Equioxx Injection

Name: Equioxx Injection

Equioxx® Injection (firocoxib)

Non-steroidal anti-inflammatory drug for intravenous use in horses only.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Warnings

For intravenous use in horses only. Do not use in horses intended for human consumption.

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.

Animal Safety

Clients should be advised to observe for signs of potential drug toxicity and be give a Client Information Sheet with each prescription.

For technical assistance or to report suspected adverse events, call 1-877-217-3543.

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. See Information for Owner or Person Treating Horse section of this package insert.

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 Injection with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided.

The concomitant use of protein bound drugs with Equioxx Injection for horses has not been studied in horses. The influence of concomitant drugs that may inhibit the metabolism of firocoxib Injection has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

The safe use of Equioxx Injection for horses has not been evaluated in horses less than one year of age, horses used for breeding, or in pregnant or lactating mares.

Consider appropriate washout times when switching from one NSAID to another NSAID or corticosteroid.

Mode of action

Firocoxib is a cyclooxygenase-inhibiting (coxib) class, non-narcotic, non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic activity1 in animal models. Based on in vitro horse data, firocoxib is a selective inhibitor of prostaglandin biosynthesis through inhibition of the inducible cyclooxygenase-2 isoenzyme (COX-2)2,3. Firocoxib selectivity for the constitutive isoenzyme, cyclooxygenase-1 (COX-1), is relatively low. However, the clinical significance of these in vitro selectivity findings has not been established.

Effectiveness

The effectiveness of Equioxx Injection was established in a biocomparability study evaluating EQUIOXX Oral Paste and Equioxx Injection. Thus, additional field studies were not performed to support the effectiveness of Equioxx Injection. Two hundred fifty-three client-owned horses of various breeds, ranging in age from 2 to 37 years and weighing from 595 to 1638 lbs, were randomly administered EQUIOXX Oral Paste or an active control drug in multi-center field studies. Two hundred forty horses were evaluated for effectiveness and 252 horses were evaluated for safety. Horses were assessed for lameness, pain on manipulation, range of motion, joint swelling, and overall clinical improvement in a non-inferiority evaluation of EQUIOXX Oral Paste compared to an active control. At study's end, 84.4% of horses treated with EQUIOXX Oral Paste were judged improved on veterinarians' clinical assessment, and 73.8% were also rated improved by owners. Horses treated with EQUIOXX Oral Paste showed improvement in veterinarian-assessed lameness, pain on manipulation, range of motion, and joint swelling that was comparable to the active control.

Storage

Store at 20-25°C with excursions between 15-30°C.

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