Prescription items are NON-RETURNABLE and NON REFUNDABLE Equioxx Tablet A non-steroidal, anti-inflammatory drug for the control of pain and inflammation associated with osteoarthritis in horses. Description: EQUIOXX (firocoxib) belongs to the coxib class of non-narcotic, non-steroidal anti-inflammatory drugs (NSAID). Firocoxib is a white crystalline compound described chemically as 3- (cyclopropylmethoxy)-4-(4-(methylsulfonyl)phenyl)-5, 5-dimethylfuranone. The empirical formula is C17H2O5S, and the molecular weight is 336.4 g/mol. The structural formula is shown to the right. Indications: EQUIOXX is indicated for the control of pain and inflammation associated with osteoarthritis in horses. Dosage and Administration: EQUIOXX Tablets can be used at a dosage of 0.045 mg/lb (0.1 mg/kg) body weight for up to an additional 9 days of treatment. Contraindications: Horses with hypersensitivity to firocoxib should not receive EQUIOXX. Warnings: EQUIOXX Tablets are for oral use in horses only. Keep EQUIOXX Tablets out of the reach of dogs and other pets in a secured location in order to prevent accidental ingestion or overdose. Human Warnings: Not for use in humans. Keep this and all medications out of the reach of children. Consult a physician in case of accidental human exposure or ingestion. Precautions: Horses should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data before and periodically during administration of any NSAID. Clients should be advised to observe for signs of potential drug toxicity and be given a Client Information Sheet with each prescription. Treatment with EQUIOXX should be terminated if signs such as inappetance, colic, abnormal feces, or lethargy are observed. As a class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal, and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Horses 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 diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached or avoided. NSAIDs may inhibit the prostaglandins that 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. Since many NSAIDs possess the potential to produce gastrointestinal ulcerations and/or gastrointestinal perforation, concomitant use of EQUIOXX with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. The concomitant use of protein bound drugs with EQUIOXX has not been studied in horses. The influence of concomitant drugs that may inhibit the metabolism of EQUIOXX has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. The safe use of EQUIOXX in horses less than one year of age, horses used for breeding, or in pregnant or lactating mares has not been evaluated. Consider appropriate washout times when switching from one NSAID to another NSAID or corticosteroid. Adverse Reactions: The safety and effectiveness of EQUIOXX Tablets was supported by a relative bioavailability study comparing EQUIOXX Tablets to the EQUIOXX Oral Paste (See Clinical Pharmacology section), in addition to pharmacovigilance information, and target animal safety data for existing firocoxib-containing products in horses. The effectiveness of EQUIOXX Injection was established in a biocomparability study demonstrating that EQUIOXX Oral Paste is bioequivalent to EQUIOXX Injection. Thus additional studies were not performed to support the effectiveness of EQUIOXX Injection or Tablets, nor were additional studies conducted to support safety of EQUIOXX Tablets. The safety of EQUIOXX Injection was established through a target animal safety study of EQUIOXX Injection administered IV followed by EQUIOXX Oral Paste In controlled field studies, 127 horses (ages 3 to 37 years) were evaluated for safety when given EQUIOXX Oral Paste at a dose of 0.045 mg/lb (0.1 mg/kg) orally once daily for up to 14 days. The following adverse reactions were observed. Horses may have experienced more than one of the observed adverse reactions during the study. Store between 59-86°F (15-30°C) with brief excursions up to°F (40°C) permitted.
