Moskva, Russian Federation
employee
employee
CSCSTI 68.41
The study evaluated the tolerability and safety of the non-steroidal anti-inflammatory drug (NSAID) robenacoxib (Onoxeb®) when administered orally at therapeutic (2 mg/kg) and double therapeutic (4 mg/kg) doses in healthy dogs (n=8) and cats (n=8) for 28 and 22 days, respectively. Monitoring of clinical status, body weight, and morphological and biochemical blood parameters did not reveal statistically significant or clinically important abnormalities that exceeded the physiological limits. In individual animals in the group that received the drug at a high dose, temporary and reversible gastrointestinal symptoms (salivation, softening of feces) were observed, which is consistent with the stated safety profile of the drug. The results confirm the good tolerability of robenacoxib and its safety for target animal species when used at recommended doses for an extended period.
robenacoxib, Onoxeb®, non-steroidal anti-inflammatory drug, safety, tolerability
1. Alekseeva, L.I. Obezbolivayuschie preparaty v terapevticheskoy praktike/ L.I. Alekseeva, E.G. Filatova, E.V. Moroz, V.P. Tyurin, E.L. Nasonov. ‒ M.: IMA-PRESS Karateev A.E., 2013. ‒ 134 s.
2. Giorgi, M. Robenacoxib: a review of its pharmacological properties and therapeutic usein dogs and cats / M. Giorgi // Journal of Veterinary Pharmacology and Therapeutics. ‒ 2017. ‒ No. 40(1). ‒ pp. 1-17.
3. Giraudel, J.M. Development of in vitro assays for the evaluation of cyclooxygenase selectivity and pharmacokinetics of robenacoxib, a new nonsteroidal anti-inflammatory drug in dogs / J.M. Giraudel, P.L. Toutain, P. Lees // American Journal of Veterinary Research. ‒2005. ‒ No. 66(6). ‒ pp. 938-945.
4. King, J.N. Preclinical pharmacology of robenacoxib: a novel selective inhibitor of cyclooxygenase-2 / J.N. KingJ., Dawson, R.E. Esser, R. Fujimoto, E.F. Kimble, S. Mani, P.L. Toutain // Journal of Veterinary Pharmacology and Therapeutics. ‒ 2009. ‒ No. 32(1). ‒ pp. 1-17.
5. Lascelles, B.D.X. Gastrointestinal tract perforation in dogs treated with a selective cyclooxygenase-2 inhibitor: 29 cases (2002–2003) //B.D.X. Lascelles, A.T. Blikslager, S.M. Fox, D. Reece //Journal of the American Veterinary Medical Association. ‒ 2005. ‒ No. 227(7). ‒ pp. 1112-1117.
6. Lees, P. Pharmacodynamics and pharmacokinetics of robenacoxib in the dog / P. Lees, J. Giraudel, M.F. Landoni, P.L. Toutain // Veterinary Record. ‒ 2015. ‒ No. 176(6). ‒ pp. 148.
7. Mansa, S. Long term treatment with carprofen of 805 dogs with osteoarthritis / S. Mansa, E. Palmer, C. Grondahl, et al. // Vet Record. ‒ 2007. ‒ No. 160. ‒ pp. 427-430.
8. Technical Bulletin for Onsior® (robenacoxib). ElancoAnimalHealth. (Aktual'naya versiya instrukcii k preparatu) https://assets.elanco.com/0cec44ed-3eaa-0009-2029-666567e7e4de/f46b2ec2-c33d-4e93-8370-0dd6cb8399e3/2021-10-15_Onsior%20tab_Instr%20%281%29.pdf
9. https://www.ema.europa.eu/en/vich-gl43-target-animal-safety-pharmaceuticals-scientific-guideline



