Rewards. - Rimadyl

Rewards.
UNLEASHED.
Rewards for you and your dog.
myrimadylrewards.com
UNLEASH
Why choose RIMADYL?
RIMADYL Rewards UNLEASHED
Healthy savings and a more active dog.
• RIMADYL was the first anti-inflammatory medication
for osteoarthritis approved for dogs in the
United States.
the rewards
The RIMADYL Rewards Program is a great way to
make both your dog and your wallet a lot happier.
With every RIMADYL (carprofen) purchase, you receive
RIMADYL points that act as cash and are good toward
any service or product your veterinary clinic has to
offer. That’s right, any service or product — whether it’s
an annual exam, more RIMADYL, or even blood work,
your RIMADYL Rewards Points will save you money,
while helping to keep your dog active.
What is RIMADYL?
RIMADYL is used to treat osteoarthritis in dogs. Did
you know that medications like aspirin can be toxic
to dogs and most often do not help? That is why we
developed RIMADYL.1,2
• RIMADYL is approved by the FDA for once- or
twice-daily dosing to help manage pain and
inflammation in joints.
• RIMADYL (carprofen) was developed just for your
dog to help improve your loved one’s mobility by
reducing joint pain and inflammation.
• Over 24 million dogs have been treated with
RIMADYL, making it the #1 OA medication
prescribed by veterinarians.3,4
Success Story
“ My dog Toby was in pain for 4 months, and we tried
a variety of medications. RIMADYL has allowed him
to be pain free for months now and get back to his
old self. Just wanted to say thank you for making a
product that basically saved his life and gave him the
quality of life he deserves.”
— Anna Roberts
IMPORTANT SAFETY INFORMATION: As a class,
NSAIDs may be associated with gastrointestinal,
kidney and liver side effects. These are usually
mild, but may be serious. Pet owners should
discontinue therapy and contact their veterinarian
immediately if side effects occur. Evaluation for
pre-existing conditions and regular monitoring are
recommended for pets on any medication, including
RIMADYL. Use with other NSAIDs or corticosteroids
should be avoided.
1. Kore, A M. Toxicology of nonsteroidal anti-inflammatory drugs. Veterinary Clinics of
North America: Small animal practice. 20:419-30; 1990. 2. Jones, R D; Baynes, R E;
Nimitz, C T. Nonsteroidal anti-inflammatory drug toxicosis in dogs and cats: 240 cases
(1989-1990).JAVMA, 201:475-7; 1992. 3. VetInsight Analytics, September 2013. 4. Data on
file. MDI market research, Zoetis Inc.
Make the switch to RIMADYL and
get FREE Rewards.
The RIMADYL Rewards Program
benefits you and your dog.
• With every purchase of RIMADYL (carprofen), you
will earn Rewards Points based on the amount of
RIMADYL you buy. These Rewards Points translate
into dollar amounts and can be used to purchase
any service or product your veterinary clinic has
to offer. As you continue to care for your dog with
RIMADYL, you will continue to accumulate dollars
on your RIMADYL Rewards Card. See program
Terms and Conditions for details.
• The Rewards dollars are automatically loaded onto
your Rewards Card. There are no rebate hassles
because you no longer have to keep up with
rebate checks.
If you have made the switch to RIMADYL (carprofen)
from another osteoarthritis prescription product within
one year of your dog’s registration, you are eligible
for up to 70 Rewards Points. Simply log in to your
account at myrimadylrewards.com to begin. For more
information see Terms and Conditions.
Earn up to 70 points when you switch
to RIMADYL from a competitive NSAID.
Receive free reminder texts or emails.
To help make your life easier, you may now opt-in to
receive important reminders easily by text or email for
both refills and dosing.
• Log in to myrimadylrewards.com.
• Visit “My Account” to set up.
• Prescription reminders can be set to one or two
months prior to need.
• Dosing can be set to daily.
Success Story
“ I just wanted to thank you for creating such an easy
online experience to get the $10 check. You make
a great product and the $10 savings is certainly
appreciated in today’s economy. RIMADYL is both a
great product and a great brand. I highly recommend
that our pet-owning friends talk to their vets about
prescribing RIMADYL for their dogs, too.
Thank you again.”
— Ronnie Beck
Unleash Rewards Today.
1.
Purchase RIMADYL (carprofen) through your local
veterinary clinic.
2.
Register at myrimadylrewards.com.
3.
Submit your veterinary receipts as proof-ofpurchase for every purchase of RIMADYL.
4.
Your points accumulate — once you reach 200
points you will receive a RIMADYL Rewards Card
loaded with the money you have earned. Hang on
to that card ...
5.
RIMADYL Rewards can be used toward any
expense at your veterinary clinic— even dog food!
Purchase these
RIMADYL* bottles:
Earn these
points**:
Points
equal to:
25mg x 30 Tablets
60
$6.50
25mg x 60 Tablets
120
$13.00
25mg x 180 Tablets
360
$39.00
75mg x 30 Tablets
70
$7.75
75mg x 60 Tablets
140
$15.50
75mg x 180 Tablets
420
$46.50
100mg x 30 Tablets
80
$9.50
100mg x 60 Tablets
160
$19.00
100mg x 180 Tablets
480
$57.00
*RIMADYL Chewable Tablets and Caplets only.
**Points are subject to change.
All RIMADYL prescriptions, regardless of number of tablets, are eligible for points.
Terms and conditions for RIMADYL Rewards include,
but are not limited to, the following:
• Limit one (1) Rewards Card per household.
• Limit up to five (5) dogs per household.
• Offer valid for purchases made up to 60 days prior to the date of the
dog’s registration. If you registered your dog prior to February 1, 2012,
you may submit receipts dated back to February 1, 2012.
• All proofs-of-purchase must be submitted within one (1) year
of RIMADYL purchase.
