PREVICOX: Product Information

PREVICOX- firocoxib tablet, chewable
Merial Limited

For oral use in dogs only.

Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

PREVICOX (firocoxib) belongs to the coxib class of non-narcotic, non-steroidal anti-inflammatory drugs. Firocoxib is a white crystalline compound described chemically as 3-(cyclopropylmethoxy)-4-(4-(methylsulfonyl)phenyl)- 5,5-dimethylfuranone. The empirical formula is C17 H20 O5 S, and the molecular weight is 336.4. The structural formula is shown below:

Chemical StructureChemical Structure

Pharmacokinetics

The absolute bioavailability of PREVICOX (firocoxib) is approximately 38% when administered as a 5 mg/kg oral dose to fasted adult dogs. Firocoxib is rapidly cleared from the blood via hepatic metabolism and fecal excretion (CLsystemic = ~0.4 L/hr/kg). Despite a high level of plasma protein binding (96%), firocoxib exhibits a large volume of distribution (Vdλ of total drug = ~4.6 L/kg) and a terminal elimination half life of 7.8 hours (%CV = 30%). The oral drug absorption process is highly variable among subjects. Co-administration of PREVICOX with food delays drug absorption (Tmax from 1 to 5 hours) and decreases peak concentrations (Cmax from 1.3 to 0.9 mcg/mL). However, food does not affect the overall oral bioavailability at the recommended dose.

Indications

PREVICOX (firocoxib) Chewable Tablets are indicated for the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs.

Dosage and Administration

Always provide the Client Information Sheet with prescription. Carefully consider the potential benefits and risks of PREVICOX and other treatment options before deciding to use PREVICOX. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage of PREVICOX (firocoxib) for oral administration in dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. The dogs can be treated with PREVICOX approximately two hours prior to surgery. The tablets are scored and dosage should be calculated in half tablet increments. PREVICOX Chewable Tablets can be administered with or without food.

Contraindications

Dogs with known hypersensitivity to firocoxib should not receive PREVICOX.

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.

For oral use in dogs only. Use of this product at doses above the recommended 2.27 mg/lb (5.0 mg/kg) in puppies less than seven months of age has been associated with serious adverse reactions, including death (see Animal Safety). Due to tablet sizes and scoring, dogs weighing less than 12.5 lb (5.7 kg) cannot be accurately dosed.

All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory testing to establish hematological and serum baseline data is recommended prior to and periodically during administration of any NSAID. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions and Animal Safety) and be given a Client Information Sheet about PREVICOX Chewable Tablets.

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

Precautions

This product cannot be accurately dosed in dogs less than 12.5 pounds in body weight.

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

As a class, cyclooxygenase inhibitory NSAIDs may be associated with renal, gastrointestinal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Dogs 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 concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached and monitored. 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 NSAIDS possess the potential to produce gastrointestinal ulceration and/or gastrointestinal perforation, concomitant use of Previcox Chewable Tablets with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. The concomitant use of protein bound drugs with PREVICOX Chewable Tablets has not been studied in dogs. Commonly used protein-bound drugs include cardiac, anticonvulsant, and behavioral medications. The influence of concomitant drugs that may inhibit the metabolism of PREVICOX Chewable Tablets has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

If additional pain medication is needed after the daily dose of PREVICOX, a non-NSAID class of analgesic may be necessary.

Appropriate monitoring procedures should be employed during all surgical procedures. Anesthetic drugs may affect renal perfusion, approach concomitant use of anesthetics and NSAIDs cautiously. The use of parenteral fluids during surgery should be considered to decrease potential renal complications when using NSAIDs perioperatively.

The safe use of PREVICOX Chewable Tablets in pregnant, lactating or breeding dogs has not been evaluated.

Adverse Reactions

Osteoarthritis

In controlled field studies, 128 dogs (ages 11 months to 15 years) were evaluated for safety when given PREVICOX Chewable Tablets at a dose of 2.27 mg/lb (5.0 mg/kg) orally once daily for 30 days. The following adverse reactions were observed. Dogs may have experienced more than one of the observed adverse reactions during the study.

Adverse Reactions Seen in U.S. Field Studies
Adverse Reactions Previcox n=128 Active Control n=121
Vomiting 5 8
Diarrhea 1 10
Decreased Appetite or Anorexia 3 3
Lethargy 1 3
Pain 2 1
Somnolence 1 1
Hyperactivity 1 0

PREVICOX (firocoxib) Chewable Tablets were safely used during field studies concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics.

Soft-tissue Surgery

In controlled field studies evaluating soft-tissue postoperative pain and inflammation, 258 dogs (ages 10.5 weeks to 16 years) were evaluated for safety when given PREVICOX Chewable Tablets at a dose of 2.27 mg/lb (5.0 mg/kg) orally approximately 2 hours prior to surgery and once daily thereafter for up to two days. The following adverse reactions were observed. Dogs may have experienced more than one of the observed reactions during the study.

Adverse Reactions Seen in the Soft-tissure Surgery Postoperative Pain Field Studies
Adverse Reactions Firocoxib Group n=127 Control Group *n=131
*
Sham-dosed (pilled)
Vomiting 5 6
Diarrhea 1 1
Bruising at Surgery Site 1 1
Respiratory Arrest 1 0
SQ Crepitus in Rear Leg and Flank 1 0
Swollen Paw 1 0
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