In patients with advanced renal disease, treatment with etoricoxib is not recommended: If therapy must be initiated in such patients, close monitoring of the renal function is advisable.
Patients with pre-existing severely impaired renal function, uncompensated heart failure or cirrhosis should be treated with utmost caution because under conditions of compromised renal perfusion, administration of etoricoxib may cause a reduction in prostaglandin formation and secondary in renal blood flow, and thereby impair renal function. Monitoring of renal function in such patients should be considered, and if need be, therapy should be discontinued to allow recovery to the pretreatment state.
In patients with considerable dehydration, it is advisable to rehydrate patients prior to starting therapy with etoricoxib.
As with other drugs known to inhibit prostaglandin synthesis the possibility of fluid retention, oedema or hypertension should be taken into consideration when etoricoxib is used in patents with pre-existing oedema, hypertension or heart failure.
While on treatment with etoricoxib, antiplatelet therapy if ongoing, should not be discontinued and, if indicated, should be considered in patients at risk for or with a history or cardiovascular or other thrombotic effects.
Caution should be exercised in patients with a medical history of ischemic heart disease because of the pharmacodynamic profile of COX-2 selective inhibitors.
Physicians should be aware that upper gastrointestinal (GI) ulcers/ulcer complications have occurred in patients treated with etoricoxib. Independent of treatment, complications have occurred in patients treated with etoricoxib. Independent of treatment, patients with a prior history of GI perforation ulcers and bleeding (PUB) and patients >65 years of age are known to be at a higher risk for a PUB.
Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal have been reported in a very few patients up to one year period.
Caution to be exercised in treating patients with symptoms and signs of liver dysfunction or in whom an abnormal liver function test has occurred.
The drug should be used with caution in patients who have previously experienced acute asthmatic attacks, urticaria, or rhinitis, which were precipitated by salicylate or non-selective cyclooxygenase inhibitors.
Etoricoxib may mask fever which is a sign of infection. The physician should be aware of this when using the drug in those treated for infection.
Paediatric use: Safety and effectiveness of etoricoxib in paediatric patients have not been established.