Firocoxib

Indications

EquiCoxib Oral Solution 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 EquiCoxib (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. Only administer EquiCoxib with the provided dosing syringe. Each 1.25 mL volume will treat 250 pounds of body weight and each additional 0.25 mL volume corresponds to approximately a 50 lb weight increment. The provided dosing syringe is calibrated so that each line corresponds to a 50 lb weight increment. To deliver the correct dose, round the horse's body weight up to the nearest 50 pound increment (if body weight is an exact 50 pound increment, do not round up). FOR ORAL USE ONLY. DO NOT INJECT EQUICOXIB. ONLY ADMINISTER WITH THE PROVIDED DOSING SYRINGE. EquiCoxib Oral Dosing Guide Body Weight (lb) Dose Volume (mL) 250 1.25 mL 500 2.5 mL 750 3.75 mL 1000 5 mL 1250 6.25 mL 1) Remove draw-off cap. Peel off the foil-backed seal from the bottle. 2) Screw the draw-off cap tightly back on the bottle. 3) Remove the seal from the top of the cap exposing the cross-hatched opening in the center of the silicone liner. 4) Remove the provided oral dosing syringe from its plastic cover. 5) Insert the oral dosing syringe firmly into the cross-hatched opening of the caps silicone liner. 6) Turn the bottle with attached syringe upside down. Pull back the syringe plunger until the widest portion of the plunger lines up with the line that corresponds with the animals weight. Each line between the 250 lb increments corresponds to 50 lb. 7) Turn the bottle with attached syringe right side up and separate the dosing syringe from the bottle. 8) Give orally according to your veterinarians instructions. DO NOT INJECT. Syringe Dosing

Contraindications

Horses with hypersensitivity to firocoxib should not receive EquiCoxib Oral Solution.

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. Wash hands with soap and water after use. 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. Keep EquiCoxib in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Aurora Pharmaceutical at 1-888-215-1256 or www.aurorapharmaceutical.com. 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.

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 EquiCoxib 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 EquiCoxib Oral Solution with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. The concomitant use of protein bound drugs with EquiCoxib Oral Solution has not been studied in horses. The influence of concomitant drugs that may inhibit the metabolism of EquiCoxib Oral Solution has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. The safe use of EquiCoxib Oral Solution 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 firocoxib 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 Firocoxib 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 Aurora Pharmaceutical Inc. at 1-888-215-1256 or www.aurorapharmaceutical.com. 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 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 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. Clinical Pharmacokinetics / Pharmacodynamics: Pharmacokinetics: When administered as a 0.045 mg/lb (0.1 mg/kg) dose in oral paste to adult horses with normal access to roughage, feed, and water, the absolute bioavailability of firocoxib from oral paste is approximately 79%. Following oral administration, drug peak concentration (Cmax) of 0.08 mcg/mL can be reached at 4 hours (Tmax) post-dosing. However, in some animals, up to 12 hours may be needed before significant plasma concentrations are observed. Little drug amount distributes into blood cells. The major metabolism mechanism of firocoxib in the horse is decyclopropylmethylation followed by glucuronidation of that metabolite. Based upon radiolabel studies, the majority of firocoxib is eliminated in the urine as the decyclopropylmethylated metabolite. Despite a high rate of plasma protein binding (98%), firocoxib exhibits a large volume of distribution (mean Vd(ss) = 1652 mL/kg). The terminal elimination half-life (T 1/2 ) in plasma averages 30-40 hours after IV or oral paste dosing. Therefore, drug accumulation occurs with repeated dose administrations and steady state concentrations are achieved beyond 6-8 daily oral doses in the horse. Dose linearity exists from 1X-2X of 0.1 mg/kg/day. Mode of action: EquiCoxib (firocoxib) is a cyclooxygenase-inhibiting (coxib) class, non-narcotic, non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic activity 1 in animal models. Based on in vitro horse data, firocoxib is a selective inhibitor of prostaglandin biosynthesis through inhibition of inducible cyclooxygenase-2-isoenzyme (COX-2) 2 . 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.