• Rebate amount must be redeemed within one (1) year of last Rewards Card
load or by card expiration date. Dollars not redeemed in that time are
forfeited.
• All Rewards Card purchases are final. Refunds to the card are not
technically possible.
Visit myrimadylrewards.com for full program rules.
All trademarks are the property of Zoetis Inc.,
its affiliates and/or its licensors. ©2015 Zoetis Inc.
All rights reserved. RIM-00077
They protected us.
Now we can return the favor.
Military and police K-9s are often the first to go
into harm’s way, saving many human lives. After a
lifetime of service these brave dogs can have major
health issues, including osteoarthritis (OA), due to
their stressful work, injuries or age. In retirement,
these dedicated K-9s receive no compensation or
health benefits.
In partnership with The Sage Foundation for Dogs
Who Serve and National Police Dog Foundation,
Zoetis created the RIMADYL K-9 Courage Program
to provide approximately $150,000 to provide
veterinary care for up to 500 dogs annually. This will
help ensure these courageous dogs continue to live
happy, healthy lives.
If you are a proud caregiver of a retired military or
police dog, you may be able to receive a debit card
worth $300 every year to be used on any product or
service at your veterinary clinic.
To apply, see full rules of the program or if you want
to make a difference in the lives of these brave
animals, please visit:
RIMADYLK9COURAGE.COM
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
Serious
adverse
reactions
with
can occur
withoutsodium
warning
and inand
rare
situations
result
in death
(seepH,
acid, 169.0
mg lecithin,
10.0 mgassociated
benzyl alcohol,
6.17this
mg drug
sodiumclass
hydroxide,
with additional
hydroxide
hydrochloric
acid
as needed
to adjust
and water
for injection.Owners should be advised to discontinue Rimadyl therapy and contact their veterinarian immediately if signs of
Adverse
Reactions).
intolerance
are observed. Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and antipyretic activity
CLINICAL PHARMACOLOGY:
1
UNLEASH
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
the rewards
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-methyl9H-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 Post-Approval 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, 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. Consider appropriate washout times when switching from
one NSAID to another or when switching from corticosteroids use to NSAID use.
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 Zoetis at 1-888-963-8471.
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,
approximately equipotent to indomethacin in animal models.
The
vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn,
Theveterinary
mechanismcare,
of action
of carprofen,islike
that of other
NSAIDs,
is believed
to be associated
with the inhibition
of cyclooxygenase
Twoduring
unique
and
if appropriate,
initiated.
Owners
should
be advised
of the importance
of periodic
follow up foractivity.
all dogs
cyclooxygenases have been described in mammals.2 The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for normal gastroadministration
of any
NSAID.
intestinal 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
a particular
NSAID
ADVERSE
REACTIONS:
During investigational
studies
for the caplet
formulation
with twice daily
administration
of 1ofmg/lb,
no clinically
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
significant
adverse
were reported.
Some
observed
during
field studies
which
were prostaglandins
similar for
4 Clinical relevance
of these data
has clinical
not beensigns
shown.were
Carprofen
has also
been shown
to inhibit(n=297)
the release
of several
COX-2 versus
COX-1.reactions
carprofen
capletand
placebo-treated
dogs.
Incidences
of
the
following
were
observed
in
both
groups:
vomiting
(4%),
diarrhea
(4%),
in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human rheumatoid synovial cells, indicating inhibition of acute (PMN
1
system) in
andappetite
chronic (synovial
cell system)
inflammatory
reactions.
changes
(3%), lethargy
(1.4%),
behavioral
changes
(1%), and constipation (0.3%). The product vehicle served as control.
5–9
Several
studies
have demonstrated
that carprofen
hasduring
modulatory
effects
onstudies
both humoral
cellular
responses.
alsoThe
indicate
that
There
were
no serious
adverse events
reported
clinical
field
with and
once
dailyimmune
administration
of 2 Data
mg/lb.
following
carprofen inhibits the production of osteoclast-activating factor (OAF), PGE1, and PGE2 by its inhibitory effect in prostaglandin biosynthesis.1
categories of abnormal health observations were reported. The product
vehicle served as control.
Based upon comparison with data obtained from intravenous administration, carprofen is rapidly and nearly completely absorbed (more than 90%
10 Peak
of Dogs
with
Abnormal
Health
Observations
Clinical
Field
(2 mg/lbofonce
daily)
blood plasma
concentrations
are Reported
achieved inin
1–3
hours after
oralStudy
administration
1, 5, and
25 mg/kg to
bioavailable) Percentage
when administered
orally.
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
Observation
RIMADYL
(n=129)
Placebo
(n=132)
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%
Inappetence
1.6of distribution.
1.5
bound to plasma protein and exhibits a very small volume
Vomiting
Comparison of a single 25 mg dose in Beagle dogs after3.1
subcutaneous and oral administration demonstrated3.8
that the dorsoscapular subcutaneous
Diarrhea/Soft
3.1
administrationstool
results in a slower rate of drug input (as reflected
by mean peak observed concentrations) but4.5
comparable total drug absorption within a
12 hour dosing
interval (as reflected by area under the curve
Behavior
change
0.8 from hours zero to 12 postdose).
0.8
Carprofen is eliminated in the dog primarily by biotransformation
in the liver followed by rapid excretion of the0.8resulting metabolites (the ester glucuronide of
Dermatitis
0.8
carprofen and the ether glucuronides of 2 phenolic metabolites,
7-hydroxy carprofen and 8-hydroxy carprofen)
PU/PD
0.8
— in the feces (70–80%) and urine (10–20%).
Some enterohepatic circulation of the drug is observed.
SAP increase
7.8
8.3
INDICATIONS: Rimadyl is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated
ALT
increase
5.4
4.5
with soft tissue and orthopedic surgeries in dogs.
AST
increase
2.3 exhibiting previous hypersensitivity to carprofen.
