of cultured-induced suppressor macrophages.
ZERO
Cell Immunol 72:14, 1982.
PERIOD ZERO
10. Schmitt M, et al: Biopharmaceutical evaluation
ZERO
of carprofen
following single intravenous, oral, and rectal doses in dogs. Biopharm Drug Dispos 11(7):585, 1990.
DOLLAR ONE
11. Kore AM: Toxicology of nonsteriodal
anti-inflammatory drugs. Veterinary Clinics of North America, Small Animal Practice 20, March 1990.
12. Binns SH: Pathogenesis and pathophysiology of ischemic injury in cases of acute renal failure. Compend
for Cont Ed 16:1, January 1994.
13. Boothe DM: Prostaglandins: Physiology and clinical implications. Compend for Cont Ed 6:11, November
1984.
14. Rubin SI: Nonsteroidal anti-inflammatory drugs, prostaglandins, and the kidney. JAVMA 188:9, May
1986.
15. Ko CH, Lange DN, Mandsager RE, et al: Effects of butorphanol and carprofen on the minimal alveolar
concentration of isoflurane in dogs. JAVMA 217:1025–1028, 2000.
For a copy of the Material Safety Data Sheet (MSDS) call 1-800-733-5500. To report adverse reactions
call Pfizer Animal Health at 1-800-366-5288.
NADA #141-053, NADA #141-111, NADA #141-199 Approved by FDA.
2, 2009
Injectable Manufactured by: Vericore Limited, Dundee, United Kingdom
must be cashed
by January
Distributed by:
Exton, PA 19341, USA
Div. of Pfizer Inc
NY, NY 10017
August 2006
Printed in USA
Fido
Pfizer Animal Health
3060 Peachtree Road, Suite 2000
Atlanta, GA 30305
Octobe
Happy Land Animal Hospital
3 Key Components of Compliance: 2
• Recommendation
• Acceptance
• Follow-Through
Important Safety Information:
******************** TEN AND 00 CENTS ********************
Fido
Kim Novick
81 Kirkwood Dr
Newtown PA 18940-1791
As with other NSAIDs, rare but serious side effects involving the digestive system, kidneys, or liver may occur. Regular
monitoring is required for pets on medication. Pet owners should be advised to discontinue RIMADYL therapy if side
effects occur and to contact their veterinarian. Refer to the full prescribing information for complete details.
1. VetInsight Analytics, September, 2010.
2. 2009 AAHA Compliance Follow-up Study.
Here’s how it works
CONTINUE: Return > Refill > Reward > Remind
Return
• Dog returns to the hospital for evaluation
and dog owner purchases RIMADYL
Remind
Dog owner receives email reminders and
may download a mobile app:
• Reminders to return to hospital for
follow-ups
• Reminders to give their dog their doses
• Refill prescriptions
• Manage their Rewards
AT&T
Refill
12:34 PM
• Dog owner submits proof of RIMADYL
purchase at rimadog.com and begins
accumulating Rewards Points
• Dog owner continues to administer
RIMADYL as instructed by veterinarian
• Dog owner continues to upload RIMADYL
proofs-of-purchase—mobile app
available for uploading proofs-of-purchase
• Reward Points translate to dollars earned
• Each point is approximately 10 cents
per point-visit rimadog.com for exact
points value
Reward
• Dog owner accumulates a
minimum of 200 points
• Receives Debit Card (Rewards
Card) with dollars earned
• More purchases = more
rewards loaded on card
3060 Peachtree Road, Suite 2000
Atlanta, GA 30305
Sample Pet Owner
1234 Any Street
Apartment ABC
Somewhere, USA 12345
A Rewards539094
Pro 0000000000
that Offsets thegram
Your Dog’s Car Costs of
e
GOOD THRU 08/13
J. SMITH
HAPPYLAND PET HOSPITAL
Program Rule
s
The RIMADY
L Rewards
RIMADYL REWAR
Program is
with your
a rewarding
veterinarian
DS PROGR
• Limit one
way to partner
AM:
to ensure
your dog.
