Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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 NSAlDs 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 NSAlDs 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. Since NSAIDs possess the potential to induce gastrointestinal ulcerations and/or gastrointestinal perforations, concomitant use carprofen and other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. If additional pain medication is needed after administration of the total daily dose of carprofen, a non-NSAID or non-corticosteroid class of analgesia should be considered. The use of another NSAID is not recommended. Sensitivity to drug-associated adverse reactions varies with the individual patient. Carprofen treatment was not associated with renal toxicity or gastrointestinal ulceration in well-controlled safety studies of up to ten times the dose in dogs.
Novox® Caplets is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrandís disease), as safety has not been established in dogs with these disorders. The safe use of Novox® Caplets in animals less than 6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not been established. 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.
If additional pain medication is warranted after administration of the total daily dose of Novox® Caplets, 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 corticosteroid use to NSAID use.
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).
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 NovoxÆ caplets 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.