0.8
CONTRAINDICATIONS:
Rimadyl should not be used in dogs
BUN
increase
3.1
1.5
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.
Bilirubinuria
16.3
12.1
Do not use in cats.
Ketonuria
14.7
9.1
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 oflisted
potential
drug toxicity
(seeofInformation
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determine clinical relevance.
PRECAUTIONS:
As a class,
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may be
associated with
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renal and
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toxicity. Effects
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During
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studies
of surgicalinhibitory
pain forNSAIDs
the caplet
formulation,
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product
vehicle
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as control.
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prostaglandins that cause inflammation they may also inhibit those prostaglandins which maintain normal homeostatic
acid.11–14
function.
Theseof
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resultObservations
in clinically sigReported
nificant disease
in patients
withField
underlying
or pre-existing
disease
more often
in
Percentage
Dogs with Abnormal
Health
in Surgical
Pain
Studies
with Caplets
(2 mg/lb
oncethan
daily)
healthy patients.12,14 NSAID therapy could unmask occult disease which has previously been undiagnosed due to the absence of apparent clinical signs.
Observation*
(n=148)
Placebo
(n=149)while on NSAID therapy.11–14
Patients with underlying renal disease for example,RIMADYL
may experience
exacerbation or decompensation of their
renal disease
The use of parenteral fluids during surgery should be considered
when using NSAIDs perioperatively.
Vomiting
10.1 to reduce the potential risk of renal complications
13.4
Diarrhea/soft
stool
6.1 reactions may occur with its use. The most frequently
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Carprofen is an
NSAID, and as with others in that class, adverse
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neurologic, dermatologic, and hepatic effects 0have also been reported. Patients at
Ocular
disease signs. Events involving suspected renal, hematologic,
2.7
greatest risk for renal toxicity are those that are dehydrated,1.4
on concomitant diuretic therapy, or those with renal, cardiovascular,
and/or hepatic
Inappetence
0
dysfunction. Concurrent administration of potentially nephrotoxic drugs should be approached cautiously, with appropriate monitoring. Concomitant use of
Dermatitis/Skin
lesion
2.0 or corticosteroids, should be avoided because1.3
Rimadyl with other
anti-inflammatory drugs, such as other NSAIDs
of the potential increase of adverse
Dysrhythmia
0.7
0 varies with the individual patient.
reactions, including gastrointestinal ulcerations and/or perforations.
Sensitivity to drug-associated adverse reactions
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Rimadyl treatment was not
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0
associated with renal
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in well-controlled safety studies of up to 10 times the dose
Oral/Periodontal
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Pyrexia
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1.3
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0 of Rimadyl when administered
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* Apatients
singlerequiring
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15 It is suggested
to usewere
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sites forinadditional
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may reduce
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level of inhalant
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needed.
During
investigational
studies
for the
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gastrointestinal
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These
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included
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soft stools.
is notwere
recommended.
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when
switching
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another or when
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There
no serious
adverse
events reported
during
clinical
fieldfrom
studies
for the
formulation.
categories
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abnormal
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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
of Dogs
with
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Observations
in Clinical
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the
quantities of Percentage
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please
callInjectable
your veterinarian for
immediate assistance and notify Zoetis at 1-888-963-8471.
Observation*
RIMADYL (n=168)
Placebo (n=163)
INFORMATION FOR DOG OWNERS:
Vomiting
10.1
9.2
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
Diarrhea/soft
2.4reactions may include decreased appetite, vomiting,
3.7diarrhea, dark or tarry stools,
of the clinicalstool
signs associated with drug intolerance. Adverse
Dermatitis
0.6due to anemia, yellowing of gums, skin or white of the
1.2eye due to jaundice, lethargy,
increased water consumption, increased urination, pale gums
incoordination, seizure, or behavioral changes.
Dysrhythmia
0.6
0.6
Serious adverse reactions associated with this drug class can
Swelling
0 occur without warning and in rare situations result
1.2in death (see Adverse Reactions).
Owners should be advised to discontinue Rimadyl therapy and
Dehiscence
1.2 contact their veterinarian immediately if signs of 0intolerance are observed.
The increase
vast majority of patients with drug related adverse reactions
WBC
13.7 have recovered when the signs are recognized, the
6.7 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.
REACTIONS: During investigational studies for the caplet formulation with twice daily administration of 1 mg/lb, no clinically significant adverse
* AADVERSE
single dog
may have experienced more than one occurrence of an event.
reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen caplet- and placebo-treated
Post-Approval
Experience:
dogs. Incidences
of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes
Although
all adverse
reactions
are reported,
theas
following
(1%), andnot
constipation
(0.3%).
The product
vehicle served
control. adverse reactions are based on voluntary post-approval adverse drug
experience
The categories
of adverse
listed
decreasing
order of frequency
by following
body system.
There werereporting.
no serious adverse
events reported
during reactions
clinical fieldare
studies
withinonce
daily administration
of 2 mg/lb. The
categories of abnormal
health observations
were reported.
The constipation,
product vehicleinappetence,
served as control.
Gastrointestinal:
Vomiting,
diarrhea,
melena, hematemesis, gastrointestinal ulceration, gastrointestinal
bleeding, pancreatitis.
Dogs withacute
Abnormal
Health
Observations
Reported
in Clinical
Fieldabnormal
Study (2 mg/lb
daily) test(s),
Hepatic: Inappetence,Percentage
vomiting, of
jaundice,
hepatic
toxicity,
hepatic
enzyme
elevation,
liveronce
function
hyperbilirubinemia,
one-fourth of hepatic reports were in Labrador
Retrievers.
Observation bilirubinuria, hypoalbuminemia. Approximately
Rimadyl (n=129)
Placebo (n=132)
Neurologic:
Ataxia, paresis, paralysis, seizures, vestibular signs,
Inappetence
1.6 disorientation.
