Coxiron Special Precautions

Selective COX-2 inhibitor class of drugs may be associated with an increased risk of thrombotic events (especially myocardial infarction and stroke). As the cardiovascular risks of selective COX-2 inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Patients with significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking) or peripheral arterial disease should only be treated with etoricoxib after careful consideration.
Selective COX-2 inhibitors are not a substitute for aspirin for cardiovascular prophylaxis because of their lack of effect on platelets. Because etoricoxib, a member of this class, does not inhibit platelet aggregation, antiplatelet therapies should not be discontinued.
There is a further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) for etoricoxib, other selective COX-2 inhibitors and NSAIDs, when taken concomitantly with acetylsalicylic acid (even at low doses). The relative differences in gastrointestinal safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAlDs + acetylsalicylic acid has not been adequately evaluated in long-term use.
In patients with advanced renal disease, treatment with etoricoxib is not recommended. Clinical experience in patients with estimated creatinine clearance of <30 ml/min is very limited. If therapy with etoricoxib must be initiated in such patients, dose monitoring of the patient's renal function is advisable.
Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion. Therefore, under conditions of compromised renal perfusion, administration of etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function. Patients at greatest risk of this response are those with pre-existing significantly, impaired renal function, uncompensated heart failure, or cirrhosis. Monitoring of renal function in such patients should be considered. As with other drugs known to inhibit prostaglandin synthesis, discontinuation of therapy with etoricoxib would be expected to be followed by recovery to the pretreatment state.
Caution should be used when initiating treatment with etoricoxib 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, fluid retention, edema and hypertension have been observed in some patients taking etoricoxib. The possibility of exacerbating fluid retention, edema or hypertension should be taken into consideration when etoricoxib is used in patients with pre-existing edema, hypertension or heart failure.
Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. Therefore, special attention should be paid to blood pressure monitoring during treatment with etoricoxib. If blood pressure rises significantly, alternative treatment should be considered.
Caution should be exercised in patients with a medical history of ischemic heart disease because of the pharmacodynamic profile of COX-2 selective inhibitors noted previously.
Physicians should be aware that individual patients may develop upper gastrointestinal (GI) ulcers/ulcer complications irrespective of treatment. Upper GI ulcers/ulcer complications have occurred in patients treated with etoricoxib. These events can occur at any time during use and without warning symptoms.
Independent of treatment, patients with a prior history of GI perforation, ulcers and bleeding (PUB) and patients greater than 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 patients treated for up to one year with etoricoxib.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be evaluated for persistently abnormal liver function tests. If persistently abnormal liver function tests (three times the upper limit of normal) are detected, etoricoxib should be discontinued.
Etoricoxib should be used with caution in patients who have previously experienced acute asthmatic attacks, urticaria, or rhinitis, which were precipitated by salicylates or nonselective cyclooxygenase inhibitors. Since the pathophysiology of these reactions is unknown, physicians should weigh the potential benefits of prescribing etoricoxib versus the potential risks.
Etoricoxib may mask fever, which is a sign of infection. The physician should be aware of this when using etoricoxib in patients being treated for infection.
Use in Children: Safety and effectiveness of etoricoxib in pediatric patients have not been established.
Use in the Elderly: Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young. No overall differences in safety or effectiveness were observed between elderly and younger patients.