(1) Reward
the health
It’s also a
s Card per
and well-be
great way
made after
household.
ing of
long-term
to help you
September
Offer valid
care your
offset the costs
1
30, 2011 or
for purchas
• Invoice
dog needs.
We’re glad you’re using RIMADYL® (carprofen), the #1 pain medication
prescribed by veterinarians
, for
to help manage
the is
from date
es
required to
the
of registra
inflammation and pain associated with your dog’s
arthritic joints. To show our appreciation we’ve enclosed a $10 •reward
good validate proof of
tion.
Invoice card
What
must include
purchase.
does healthy
the followin
rewards mean?
towards your next purchase of RIMADYL.
• Purchas
g information:
your Reward
e of RIMADY
It means that
s points towards
L chewable
you can use
• Dog’s name
tablets or caplets
clinic includin
ANY expens
g diagnostics
e at your veterina
• Customer’s
and annual
ry
name
exams.
Dear Valued Customer
Introducing healthy rewards for you and your dog!
• Veterinary
clinic
name or authoriz
DOLLA
The RIMADYL Rewards Program is uniquely EARN
designed
to benefit
your dog’s health while helping you provide long term
care.
• MG and
RS WITH
ed home delivery
sizes of bottle
YOUR LOVIN
As you continu
company name
purchased
As you continue to care for your dog with RIMADYL,
you’ll ebe
to accumulate
reward points that translate into
dollar amounts.
G CARE.
• Receipts
to eligible
(i.e., 25mg,
care for your
will not be
medica
30 tablets)
dog earned dollars. See the enclosed brochure for
tionyour
As you continue to earn points, we continue to
reload
Rewards Card
with
prescri
unauthorizedmore accepted from online
bed by veterina with RIMADYL, the #1
pharmacies
reward
home delivery
pain
rians,
information on the exciting RIMADYL Rewards
Program
sign your
dog up
at www.rimadog.com.
pointsand
or
• Invoice may
you’ll accumu
companies.
based
on the amoun
be sent via
late
These reward
t of RIMADY
mail, fax, or
• All proofs
points transla
L you purchas
by uploadi
of purchas
spend exclusi
te into dollar
ng a photo
e must be
e.
amounts you
purchase.
online.
vely at your
submitted
veterinary
within 1 (one)
can
diagnostic
clinic to offset
tests, annual
• Minimum
year of
of 200 points
the cost for
exams, addition
The RimaDog™ Community is your officialother
online
companion,
thealwell
being
of dogs everywhere.
That’s why
we’re per
clinic
expense. helping ensure
of initial
RIMADY
proof of purchas dog must be approve
L or any friends. Together,
thrilled to have the support of members like you who only want the best for their furry, four-legged
we’re reviving
thee submis
d within 1
the first
(one) year
sion for Reward
time. After
spirit inside every RimaDog!
that, points
s Card to be
valid proof
will be loaded
loaded
of purchas
to the card
e provided.
• Purchases
with each
for multiple
Sincerely,
dogs cannot
point require
be combin
ments. Maximu
ed to meet
• Rebate amount
m 3,360 points
minimum
per dog per
The RIMADYL Team
must be redeem
year.
Rewards Card
ed within 1
load or by
Pfizer Animal Health
(one) year
card expirati
of last
in that time
on date. Dollars
are forfeited
.
not redeem
• Users
ed
monitor or any
P.S. You can use your RIMADYL Rewards Card to offset the costs for diagnostic testing, annual exams, additionalcan
RIMADYL
balance inquirie and track progress
of proof of
other expense exclusively at your veterinary clinic.
s and more
purchase approva
by logging
on www.ri
madog.com.
in to their MY
ls,
ACCOUNT
profile
1. VetInsight Analytics, September, 2010.
Limit up to
5 dogs per
household.
Program
IMPORTANT SAFETY INFORMATION: RIMADYL is a non-steroidal anti-inflammatory medication available
only by
canprescription
change at through
any time without
your veterinarian. As with other NSAID-class medications, signs of RIMADYL intolerance may include appetite loss, vomiting and
notice. U.S.