1.5
Urinary:Vomiting
Hematuria, polyuria, polydipsia, urinary incontinence,3.1urinary tract infection, azotemia, acute renal failure,
3.8 tubular abnormalities
including
acute tubular
Diarrhea/Soft
stool necrosis, renal tubular acidosis, glucosuria.
3.1
4.5
Behavioral:
Sedation,
Behavior
change lethargy, hyperactivity, restlessness, aggressiveness.
0.8
0.8
Hematologic:
Immune-mediated hemolytic anemia, immune-mediated
thrombocytopenia, blood loss anemia, epistaxis.
Dermatitis
0.8
0.8
Dermatologic:
Pruritus,
increased
shedding,
alopecia,
pyotraumatic
moist
dermatitis
(hot
spots),
necrotizing
panniculitis/vasculitis,
PU/PD
0.8
—
ventralSAP
ecchymosis.
including necrosis, abscess and seroma formation,
increase In rare situations, injection site reactions7.8
8.3 and granulomas have
been reported
with the injectable formulation.
ALT increase
5.4
4.5
Immunologic
or hypersensitivity: Facial swelling, hives, erythema.
AST increase
2.3
0.8
increasedeath has been associated with some of the
3.1adverse reactions listed above.
1.5
In rare BUN
situations,
Bilirubinuria
12.1
To report
a suspected adverse reaction call 1-888-963-8471. 16.3
Ketonuria
14.7
9.1
DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully consider the potential benefits
Clinical pathology parameters listed represent reports of increases from pre-treatment values; medical judgment is necessary to determine clinical
and
risk of Rimadyl and other treatment options before deciding to use Rimadyl. Use the lowest effective dose for the shortest duration
relevance.
consistent
with individual
response.
dosage for
oral administration
to dogs
is 2 mg/lb
mg/kg)
body weight
During investigational
studies
of surgicalThe
painrecommended
for the caplet formulation,
no clinically
significant adverse
reactions
were(4.4
reported.
Theofproduct
vehicle daily.
The
totalas
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
served
control.
daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Rimadyl tablets are scored and
Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Caplets (2 mg/lb once daily)
dosage should
be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down
on bothObservation*
sides of the score. Rimadyl chewable tablets are Rimadyl
palatable
and willingly consumed by most dogs when
offered
by the owner.
(n=148)
Placebo
(n=149)
Vomiting
10.1 be taken to ensure that the dog consumes the13.4
Therefore, they may be fed by hand or placed on food. Care should
complete dose.
Diarrhea/Soft stool
6.1
6.0
The recommended
dogs is 2 mg/lb (4.4 mg/kg) of body weight daily. The0 total daily dose may
Ocular diseasedosage for subcutaneous administration to 2.7
Inappetenceas either 2 mg/lb of body weight once daily or divided
1.4
0 daily. For control of
be administered
and administered as 1 mg/lb (2.2 mg/kg) twice
Dermatitis/Skin
2.0 procedure.
1.3
post-operative
pain, lesion
administer approximately 2 hours before the
Dysrhythmia
0.7
0
PALATABILITY:
Apnea A controlled palatability study was conducted which
1.4 demonstrated that Rimadyl chewable tablets0were readily accepted
Oral/Periodontal
1.4
0
and consumed
on firstdisease
offering by a majority of dogs.
Pyrexia
0.7
1.3
EFFECTIVENESS:
of the effectiveness of Rimadyl for the
and for the
Urinary tractConfirmation
disease
1.4 relief of pain and inflammation associated with osteoarthritis,
1.3
drainage pain associated with soft tissue and orthopedic
1.4 surgeries, was demonstrated in 7 placebo-controlled,
0
controlWound
of postoperative
masked studies
examining
andmore
analgesic
effectiveness
Rimadyl
* A singlethe
doganti-inflammatory
may have experienced
than one
occurrence ofofan
event. caplets and injectable in various breeds of dogs.
During investigational
studies formasked,
the chewable
tablet formulation,
gastrointestinal
observed in some
dogs.
These signs
included vomiting
Separate
placebo-controlled,
multicenter
field studies
confirmedsigns
the were
anti-inflammatory
and
analgesic
effectiveness
of 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.
Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute
tubular necrosis, renal tubular acidosis, glucosuria.
Rimadyl
caplets
when
dosedhyperactivity,
at 2 mg/lb once
daily oraggressiveness.
when divided and administered at 1 mg/lb twice daily. In these 2 field studies, dogs
Behavioral:
Sedation,
lethargy,
restlessness,
Hematologic:
Immune-mediated
immune-mediated
blood based
loss anemia,
epistaxis. evaluations by the veterinarian
diagnosed
with
osteoarthritishemolytic
showedanemia,
statistically
significant thrombocytopenia,
overall improvement
on lameness
Dermatologic:
Pruritus, increased
alopecia,
pyotraumatic
moistdoses.
dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis.
and
owner observations
whenshedding,
administered
Rimadyl
at labeled
In rare situations, injection site reactions including necrosis, abscess and seroma formation, and granulomas have been reported with the injectable
Based
upon the blood level comparison between subcutaneous and oral administration, Rimadyl effectiveness for osteoarthritis after
formulation.
Immunologic or hypersensitivity:
swelling,
hives, erythema.
dorsoscapular
subcutaneous Facial
and oral
administration
should be similar, although there may be a slight delay in the onset of relief after
In rare situations,
death has been associated with some of the adverse reactions listed above.
subcutaneous
injection.
To report a suspected adverse reaction call 1-888-963-8471.
Separate
placebo-controlled,
multicenter
field studies
confirmed
the effectiveness
of Rimadyl
caplets
and injectable
for
DOSAGE AND
ADMINISTRATION:masked,
Always provide
Client Information
Sheet
with prescription.
Carefully consider
the potential
benefits
and risk of Rimadyl
andcontrol
other treatment
options before
to use Rimadyl.
