Deramaxx

Deramaxx (deracoxib) is a non-narcotic, non-steroidal anti-inflammatory drug (NSAID) of the coxib class. Deramaxx tablets are round, biconvex, chewable tablets that contain deracoxib formulated with beefy flavoring. The molecular weight of deracoxib is 397.38. The empirical formula is C17-H14-F3-N3-O3-S. Deracoxib is 4-[3-(difluoromethyl)-5-(3-fluoro-4-methoxyphenyl)-1H-pyrazole-1-yl] benzenesulfonamide, and can be termed a diaryl substituted pyrazole. The structural formula is:

Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. For use in dogs only.

All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID is recommended. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions, Animal Safety and Post-Approval Experience) and be given an “Information for Dog Owners” Sheet.

Since NSAIDs possess the potential to produce gastrointestinal ulceration and/or perforation, concomitant use of Deramaxx tablets with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. As a class, NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Dogs that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for adverse events are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Plasma levels of deracoxib may increase in a greater than dose-proportional fashion above 8 mg/kg/day. Deramaxx tablets have been safely used during field studies in conjunction with other common medications, including heartworm preventatives, anthelmintics, anesthetics, pre-anesthetic medications, and antibiotics. If additional pain medication is needed after a daily dose of Deramaxx tablets, a non-NSAID/non-corticosteroid class of analgesic may be necessary. It is not known whether dogs with history of hypersensitivity to sulfonamide drugs will exhibit hypersensitivity to Deramaxx tablets. The safe use of DERMAXX tablets in dogs younger than 4 months of age, dogs used for breeding, or in pregnant or lactating dogs has not been evaluated.

NSAIDs may inhibit the prostaglandins which maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Appropriate monitoring procedures should be employed during all surgical procedures. The use of parenteral fluids during surgery should be considered to decrease potential renal complications when using NSAIDs perioperatively. Concurrent administration of potentially nephrotoxic drugs should be carefully approached.

The use of concomitantly protein-bound drugs with Deramaxx tablets has not been studied in dogs. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of Deramaxx tablets has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. Consider appropriate washout times when switching from one NSAID to another or when switching from corticosteroid use to NSAID use.

Deramaxx tablets were evaluated in masked, placebo-controlled multi-site field studies involving client-owned animals to determine effectiveness.

A total of 207 dogs of forty three (43) different breeds, 1-15 years old, weighing 7-141 lbs were included in the field safety analysis. The following table shows the number of dogs displaying each clinical observation.

1Dogs may have experienced more than one of the observations during the study.

This table does not include one dog that was dosed at 16.92 mg/kg/day for the study duration. Beginning on the last day of treatment, this dog experienced vomiting, diarrhea, increased water intake and decreased appetite. Hematology and clinical chemistry values were unremarkable. The dog recovered uneventfully within 3 days of cessation of dosing.

Incisional drainage was most prevalent in dogs enrolled at a single study site. There were no statistically significant changes in the mean values for hepatic or renal clinical pathology indices between Deramaxx tablet- and placebo-treated dogs. Four Deramaxx tablet-treated dogs and two placebo-treated dogs exhibited elevated bilirubin during the dosing phase. One Deramaxx tablet-treated dog exhibited elevated ALT, BUN and total bilirubin and a single vomiting event. None of the changes in clinical pathology values were considered clinically significant.

The results of this clinical study demonstrate that Deramaxx tablets, when administered daily for 7 days to control postoperative orthopedic pain and inflammation in dogs, are well tolerated.