Rederox: Product Information (Page 2 of 3)

Chewable Tablets

Information for Dog Owners:

Rederox Chewable Tablets, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include vomiting, diarrhea, decreased appetite, dark or tarry stools, increased water consumption, increased urination, anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. Serious adverse reactions associated with this drug class can occur without warning and in some cases result in death (see Warnings, Post-Approval Experience and Adverse Reactions). Owners should be advised to discontinue Rederox Chewable Tablets therapy and contact their veterinarian immediately if signs of intolerance are observed.

The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all dogs during administration of any NSAID.

Storage Conditions:

Rederox Chewable Tablets should be Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [see USP Controlled Room Temperature]

Keep this and all medications out of reach of children.

Use within 90 days of splitting.

How Supplied:

Rederox Chewable Tablets are available as 12 mg, 25 mg, 75 mg and 100 mg round, brownish, half-scored tablets in 30 and 90 count bottles.

NDC Number	Tablet Size	Tablets/Bottle
17033-235-30	12 mg	30
17033-235-90	12 mg	90
17033-236-30	25 mg	30
17033-236-90	25 mg	90
17033-237-30	75 mg	30
17033-237-90	75 mg	90
17033-238-30	100 mg	30
17033-238-90	100 mg	90

References:

¹

Data on file under NADA 141-203

²

Data on file under NADA 141-203

³

Smith, et al.: “Pharmacological Analysis of Cyclo-oxygenase-1 in Inflammation,” Proc. Natl. Acad. Sci. USA (October 1998) 95: 13313-13318, Pharmacology.

⁴

Zhang, et al.: “Inhibition of Cyclo-oxygenase-2 Rapidly Reverses Inflammatory Hyperalgesia and Prostaglandin E2 Production,”JPET , (1997) 283: 1069-1075.

⁵

Verburg, KM et al. “Cox-2 Specific Inhibitors: Definition of a New Therapeutic Concept.” Amer J of Therapeutics 8, 49-64, 2001.

⁶

Data on file under NADA 141-203

⁷

Holton, L., Reid, J., Scott, E.M., Pawson, P. and Nolan, A. (2001). Development of a behaviour-based scale to measure acute pain in dogs. Veterinary Record, 148, 525-53.

Approved by FDA under ANADA # 200-704

Distributed by:
Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA

Made in India
Neutral Code No. Drugs/TS/32/2008

Rederox™ is a trademark of Dechra Veterinary Products, LLC.
© 2021 Dechra Veterinary Products, LLC.

Rev. October 2021

Dechra

Rederox™ (deracoxib) Chewable Tablets

For Oral Use in Dogs Only
Do Not Use in Cats

Information for Dog Owners

Rederox™ (deracoxib) Chewable Tablets are for the control of pain and inflammation due to osteoarthritis or following orthopedic and dental surgery.

This summary contains important information about Rederox Chewable Tablets. You should read this information before starting your dog on Rederox Chewable Tablets. 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 Rederox Chewable Tablets.

What is Rederox Chewable Tablets?

Rederox Chewable Tablets are a prescription non-steroidal anti-inflammatory drug (NSAID) of the coxib class. They are indicated for the control of postoperative pain and inflammation associated with orthopedic (bone) and dental surgery in dogs and for the control of pain and inflammation (soreness) associated with osteoarthritis in dogs. The tablets are flavored to make administration more convenient.

What kind of results can I expect when my dog takes Rederox Chewable Tablets for postoperative orthopedic and dental pain and inflammation?

Rederox Chewable Tablets allow your dog to recover more comfortably by controlling pain and inflammation that follow orthopedic and dental surgery.

• The postoperative orthopedic pain dose is a higher dose; administration at this dose should not exceed 7 days total, including the days the patient is administered Rederox Chewable Tablets while in the hospital.
• Control of pain and inflammation may vary from dog to dog.
• If Rederox 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.

What kind of results can I expect when my dog takes Rederox Chewable Tablets for pain and inflammation due to osteoarthritis?

Osteoarthritis is a painful condition caused by damage to cartilage and other parts of the joint 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

While Rederox Chewable Tablets is not a cure for osteoarthritis, it can control the pain and inflammation of osteoarthritis and improve your dog’s mobility. Response may vary from dog to dog but can be quite dramatic. Rederox Chewable Tablets may need to be given on a periodic basis for the animal’s lifetime. Use the lowest dose to provide adequate relief. Always consult with your veterinarian before altering the dose.

What dogs should not take Rederox Chewable Tablets?