Useonce
the lowest
dosebreeds
for the shortest
consistent
individual
response.
the
of postoperative
paindeciding
when dosed
at 2 mg/lb
dailyeffective
in various
of dogs.duration
In these
studies,with
dogs
presented
for
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
ovariohysterectomy,
andand
aural
surgeriesaswere
administered
Rimadyl
preoperatively
and for a maximum
of 3 days (soft
2 mg/lb of body weight cruciate
once dailyrepair
or divided
administered
1 mg/lb
(2.2 mg/kg) twice
daily. For
the control of postoperative
pain, administer
tissue)
or
4
days
(orthopedic)
postoperatively.
In
general,
dogs
administered
Rimadyl
showed
statistically
significant
reduction
approximately 2 hours before the procedure. Rimadyl tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be in pain
halved compared
by placing the
on a hard surface and pressing down on both sides of the score. Rimadyl chewable tablets are palatable and willingly
scores
totablet
controls.
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
ANIMAL
SAFETY
STUDIES:
Laboratory studies in unanesthetized dogs and clinical field studies have demonstrated that Rimadyl is well
dog consumes
the complete
dose.
tolerated
in dogs after oral administration.
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
either animal
2 mg/lb of
body weight
once
daily orwas
divided
and administered
(2.2Beagle
mg/kg) twice
control
of post-operative
Inastarget
safety
studies,
Rimadyl
administered
orallyasto1 mg/lb
healthy
dogsdaily.
at 1,For
3, and
5 mg/lb
twice dailypain,
(1, 3administer
and 5 times
approximately
2 hours
before
thedose)
procedure.
the
recommended
total
daily
for 42 consecutive days with no significant adverse reactions. Serum albumin for a single female
PALATABILITY:
controlled
palatability
study was to
conducted
that Rimadylreturned
chewableto
tablets
were readily accepted
dog
receiving 5Amg/lb
twice
daily decreased
2.1 g/dLwhich
after demonstrated
2 weeks of treatment,
the pre-treatment
value and
(2.6 consumed
g/dL) after
first offering
by a majority
dogs.
4 on
weeks
of treatment,
and of
was
2.3 g/dL at the final 6-week evaluation. Over the 6-week treatment period, black or bloody stools were
EFFECTIVENESS:
Confirmation
of the
effectiveness
of Rimadyl
fordaily
the relief
and(2inflammation
with3osteoarthritis,
for Redness
the controlof the
observed
in 1 dog
(1 incident)
treated
with 1 mg/lb
twice
andofinpain
1 dog
incidents) associated
treated with
mg/lb twiceand
daily.
of postoperative
tissue
and
orthopedic
surgeries,
wasdaily.
demonstrated in 7 placebo-controlled, masked studies examining the
colonic
mucosapain
wasassociated
observedwith
in 1soft
male
that
received
3 mg/lb
twice
anti-inflammatory and analgesic effectiveness of Rimadyl caplets and injectable in various breeds of dogs.
Two
of 8 dogs
receiving 10 masked,
mg/lb orally
twicefield
daily
(10 times
the recommended
totaland
daily
dose) for
14 days exhibited
Separate
placebo-controlled,
multicenter
studies
confirmed
the anti-inflammatory
analgesic
effectiveness
of Rimadylhypoalbuminemia.
caplets when
The
mean
dogs
receiving
this doseatwas
lower
(2.38
g/dL)
than2each
of 2 placebo
control with
groups
(2.88 andshowed
2.93 g/
dosed
at 2 albumin
mg/lb oncelevel
dailyinorthe
when
divided
and administered
1 mg/lb
twice
daily.
In these
field studies,
dogs diagnosed
osteoarthritis
statistically
significant
overall
improvement
based
on lameness
by the veterinarian
and of
owner
observations
administered
at
dL,
respectively).
Three
incidents
of black
or bloody
stoolevaluations
were observed
in 1 dog. Five
8 dogs
exhibitedwhen
reddened
areasRimadyl
of duodenal
labeled doses.
mucosa
on gross pathologic examination. Histologic exam of these areas revealed no evidence of ulceration, but did show minimal
Based upon of
thethe
blood
level comparison
and oral administration, Rimadyl effectiveness for osteoarthritis after dorsoscapular
congestion
lamina
propria in 2between
of the 5subcutaneous
dogs.
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 and injectable for the control of postoperative
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
pain when dosedtotal
at 2 mg/lb
variousofbreeds
of dogs.
these
studies,the
dogsdrug
presented
for ovariohysterectomy,
cruciate
aural No
recommended
daily once
dosedaily
of 2 inmg/lb)
carprofen.
InInboth
studies,
was well
tolerated clinically
by allrepair
of theand
animals.
surgeries
were administered
Rimadyl
andthe
fortreated
a maximum
of 3 days
or 4dogs
days (orthopedic)
postoperatively.
In general,
dogs
gross
or histologic
changes
were preoperatively
seen in any of
animals.
In (soft
bothtissue)
studies,
receiving the
highest doses
had average
administered
RimadylL-alanine
showed statistically
significant reduction
pain scores compared
increases
in serum
aminotransferase
(ALT) of inapproximately
20 IU. to controls.
ANIMAL SAFETY: Laboratory studies in unanesthetized dogs and clinical field studies have demonstrated that Rimadyl is well tolerated in dogs after oral
Inadministration.
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 Rimadyl
slight redness
or rash and
diagnosed
as non-specific
dermatitis.
