PREVICOX: Product Information (Page 3 of 4)

Palatability

PREVICOX Chewable Tablets were rated both convenient to administer (97.2%) and palatable to the dog (68.5%) by owners in multi-center field studies involving client-owned dogs of various breeds and sizes.

Animal Safety

In a target animal safety study, firocoxib was administered orally to healthy adult Beagle dogs (eight dogs per group) at 5, 15, and 25 mg/kg (1, 3, and 5 times the recommended total daily dose) for 180 days. At the indicated dose of 5 mg/kg, there were no treatment related adverse events. Decreased appetite, vomiting, and diarrhea were seen in dogs in all dose groups, including unmedicated controls, although vomiting and diarrhea were seen more often in dogs in the 5X dose group. One dog in the 3X dose group was diagnosed with juvenile polyarteritis of unknown etiology after exhibiting recurrent episodes of vomiting and diarrhea, lethargy, pain, anorexia, ataxia, proprioceptive deficits, decreased albumin levels, decreased and then elevated platelet counts, increased bleeding times, and elevated liver enzymes. On histopathologic examination, a mild ileal ulcer was found in one 5X dog. This dog also had a decreased serum albumin which returned to normal by study completion. One control and three 5X dogs had focal areas of inflammation in the pylorus or small intestine. Vacuolization without inflammatory cell infiltrates was noted in the thalamic region of the brain in three control, one 3X, and three 5X dogs. Mean ALP was within the normal range for all groups but was greater in the 3X and 5X dose groups than in the control group. Transient decreases in serum albumin were seen in multiple animals in the 3X and 5X dose groups, and in one control animal.

In a separate safety study, firocoxib was administered orally to healthy juvenile (10-13 weeks of age) Beagle dogs at 5, 15, and 25 mg/kg (1, 3, and 5 times the recommended total daily dose) for 180 days. At the indicated (1X) dose of 5 mg/kg, on histopathologic examination, three out of six dogs had minimal periportal hepatic fatty change. On histopathologic examination, one control, one 1X, and two 5X dogs had diffuse slight hepatic fatty change. These animals showed no clinical signs and had no liver enzyme elevations. In the 3X dose group, one dog was euthanized because of poor clinical condition (Day 63). This dog also had a mildly decreased serum albumin. At study completion, out of five surviving and clinically normal 3X dogs, three had minimal periportal hepatic fatty change. Of twelve dogs in the 5X dose group, one died (Day 82) and three moribund dogs were euthanized (Days 38, 78, and 79) because of anorexia, poor weight gain, depression, and in one dog, vomiting. One of the euthanized dogs had ingested a rope toy. Two of these 5X dogs had mildly elevated liver enzymes. At necropsy all five of the dogs that died or were euthanized had moderate periportal or severe panzonal hepatic fatty change; two had duodenal ulceration; and two had pancreatic edema. Of two other clinically normal 5X dogs (out of four euthanized as comparators to the clinically affected dogs), one had slight and one had moderate periportal hepatic fatty change. Drug treatment was discontinued for four dogs in the 5X group. These dogs survived the remaining 14 weeks of the study. On average, the dogs in the 3X and 5X dose groups did not gain as much weight as control dogs. Rate of weight gain was measured (instead of weight loss) because these were young growing dogs. Thalamic vacuolation was seen in three of six dogs in the 3X dose group, five of twelve dogs in the 5X dose group, and to a lesser degree in two unmedicated controls. Diarrhea was seen in all dose groups, including unmedicated controls.

In a separate dose tolerance safety study involving a total of six dogs (two control dogs and four treated dogs), firocoxib was administered to four healthy adult Beagle dogs at 50 mg/kg (ten times the recommended daily dose) for twenty-two days. All dogs survived to the end of the study. Three of the four treated dogs developed small intestinal erosion or ulceration. Treated dogs that developed small intestinal erosion or ulceration had a higher incidence of vomiting, diarrhea, and decreased food consumption than control dogs. One of these dogs had severe duodenal ulceration, with hepatic fatty change and associated vomiting, diarrhea, anorexia, weight loss, ketonuria, and mild elevations in AST and ALT. All four treated dogs exhibited progressively decreasing serum albumin that, with the exception of one dog that developed hypoalbuminemia, remained within normal range. Mild weight loss also occurred in the treated group. One of the two control dogs and three of the four treated dogs exhibited transient increases in ALP that remained within normal range.

