236


EQUINE VETERINARY EDUCATION / AE / MAY 2015


Murray, M.J., Ball, M.M. and Parker, G.A. (1988) Megaesophagus and aspiration pneumonia secondary to gastric ulceration in a foal. J. Am. Vet. Med. Ass. 192, 381-383.


Reichelt, U., Hamann, J. and Lischer, C. (2012) Balloon dilation of oesophageal strictures in two horses. Equine Vet. Educ. 24, 379- 384.


Rohrbach, B.W. and Rooney, J.R. (1980) Congenital esophageal ectasia in a Thoroughbred foal. J. Am. Vet. Med. Assoc. 177, 65-67.


Sams, A.E.,Weldon, A.D. and Rakestraw, P. (1993) Surgical treatment of intramural esophageal inclusion cysts in three horses. Vet. Surg. 22, 135-139.


Siersema, P.D. (2008) Treatment options for esophageal strictures. Nat. Clin. Pract. Gastroenterol. Hepatol. 5, 142-152.


Smith, T.R. (2004) Unusual vascular ring anomaly in a foal. Can. Vet. J. 45, 1016-1018.


Tutuian, R. and Castell, D.O. (2006) Esophageal motility disorders (distal esophageal spasm, nutcracker esophagus, and hypertensive lower esophageal sphincter): modern management. Curr. Treat. Options Gastroenterol. 9, 283-294.


van der Linde-Sipman, J.S., Goedegebuure, S.A. and Kroneman, J. (1979) Persistent right aortic arch associated with a persistent left ductus arteriosus and an interventricular septal defect in a horse. Vet. Q. 1, 189-194.


Wooldridge, A.A., Eades, S.C., Hosgood, G.L. and Moore, R.M. (2002) Effects of treatment with oxytocin, xylazine, butorphanol, guaifenesin, acepromazine, and detomidine on esophageal manometric pressure in conscious horses. Am. J. Vet. Res. 63, 1738-1744.


EQUIOXX®


(firocoxib) Oral Paste for Horses Non-steroidal anti-inflammatory drug for oral use in horses only.


Contraindications: Horses with hypersensitivity to firocoxib or other NSAIDs should not receive EQUIOXX®


control of pain and inflammation associated with osteoarthritis in horses. 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: Client 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 1-877- 217-3543.


Precautions: Horses should undergo a thorough history and physical examina- tion 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.


colic, abnormal feces, or lethargy are observed. Treatment with EQUIOXX® should be terminated if signs such as inappetence,


As a class, cyclooxygenase inhibitory NSAIDs may be associated with renal and gastrointestinal toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. 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


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


Oral Paste is administered for up to 14 days for the


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.


Oral Paste has not been studied in horses. The safe use of EQUIOXX® used for breeding, or in pregnant or lactating mares has not been evaluated.


Adverse Reactions: In controlled field studies, 127 horses (ages 3 to 37 years) were evaluated for safety when given EQUIOXX®


Adverse Reactions Seen In U.S. Field Studies EQUIOXX n=127


Oral Paste was safely used concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics, during the field studies.


EQUIOXX® (firocoxib)


Loose stool Polydipsia Urticaria


0 2 1 0 1 0 0


Adverse Reactions


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.


Abdominal pain Diarrhea Excitation Lethargy


1 0 0 1 0 1 1


Information for Owner or Person Treating Horse: You should give the 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,


Oral Paste at a dose


Active Control n=125


Oral Paste in horses less than one year in age, horses


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


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, concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored. The concomitant use of protein bound drugs with EQUIOXX®


tongue, lips and face, weight loss, colic, diarrhea, or icterus. Serious adverse reactions associated with this drug class can occur without warning and, in rare 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.


Effectiveness: 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 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 compared to an active control. At study’s end, 84.4% of horses treated with EQUIOXX were judged improved on veterinarians’ clinical assessment, and 73.8% were also rated improved by owners. Horses treated with EQUIOXX showed improvement in veterinarian-assessed lameness, pain on manipulation, range of motion, and joint swelling that was comparable to the active control.


Storage Information: Store below 86°F (30°C). Brief excursions up to 104°F (40°C) are permitted.


How Supplied: EQUIOXX is available in packs of 20, 72 and 216 individually- boxed syringes. Each syringe contains 6.93 grams of EQUIOXX® to treat a 1250 lb. horse.


paste, sufficient


Marketed by: Merial LLC, Duluth, GA 30096-4640 Made in Brazil For technical assistance or to report suspected adverse reactions, call 1-877-217- 3543. NADA 141-253, Approved by FDA ©2010 Merial. All Rights Reserved. U.S. Pat. No.: 5981576, 6020343


®EQUIOXX is a registered trademark of Merial.


© 2014 EVJ Ltd


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84