Firocoxib Tablets for Horses

How to Order Prescriptions

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Description

Firocoxib Tablets for Horses are administered once daily for up to 14 days for the control of pain and inflammation associated with osteoarthritis in horses.

Dosage and Administration

The recommended dosage of Firocoxib Tablets for Horses is one 57 mg tablet administered orally to horses weighing 800-1300 lbs, once daily for up to 14 days. For ease of administration, Tablets for Horses may be given with food. 

Contraindications

Horses with a hypersensitivity to firocoxib should not receive Firocoxib Tablets for Horses.

Warnings

For use in horses only. Do not use in horses intended for human consumption. Store Firocoxib Tablets for Horses out of the reach of dogs and other pets in a secured location in order to prevent ingestion or overdose. 

Precautions

Horses should undergo a thorough history and 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 Firocoxib Tablets for Horses should be terminated if signs such as inappetence, 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 ulcerations and/or gastrointestinal perforation, concomitant use of Firocoxib Tablets for Horses with other inflammatory drugs, such as NSAIDs or should be avoided. 

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

The safe use of Firocoxib Tablets for Horses in horses in 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 firocoxib tablets were established in a relative bioavailability study comparing firocoxib tablets and firocoxib tablets. 

In controlled field studies, 127 horses (ages 3 to 37) were evaluated for safety when given 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 more than one of the observed adverse reactions during the study.

Adverse Reactions	Firocoxib       n = 127	Active Control n = 125
Abdominal pain	0	1
Diarrhea	2	0
Excitation	1	0
Lethargy	0	1
Loose stool	1	0
Polydipsia	0	1
Urticaria	0	1

In these field trials, firocoxib oral paste was safely used concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics. The safety data sheet (SDS) contains more detailed occupational safety information. 

Effectiveness

The effectiveness of firocoxib tablets were established in a relative bioavailability study comparing firocoxib tablets and firocoxib oral paste. Therefore, additional studies were not performed to support the effectiveness of firocoxib tablets. Two hundred fifty-three client-owned horses of various breeds, ranging in age 2 to 37 years and weighing from 595 to 1638 lbs, were randomly administered firocoxib 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 motion, joint swelling, and overall clinical improvement in a non-inferiority evaluation of firocoxib oral paste compared to an active control. At study's end, 84.4% of horses treated with firocoxib oral paste were judged improved on veterinarians' clinical assessment, and 73.8% were also rated improved by owners. Horses treated with firocoxib 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 controlled room temperature 20-25ºC (68-77ºF), excursions permitted between 15-40ºC (59-104ºF).