Storage

Store at room temperature, between 59°–86° F (15°–30° C). Brief periods up to 104° F (40° C) are permitted.

To Request a Material Safety Data Sheet (MSDS), call 1-877-217-3543.

How Supplied

PREVICOX is available as round, beige to tan, half-scored tablets in two strengths, containing 57 mg or 227 mg firocoxib. Each tablet strength is supplied in 3 count, 10 count and 30 count blister packages and 60 count and 180 count bottles.

1
Willoughby DA, Moore AR and Colville-Nash PR. COX-1, COX-2, and COX-3 and the future treatment of chronic inflammatory disease. Lancet 2000;355:646-648.
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Smith, et al., Pharmacological Analysis of Cyclo-oxygenase-1 in Inflammation. Proc. Natl. Acad. Sci. USA, Pharmacology 1998;95:13313-13318.
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Jones CJ and Budsberg SC. Physiologic characteristics and clinical importance of the cyclooxygenase isoforms in dogs and cats. JAVMA 2000;217(5):721-729.
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Zhang, et al., Inhibition of Cyco-oxygenase-2 Rapidly Reverses Inflammatory Hyperalgesia and Prostaglandin E2 Production. JPET 1997;283:1069-1075.
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Jones and Budsberg, pp. 721-729.
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Zhang, et al., pp. 1069-1075.
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Chandrasekharan NV, Dai H, et al. COX-3, a cyclooxygenase-1 variant inhibited by acetaminophen and other analgesic/antipyretic drugs: Cloning, structure and expression. Proc. Natl. Acad. Sci. USA , 2002;99(21):13926-13931.
8
Data on file.

Made in France
Marketed by: Merial Limited, Duluth, GA 30096-4640, USA.
1-877-217-3543
NADA 141-230, Approved by FDA
©2012 Merial. All Rights Reserved.
®PREVICOX is a registered trademark of Merial.

Rev. 03-2012

053 904627

Information for Dog Owners about PREVICOX® (firocoxib) Chewable Tablets

PREVICOX Chewable Tablets are used for the control of pain and inflammation due to osteoarthritis or associated with soft-tissue and orthopedic surgery in your dog.

This summary contains important information about PREVICOX. You should read this information before you start giving your dog PREVICOX tablets and review it each time your prescription is refilled. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or you want to know more about PREVICOX.

What is PREVICOX?

PREVICOX is a veterinary prescription non-steroidal anti-inflammatory drug (NSAID) used to control pain and inflammation due to osteoarthritis, or associated with soft-tissue and orthopedic surgery in dogs.

Osteoarthritis is a painful condition caused by “wear and tear” of cartilage and other parts of the joints that may result in the following changes or signs in your dog:

  • Limping or lameness.
  • Decreased activity or exercise (reluctance to stand, climb stairs, jump or run, or difficulty in performing these activities).
  • Stiffness or decreased movement of joints.

PREVICOX is indicated for the control of postoperative pain and inflammation following soft-tissue and orthopedic surgeries (e.g. spays, cruciate ligament repair). Your veterinarian may administer PREVICOX before the procedure and recommend that the dog be treated for a few days after going home.

What kind of results can I expect when my dog is on PREVICOX for osteoarthritis?

While PREVICOX is not a cure for osteoarthritis, it can control the pain and inflammation and improve your dog’s mobility.

  • Response varies from dog to dog, but improvement can be quite dramatic.
  • In most dogs, improvement can be seen within days.
  • If PREVICOX is discontinued or not given as directed, your dog’s pain and inflammation may return.

What kind of results can I expect when my dog is on PREVICOX for the control of pain and inflammation following soft-tissue and orthopedic surgery?

  • PREVICOX Chewable Tablets allow your dog to recover more comfortably by controlling pain and inflammation following soft-tissue and orthopedic surgery.
  • Control of pain and inflammation may vary from dog to dog.
  • If PREVICOX Chewable Tablets are not given according to your veterinarian’s directions, your dog’s pain may return.
  • Consult your veterinarian if your dog appears to be uncomfortable.

Which dogs should not take PREVICOX?

Your dog should not be given PREVICOX if he/she:

  • Has an allergic reaction to firocoxib, the active ingredient in PREVICOX.
  • Has had an allergic reaction (such as hives, facial swelling, or red or itchy skin) to aspirin or other NSAIDs.
  • Is presently taking aspirin, other NSAIDs, or corticosteroids.
  • Is under 12.5 pounds in body weight.
  • Has pre-existing kidney or liver disease.
  • Has decreased appetite, vomiting or diarrhea.