Residents
diarrhea, which could indicate side effects involving the digestive tract, liver or kidneys. Some of these side effects may occur without
Only.
warning and, in rare situations may be serious, resulting in hospitalization or even death. If these signs occur, discontinue RIMADYL
RIMADYL
is a registered
therapy and consult your veterinarian. See the “Important Information for Dog Owners” section of the full
prescribing
information.
RIM091101
trademark
Your RimaDog Community
This card is issued by FNB Bank. Services are provided by FirstView Financial, LLC. Your Card funds are FDIC insured.
All brands are the property of Pfizer, Inc., its affiliates, and/or its licensors. © 2011 Pfizer Inc. All Rights Reserved.
RIM0511009A
9
of Pfizer Inc.
© 2011 Pfizer
Inc. All rights
reserved.
FVIBB02
RIMADYL Rew
ard
s Program:
Healthy Rew
ard
and Your Dog s for You
www.rimadog.
com
Pet owners receive the above items
Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Studies with the Injectable
Observation*
Vomiting
Diarrhea/soft stool
Dermatitis
Dysrhythmia
Swelling
Dehiscence
WBC increase
Caplets/Chewable Tablets
For oral use in dogs only
Sterile Injectable Solution 50 mg/mL
For subcutaneous use in dogs only
Non-steroidal, anti-inflammatory drug
Rimadyl (n=129)
1.6
3.1
3.1
0.8
0.8
0.8
7.8
5.4
2.3
3.1
16.3
14.7
Placebo (n=132)
1.5
3.8
4.5
0.8
0.8
–
8.3
4.5
0.8
1.5
12.1
9.1
Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgement is necessary to determine clinical relevance.
During investigational studies of surgical pain for the caplet formulation, no clinically significant adverse reactions were reported. The product
vehicle served as control.
Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Caplets (2 mg/lb once daily)
Observation*
Vomiting
Diarrhea/Soft stool
Ocular disease
Inappetence
Dermatitis/Skin lesion
Dysrhythmia
Apnea
Oral/Periodontal disease
Pyrexia
Urinary tract disease
Wound drainage
Rimadyl (n=148)
10.1
6.1
2.7
1.4
2.0
0.7
1.4
1.4
0.7
1.4
1.4
Placebo (n=149)
13.4
6.0
0
0
1.3
0
0
0
1.3
1.3
0
* A single dog may have experienced more than one occurrence of an event.
During investigational studies for the chewable tablet formulation, gastrointestinal signs were observed in some dogs. These signs included
vomiting and soft stools.
There were no serious adverse events reported during clinical field studies for the injectable formulation. The following categories of abnormal
health observations were reported. The product vehicle served as control.
Post-Approval Experience:
Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience
reporting. The categories of adverse reactions are listed by body system.
Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis.
Hepatic: Inappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia,
bilirubinuria, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers.
Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation.
Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities
including acute tubular necrosis, renal tubular acidosis, glucosuria.
Behavioral: Sedation, lethargy, hyperactivity, restlessness, aggressiveness.
Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis.
Dermatologic: Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis.
In rare situations, injection site reactions including necrosis, abscess and seroma formation, and granulomas have been reported with the
injectable formulation.
Immunologic or hypersensitivity: Facial swelling, hives, erythema.
In rare situations, death has been associated with some of the adverse reactions listed above.
To report a suspected adverse reaction call 1-800-366-5288.
DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk
of Rimadyl and other treatment options before deciding to use Rimadyl. Use the lowest effective dose for the shortest duration consistent with
individual response. The recommended dosage for oral administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose
may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For the control of
postoperative pain, administer approximately 2 hours before the procedure. Rimadyl tablets are scored and dosage should be calculated in halftablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. Rimadyl chewable
tablets are palatable and willingly consumed by most dogs when offered by the owner. Therefore, they may be fed by hand or placed on food. Care
should be taken to ensure that the dog consumes the complete dose.
