Onsior 6 mg for cats 1 tablet
Treatment of acute pain and inflammation associated with musculo-skeletal disorders and reduction of moderate pain and inflammation associated with orthopaedic surgery in cats
Onsior 6 mg tablets for cats
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Robenacoxib 6 mg.
For the full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Round, beige to brown tablets with imprints “NA” on one side and “AK” on the other side.
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
For the treatment of acute pain and inflammation associated with musculo-skeletal disorders in cats. For the reduction of moderate pain and inflammation associated with orthopaedic surgery in cats.
Do not use in cats suffering from gastrointestinal ulceration.
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in pregnant and lactating animals (see section 4.7).
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Use in cats with impaired cardiac, renal or hepatic function or in cats that are dehydrated, hypovolaemic or hypotensive may involve additional risks. If use cannot be avoided, these cats require careful monitoring.
Use this veterinary medicinal product under strict veterinary monitoring in cats with a risk of gastrointestinal ulcers, or if the cat previously displayed intolerance to other NSAIDs.
Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use of the veterinary medicinal product.
In small children, accidental ingestion increases the risk for NSAID adverse effects. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
In pregnant women, particularly near term pregnant women, prolonged dermal exposure increases the risk for premature closure of the ductus arteriosus in the foetus.
4.6 Adverse reactions (frequency and seriousness)
Mild and transient diarrhoea, soft faeces or vomiting were commonly reported. In very rare cases, lethargy may be observed.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
common (more than 1 but less than 10 animals in 100 animals)
uncommon (more than 1 but less than 10 animals in 1,000 animals)
rare (more than 1 but less than 10 animals in 10,000 animals)
very rare (less than 1 animal in 10,000 animals, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats used for breeding.
4.8 Interaction with other medicinal products and other forms of interaction
Onsior must not be administered in conjunction with other NSAIDs. Pre-treatment with other anti-inflammatory medicines may result in additional or increased adverse effects and, accordingly, a treatment-free period with such substances should be observed for at least 24 hours before the commencement of treatment with Onsior. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Concomitant treatment with medicines displaying action on renal flow, e.g. diuretics or angiotensin converting enzyme (ACE) inhibitors, should be subject to clinical monitoring.
Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increased risk of renal toxicity.
Concurrent use of other active substances that have a high degree of protein binding may compete with robenacoxib for binding and thus lead to toxic effects.
4.9 Amounts to be administered and administration route
For oral use.
Give either without food or with a small amount of food. Onsior tablets are easy to administer and well accepted by most cats. The tablets should not be divided or broken.
The recommended dose of robenacoxib is 1 mg/kg body weight with a range 1–2.4 mg/kg. The following number of tablets should be given once daily at the same time every day:
Body weight (kg): Number of tablets
2.5 to < 6: 1 tablet
6 to < 12: 2 tablets
Acute musculoskeletal disorders treat: for up to 6 days.
Orthopaedic surgery: Give as a single oral treatment prior to orthopaedic surgery.
Premedication should only be carried out in combination with butorphanol-analgesia. The tablet(s) should be administered without food at least 30 minutes prior to surgery.
After surgery, once daily treatment may be continued for up to two further days. If necessary, additional analgesic treatment with opioids is recommended.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In healthy young cats aged 7–8 months, oral robenacoxib administered at high overdoses (4, 12 or 20 mg/kg/day for 6 weeks) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised cats. There is no specific antidote. Symptomatic supportive therapy is recommended and should consist of administration of gastrointestinal protective agents and infusion of isotonic saline.
4.11 Withdrawal periods
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids, coxibs. ATCvet code: QM01AH91.
5.1 Pharmacodynamic properties
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. It is a potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is present in two forms. COX-1 is the constitutive form of the enzyme and has protective functions, e.g. in the gastrointestinal tract and kidneys. COX-2 is the inducible form of the enzyme which is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.
In the in vitro whole blood assay in cats, the selectivity of robenacoxib was approximately 500 fold higher for COX-2 (IC50 0.058 μM) as compared to COX-1 (IC50 28.9 μM). At a dose of 1–2 mg/kg body weight, robenacoxib tablets produced a marked inhibition of COX-2 activity in cats and had no effect on COX-1 activity. In an inflammation model in cats, robenacoxib injection had analgesic,
anti-inflammatory and anti-pyretic effects and a rapid onset of action (0.5 h). In clinical trials in cats, robenacoxib tablets reduced pain and inflammation associated with musculoskeletal disorders and reduced the need for rescue treatment when given as premedication in case of orthopaedic surgery, in combination with opioids.
5.2 Pharmacokinetic particulars
After oral administration of robenacoxib tablets at approximately 2 mg/kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1,159 ng/ml and an AUC of 1,337 ng·h/ml. Co-administration of robenacoxib tablets with one third of the daily food ration produced no change in Tmax (0.5 h), Cmax (1,201 ng/ml) or AUC (1383 ng·h/ml). Co-administration of robenacoxib tablets with the entire daily food ration produced no delay in Tmax (0.5 h), but a lower Cmax (691 ng/ml) and a slightly lower AUC (1,069 ng·h/ml). The systemic bioavailability of robenacoxib tablets was 49% without food.
Robenacoxib has a relatively small volume of distribution (Vss 190 ml/kg) and is highly bound to plasma proteins (>99%).
In cats robenacoxib is extensively metabolised by the liver. Apart from one lactam metabolite, the identity of other metabolites is not known in cats.
Robenacoxib is rapidly cleared from blood (CL 0.44 L/kg/h) with an elimination t1/2 of 1.1 h after intravenous administration. After oral administration of tablets, the terminal half-life from blood was
1.7 h. Robenacoxib persists longer and at higher concentrations at sites of inflammation than in blood.
Robenacoxib is excreted predominantly via the biliary route (~70%) rather than via the kidneys (~30%). The pharmacokinetics of robenacoxib do not differ between male and female cats.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Silica, colloidal anhydrous
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
6.4. Special precautions for storage
Store below 25 °C.