PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non steroids.
ATCvet code: QM01AH90
Pharmacodynamic properties
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) – mediated prostaglandin synthesis. Cyclooxygenase is responsible for generation of prostaglandins. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Coxibs therefore display analgesic, anti-inflammatory and antipyretic properties. COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception and cognitive function). In in vitro canine whole blood assays, firocoxib exhibits approximately 380-fold selectivity for COX-2 over COX-1. The concentration of firocoxib required to inhibit 50 % of the COX-2 enzyme (i.e., the IC50) is 0.16 (± 0.05) µM, whereas the IC50 for COX-1 is 56 (± 7) µM.
Pharmacokinetic particulars
Following oral administration in dogs at the recommended dose of 5 mg per kg of bodyweight, firocoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 1.25 (± 0.85) hours. The peak concentration (Cmax) is 0.52 (± 0.22) µg/ml (equivalent to approximately 1.5 µM), area under the curve (AUC 0-24) is 4.63 (±1.91) µg x hr/ml, and oral bioavailability is 36.9 (± 20.4) percent. The elimination half-life (t½) is 7.59 (± 1.53) hours. Firocoxib is approximately 96 % bound to plasma proteins. Following multiple oral administrations, the steady state is reached by the third daily dose.Firocoxib is metabolised predominantly by dealkylation and glucuronidation in the liver. Elimination is principally in the bile and gastrointestinal tract.
Excipients
Lactose monohydrate, Microcrystalline cellulose, Chartor hickory smoke flavour, Hydroxypropyl cellulose, Croscarmellose sodium, Magnesium stearate, Caramel (E150d), Silica (colloidal anhydrous), yellow iron oxide (E172), Red iron oxide (E172).
Major incompatibilities
Not applicable.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Divided tablets may be stored for up to 1 month in the original package.
Special precautions for storage
Do not store above 30 °C. Store in the original package.
Immediate packaging
Previcox tablets are supplied in blisters (transparent PVC/aluminium foil) or in 30 ml or 100 ml high density polyethylene bottles (with polypropylene closure).
The chewable tablets (57 mg or 227 mg) are available in the following pack sizes:
- 1 cardboard box containing 1 blister of 10 tablets (10 tablets)
- 1 cardboard box containing 3 blister of 10 tablets (30 tablets)
- 1 cardboard box containing 18 blister of 10 tablets (180 tablets)
- 1 cardboard box containing 1 bottle of 60 tablets.
Not all pack sizes may be marketed.
Disposal
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.