Rimadyl Injectable (Carprofen)
The injectable formulation of Rimadyl (carprofen 50 mg/mL) is for SQ use in dogs only.
Carprofen, an NSAID of the propionic acid class, 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.
IMADYL®
Zoetis
(carprofen)
Sterile Injectable Solution
50 mg/mL
Non-steroidal anti-inflammatory drug
For subcutaneous use in dogs only
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION: Rimadyl Injectable is a sterile solution containing carprofen, a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid class that includes ibuprofen, naproxen, and ketoprofen. Carprofen is the non-proprietary designation for a substituted carbazole, 6-chloro-α-methyl-9H-carbazole-2-acetic acid. The empirical formula is C15H12CINO2 and molecular weight 273.72.
The chemical structure of carprofen is:
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.
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 human exposure. 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 for the caplet formulation, 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 with once daily oral 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
|
Rimadyl (n=129)
|
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
|
Clinical pathology parameters listed represent reports of increases from pre-treatment values; the use of clinical judgement is necessary to determine clinical relevance (refers also to table below).
There were no serious adverse events reported during clinical field studies for the injectable formulation. The following categories of abnormal health observations were reported. Saline served as placebo control.
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Percentage of Dogs with Abnormal Health Observations Reported in Clinical Pain Field Studies with the Injectable
|
|
Observation*
|
Rimadyl (n=168)
|
Placebo (n=163)
|
|
Vomiting
|
10.1
|
9.2
|
|
Diarrhea/soft stool
|
2.4
|
3.7
|
|
Dermatitis
|
0.6
|
1.2
|
|
Dysrhythmia
|
0.6
|
0.6
|
|
Swelling
|
0
|
1.2
|
|
Dehiscence
|
1.2
|
0
|
|
WBC increase
|
13.7
|
6.7
|
* A single dog may have experienced more than one occurrence of an event.
Post-Approval Experience:
STORAGE: Store 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 Injectable is supplied in 20-mL, amber, glass, sterile, multi-dose vials.