The recommended dosage for subcutaneous administration to dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The total daily dose may be
administered as either 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb (2.2 mg/kg) twice daily. For control of postoperative
pain, administer approximately 2 hours before the procedure.
PALATABILITY: A controlled palatability study was conducted which demonstrated that Rimadyl chewable tablets were readily accepted and
consumed on first offering by a majority of dogs.
EFFECTIVENESS: Confirmation of the effectiveness of Rimadyl for the relief of pain and inflammation associated with osteoarthritis, and for the
control of postoperative pain associated with soft tissue and orthopedic surgeries, was demonstrated in 7 placebo-controlled, masked studies
examining the anti-inflammatory and analgesic effectiveness of Rimadyl caplets in various breeds of dogs.
Separate placebo-controlled, masked, multicenter field studies confirmed the anti-inflammatory and analgesic effectiveness of Rimadyl caplets
when dosed at 2 mg/lb once daily or when divided and administered at 1 mg/lb twice daily. In these 2 field studies, dogs diagnosed with
osteoarthritis showed statistically significant overall improvement based on lameness evaluations by the veterinarian and owner observations
when administered Rimadyl at labeled doses.
Based upon the blood level comparison between subcutaneous and oral administration, Rimadyl effectiveness for osteoarthritis after
dorsoscapular subcutaneous and oral administration should be similar, although there may be a slight delay in the onset of relief after
subcutaneous injection.
Separate placebo-controlled, masked, multicenter field studies confirmed the effectiveness of Rimadyl caplets for the control of postoperative pain
when dosed at 2 mg/lb once daily in various breeds of dogs. In these studies, dogs presented for ovariohysterectomy, cruciate repair and aural
surgeries were administered Rimadyl preoperatively and for a maximum of 3 days (soft tissue) or 4 days (orthopedic) postoperatively. In general,
dogs administered Rimadyl showed statistically significant reduction in pain scores compared to controls.
ANIMAL SAFETY STUDIES: Laboratory studies in unanesthetized dogs and clinical field studies have demonstrated that Rimadyl is well
tolerated in dogs after oral administration.
In target animal safety studies, Rimadyl was administered orally to healthy Beagle dogs at 1, 3, and 5 mg/lb twice daily (1, 3 and 5 times the
recommended total daily dose) for 42 consecutive days with no significant adverse reactions. Serum albumin for a single female dog receiving 5
mg/lb twice daily decreased to 2.1 g/dL after 2 weeks of treatment, returned to the pre-treatment value (2.6 g/dL) after 4 weeks of treatment, and
was 2.3 g/dL at the final 6-week evaluation. Over the 6-week treatment period, black or bloody stools were observed in 1 dog (1 incident) treated
with 1 mg/lb twice daily and in 1 dog (2 incidents) treated with 3 mg/lb twice daily. Redness of the colonic mucosa was observed in 1 male that
received 3 mg/lb twice daily.
Two of 8 dogs receiving 10 mg/lb orally twice daily (10 times the recommended total daily dose) for 14 days exhibited hypoalbuminemia. The mean
albumin level in the dogs receiving this dose was lower (2.38 g/dL) than each of 2 placebo control groups (2.88 and 2.93 g/dL, respectively). Three
incidents of black or bloody stool were observed in 1 dog. Five of 8 dogs exhibited reddened areas of duodenal mucosa on gross pathologic
examination. Histologic exam of these areas revealed no evidence of ulceration, but did show minimal congestion of the lamina propria in 2 of the
5 dogs.
In separate safety studies lasting 13 and 52 weeks, respectively, dogs were administered orally up to 11.4 mg/lb/day (5.7 times the recommended
total daily dose of 2 mg/lb) of carprofen. In both studies, the drug was well tolerated clinically by all of the animals. No gross or histologic
changes were seen in any of the treated animals. In both studies, dogs receiving the highest doses had average increases in serum L-alanine
aminotransferase (ALT) of approximately 20 IU.
In the 52-week study, minor dermatologic changes occurred in dogs in each of the treatment groups but not in the control dogs. The changes were
described as slight redness or rash and were diagnosed as non-specific dermatitis. The possibility exists that these mild lesions were treatment
related, but no dose relationship was observed.