Description

EquiCoxib  (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 C 17 H 20 O 5 S, and the molecular weight is 336.4. The structural formula is shown below: Firocoxib structure image

Storage

Store below 77°F (25°C). Brief excursions up to 104°F (40°C) are permitted.

Other labels for this ingredient

These labels are also stored for the same active ingredient. They are not identical to the one reprinted above, and each is listed by product and set id rather than merged with it.

• Firocoxib Chewable Tablets for Dogs, Pegasus Laboratories, Inc.. Set id 62d8df49-5c1a-4944-a924-89388d8e22f2.
• Firocoxib Chewable Tablets for Dogs, Pegasus Laboratories, Inc.. Set id f456b173-3ddd-499b-9993-929ff5f7b875.
• covetrus® Firocoxib Chewable Tablets For oral use in dogs only., BUTLER ANIMAL HEALTH SUPPLY, LLC dba COVETRUS NORTH AMERICA. Set id 84316ce3-5985-4a3b-9bc0-a789a9e9e8b1.
• PREVICOX ® (firocoxib) Chewable Tablets, Boehringer Ingelheim Animal Health USA Inc. Set id 73ab8cac-5735-4e80-8fef-01c424939ab4.
• MWI/VetOne Norbrook Laboratories Limited OstiCoxib FIROCOXIB FIROCOXIB FIROCOXIB beige to brown speckled ROUND 57 LIVER OstiCoxib FIROCOXIB FIROCOXIB FIROCOXIB beige to brown speckled ROUND 227 LIVER Please scan this QR code to access the Client Information sheet OstiCoxib™ (firocoxib) Chewable Tablets For oral use in dogs only. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. QR Code Description:, MWI/VetOne. Set id fb488077-abbe-4b5f-b43c-229ef314f25e.
• PREVICOX ® (firocoxib) Chewable Tablets, Boehringer Ingelheim Animal Health USA Inc. Set id e6d96ec6-04a4-4986-ac9d-82aa79b28bd4.
• FLEXIRA ™ (firocoxib), Aspen Veterinary Resources. Set id b2fa6b63-1ed1-4185-b287-fc5644bd4f73.
• Firocoxib Chewable Tablets For oral use in dogs only., FELIX PHARMACEUTICALS PRIVATE LIMITED. Set id 1631a313-c681-46cb-ae5b-871cea54219b.
• Firocoxib Chewable Tablets For oral use in dogs only., BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA. Set id f0a3c881-524a-4c6a-bbe9-ef74a782ff8c.
• Firox™ (firocoxib), Norbrook Laboratories Limited. Set id 42186833-4581-4c7e-876f-6ffe37b1f94b.
• OstiCoxib® (firocoxib chewable tablets) For oral use in dogs only., MWI/Vetone. Set id dcd2ac5e-a42b-4fcc-ab0a-0cef02de1560.
• Firocoxib Tablets for Horses 57 mg, FELIX PHARMACEUTICALS PRIVATE LIMITED. Set id 6010712b-84a6-4dd4-9fa2-9c4032f24c6e.
• Firocoxib Tablets for Horses 57 mg, BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA. Set id 96dd012c-9b0c-47f8-b56d-d536304f309f.
• OstiCoxib™ EQ (Firocoxib Tablets for Horses) 57 mg, MWI/Vetone. Set id e5516161-2fbc-4cec-a780-77a471fa73d4.
• Firocoxib Tablets for Horses, Pegasus Laboratories, Inc.. Set id 212741ad-0a21-438f-a108-36afb1d507e0.
• Equioxx ® (firocoxib) Tablets 57 mg, Boehringer Ingelheim Animal Health USA Inc.. Set id 3f891a61-ce58-4cc1-97e2-a161907ea8eb.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming firocoxib as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.