EQUIOXX: Product Information

EQUIOXX- firocoxib paste
Boehringer Ingelheim Animal Health USA Inc.

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

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

Description:

EQUIOXX® (firocoxib) belongs to the coxib class of non-narcotic, non-steroidal anti-inflammatory drugs (NSAIDs). Firocoxib is a white crystalline compound described chemically as 3-(cyclopropylmethoxy)-4-(4-(methylsulfonyl)phenyl)-5,5-dimethylfuranone. The empirical formula is C17 H20 O5 S, and the molecular weight is 336.4. The structural formula is shown below:

Picture of structural formulaPicture of structural formula

Indications:

EQUIOXX Oral Paste is administered for up to 14 days for the control of pain and inflammation associated with osteoarthritis in horses.

Dosage and Administration:

Always provide the Client Information Sheet with the prescription. The recommended dosage of EQUIOXX (firocoxib) for oral administration in horses is 0.045 mg/lb (0.1 mg/kg) of body weight once daily for up to 14 days. In target animal safety studies, toxicity was seen at the recommended dose when the duration of treatment exceeded 30 days. Each marking on the syringe will treat 250 pounds of body weight, and each notch corresponds to approximately a 50 lb weight increment. To deliver the correct dose, round the horse’s body weight up to the nearest 50 pound increment (if the body weight is an exact 50 pound increment, do not round up). EQUIOXX may be given with or without food.

1)
While holding plunger, turn the knurled ring on the plunger ¼ turn to the left and slide the knurled ring along the plunger shaft so that the side nearest the barrel is at the appropriate 50 lb weight notch, aligning the arrow on the plunger with the notch on the ring, as shown in the pictogram.
2)
Lock the ring in place by making ¼ turn to the right. Ensure it is locked (it should no longer slide).
Picture of syringe barrel

Contraindications:

Horses with hypersensitivity to firocoxib should not receive EQUIOXX Oral Paste.

Warnings:

For oral 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 ingestion by humans.

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

For technical assistance or to report suspected adverse events, call 1-888-637-4251.

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 Oral Paste with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. The concomitant use of protein bound drugs with EQUIOXX Oral Paste has not been studied in horses. The influence of concomitant drugs that may inhibit the metabolism of EQUIOXX Oral Paste has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. The safe use of EQUIOXX Oral Paste in horses less than one year in 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:

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.

Adverse Reactions Seen in U.S. Field Studies

EQUIOXX (firocoxib) Oral Paste was safely used concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics, during the field studies. The safety data sheet (SDS) contains more detailed occupational safety information.

To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or online at www.fda.gov/reportanimalae.

Adverse Reactions EQUIOXX
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

Information for Owner or Person Treating Horse:

You should give a Client Information Sheet to the person treating the horse and advise them of the potential for adverse reactions and the clinical signs associated with NSAID intolerance. Adverse reactions may include erosions and ulcers of the gums, tongue, lips and face, weight loss, colic, diarrhea, or icterus. Serious adverse reactions associated with this drug class can occur without warning and, in some situations, result in death. Clients should be advised to discontinue NSAID therapy and contact their veterinarian immediately if any of these signs of intolerance are observed. The majority of patients with drug-related adverse reactions recover when the signs are recognized, drug administration is stopped, and veterinary care is initiated.

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