Clinical field studies were conducted with 549 dogs of different breeds at the recommended oral doses for 14 days (297 dogs were included in
a study evaluating 1 mg/lb twice daily and 252 dogs were included in a separate study evaluating 2 mg/lb once daily). In both studies the drug
was clinically well tolerated and the incidence of clinical adverse reactions for Rimadyl-treated animals was no higher than placebo-treated
animals (placebo contained inactive ingredients found in Rimadyl). For animals receiving 1 mg/lb twice daily, the mean post-treatment serum
ALT values were 11 IU greater and 9 IU less than pre-treatment values for dogs receiving Rimadyl and placebo, respectively. Differences were not
statistically significant. For animals receiving 2 mg/lb once daily, the mean post-treatment serum ALT values were 4.5 IU greater and 0.9 IU less
than pre-treatment values for dogs receiving Rimadyl and placebo, respectively. In the latter study, 3 Rimadyl-treated dogs developed a 3-fold or
greater increase in (ALT) and/or (AST) during the course of therapy. One placebo-treated dog had a greater than 2-fold increase in ALT. None of
these animals showed clinical signs associated with laboratory value changes. Changes in the clinical laboratory values (hematology and clinical
chemistry) were not considered clinically significant. The 1 mg/lb twice daily course of therapy was repeated as needed at 2-week intervals in 244
dogs, some for as long as 5 years.
Clinical field studies were conducted in 297 dogs of different breeds undergoing orthopedic or soft-tissue surgery. Dogs were administered
2 mg/lb of Rimadyl 2 hours prior to surgery then once daily, as needed for 2 days (soft tissue surgery) or 3 days (orthopedic surgery). Rimadyl was
well tolerated when used in conjunction with a variety of anesthetic-related drugs. The type and severity of abnormal health observation in Rimadyland placebo-treated animals were approximately equal and few in number (see Adverse Reactions). The most frequent abnormal health observation
was vomiting and was observed at approximately the same frequency in Rimadyl- and placebo-treated animals. Changes in clinicopathologic indices
of hematopoetic, renal, hepatic, and clotting function were not clinically significant. The mean post-treatment serum ALT values were 7.3 IU and 2.5
IU less than pre-treatment values for dogs receiving Rimadyl and placebo, respectively. The mean post-treatment AST values were 3.1 IU less for
dogs receiving Rimadyl and 0.2 IU greater for dogs receiving placebo.
Clinical field studies on the use of Rimadyl Injectable were conducted on 331 dogs undergoing orthopedic or soft tissue surgery. Dogs were
administered 2 mg/lb of Rimadyl subcutaneously 2 hours prior to surgery and once daily thereafter, as needed, for 2 days (soft tissue surgery) or 3
days (orthopedic surgery). Rimadyl was well tolerated when used in conjunction with a variety of anesthetic-related drugs. The type and severity of
abnormal health observations in Rimadyl- and placebo-treated animals were approximately equal and few in number (see Adverse Reactions). The
TAKE TIME
most frequent abnormal health observation was vomiting and was observed at approximately
the same frequency in Rimadyl- and placebo-treated
animals. Changes in clinicopathologic indices of hematopoetic, renal, hepatic, and clotting function were not clinically significant. The mean posttreatment serum ALT values were 8.4 IU and 7.0 IU less than pre-treatment values for dogs receiving Rimadyl and placebo, respectively. The mean
post-treatment AST values were 1.5 IU and 0.7 IU greater for dogs receiving Rimadyl and placebo, respectively.
STORAGE: Store tablets at controlled room temperature 15°–30°C (59°–86°F). Store injectable under refrigeration 2°–8°C (36°–46°F). Once
broached, product may be stored at temperatures up to 25°C (77°F) for 28 days.
