Carprofen is a white, crystalline compound. It is freely soluble in ethanol, but practically insoluble in water at 25°C.
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.
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.
ADVERSE REACTIONS: During investigational studies of osteoarthritis 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- 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 of osteoarthritis with once daily administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control.
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Percentage of Dogs with Abnormal Health Observations Reported in Osteoarthritis Field Study (2 mg/lb once daily)
|
|
Observation
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Rimadyl (n=129)
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Placebo (n=132)
|
|
Inappetence
|
1.6
|
1.5
|
|
Vomiting
|
3.1
|
3.8
|
|
Diarrhea/Soft stool
|
3.1
|
4.5
|
|
Behavior change
|
0.8
|
0.8
|
|
Dermatitis
|
0.8
|
0.8
|
|
PU/PD
|
0.8
|
-
|
|
SAP increase
|
7.8
|
8.3
|
|
ALT increase
|
5.4
|
4.5
|
|
AST increase
|
2.3
|
0.8
|
|
BUN increase
|
3.1
|
1.5
|
|
Bilirubinuria
|
16.3
|
12.1
|
|
Ketonuria
|
14.7
|
9.1
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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.
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Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Caplets (2 mg/lb once daily)
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|
Observation*
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Rimadyl (n=148)
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Placebo (n=149)
|
|
Vomiting
|
10.1
|
13.4
|
|
Diarrhea/soft stool
|
6.1
|
6.0
|
|
Ocular disease
|
2.7
|
0
|
|
Inappetence
|
1.4
|
0
|
|
Dermatitis/skin lesion
|
2.0
|
1.3
|
|
Dysrhythmia
|
0.7
|
0
|
|
Apnea
|
1.4
|
0
|
|
Oral/periodontal disease
|
1.4
|
0
|
|
Pyrexia
|
0.7
|
1.3
|
|
Urinary tract disease
|
1.4
|
1.3
|
|
Wound drainage
|
1.4
|
0
|
* A single dog may have experienced more than one occurrence of an event.
Post-Approval Experience:
STORAGE: Store at controlled room temperature 15°-30°C (59°-86°F).
HOW SUPPLIED: Rimadyl caplets are scored, and contain 25 mg, 75 mg, or 100 mg of carprofen per caplet. Each caplet size is packaged in bottles containing 30, 60, or 180 caplets, or blister packs containing 4 caplets.
