Sava Healthcare Carodyl 25 mg (10 tab)

Sava Healthcare Carodyl  25 mg (10 tab)

Each chewable tablet contains:

Carprofen USP... 25 mg

Excipients....q.s.

For The Use Of a Veterinarian Only.

CARODYL CHEWABLE TABLETS (carprofen) Non-steroidal anti-inflammatory drug

For oral use in dogs only

DESCRIPTION:

Carodyl (carprofen) is a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid class that includes ibuprofen, naproxen, and ketoprofen. Carprofen is the nonproprietary designation for a substituted carbazole, 6-chloro-a-methyl-9H-carbazole-2-acetic acid.

CLINICAL PHARMACOLOGY:

Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and antipyretic activity approximately equipotent to indomethacin in animal models. The mechanism of action of carprofen, like that of other NSAIDs, is believed to be associated with the inhibition of cyclooxygenase activity. Two unique cyclooxygenases have been described in mammals.The specificity of a particular NSAID may vary from species to species. In an in vitro study using canine cell cultures, carprofen demonstrated selective inhibition. Carprofen has also been shown to inhibit the release of several prostaglandins in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system) inflammatory reactions.

Several studies have demonstrated that carprofen has modulatory effects on both humoral and cellular immune responses. Data also indicate that carprofen inhibits the production of osteoclast-activating factor (OAF), PGE₁, and PGE by its inhibitory effect in prostaglandin biosynthesis.

Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and 25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8 hours) after single oral doses varying from 1-35 mg/kg of body weight After a 100 mg single intravenous bolus dose, the mean elimination half-life was approximately 11.7 hours in the dog. Carodyl is more than 99% bound to plasma protein and exhibits a very small volume of distribution.

Carprofen is eliminated in the dog primarily by biotransformation in the liver followed by rapid excretion of the resulting metabolites (the ester glucuronide of carprofen and the ether glucuronides of 2 phenolic metabolites, 7-hydrog carprofen and 8-hydroq carprofen) in the feces (70-80%) and urine (10-20%). Some enterohepatic circulation of the drug is observed.

INDICATIONS:

Carodyl is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

CONTRAINDICATIONS:

Carodyl should not be used in dogs exhibiting previous hypersensitivity to carprofen.

WARNINGS:

Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by humans.

For use in dogs only. Do not use in cats.

All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of any NSAID should be considered.

Owners should be advised to observe for signs of potential drug toxicity.

PRECAUTIONS:

Carodyl is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrands disease), as safety has not been established in dogs with these disorders. The safe use of Carodyl in animals less than 6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not been established. Studies to determine the activity of Carodyl when administered concomitantly with other protein-bound or similarly metabolized drugs have not been conducted. Drug compatibility should be monitored closely in patients requiring additional therapy.

Such drugs commonly used include cardiac, anticonvulsant and behavioral medications. It has been suggested that treatment with carprofen may reduce the level of inhalant anesthetics needed.

If additional pain medication is warranted after administration of the total daily dose of Carodyl, alternative analgesia should be considered. The use of another NSAID is not recommended. Consider appropriate washout times when switching from one NSAID to another or when switching from corticosteroid use to NSAID use. Due to the palatable nature of Carodyl chewable tablets, store out of reach of dogs in a secured location. Severe adverse reactions may occur if large quantities of tablets are ingested. If you suspect your dog has consumed Carodyl chewable tablets above the labeled dose, please call your veterinarian for immediate assistance.

INFORMATION FOR DOG OWNERS:

Cacodyl, 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 decreased appetite, vomiting, diarrhea, dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. 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.

DOSAGE AND ADMINISTRATION:

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of Carodyl and other treatment options before deciding to use Carodyl. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. Carodyl chewable tablets are scored and dosage should be calculated in half-tablet increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both sides of the score. Carodyl chewable tablets are palatable and willingly consumed by most dogs when offered by the owner. Therefore, they may be fed by hand or placed on food. Care should be taken to ensure that the dog consumes the complete dose.

ANIMAL SAFETY:

Laboratory studies in unanesthetized dogs and clinical field trials have demonstrated that Carodyl is well tolerated in dogs after oral administration.

STORAGE: Store below 30°C. Protect from direct Sunlight.

FOR VETERINARY USE ONLY NOT FOR HUMAN USE