Your dog should not be given Rederox Chewable Tablets if s/he:

• Has had an allergic reaction to deracoxib, the active ingredient in Rederox Chewable Tablets
• 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 (unless directed by your veterinarian)
• Has bloody stool or vomit
• Has a pre-existing kidney or liver condition
• Has any condition predisposing to dehydration
• Is anorexic (loss of appetite)

Rederox Chewable Tablets should only be given to dogs. Do not use in cats.

People should not take Rederox Chewable Tablets. Keep Rederox Chewable Tablets and all medication out of reach of children. Call your physician immediately if you accidentally take Rederox Chewable Tablets.

What to discuss with your veterinarian before giving Rederox Chewable Tablets?

Tell your veterinarian about:

• Any side effects your dog has experienced from Rederox Chewable Tablets or other NSAIDs
• Any digestive upset (vomiting or diarrhea) your dog has had
• Any kidney disease your dog has had
• Any other medical problems or allergies that your dog has now or has had in the past
• All medications that you are giving your dog or plan to give your dog, including those you can get without prescription and any dietary supplements
• If you plan to breed your dog, or if your dog is pregnant or nursing

Talk to your veterinarian about:

• The orthopedic or dental surgery your dog will undergo
• What tests might be done before surgery is performed or Rederox Chewable Tablets are prescribed
• The signs of pain or inflammation that may occur after surgery
• Normal events that can be expected after your dog undergoes surgery
• The proper amount of exercise after surgery to aid recovery
• The signs of osteoarthritis you have observed (for example, limping or stiffness)
• The importance of weight control, physical therapy and exercise in the management of osteoarthritis
• How often your dog may need to be examined by your veterinarian
• The risks and benefits of using Rederox Chewable Tablets

How to give Rederox Chewable Tablets to your dog.

Rederox Chewable Tablets should be given according to your veterinarian’s instructions. Your veterinarian will tell you what amount of Rederox Chewable Tablets is right for your dog and for how long they should be given. Do not change the way you give Rederox Chewable Tablets to your dog without first speaking with your veterinarian. Rederox Chewable Tablets should be given by mouth and may be given with or without food, although with food is preferable.

What are the possible side effects that may occur in my dog during therapy with Rederox Chewable Tablets?

Rederox Chewable Tablets may cause some side effects in individual dogs. Serious side effects associated with this drug can occur with or without warning and, in some cases, result in death. The most common side effects associated with Rederox Chewable Tablets therapy involve the digestive tract (vomiting, decreased appetite and diarrhea). Liver and kidney problems have also been reported. It is important to stop the medication and contact your veterinarian immediately if you think your dog may have a medical problem or side effect while on Rederox Chewable Tablets. If you have additional questions about possible side effects, talk with your veterinarian or call Dechra at (866) 933-2472.

Look for the following side effects that may indicate that your dog is having a problem with Rederox Chewable Tablets or may have another medical problem:

• Vomiting
• Decrease in appetite
• Change in behavior, such as depression, restlessness, aggression or apprehension
• Change in bowel movements such as diarrhea or change in stool color (black, tarry or bloody stool)
• Change in drinking or urination
• Yellowing of gums, skin or whites of the eyes (jaundice)

Can Rederox Chewable Tablets be given with other medications?

Rederox Chewable Tablets should not be given with other non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (for example, aspirin, carprofen, etodolac, prednisone).

Tell your veterinarian about all medications that you have given your dog in the past, and any medications that you are planning to give with Rederox Chewable Tablets. This should include any medications that you can get without a prescription and any dietary supplements. Your veterinarian may want to evaluate the potential for any drug interactions and to assure drug compatibility.

What can I do in case my dog eats more than the prescribed amount of Rederox Chewable Tablets?

Contact your veterinarian immediately if your dog eats more than the prescribed amount of Rederox Chewable Tablets.

What else should I know about Rederox Chewable Tablets?

This sheet provides a summary of information about Rederox Chewable Tablets. If you have any questions or concerns about Rederox Chewable Tablets, postoperative orthopedic and dental pain and inflammation, or osteoarthritis, talk to your veterinarian.

As with all prescribed medications, Rederox Chewable Tablets should only be given to the dog for which they are prescribed. They should be given to your dog only for the condition for which they were prescribed, at the prescribed dose, as directed by your veterinarian. It is important to periodically discuss your dog’s response to Rederox Chewable Tablets at regular checkups. Your veterinarian will best determine if your dog is responding as expected and if your dog should continue receiving Rederox Chewable Tablets.

Keep Rederox in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Use within 90 days of splitting.

Approved by FDA under ANADA # 200-704

Distributed by:
Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA

Made in India
Neutral Code No. Drugs/TS/32/2008

Rederox™ is a trademark of Dechra Veterinary Products, LLC.
© 2021 Dechra Veterinary Products, LLC.

Rev. October 2021

Dechra