HOW SUPPLIED: Rimadyl caplets and chewable tablets are scored, and contain 25OBSERVE
mg, 75 mg,LABEL
or 100 mg of carprofen per caplet or tablet. Each
DIRECTIONS
caplet size is packaged in bottles containing 30, 60, or 180 caplets, or blister paks containing
4 caplets. Each chewable tablet size is packaged in
bottles containing 7, 30, 60, or 180 tablets. Rimadyl Injectable is supplied in 20-mL, amber, glass, sterile, multi-dose vials.
REFERENCES:
1. Baruth H, et al: In Anti-Inflammatory and Anti-Rheumatic Drugs, Vol. II, Newer Anti-Inflammatory Drugs, Rainsford KD, ed. CRC Press, Boca Raton, p. 33, 1986.
2. Vane JR, Botting RM: Mechanism of action of anti-inflammatory drugs. Scand J Rheumatol 25:102, pp. 9–21, 1996.
3. Grossman CJ, Wiseman J, Lucas FS, et al: Inhibition of constitutive and inducible cyclooxygenase activity in human platelets and mononuclear cells by NSAIDs and COX2 inhibitors. Inflammation Research 44:253–257, 1995.
4. Ricketts AP, Lundy KM, Seibel SB: Evaluation of selective inhibition of canine cyclooxygenase 1 and 2 by carprofen and other nonsteroidal anti-inflammatory drugs. Am J
Vet Res 59:11, pp. 1441–1446, November 1998.
5. Ceuppens JL, et al: Non-steroidal anti-inflammatory agents inhibit the synthesis of IgM rheumatoid factor in vitro. Lancet 1:528, 1982.
6. Ceuppens JL, et al: Endogenous prostaglandin E2 enhances polyclonal immunoglobulin production by ionically inhibiting T suppressor cell activity. Cell Immunol 70:41, 1982.
7. Schleimer RP, et al: The effects of prostaglandin synthesis inhibition on the immune response. Immunopharmacology 3:205, 1981.
8. Leung KH, et al: Modulation of the development of cell mediated immunity: Possible roles of the products of cyclooxygenase and lipoxygenase pathways of arachidonic
acid metabolism. Int J Immunopharmacology 4:195, 1982.
9. Veit BC: Immunoregulatory activity of cultured-induced suppressor macrophages. Cell Immunol 72:14, 1982.
10. Schmitt M, et al: Biopharmaceutical evaluation of carprofen following single intravenous, oral, and rectal doses in dogs. Biopharm Drug Dispos 11(7):585, 1990.
11. Kore AM: Toxicology of nonsteriodal anti-inflammatory drugs. Veterinary Clinics of North America, Small Animal Practice 20, March 1990.
12. Binns SH: Pathogenesis and pathophysiology of ischemic injury in cases of acute renal failure. Compend for Cont Ed 16:1, January 1994.
13. Boothe DM: Prostaglandins: Physiology and clinical implications. Compend for Cont Ed 6:11, November 1984.
14. Rubin SI: Nonsteroidal anti-inflammatory drugs, prostaglandins, and the kidney. JAVMA 188:9, May 1986.
15. Ko CH, Lange DN, Mandsager RE, et al: Effects of butorphanol and carprofen on the minimal alveolar concentration of isoflurane in dogs. JAVMA 217:1025–1028, 2000.
TAKE TIME —OBSERVE LABEL DIRECTIONS
For a copy of the Material Safety Data Sheet (MSDS) call 1-800-733-5500. To report adverse reactions call Pfizer Animal Health at 1-800-366-5288.
NADA #141-053, NADA #141-111, NADA #141-199 Approved by FDA.
Injectable Manufactured by: Vericore Limited, Dundee, United Kingdom
Made in India
Distributed by:
TAKE
TIME
Div. of Pfizer Inc
NY, NY 10017
All trademarks are the property of Zoetis, Inc. or its subsidiaries, affiliates and licensees. ©2013 Zoetis Inc. All rights reserved.
RIM1011021
Placebo (n=163)
9.2
3.7
1.2
0.6
1.2
0
6.7
* A single dog may have experienced more than one occurrence of an event.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION: Rimadyl (carprofen) is a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid class that includes ibuprofen,
naproxen, and ketoprofen. Carprofen is the nonproprietary designation for a substituted carbazole, 6-chloro-α-methyl-9H-carbazole-2-acetic acid.
