PREVICOX: Product Information (Page 2 of 4)

Orthopedic Surgery

In a controlled field study evaluating orthopedic postoperative pain and inflammation, 226 dogs of various breeds, ranging in age from 1 to 11.9 years in the PREVICOX-treated groups and 0.7 to 17 years in the control group were evaluated for safety. Of the 226 dogs, 118 were given PREVICOX Chewable Tablets at a dose of 2.27 mg/lb (5.0 mg/kg) orally approximately 2 hours prior to surgery and once daily thereafter for a total of three days. The following adverse reactions were observed. Dogs may have experienced more than one of the observed reactions during the study.

Adverse Reactions Seen in the Orthopedic Surgery Postoperative Pain Field Study
Adverse Reactions Firocoxib Group n=118 Control Group * n=108
A case may be represented in more than one category.
*
Sham-dosed (pilled).
One dog had hemorrhagic gastroenteritis.
Vomiting 1 0
Diarrhea 2 1
Bruising at Surgery Site 2 3
Inappetence/Decreased Appetite 1 2
Pyrexia 0 1
Incision Swelling, Redness 9 5
Oozing Incision 2 0

Post-Approval Experience (Rev. 2009)

The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system:

Gastrointestinal: vomiting, anorexia, diarrhea, melena, gastrointestinal perforation, hematemesis, hematachezia, weight loss, gastrointestinal ulceration, peritonitis, abdominal pain, hypersalivation, nausea

Urinary: elevated BUN, elevated creatinine, polydypsia, polyuria, hematuria, urinary incontinence, proteinuria, kidney failure, azotemia, urinary tract infection

Neurological/Behavioral/Special Sense: depression/lethargy, ataxia, seizures, nervousness, confusion, weakness, hyperactivity, tremor, paresis, head tilt, nystagmus, mydriasis, aggression, uveitis

Hepatic: elevated ALP, elevated ALT, elevated bilirubin, decreased albumin, elevated AST, icterus, decreased or increased total protein and globulin, pancreatitis, ascites, liver failure, decreased BUN

Hematological: anemia, neutrophilia, thrombocytopenia, neutropenia

Cardiovascular/Respiratory: tachypnea, dyspnea, tachycardia

Dermatologic/Immunologic: pruritis, fever, alopecia, moist dermatitis, autoimmune hemolytic anemia, facial/muzzle edema, urticaria

In some cases, death has been reported as an outcome of the adverse events listed above.

For a complete listing of adverse reactions for firocoxib reported to the CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055394.htm

Information For Dog Owners

PREVICOX, 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 vomiting, diarrhea, decreased appetite, 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 (see Adverse Reactions). Owners should be advised to discontinue PREVICOX 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.

Clinical Pharmacology

Mode of action

PREVICOX (firocoxib) is a cyclooxygenase-inhibiting (coxib) class, non-narcotic, non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic properties. There are two main cyclooxygenase enzymes, COX-1 and COX-2, and a newly discovered third enzyme, COX-3, which has yet to be fully characterized.1 Cyclooxygenase-1 (COX-1) is the enzyme responsible for facilitating constitutive physiologic processes, e.g., platelet aggregation, gastric mucosal protection, and renal perfusion.2 It also is constitutively expressed in the brain, spinal cord, and reproductive tract.3 Cyclooxygenase-2 (COX-2) is responsible for the synthesis of inflammatory mediators, but it is also constitutively expressed in the brain, spinal cord and kidneys.4, 5, 6 Cyclooxygenase-3 (COX-3) is also constitutively expressed in the canine and human brain and also the human heart.7 Results from in vitro studies showed firocoxib to be highly selective for the COX-2 enzyme when canine blood was exposed to drug concentrations comparable to those observed following a once daily 5 mg/kg oral dose in dogs.8 However, the clinical significance of these findings has not been established.

Effectiveness

Two hundred and forty-nine dogs of various breeds, ranging in age from 11 months to 20 years, and weighing 13 to 175 lbs, were randomly administered PREVICOX or an active control drug in two field studies. Dogs were assessed for lameness, pain on manipulation, range of motion, joint swelling, and overall improvement in a non-inferiority evaluation of PREVICOX compared with the active control. At the study’s end, 87% of the owners rated PREVICOX-treated dogs as improved. Eighty-eight percent of dogs treated with PREVICOX were also judged improved by the veterinarians. Dogs treated with PREVICOX showed a level of improvement in veterinarian-assessed lameness, pain on palpation, range of motion, and owner-assessed improvement that was comparable to the active control. The level of improvement in PREVICOX-treated dogs in limb weight bearing on the force plate gait analysis assessment was comparable to the active control.

In a separate field study, two hundred fifty-eight client-owned dogs of various breeds, ranging in age from 10.5 weeks to 16 years and weighing from 7 to 168 lbs, were randomly administered PREVICOX or a control (sham-dosed-pilled) for the control of postoperative pain and inflammation associated with soft-tissue surgical procedures such as abdominal surgery (e.g. ovariohysterectomy, abdominal cryptorchidectomy, splenectomy, cystotomy) or major external surgeries (e.g. mastectomy, skin tumor removal ≥8 cm). The study demonstrated that PREVICOX treated dogs had significantly lower need for rescue medication than the control (sham-dosed-pilled) in controlling postoperative pain and inflammation associated with soft-surgery.

A multi-center field study with 226 client-owned dogs of various breeds, and ranging in age from 1 to 11.9 years in the PREVICOX-treated groups and 0.7 to 17 years in the control group was conducted. Dogs were randomly assigned to either the PREVICOX or the control (sham-dosed-pilled) group for the control of postoperative pain and inflammation associated with orthopedic surgery. Surgery to repair a ruptured cruciate ligament included the following stabilization procedures: fabellar suture and/or imbrication, fibular head transposition, tibial plateau leveling osteotomy (TPLO), and ‘over the top’ technique. The study (n = 220 for effectiveness) demonstrated that PREVICOX-treated dogs had significantly lower need for rescue medication than the control (sham-dosed-pilled) in controlling postoperative pain and inflammation associated with orthopedic surgery.

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