The(1,
possibility
exists
that these mild
In target animal
safety studies,
was administered
orallywere
to healthy
Beagle dogs
at 1, 3, and 5 mg/lb
twice daily
3 and 5 times
the recommended
lesions
were
treatment
related, days
but no
relationship
wasreactions.
observed.
total daily
dose)
for 42 consecutive
withdose
no significant
adverse
Serum albumin for a single female dog receiving 5 mg/lb twice daily
decreased
to studies
2.1 g/dL after
of treatment,
returned
pre-treatment
(2.6recommended
g/dL) after 4 weeks
of doses
treatment,
was 2.3
g/dLdogs
at thewere
final
Clinical
field
were2 weeks
conducted
with 549
dogs to
ofthe
different
breedsvalue
at the
oral
forand
14 days
(297
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
included
in a study
evaluating
1 mg/lb
twice
andof252
were
included
in a separate
evaluating
2 mg/lb
1 dog (2 incidents)
treated
with 3 mg/lb
twice
daily.daily
Redness
thedogs
colonic
mucosa
was observed
in 1 malestudy
that received
3 mg/lb
twice once
daily. daily). In
both
studies the drug was clinically well tolerated and the incidence of clinical adverse reactions for Rimadyl-treated animals was no
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
higher
placebo-treated
animals
(placebo
contained
inactive
ingredients
Rimadyl).
receiving
mg/lb twice
level inthan
the dogs
receiving this dose
was lower
(2.38 g/dL)
than each
of 2 placebo
control found
groupsin
(2.88
and 2.93 For
g/dL,animals
respectively).
Three1incidents
of daily,
the
mean
post-treatment
serum ALT
values
11 IU
greaterreddened
and 9 IU
lessofthan
pre-treatment
values
for dogsexamination.
receiving Rimadyl
black
or bloody
stool were observed
in 1 dog.
Fivewere
of 8 dogs
exhibited
areas
duodenal
mucosa on gross
pathologic
Histologicand
exam of these
areas revealed
no evidence
of ulceration,
but did significant.
show minimalFor
congestion
the lamina 2propria
2 of the
5 dogs.
placebo,
respectively.
Differences
were
not statistically
animalsofreceiving
mg/lbinonce
daily,
the mean post-treatment
In separate
safety studies
and 52and
weeks,
were administered
orally
to 11.4
mg/lb/day
(5.7 times
theplacebo,
recommended
total
serum
ALT values
were lasting
4.5 IU 13
greater
0.9respectively,
IU less thandogs
pre-treatment
values
for up
dogs
receiving
Rimadyl
and
respectively.
In
daily
dosestudy,
of 2 mg/lb)
of carprofen. In both
the drug
was well
of theand/or
animals.(AST)
No gross
or histologic
changes
were seen
the
latter
3 Rimadyl-treated
dogsstudies,
developed
a 3-fold
ortolerated
greater clinically
increasebyinall(ALT)
during
the course
of therapy.
One
in any of the treated animals. In both studies, dogs receiving the highest doses had average increases in serum L-alanine aminotransferase (ALT) of
placebo-treated
dog
had
a
greater
than
2-fold
increase
in
ALT.
None
of
these
animals
showed
clinical
signs
associated
with
laboratory
approximately 20 IU.
value changes. Changes in the clinical laboratory values (hematology and clinical chemistry) were not considered clinically significant.
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
The
1 mg/lb
daily course
therapy
was repeated
as needed
at 2-week
intervalsexists
in 244that
dogs,
for as were
long treatment
as 5 years.
described
astwice
slight redness
or rashofand
were diagnosed
as non-specific
dermatitis.
The possibility
thesesome
mild lesions
related,
but no dose
was conducted
observed. in 297 dogs of different breeds undergoing orthopedic or soft tissue surgery. Dogs were
Clinical
fieldrelationship
studies were
Clinical field studies
were
549prior
dogs of
at the daily,
recommended
oral for
doses
for 14(soft
days tissue
(297 dogs
were included
in a (orthopedic
study
administered
2 mg/lb
of conducted
Rimadyl 2with
hours
to different
surgerybreeds
then once
as needed
2 days
surgery)
or 3 days
evaluatingRimadyl
1 mg/lb twice
252 dogs
wereused
included
in a separate study
2 mg/lb
once daily). In both
studies
thetype
drugand
was severity
clinically well
surgery).
was daily
well and
tolerated
when
in conjunction
with aevaluating
variety of
anesthetic-related
drugs.
The
of
tolerated and the incidence of clinical adverse reactions for Rimadyl-treated animals was no higher than placebo-treated animals (placebo contained
abnormal
health
observation
in
Rimadyland
placebo-treated
animals
were
approximately
equal
and
few
in
number
(see
Adverse
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
Reactions).
The most frequent
health
observation
was
vomiting and
was observed
at approximately
theFor
same
frequency
less than pre-treatment
values for abnormal
dogs receiving
Rimadyl
and placebo,
respectively.
Differences
were not statistically
significant.
animals
receivingin
Rimadylanddaily,
placebo-treated
animals. Changes
clinicopathologic
indices
ofIU
hematopoietic,
renal, hepatic,
function
2 mg/lb once
the mean post-treatment
serum ALT in
values
were 4.5 IU greater
and 0.9
less than pre-treatment
values forand
dogsclotting
receiving
Rimadyl were
andclinically
placebo, respectively.
themean
latter study,
3 Rimadyl-treated
a 3-fold
increase
in than
(ALT) pre-treatment
and/or (AST) during
the course
of
not
significant.InThe
post-treatment
serumdogs
ALTdeveloped
values were
7.3orIUgreater
and 2.5
IU less
values
for dogs
therapy. One
placebo-treated
dog had
a greater than
2-fold
increase
in ALT. NoneAST
of these
animals
showed
signs
associated
withRimadyl
laboratory
receiving
Rimadyl
and placebo,
respectively.
The
mean
post-treatment
values
were
3.1 IUclinical
less for
dogs
receiving
and 0.2 IU
value changes. Changes in the clinical laboratory values (hematology and clinical chemistry) were not considered clinically significant. The 1 mg/lb twice
greater
for dogs
receiving
placebo.
daily course
of therapy
was repeated
as needed at 2-week intervals in 244 dogs, some for as long as 5 years.
