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Date: Wednesday, April 30, 2025 9:45

Release 2.21
Carprodyl Quadri® 50 mg tablets for dogs (NI)
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Other NSAIDs
Active ingredient: Carprofen
Product:Carprodyl Quadri® 50 mg tablets for dogs (NI)
Product index: Carprodyl Quadri® 50 mg tablets for dogs (NI)
Incorporating:
Qualitative and quantitative composition
Each tablet contains:
Active substance:
Carprofen .......................................................... 50 mg
Excipients:
Qualitative composition of excipients and other constituents
Pig liver flavour
Yeast
Croscarmellose sodium
Copovidone
Magnesium stearate
Anhydrous colloidal silica
Microcrystalline cellulose
Lactose monohydrate
Pharmaceutical form
Clover-shaped scored beige tablet.
The tablet can be divided into four equal parts.
Clinical particulars
Target species
Dogs
Special warnings
See sections Contraindications and Special Precautions for Use.
Special precautions for use
Special precautions for safe use in the target species:
Use in aged dogs may involve additional risk. If such a use cannot be avoided, dogs may require a reduced dosage and 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.
As with other NSAIDs, photodermatitis during treatment with carprofen has been observed in laboratory animals and in humans. These skin reactions have never been observed in dogs.
Do not administer other NSAIDs concurrently or within 24 hours of each other.
Due to the good palatability of the tablet, they should be stored in a safe place out of the reach of animals. Intake of dose exceeding the recommended number of tablets may lead to severe adverse effects. If this is the case, seek veterinary assistance immediately.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after handling the veterinary medicinal product.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs
Rare (1 to 10 animals / 10,000 animals treated):
Renal disorder1 Hepatic disorder 1,3
Very rare
(<1 animal / 10,000 animals
treated, including isolated reports):
Vomiting2, Soft stool2 /Diarrhoea2, Blood in faeces2 Appetite loss2, Lethargy2
1As with other NSAIDs
2 Typical undesirable effects associated with NSAIDs, these adverse reactions generally occur 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.
3 Idiosyncratic effects
If adverse reactions occur, use of the product should be stopped and the advice of a veterinarian should be sought.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Interaction with other medicinal products and other forms of interaction
Carprofen is highly bound to plasma proteins and compete with other highly bound drugs, which can increase their respective toxic effects.
Do not use this veterinary medicinal drug concurrently with other NSAIDs or with glucocorticoids.
Concurrent administration of potentially nephrotoxic drugs (e.g. aminogylcoside antibiotics) should be avoided.
Refer also to Special precautions for use.
Administration routes and dosage
Oral use.
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. The analgesic effect from each dose persists for at least 12 hours.
The daily dose may be reduced, subject to clinical response.
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 pre-operative treatment with an injectable carprofen may be followed with carprofen tablets at 4 mg/kg/day for 5 days.
Do not exceed the stated dose. To ensure a correct dosage, body weight should be determined as accurately as possible.
The breakability method is the following: Put the tablet on a plain surface, with its scored side facing the surface (convex face up). With the tip of forefinger, exert a slight vertical pressure on the middle of the tablet to break it in its width into halves. In order to obtain quarters, then exert a slight pressure on the middle of one half with forefinger to break it in its length.
The tablet is divisible and can be used as follows:
Number of tablets per day
Dog weight (kg)
¼
> 3 - < 6
½
≥ 6 - < 9
¾
≥ 9 - < 12.5
1
≥ 12.5 - < 15.5
1 ¼
≥ 15.5 - < 18.5
1 ½
≥ 18.5 - < 21.5
1 ¾
≥ 21.5 - < 25
2
≥ 25 - < 28
2 ¼
≥ 28 - < 31
2 ¾
≥ 34 - < 37
3
≥ 37 - < 40
3 ¼
≥ 40 - < 43
3 ½
≥ 43 - < 45
Symptoms of overdose (and where applicable, emergency procedures, and antidotes)
Bibliographic data report that carprofen is well tolerated in dogs at twice the recommended dosage for 42 days.
Doses up to 3 times the recommended dose are reported to be without adverse effects.
There is no specific antidote to carprofen but general supportive therapy as applied to clinical overdose with NSAIDs should be applied.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable
Withdrawal periods
Not applicable.
Pharmacological particulars
ATCvet code: QM01AE9
Pharmacodynamics
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, is not well known. However, it was shown that the inhibition of the cyclo-oxygenase enzyme by carprofen is relatively weak at the recommanded dosage. Moreover, it was shown that carprofen doesn’t inhibit the generation of thromboxane (TX) B2 in dog clotting blood and neither prostaglandin (PG) E2 nor 12-hydroxyeicosatetraenoic acid (HETE) in inflammatory exudate are inhibited. This suggests the mechanism of action of carprofen is not the inhibition of the eicosanoids. Some authors suggested an activity of carprofen on one or numerous inflammatoy mediators not yet identified but no clinical evidence could be shown.
Carprofen exists in two enantiomeric forms, R(-)-carprofen and S(+)-carprofen and the racemic form is the one marketed. Laboratory animal studies suggest that the S(+) enantiomer possesses greater anti-inflammatory potency.
Ulcerogenic potential of carprofen has been shown in the rodents but not in the dogs.
Pharmacokinetics
After a single oral administration of 4 mg of carprofen per kg of bodyweight in dog, the time to obtain a maximum plasmatic concentration of 23µg/ml is about 2 hours. The oral bioavailability is more than 90% of the total dose. Carprofen is more than 98% bound to plasma proteins and its volume of distribution is low.
Carprofen is excreted in the bile with 70 % of an intra-venous dose of carprofen being eliminated in the faeces, mainly as the glucuronide conjugate. Carprofen undergoes an enantioselective enterohepatic cycle in dog, with only the S(+) enantiomer being significantly recycled. The plasmatic clearance of the S(+) carprofen is about twice that of the R(-) carprofen. The biliary clearance of S(+) carprofen seems to be subject to stereoselectivity too as it is about three times higher than that of R(-) carprofen.
Pharmaceutical particulars
Major incompatibilities
Not applicable.
Special precautions for storage
Do not store above 30°C.
Protect from light.
Divided tablets should be stored in the blister pack. Any divided tablet portions remaining after 72 hours should be discarded.
Nature and composition of immediate packaging
Blister complex: PVDC-PVC/Aluminium heat sealed blisters with 10 tablets / blister.
Cardboard box with 2 blisters of 10 tablets
Cardboard box with 10 blisters of 10 tablets
Cardboard box with 20 blisters of 10 tablets
Cardboard box with 30 blisters of 10 tablets
Cardboard box with 40 blisters of 10 tablets
Cardboard box with 50 blisters of 10 tablets
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK (NI): Vm 15052/3026
Significant changes
Date of the first authorisation or date of renewal
31 January 2008
Date of revision of the text
April 2024
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:CARPRODYL QD50 10X10T
GTIN:03411112263981