Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction 
Company name: Ceva Animal Health Ltd
Address: 90 The Broadway
Chesham
Buckinghamshire
HP5 1EG
Telephone: 01494 781510
Fax: 01494 781519
Email: cevauk@ceva.com
Website: www.ceva.com
Presentation
Carprodyl® F tablets are scored, circular beige tablets containing as active ingredient 20 mg, 50 mg or 100 mg carprofen.
Uses
For analgesia and reduction of inflammation caused by musculo-skeletal disorders and degenerative joint disease of the dog. Carprodyl® F tablets can also be used in the management of post-operative pain in dogs.
Dosage and administration
For oral administration. The tablets are flavoured and are readily consumed by most dogs when offered. An initial dose of 4 mg carprofen/kg bodyweight/day is recommended to be given as a single dose or in two equally divided doses. Subject to clinical response the dose may be reduced. To extend analgesic and anti-inflammatory cover post operatively, parenteral therapy with carprofen injection may be followed with carprofen tablets at 4mg/kg/day for up to 5 days.
Duration of treatment will be dependent upon the response seen. Long-term treatment should be under regular veterinary supervision. Do not exceed stated dose.
Contra-indications, warnings, etc
The elimination time of NSAIDs, including carprofen, in the cat is longer than in the dog and the therapeutic index is narrower. Consequently, do not use in cats.
Do not use in pregnant or lactating bitches.
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal ulceration or bleeding or where there is evidence of a blood dyscrasia or hypersensitivity to the product. Do not use in puppies less than 4 months of age.
Special precautions for use in animals
Use in aged dogs may involve additional risk. If such a use cannot be avoided, dogs may require careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic drugs should be avoided.
NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated.
Do not administer other NSAIDs concurrently or within 24 hours. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects.
Response to long-term treatment should be monitored at regular intervals by a veterinary surgeon.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the event of accidental ingestion of the tablets, seek medical advice and show the doctor the package leaflet. Wash hands after handling the product.
Overdose (symptoms, emergency procedures, antidotes)
No signs of toxicity appeared when dogs were treated with carprofen at levels up to 6 mg/kg twice daily for 7 days (3 times the recommended dose rate of 4 mg/kg) and 6 mg/kg once daily for a further 7 days (1.5 times the recommended dose rate of 4 mg/kg). There is no specific antidote for carprofen overdosage but general supportive therapy, as applied to clinical overdosage with NSAIDs, should be given.
Interaction with other medicinal products and other forms of interaction
Carprofen must not be administered with glucocorticoids.
For animal treatment only. Keep out of reach and sight of children.
Pharmaceutical precautions
This medicinal product does not require any special temperature storage conditions
Store tablets and half-tablets in the original blister in order to protect from light.
Legal category
POM-V
Packaging Quantities
Box containing 2 blisters of 10 tablets
Box containing 10 blisters of 10 tablets
Box containing 20 blisters of 10 tablets
Box containing 50 blisters of 10 tablets
Not all pack sizes may be marketed.
Further information
Carprofen is a non-steroidal anti-inflammatory drug (NSAID) of the 2-aryl propionic acid class and possesses anti-inflammatory, analgesic and antipyretic activities.
The mechanism of action of carprofen, like other NSAIDs, is believed to be associated with the inhibition of cyclo-oxygenase activity.
Two unique cyclo-oxygenases have been described in mammals. The constitutive cyclo-oxygenase, COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and renal function. The inducible cyclo-oxygenase, COX-2, generates prostaglandins involved in inflammation. Inhibition of COX-1 is thought to be associated with gastrointestinal and renal toxicity while inhibition of COX-2 provides anti-inflammatory activity. In an in-vitro study, using canine cell cultures, carprofen demonstrated selective inhibition of COX-2 versus COX-1. Clinical relevance of these data has not be shown.
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. Carprofen also inhibits the production of osteoclast-activating factor (OAF), PGE1 and PGE2 by its inhibitory effect on prostaglandin biosynthesis.
After oral administration, carprofen is well absorbed in the dogs. Following the administration of the product tablets in dogs, a mean Cmax (maximum concentration in serum) of 6.1 mg/L and 3.6 mg/L was achieved at approximately 1 hour for Carprofen R(-) and Carprofen S(+), respectively. For both enantiomers, the mean half-life was approximately 9 hours. The analgesic effect from each dose persists for at least 12 hours.
Carprofen has a small volume of distribution and a low systemic clearance. It is highly bound to plasma protein. Carprofen is metabolised in the liver by conjugation and oxidation. The excretion of the glucuronide conjugate is mainly faecal after biliary excretion.
Marketing authorisation number
Carprodyl® F 20 mg - Vm 15052/4033
Carprodyl® F 50 mg - Vm 15052/4034
Carprodyl® F 100 mg - Vm 15052/4035
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