Clinical
studieswere
on the
use ofinRimadyl
on 331 dogs
undergoing
orthopedic
or administered
soft tissue surgery.
Clinical field
field studies
conducted
297 dogsInjectable
of different were
breedsconducted
undergoing orthopedic
or soft
tissue surgery.
Dogs were
2 mg/lb ofDogs
Rimadyl
2 hours prior2tomg/lb
surgery
once daily,
as needed for22hours
days (soft
tissue
surgery) and
or 3 days
surgery).as
Rimadyl
wasfor
well2 tolerated
were
administered
ofthen
Rimadyl
subcutaneously
prior
to surgery
once(orthopedic
daily thereafter,
needed,
days (soft
when used
in conjunction
a variety of surgery).
anesthetic-related
and severity
of abnormal
health observation
andanestheticplacebo-treated
tissue
surgery)
or 3 dayswith
(orthopedic
Rimadyldrugs.
wasThe
welltype
tolerated
when
used in conjunction
withina Rimadylvariety of
animals were approximately equal and few in number (see Adverse Reactions). The most frequent abnormal health observation was vomiting and was
related
drugs.
The
type
and
severity
of
abnormal
health
observations
in
Rimadyland
placebo-treated
animals
were
approximately
observed at approximately the same frequency in Rimadyl- and placebo-treated animals. Changes in clinicopathologic indices of hematopoietic, renal,
equal
and
few
in number
Reactions).
The
abnormal
observation
was
observed
hepatic,
and
clotting
function(see
wereAdverse
not clinically
significant.
Themost
meanfrequent
post-treatment
serumhealth
ALT values
were 7.3 IU
andvomiting
2.5 IU lessand
thanwas
pre-treatment
for dogs receiving
Rimadyl
and placebo,
respectively.
mean post-treatment
AST Changes
values were
IU less for dogs receiving
and 0.2 IU
atvalues
approximately
the same
frequency
in Rimadyland The
placebo-treated
animals.
in3.1
clinicopathologic
indicesRimadyl
of hematopoetic,
greater
for dogsand
receiving
placebo.
renal,
hepatic,
clotting
function were not clinically significant. The mean post-treatment serum ALT values were 8.4 IU and 7.0 IU less
Clinical
field studies on
the use
Rimadyl
InjectableRimadyl
were conducted
on 331 respectively.
dogs undergoingThe
orthopedic
or soft tissue surgery.
were
administered
than
pre-treatment
values
forofdogs
receiving
and placebo,
mean post-treatment
AST Dogs
values
were
1.5 IU and 0.7
of Rimadyl
subcutaneously
2 hours and
priorplacebo,
to surgeryrespectively.
and once daily thereafter, as needed, for 2 days (soft tissue surgery) or 3 days (orthopedic
IU2 mg/lb
greater
for dogs
receiving Rimadyl
surgery). Rimadyl was well tolerated when used in conjunction with a variety of anesthetic-related drugs. The type and severity of abnormal health
Swelling
andinwarmth
associated with
the injection
site afterequal
subcutaneous
administration
of Rimadyl
Injectable.
These findings
observations
Rimadyl-were
and placebo-treated
animals
were approximately
and few in number
(see Adverse
Reactions).
The most frequent
abnormal
healthnot
observation
vomiting and
wasterm
observed
at the
approximately
same
in Rimadyl- and placebo-treated animals. Changes in clinicowere
clinicallywas
significant.
Long
use of
injectablethehas
notfrequency
been studied.
pathologic indices of hematopoetic, renal, hepatic, and clotting function were not clinically significant. The mean post-treatment serum ALT values were
STORAGE:
Store
tablets
at controlledvalues
roomfortemperature
15°–30°C
(59°–86°F).
Store injectable
under
refrigeration
(36°–46°F).
8.4 IU and 7.0
IU less
than pre-treatment
dogs receiving
Rimadyl and
placebo, respectively.
The mean
post-treatment
AST2°–8°C
values were
1.5 IU Once
and 0.7 IU greater
formay
dogsbe
receiving
and placebo,uprespectively.
broached,
product
storedRimadyl
at temperatures
to 25°C (77°F) for 28 days.
Swelling
and warmth
were associated
withchewable
the injectiontablets
site after
subcutaneous
of Rimadyl
These
findings were
clinically
HOW
SUPPLIED:
Rimadyl
caplets and
are
scored, andadministration
contain 25 mg,
75 mg,Injectable.
or 100 mg
of carprofen
pernot
caplet
or tablet.
significant. Long term use of the injectable has not been studied.
Each caplet size is packaged in bottles containing 30, 60, or 180 caplets. Each chewable tablet size is packaged in bottles containing 7,
STORAGE:
Store
tabletsRimadyl
at controlled
room temperature
15°–30°C
(59°–86°F).
injectable
refrigeration
30,
60, or 180
tablets.
Injectable
is supplied
in 20-mL,
amber,Store
glass,
sterile,under
multi-dose
vials.2°–8°C (36°–46°F). Once broached,
product may be stored at temperatures up to 25°C (77°F) for 28 days.
REFERENCES:
HOW SUPPLIED: Rimadyl caplets and chewable tablets are scored, and contain 25 mg, 75 mg, or 100 mg of carprofen per caplet or tablet. Each caplet
1.size
Baruth
H, et al:
Anti-Inflammatory
Drugs,tablet
Vol. size
II, Newer
Anti-Inflammatory
Drugs,
KD, ed.Rimadyl
CRC Press,
is packaged
in In
bottles
containing 30, 60, and
or 180Anti-Rheumatic
caplets. Each chewable
is packaged
in bottles containing
7, 30,Rainsford
60, or 180 tablets.
Boca
Raton,
p. 33, 1986.
Injectable
is supplied
in 20-mL, amber, glass, sterile, multi-dose vials.