The empirical formula is C15H12ClNO2 and the molecular weight 273.72. The chemical structure of carprofen is shown above. Carprofen is a white,
crystalline compound. It is freely soluble in ethanol, but practically insoluble in water at 25°C.
Rimadyl Injectable is a sterile solution containing carprofen. Each mL of Rimadyl Injectable contains 50.0 mg carprofen, 30.0 mg arginine, 88.5 mg
glycocholic acid, 169.0 mg lecithin, 10.0 mg benzyl alcohol, 6.17 mg sodium hydroxide, with additional sodium hydroxide and hydrochloric acid as
needed to adjust pH, and water for injection.
CLINICAL PHARMACOLOGY: Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and antipyretic
activity approximately equipotent to indomethacin in animal models.1
The mechanism of action of carprofen, like that of other NSAIDs, is believed to be associated with the inhibition of cyclooxygenase activity. Two
unique cyclooxygenases have been described in mammals.2 The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for
normal gastrointestinal and renal function. The inducible cyclooxygenase, COX-2, generates prostaglandins involved in inflammation. Inhibition
of COX-1 is thought to be associated with gastrointestinal and renal toxicity while inhibition of COX-2 provides anti-inflammatory activity. The
specificity of a particular NSAID for COX-2 versus COX-1 may vary from species to species.3 In an in vitro study using canine cell cultures,
carprofen demonstrated selective inhibition of COX-2 versus COX-1.4 Clinical relevance of these data has not been shown. Carprofen has also
been shown to inhibit the release of several prostaglandins in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human
rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system) inflammatory reactions.1
Several studies have demonstrated that carprofen has modulatory effects on both humoral and cellular immune responses.5–9 Data also indicate
that carprofen inhibits the production of osteoclast-activating factor (OAF), PGE1, and PGE2 by its inhibitory effect in prostaglandin biosynthesis.1
Based upon comparison with data obtained from intravenous administration, carprofen is rapidly and nearly completely absorbed (more than 90%
bioavailable) when administered orally.10 Peak blood plasma concentrations are achieved in 1–3 hours after oral administration of 1, 5, and 25 mg/
kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5–9.8 hours) after single oral doses varying from 1–35 mg/kg
of body weight. After a 100 mg single intravenous bolus dose, the mean elimination half-life was approximately 11.7 hours in the dog. Rimadyl is
more than 99% bound to plasma protein and exhibits a very small volume of distribution.
Comparison of a single 25 mg dose in Beagle dogs after subcutaneous and oral administration demonstrated that the dorsoscapular subcutaneous
administration results in a slower rate of drug input (as reflected by mean peak observed concentrations) but comparable total drug absorption
within a 12 hour dosing interval (as reflected by area under the curve from hours zero to 12 postdose).
Carprofen is eliminated in the dog primarily by biotransformation in the liver followed by rapid excretion of the resulting metabolites (the ester
glucuronide of carprofen and the ether glucuronides of 2 phenolic metabolites, 7-hydroxy carprofen and 8-hydroxy carprofen) in the feces
(70–80%) and urine (10–20%). Some enterohepatic circulation of the drug is observed.
INDICATIONS: Rimadyl is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain
associated with soft tissue and orthopedic surgeries in dogs.
CONTRAINDICATIONS: Rimadyl should not be used in dogs exhibiting previous hypersensitivity to carprofen.
WARNINGS: Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans. For use in dogs
only. Do not use in cats.
All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish
hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered. Owners
should be advised to observe for signs of potential drug toxicity (see Information for Dog Owners, Adverse Reactions, Animal Safety and PostApproval Experience).
