Carprofen Caplets
Non-Steroidal Anti-Inflammatory Drug
Dechra Carprofen Caplets are 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.
Carprofen is a non-steroidal anti-inflammatory drug
(NSAID) of the propionic acid class that includes ibuprofen, naproxen,
and ketoprofen. Carprofen is a non-narcotic medication with analgesic and antipyretic
activity. The mechanism of action of carprofen, like that of other
NSAIDs, is believed to be associated with the inhibition of
cyclooxygenase activity.
DOSAGE AND ADMINISTRATION
Always provide Client Information Sheet with
prescription. Carefully consider the potential benefits and risk of
Carprofen Caplets and other treatment options before deciding to use
Carprofen Caplets. 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. Caplets are scored and
dosage should be calculated in half-caplet increments.
Warnings: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
CONTRAINDICATIONS
Carprofen Caplets should not be used in dogs exhibiting previous hypersensitivity to carprofen.
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. 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 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. The use of parenteral fluids during surgery should be considered to
reduce the potential risk of renal complications when using NSAIDs
perioperatively. Consider appropriate washout times when switching from
one NSAID to another or when switching from corticosteroid use to NSAID
use.
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 Carprofen
Caplets 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 effects varies with
the individual patient. Dogs that have experienced adverse reactions
from one NSAID may experience adverse reactions from another NSAID.
Carprofen treatment was not associated with renal toxicity or
gastrointestinal ulceration in well-controlled safety studies of up to
ten times the dose in healthy dogs.
Carprofen Caplets are 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
carprofen 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 carprofen 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.
ADVERSE REACTIONS
There were no serious adverse events reported during clinical field studies with once daily administration of 2 mg/lb. The following is a list of possible adverse reactions.
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.
Immunologic or hypersensitivity: Facial swelling, hives, erythema.
In rare situations, death has been associated with some of the adverse reactions listed above.
INFORMATION FOR DOG OWNERS
Carprofen, 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. Owners should be advised to
discontinue carprofen 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.
STORAGE
Store caplets at controlled room temperature 15°-30C (59°-86°F).
HOW SUPPLIED
Carprofen Caplets 25 mg
Bottles of 60
|
NDC 26637-531-60
|
Bottles of 180
|
NDC 17033-359-18
|
Carprofen Caplets 75 mg
Bottles of 60
|
NDC 26637-532-60
|
Bottles of 180
|
NDC 26637-532-18
|
Carprofen Caplets 100 mg
Bottles of 60
|
NDC 26637-533-60
|
Bottles of 180
|
NDC 26637-533-18
|
Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.