2. Vane JR, Botting RM: Mechanism of action of anti-inflammatory drugs. Scand J Rheumatol 25:102, pp. 9–21, 1996.
3.REFERENCES:
Grossman CJ, Wiseman J, Lucas FS, et al: Inhibition of constitutive and inducible cyclooxygenase activity in human platelets and
1. Baruth H, etcells
al: In Anti-Inflammatory
Anti-Rheumatic
Vol. II, Newer
Anti-Inflammatory
Drugs,1995.
Rainsford KD, ed. CRC Press, Boca Raton, p. 33, 1986.
mononuclear
by NSAIDs andand
COX-2
inhibitors.Drugs,
Inflammation
Research
44:253–257,
Vane JR,AP,
Botting
RM:KM,
Mechanism
of action
of anti-inflammatory
Scandof
J Rheumatol
25:102, pp. 9–21, 1996.
4.2.Ricketts
Lundy
Seibel SB:
Evaluation
of selectivedrugs.
inhibition
canine cyclooxygenase
1 and 2 by carprofen and other
3.
Grossman CJ,
Wiseman J, Lucasdrugs.
FS, et al:
Inhibition
of constitutive
inducible cyclooxygenase
activity in human platelets and mononuclear cells by
nonsteroidal
anti-inflammatory
Am
J Vet Res
59:11, pp.and
1441–1446,
November 1998.
NSAIDs
and
COX-2
inhibitors.
Inflammation
Research
44:253–257,
1995.
5. Ceuppens JL, et al: Non-steroidal anti-inflammatory agents inhibit the synthesis of IgM rheumatoid factor in vitro. Lancet 1:528, 1982.
Ricketts AP, Lundy KM, Seibel SB: Evaluation of selective inhibition of canine cyclooxygenase 1 and 2 by carprofen and other nonsteroidal anti-inflammatory
6.4.Ceuppens
JL, et al: Endogenous prostaglandin E2 enhances polyclonal immunoglobulin production by ionically inhibiting T suppressor
drugs. Am J Vet Res 59:11, pp. 1441–1446, November 1998.
cell
activity. Cell Immunol 70:41, 1982.
5. Ceuppens JL, et al: Non-steroidal anti-inflammatory agents inhibit the synthesis of IgM rheumatoid factor in vitro. Lancet 1:528, 1982.
7.6.Schleimer
al:Endogenous
The effects
of prostaglandin
synthesis
inhibition
on the immune
response.
3:205,
1981.
Ceuppens RP,
JL, etetal:
prostaglandin
E2 enhances
polyclonal
immunoglobulin
production
by ionicallyImmunopharmacology
inhibiting T suppressor cell
activity.
Cell
8. Leung
KH,70:41,
et al:1982.
Modulation of the development
of cell mediated immunity: Possible roles of the products of cyclooxygenase and
Immunol
lipoxygenase
pathways
arachidonic
acid metabolism.
Int J Immunopharmacology
4:195, 1982.
7. Schleimer RP,
et al: Theof
effects
of prostaglandin
synthesis inhibition
on the immune response. Immunopharmacology
3:205, 1981.
9.8.Veit
BC:
Immunoregulatory
activity
of
cultured-induced
suppressor
macrophages.
Cell
Immunol
72:14,
1982.
Leung KH, et al: Modulation of the development of cell mediated immunity: Possible roles of the products of cyclooxygenase and lipoxygenase pathways
10. Schmitt
M, etacid
al: Biopharmaceutical
evaluation
of carprofen
of arachidonic
metabolism. Int J Immuno
pharmacology
4:195, 1982.following single intravenous, oral, and rectal doses in dogs. Biopharm
Drug
Dispos
11(7):585, 1990.activity of cultured-induced suppressor macrophages. Cell Immunol 72:14, 1982.
9. Veit
BC: Immunoregulatory
11.
Kore
AM:
of nonsteroidal
anti-inflammatory
drugs.
Veterinary
Clinics
of North
America,
Small
Animal
Practice
20, March
10. Schmitt
M, Toxicology
et al: Biopharmaceutical
evaluation
of carprofen following
single
intravenous,
oral, and
rectal doses
in dogs.
Biopharm
Drug
Dispos 11(7):585,
1990.1990.
12.
SH:Toxicology
Pathogenesis
and pathophysiology
ischemi
m 20, March 1990.
11.Binns
Kore AM:
of nonsteroidal
anti-inflammatoryofdrugs.
Veterinary Clinics of North America, Small Animal Practice
12. Binns SH: Pathogenesis and pathophysiology of ischemic injury in cases of acute renal failure. Compend for Cont Ed 16:1, January 1994.
DMProstaglandins: Physiology and clinical implications.
m Compend for Cont
m Ed 6:11, November 1984. N m
13.BBoothe DM:
N
mmdrugs, prostaglandins, and the kidney. JAVMA 188:9, May
A MA
M
14. Rubin SI: Nonsteroidal
anti-inflammatory
1986.
H Lange DN,
DNMandsager
M
m m concentration of isoflurane in dogs. JAVMA
15. Ko CH,
RE, et al: Effects of butorphanol and carprofen on the minimal alveolar
A MA 2000.
217:1025–1028,
For a copy of the Material
Safety DataDSheet (MSDS)
M
Mcall
D 1-888-963-8471. To report adverse reactions call Zoetis Inc. at 1-888-963-8471.
NADA #141-053, NADA
#141-111, NADA
#141-199 Approved
NADA
NADA
NADA
A by FDA
DA
Based on Rimadyl Caplets PI
14036500, Revised January 2013;
Distributed by:
Rimadyl Chewable Tablets PI
14029100, Revised April 2013; and
Zoetis Inc.
Rimadyl Sterile Injectable Solution
Kalamazoo, MI 49007
PI 054577ZO, Revised January 2013.