Sikstop Special Precautions

The selective COX-2 inhibitor class of drugs may be associated with an increased risk of thrombotic events (especially MI and stroke), relative to placebo and some NSAIDs (naproxen). As the cardiovascular risk of selective COX-2 inhibitors may increase with dose and duration possible and the lowest effective daily dose should be used. The patients 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, anti platelet 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. NSAIDs + acetylsalicylic acid has not been adequately evaluated in long term.
In patiens with advenced renal disease, treatment with Etoricoxib is not recommended. Study experience in patients with estimated creatinine clearance of <30 mL/min is very limited. If therapy with Etoricoxib must be initiated in such patients, close 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 there by 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.
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 fluid retention, edema or hypertension should be taken into consideration when Etoricoxib is used in patients with pre-existing edema hypertension, or heart failure. All Nonsteriodal Antiinflammatory Drugs (NSAIDs), including Etoricoxib, can be associated with new onset or recurrent congestive heart failure (See SIDE EFFECTS). 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 should be considered.
Physician should be aware that individual patients may develop upper gastrointestinal (GI) ulcers/ulcer complications irrespective of treatment. Upper gastrointestinal complications [perforations, ulcers or bleeding (PUBs)], some of them resulting in fatal outcame, have occurred in patients treated with Etoricoxib. Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding. There is a further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when Etoricoxib is taken concomitantly with acetylsalicylic acid (even at low doses). A significant difference in GI safety between selective COX-2 inhibitory + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term.
Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) have been reported rarely in patient treated for up to one year with Etoricoxib 60 and 90 mg daily. The incidence of elevated AST and/or ALT in patients treated with Etoricoxib 60 and 90 mg daily was similar to that of patients treated with naproxen, but notably less than the incidence in the diclofenac group. These elevations resolved in patients treated with Etoricoxib, with approximately half resolving while patients remained on therapy.
A patients 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 non selective cyclooxygenase inhibitors. Since the pathophysiology of these reactions is unknown, physicians should weigh the potential benefits of prescribing Etoricoxib versus the potential risks.
When using Etoricoxib in the elderly and in patients with renal, hepatic, or cardiac dysfunction, medically appropriate supervision should be maintained. If these patients deteriorate during treatment, appropriate measures should be taken, including discontinuation of therapy.
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.
Effects on Ability to Drive and Use Machines: There is no information to suggest that Etoricoxib affects a patient's ability to drive or operate machinery.
Use in Pregnancy: As with other drugs known to inhibit prostaglandin synthesis, use of Etoricoxib should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.
There are no adequate and well-controlled studies in pregnant women. Etoricoxib should be used during the first two trimesters of pregnancy only if the potential benefits justified the potential risk to the fetus.
Use in Lactation: Etoricoxib excreted in the milk of lactating rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the possible adverse effects of drugs that inhibit prostaglandin synthesis on nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into taking account the importance of the drug to the mother.
Use in Children: Safety and effectiveness of Etoricoxib in pediatric patients have not been established.
Use in Elderly: Pharmacokinetics in the elderly (65 years of age and older) are similar to those in the young. In studies, a higher incidence of adverse experiences was seen in older patients compared to younger patients; the relative differences between Etoricoxib and control groups were similar in the elderly and the young. Greater sensitivity of some older individuals cannot be ruled out.