Canidryl 50 mg for dogs 1 tablet
Reduction of inflammation and pain caused by musculo-skeletal disorders and degenerative joint disease and the management of post-operative pain for soft tissue surgery in dogs
Canidryl 50 mg Tablets for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Canidryl 50 mg
Carprofen 50.0 mg/tablet
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM OF Canidryl 50 mg
A plain round flat bevelled edge white to off white tablet with a breakline on one side. The tablets can be divided into equal halves.
4. CLINICAL PARTICULARS OF Canidryl 50 mg
4.1 Target Species
4.2 Indications for Use, Specifying the Target Species
Reduction of inflammation and pain caused by musculo-skeletal disorders and degenerative joint disease. As a follow up to parenteral analgesia in the management of post-operative pain following soft tissue surgery.
Do not use in cats.
Do not use in case of hypersensitivity to 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.
Refer to section 4.7.
4.4 Special Warnings for each target species
Refer to Sections 4.3 and 4.5
4.5 Special precautions for use
Special precautions for use in animals
Use in dogs less than 6 weeks of age, or 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 potential 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 of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects.
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.
4.6 Adverse reactions (Frequency and Seriousness)
Typical undesirable effects associated with NSAIDs, such as vomiting, soft faeces/diarrhea, faecal occult blood, loss of appetite and lethargy have been reported. These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.
If adverse reactions occur, use of the product should be stopped and the advice of a veterinarian should be sought.As with other NSAIDs there is a risk of rare renal or idiosyncratic hepatic adverse events.
4.7 Use during pregnancy, lactation and lay
Studies in laboratory species (rat and rabbit) have shown evidence of foetotoxic effects of carprofen at doses close to the therapeutic dose. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Do not use in pregnant or lactating bitches.
4.8 Interaction with other medicinal and other forms of interaction
Carprofen must not be administered with glucocorticoids.
Refer also to section 4.5
4.9 Amounts to be administered and administration route
For oral administration.
4 mg carprofen per kg bodyweight per day. An initial dose of 4 mg carprofen per kg bodyweight per day given as a single daily dose or in two equally divided doses may subject to clinical response, be reduced after 7 days to 2 mg carprofen/kg bodyweight/day given as a single dose.
Duration of treatment will be dependant upon the response seen. Long term treatment should be under regular veterinary supervision.
To extend analgesic and anti-inflammatory cover post-operatively, parenteral preoperative treatment may be followed with Carprofen tablets at 4mg/kg/day for 2 days.
Do not exceed the stated dose.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
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 4mg/kg) and 6mg/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 applied.
4.11 Withdrawal Periods
5. PHARMACOLOGICAL PROPERTIES OF Canidryl 50 mg
Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug.
ATC Vet Code: QM01AE91.
5.1 Pharmacodynamic Properties
Carprofen is a member of the 2-arylpropionic acid group of non-steroidal anti-inflammatory drugs (NSAIDs), and possesses anti-inflammatory, analgesic and antipyretic activity. Carprofen is a chiral drug with the S(+) enantiomer being more active than the R(-) enantiomer. Carprofen, like most other NSAIDs is an inhibitor of the enzyme cyclo-oxygenase of the arachidonic acid cascade. However, the inhibition of prostaglandin synthesis by carprofen is slight in relation to its anti-inflammatory and analgesic potency. The precise mode of action of carprofen is not clear.
5.2 Pharmacokinetic particulars
After oral administration, carprofen is well absorbed in the dogs. Following the administration of Rofeniflex tablets in dogs, a mean Cmax (maximum concentration in serum) of 15.8 μg/ml and 12.2 μg/ml was achieved at approximately 2 hours and 1.7 hours for Carprofen R(-) and Carprofen S(+), respectively. For both enantiomers, the mean half-life was approximately 6 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 glycuronide conjugate is mainly faecal after biliary excretion.
6. PHARMACEUTICAL PARTICULARS OF Canidryl 50 mg
6.1 List of excipients
Silica Colloidal anhydrous
Grilled Meat Flavour
Shelf-life of the veterinary medicinal product packaged in blister packs: 4 years
Shelf-life of the veterinary medicinal product packaged in HDPE containers: 3 years
Any divided and unused tablets should be discarded immediately.
6.4 Special Precautions for Storage
Store in a dry place in the original package. Protect from light.