Name:
Onsior 6 mg cat – 1 blister of 6 tablets
Manufacturer:
Elanco
Description:
For the treatment of pain and inflammation associated with acute and chronic musculoskeletal disorders in cats.
For the reduction of moderate pain and inflammation associated with orthopedic surgery in cats.
Ingredients:
Robenacoxib 6 mg
List of excipients: Yeast powder, Microcrystalline cellulose, Povidone (K-30), Crospovidone, Colloidal anhydrous silica, Magnesium stearate.
Key benefits:
Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class.
Robenacoxib tablets reduced pain and inflammation associated with acute musculoskeletal disorders and reduced the need for emergency treatment when administered as premedication before orthopedic procedures in combination with opioids.
In two clinical studies in cats (mainly indoor) with chronic musculoskeletal disorders (CMSD), robenacoxib increased activity and improved subjective scores of activity, behavior, quality of life, temperament and well-being in cats.
Intended use:
Cats.
Method of administration:
Oral administration.
To be administered without food or with a small amount of food.
Presentation:
Blister of 6 tablets.
Dosage:
The recommended dose of robenacoxib is 1 mg/kg body weight, with a range of 1 – 2.4 mg/kg.
The following number of tablets should be administered once daily at the same time each day:
Onsior 6mg for cats – Dosage based on weight
Acute musculoskeletal disorders: treatment for up to 6 days.
Chronic musculoskeletal disorders: The duration of treatment should be determined individually. A clinical response is normally seen within 3-6 weeks. If no clinical response occurs after 6 weeks, treatment should be discontinued.
Orthopaedic surgery: To be administered as a single oral treatment prior to orthopaedic surgery. Premedication should only be administered 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 a maximum of two days.
Additional opioid analgesic treatment is recommended if necessary.
The interchangeable use of Onsior tablets and Onsior solution for injection has been tested in an animal safety study and has been shown to be well tolerated in cats.
In cats, Onsior solution for injection or tablets can be used interchangeably in accordance with the indications and instructions for use approved for each individual pharmaceutical form.
Treatment should not exceed one dose (either tablet or solution for injection) per day.
Please note that the recommended dose is different for the 2 formulations.
Possible adverse effects:
Mild and transient diarrhoea, soft faeces or vomiting have been commonly reported in clinical studies with treatment of up to 6 days.
Lethargy may be observed in very rare cases.
In addition, increased renal parameters (creatinine, BUN and SDMA) and renal failure have been reported very rarely, more frequently in elderly cats and with concomitant use of anaesthetic and sedative drugs.
If you notice any serious reactions or other effects not mentioned in the package leaflet, please inform your veterinary surgeon.
Precautions:
The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or less than 4 months of age.
Use in cats with impaired cardiac, renal or hepatic function or in dehydrated, hypovolaemic or hypotensive cats may involve additional risks. If use cannot be avoided, these cats require close monitoring.
Use this veterinary medicinal product under strict veterinary supervision in cats at risk of gastrointestinal ulceration or in cats with a history of intolerance to other NSAIDs.
Do not use in pregnant or lactating animals as the safety of robenacoxib has not been established during pregnancy and lactation or in cats used for breeding purposes.
Onsior should not be administered concomitantly with other NSAIDs or glucocorticosteroids.
Previous treatment with other anti-inflammatory medicinal products may result in additional or increased adverse effects and therefore a period of at least 24 hours without treatment with such substances should be allowed before treatment with Onsior is initiated.
Concomitant treatment with drugs that affect renal flow, e.g. diuretics or angiotensin converting enzyme inhibitors, should be monitored clinically.
Simultaneous administration of potentially nephrotoxic substances should be avoided because may lead to an increased risk of renal toxicity.
Concomitant use of other active substances that have a high level of protein binding may compete with robenacoxib for binding and thus cause toxic effects.
Storage:
Store in a dry place away from moisture and direct sunlight, at temperatures up to 25°C.
In case of overdose:
In healthy young cats, 7-8 months of age, robenacoxib administered orally at high doses (4, 12 or 20 mg/kg/day for 6 weeks) did not cause symptoms associated with toxicity, including signs of gastrointestinal, renal or hepatic toxicity, and did not produce effects on clotting time.
In healthy young cats, 7-8 months of age, oral administration of robenacoxib (Onsior tablets, in overdose up to 5 times the maximum recommended dose, 92.4 mg, 7.2 mg, 12 mg robenacoxib/kg body weight) for 6 months was well tolerated.
A reduction in body weight gain was observed in treated animals. In the high-dose group, kidney weights were decreased and sporadically associated with renal tubular degeneration/regeneration, but not correlated with evidence of renal dysfunction on clinical pathological parameters.
Interchangeable use of Onsior tablets and Onsior solution for injection in cats aged 4 months at overdoses of up to 3 times the maximum recommended dose (2.4 mg, 4.8 mg, 7.2 mg robenacoxib/kg body weight orally and 2.0 mg, 4.0 mg and 6.0 mg robenacoxib/kg body weight subcutaneously) resulted in a dose-dependent increase in sporadic injection site oedema and minor to moderate subacute/chronic subcutaneous tissue inflammation.
No relevant effects on body weight, bleeding time or signs of gastrointestinal, renal or hepatic toxicity were observed.
As with any NSAID, overdose may result in gastrointestinal, renal or hepatic toxicity in cats predisposed to or with a history of such conditions.
There is no specific antidote.
Symptomatic, supportive treatment is recommended, which should consist of administration of gastrointestinal protective agents and infusion of saline.
In case of overdose, please contact your veterinarian immediately.
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