PRECAUTIONS: As a class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Effects may
result from decreased prostaglandin production and inhibition of the enzyme cyclooxygenase which is responsible for the formation of prostaglandins from arachidonic acid.11–14 When NSAIDs inhibit prostaglandins that cause inflammation they may also inhibit those prostaglandins
which maintain normal homeostatic function. These anti-prostaglandin effects may result in clinically significant disease in patients with
underlying or pre-existing disease more often than in healthy patients.12,14 NSAID therapy could unmask occult disease which has previously been
undiagnosed due to the absence of apparent clinical signs. Patients with underlying renal disease for example, may experience exacerbation or
decompensation of their renal disease while on NSAID therapy.11–14 The use of parenteral fluids during surgery should be considered to reduce the
potential risk of renal complications when using NSAIDs perioperatively.
Carprofen is an NSAID, and as with others in that class, adverse reactions may occur with its use. The most frequently reported effects have been
gastrointestinal signs. Events involving suspected renal, hematologic, neurologic, dermatologic, and hepatic effects have also been reported.
Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with renal, cardiovascular, and/
or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be approached cautiously, with appropriate monitoring.
Concomitant use of Rimadyl with other anti-inflammatory drugs, such as other NSAIDs or corticosteroids, should be avoided because of the potential
increase of adverse reactions, including gastrointestinal ulcerations and/or perforations. Sensitivity to drug-associated adverse reactions varies with
the individual patient. Dogs that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Rimadyl
treatment was not associated with renal toxicity or gastrointestinal ulceration in well-controlled safety studies of up to 10 times the dose in healthy dogs.
As with any parenterally injected product, good hygienic procedures should be used when administering Rimadyl Injectable.
Rimadyl is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease), as safety has not been established in
dogs with these disorders. The safe use of Rimadyl in animals less than 6 weeks of age, in pregnant dogs, dogs used for breeding purposes, or
in lactating bitches has not been established. Safety has not been established for IV or IM administration. Studies to determine the activity of
Rimadyl when administered concomitantly with other protein-bound or similarly metabolized drugs have not been conducted. Drug compatibility
should be monitored closely in patients requiring additional therapy. Such drugs commonly used include cardiac, anticonvulsant and behavioral
medications. It has been suggested that treatment with carprofen may reduce the level of inhalant anesthetics needed.15 It is suggested to use
different sites for additional injections. If additional pain medication is warranted after administration of the total daily dose of Rimadyl, alternative
analgesia should be considered. The use of another NSAID is not recommended.
Due to the palatable nature of Rimadyl chewable tablets, store out of reach of dogs in a secured location. Severe adverse reactions may occur if
large quantities of tablets are ingested. If you suspect your dog has consumed Rimadyl chewable tablets above the labeled dose, please call your
veterinarian for immediate assistance and notify Pfizer Animal Health (1-800-366-5288).
INFORMATION FOR DOG OWNERS:
Rimadyl, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and
be informed of the clinical signs associated with drug intolerance. Adverse reactions may include decreased appetite, vomiting, diarrhea, dark
or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye due to
jaundice, lethargy, incoordination, seizure, or behavioral changes.
Serious adverse reactions associated with this drug class can occur without warning and in rare situations result in death (see Adverse Reactions).
Owners should be advised to discontinue Rimadyl therapy and contact their veterinarian immediately if signs of intolerance are observed.
The vast majority of patients with drug-related adverse reactions have recovered when the signs are recognized, the drug is withdrawn, and veterinary
care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all dogs during administration of any NSAID.
ADVERSE REACTIONS: During investigational studies for the caplet formulation with twice daily administration of 1 mg/lb, no clinically significant
adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen caplet- and
placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy
(1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control.
There were no serious adverse events reported during clinical field studies with once daily administration of 2 mg/lb. The following categories of
abnormal health observations were reported. The product vehicle served as control.
Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Study (2 mg/lb once daily)
Observation
Inappetence
Vomiting
Diarrhea/Soft stool
Behavior change
Dermatitis
PU/PD
SAP increase
ALT increase
AST increase
BUN increase
Bilirubinuria
Ketonuria
Rimadyl (n=168)
10.1
2.4
0.6
0.6
0
1.2
13.7
OBSERVE LABEL
DIRECTIONS
December 2007
Printed in USA