PREVICOX should only be given to dogs.

People should not take PREVICOX. Keep PREVICOX and all medications out of the reach of children. Call your physician immediately if you accidentally take PREVICOX.

What to tell/ask your veterinarian before giving PREVICOX.

Talk to your veterinarian about:

  • The signs of osteoarthritis you have observed in your dog, such as limping or stiffness.
  • The importance of weight control in the management of osteoarthritis.
  • What tests might be done before PREVICOX is prescribed.
  • How often your dog may need to be examined by your veterinarian.
  • The risks and benefits of using PREVICOX. Serious adverse reactions, including death, have been associated with PREVICOX administration at doses above the recommended dose in puppies less than seven months of age.

Tell your veterinarian if your dog is currently experiencing or has ever had the following medical problems:

  • Any side effects from taking PREVICOX or other NSAIDs, such as aspirin.
  • Any digestive upset (vomiting and/or diarrhea).
  • Any kidney disease.
  • Any liver disease.

Tell your veterinarian about:

  • Any other medical problems or allergies that your dog has now, or has had in the past.
  • All medicines that you are giving or plan to give to your dog, including those you can get without a prescription and any dietary supplements.

Tell your veterinarian if your dog:

  • Is under 7 months of age.
  • Is pregnant, nursing or if you plan to breed your dog.

How to give PREVICOX to your dog.

PREVICOX should be given according to your veterinarian’s instructions. Do not change the way you give PREVICOX to your dog without first speaking with your veterinarian. Your veterinarian will tell you what amount of PREVICOX is right for your dog and for how long it should be given. Most dogs will take PREVICOX Chewable Tablets from your hand, or you can place the tablet in your dog’s mouth. PREVICOX may be given with or without food.

What are the possible side effects that may occur in my dog during PREVICOX therapy?

PREVICOX, like other NSAIDS, may cause some side effects. Serious side effects associated with NSAID therapy in dogs can occur with or without warning, and, in rare situations, result in death. The most common side effects associated with PREVICOX therapy involve the digestive tract (vomiting and decreased food consumption). Liver and kidney problems have also been reported with NSAIDs. Look for the following side effects that may indicate your dog is having a problem with PREVICOX:

  • Decrease or increase in appetite.
  • Vomiting.
  • Change in bowel movements (such as diarrhea, or black, tarry or bloody stools).
  • Change in behavior (such as decreased or increased activity level, incoordination, seizure, or aggression).
  • Yellowing of gums, skin, or whites of the eyes (jaundice).
  • Change in drinking habits (frequency or amount consumed).
  • Change in urination habits (frequency, color, or smell).
  • Change in skin (redness, scabs, or scratching).
  • Unexpected weight loss.

It is important to stop the medication and contact your veterinarian immediately if you think your dog has a medical problem or side effect while taking PREVICOX tablets. If you have additional questions about possible side effects, talk with your veterinarian or call 1-877-217-3543.

Can PREVICOX be given with other medications?

PREVICOX should not be given with other NSAIDs (for example, aspirin, carprofen, etodolac, deracoxib, meloxicam, or tepoxalin) or corticosteroids (for example, prednisone, cortisone, dexamethasone, or triamcinolone).

Tell your veterinarian about all medications that you have given your dog in the past, and any medications you are planning to give with PREVICOX tablets. This should include other medicines that you can get without a prescription or any dietary supplements. Your veterinarian may want to check that all of your dog’s medicines can be given together.

What do I do in case my dog eats more than the prescribed amount of PREVICOX?

Consult your veterinarian immediately if your dog eats more than the prescribed amount of PREVICOX.

What else should I know about PREVICOX?

  • This sheet provides a summary of information about PREVICOX tablets. If you have any questions or concerns about PREVICOX, osteoarthritis pain, or postoperative pain following soft-tissue and orthopedic surgery, talk with your veterinarian.
  • As with all prescribed medicines, PREVICOX tablets should only be given to the dog for which they were prescribed. They should be given to your dog only for the condition for which they were prescribed, at the prescribed dose.
  • It is important to periodically discuss your dog’s response to PREVICOX tablets. Your veterinarian will determine if your dog is responding as expected and if your dog should continue receiving PREVICOX tablets.

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

NADA 141-230, Approved by FDA
©2012 Merial. All Rights Reserved.
®PREVICOX is a registered trademark of Merial.

Rev. 03-2012

Page 3 of 4 1 2 3 4

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