003-047-60

Deramaxx 75mg 60 ct

Deramaxx 75mg 60 chewable tablets

For Oral Use In Dogs Only

Description: DERAMAXX (deracoxib) is a non-narcotic, non-steroidal anti-inflammatory drug of the coxib class. DERAMAXX tablets are round, biconvex, chewable tablets that contain deracoxib formulated with beefy flavoring. The molecular weight of deracoxib is 397.38. The empirical formula is C17-H14-F3-N3-O3-S. Deracoxib is 4-[3-(difluoromethyl)-5-(3-fluoro-4-methoxyphenyl)-1H-pyrazole-1-yl] benzenesulfonamide, and can be termed a diaryl substituted pyrazole.

 

Indications and Usage:
Osteoarthritis Pain and Inflammation:
DERAMAXX Chewable Tablets are indicated for the control of pain and inflammation associated with osteoarthritis in dogs.

Dosage and Administration:
Osteoarthritis Pain and Inflammation: 0.45 - 0.91 mg/lb/day 1 to 2 mg/kg/day) as a single daily dose, as needed.

Postoperative Orthopedic Pain and Inflammation:
DERAMAXX Chewable Tablets are indicated for the control of postoperative pain and inflammation associated with orthopedic surgery in dogs ≥ 4 lbs (1.8 kg).

Dosage and Administration:
Postoperative Orthopedic Pain and Inflammation: 1.4-1.8 mg/lb/day (3 to 4 mg/kg/day) as a single daily dose, as needed, not to exceed 7 days of administration.
Always provide “Information for Dog Owners” Sheet with prescription.

Since DERAMAXX tablet bioavailability is greatest when taken with food, postprandial administration is preferable. However, DERAMAXX tablets have been shown to be effective under both fed and fasted conditions; therefore, they may be administered in the fasted state if necessary. For postoperative orthopedic pain, administer DERAMAXX tablets prior to the procedure. Tablets are scored and dosage should be calculated in half-tablet increments. In clinical practice it is recommended to adjust the individual patient dose while continuing to monitor the dog's status until a minimum effective dose has been reached.

Contraindications:
Dogs with known hypersensitivity to DERAMAXX or other NSAIDs should not receive DERAMAXX tablets.

Warnings:
Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. For use in dogs only. All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID is recommended. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions, Animal Safety and Post-Approval Experience) and be given an “Information for Dog Owners” Sheet.

Sensitivity to drug-associated adverse events varies with the individual patient. As a class, NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Patients at greatest risk for NSAID toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Since many NSAIDs possess the potential to produce gastrointestinal ulceration and/or perforation, concomitant use of DERAMAXX tablets with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided.

Palatability:
DERAMAXX tablets were evaluated for palatability in 100 client-owned dogs of a variety of breeds and sizes. Dogs received two doses of DERAMAXX tablets, one on each of two consecutive days. DERAMAXX tablets were accepted by 94% of dogs on the first day of dosing and by 92% of dogs on the second day of dosing.

Effectiveness:
DERAMAXX tablets were evaluated in masked, placebo-controlled multi-site field studies involving client-owned animals to determine effectiveness.

Postoperative Orthopedic Pain and Inflammation Field Study:
In this study, 207 dogs admitted to veterinary hospitals for repair of a cranial cruciate injury were randomly administered DERAMAXX tablets or a placebo. Drug administration started the evening before surgery and continued once daily for 6 days postoperatively. Effectiveness was evaluated in 119 dogs and safety was evaluated in 207 dogs. Statistically significant differences in favor of DERAMAXX tablets were found for lameness at walk and trot, and pain on palpation values at all post-surgical time points. The results of this field study demonstrate that DERAMAXX tablets, when administered daily for 7 days are effective for the control of postoperative pain and inflammation associated with orthopedic surgery.

Storage Conditions:
DERAMAXX tablets should be stored at room temperature between 59° and 86°F (15-30°C).

Keep this and all medications out of reach of children.