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Date: Monday, May 20, 2024 5:30

Description: Virbac 2013
Release 2.36
Carprox Vet 20mg, 50mg and 100mg Tablets for Dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Other NSAIDs
Active ingredient: Carprofen
Product:Carprox Vet Tablets for Dogs
Product index: Carprox Vet
Incorporating:
Qualitative and quantitative composition
Each tablet contains as active ingredient either 20mg, 50mg or 100mg Carprofen.
Pharmaceutical form
Tablet - Round, dark brown, marbled tablets with visible darker spots, one-side scored and bevel-edged.
The tablet can be divided into equal halves
Clinical particulars
Target species
Dogs
Indications for use
Reduction of inflammation and pain caused by musculoskeletal disorders and degenerative joint disease. As a follow up to parenteral analgesia in the management of post operative pain.
Contraindications
Do not use in cats.
Do not use in pregnant or lactating bitches.
Do not use in dogs less than 4 months of age.
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 gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia.
Special warnings for each target species
Refer to Contraindications and Special precautions for use
Special precautions for use
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.
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.
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.
Adverse reactions
Typical undesirable effects associated with NSAIDs such as vomiting, soft faeces/diarrhoea, 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.
Use during pregnancy, lactation or 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.
Interactions
Do not administer other NSAIDs and glucocorticoids concurrently or within 24 hours of administration of the product. Carprofen is highly bound to plasma proteins and may compete with other highly bound drugs, which can lead to toxic effects.
Concurrent administration of potential nephrotoxic drugs should be avoided
Amounts to be administered and administration route
For oral administration.
An initial dose of 2 to 4 mg carprofen per kg bodyweight per day is recommended to be given as a single or in two equally divided doses. Subject to clinical response, the dose may be reduced after 7 days to 2 mg carprofen/kg bodyweight/day given as a single dose.
To extend analgesic cover post-operatively, parenteral therapy with solution for injection may be followed with tablets at 4 mg/kg/day for up to 5 days.
Duration of treatment will be dependent upon the response seen, but the dog’s condition should be re-appraised by the veterinary surgeon after 14 days therapy.
Overdose
Do not exceed the stated dose.
Although studies investigating the safety of carprofen at overdose have been performed, 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.
Withdrawal periods
Not Applicable
Pharmacological particulars
Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, nonsteroids, propionic acid derivatives.
ATCvet code: QM01AE91
Pharmacodynamic properties
Carprofen possesses anti-inflammatory, analgesic and antipyretic activity. Like most other NSAID’s, carprofen 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.
Carprofen is a chiral drug with the S(+) enantiomer being more active than the R(-) enantiomer. There is no chiral inversion between the enantiomers in-vivo.
Pharmacokinetic properties
Carprofen is well absorbed after oral administration ([>90%) and is highly protein bound. Peak plasma concentrations are achieved between 1 h and 3 h after administration.
Carprofen is characterized by a half-life of approximately 10 hours in dogs.
Carprofen is eliminated in dogs primarily by means of biotransformation in the liver, followed by rapid excretion of the resulting metabolites in faeces (70-80%) and urine (10-20%). Some enterohepatic circulation has been detected.
Pharmaceutical particulars
Excipients
Lactose monohydrate
Maize starch
Ferric oxide red (E172)
Ferric oxide black (E172)
Povidone K30
Sodium starch glycolate, type A
Colloidal anhydrous silica
Meat flavour 10022
Talc
Magnesium stearate
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Return any halved tablet to the opened blister and use within 24 hours.
Special precautions for storage
Do not store above 25°C.
Store in the original package in order to protect from light and moisture.
Immediate packaging
10 tablets per blister strip.
20mg x 20 tablets
50mg x 100 tablets
100mg x 100 tablets
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Marketing Authorisation Number
Carprox Vet 20mg Vm 01656/4010
Carprox Vet 50mg Vm 01656/4012
Carprox Vet 100mg Vm 01656/4013
Significant changes
Date of the first authorisation or date of renewal
19 November 2010
Date of revision of the text
March 2020
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Carprox Vet 20mg
GTIN:03838989626815
GTIN description:Carprox Vet 50mg
GTIN:03838989626822
GTIN description:Carprox Vet 100mg
GTIN:03838989626839