Sign Out
Etoricoxib may be associated with an increased risk of thrombotic events (especially MI 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.
Etoricoxib should not be used in patients with ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease. It should be used with caution in patients with significant risk factors for cardiovascular disease such as hypertension, hyperlipidaemia, and diabetes mellitus.
Warning to prescriber when prescribing COX-2 Inhibitors to patients with risk factors of heart disease, hypertension (high blood pressure), hyperlipidemia, diabetes, smoking patient and patient with peripheral arterial disease. Selective COX-2 inhibitors are not a substitute for aspirin for cardiovascular prophylaxis because of their lack of effect on platelets. Hence, 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 when taken concomitantly with acetylsalicylic acid (even at low doses).
In patients with advanced renal disease, treatment with etoricoxib is not recommended. If therapy with etoricoxib must be initiated in such patients, renal function should be monitored closely. Long-term use of NSAIDs has resulted in renal papillary necrosis and other renal injury. Monitoring of renal function should be considered for those with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis.
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.
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 Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including etoricoxib, can be associated with new onset or recurrent congestive heart failure. Etoricoxib, particularly at high doses, may be associated with more frequent and severe hypertension compared with other NSAIDs and selective cyclooxygenase-2 (COX-2) inhibitors; blood pressure monitoring during etoricoxib treatment is recommended. Etoricoxib should not be used in patients with hypertension whose blood pressure is not controlled.
Conditions predisposing to gastrointestinal events (eg, history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis, smoking, advancing age, concurrent aspirin or corticosteroids, alcohol abuse, stress).
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 with history of acute asthmatic attacks, urticaria, or rhinitis, which were caused by salicylates or non-selective cyclooxygenase inhibitors.
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.
It should be avoided in patients with severe hepatic impairment (Child-Pugh score of 10 or more). Therapy should be stopped if persistently abnormal liver enzyme values are seen.
Use of etoricoxib is associated with very rare occurrence of serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. These serious events may occur without warning and patients are at highest risk for these reactions early in the course of therapy.
Patients with history of mild allergic phenomena related to ingestion of other nonsteroidal anti-inflammatory drugs (eg, rash) should be treated with caution. Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Etoricoxib may mask fever, which is a sign of infection.
RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAIDs: Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events.
Fertility: The use of etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive.
Use in Pregnancy: No clinical data on exposed pregnancies are available for etoricoxib. The potential for human risk in pregnancy is unknown. Etoricoxib, as with other medicinal products inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. Etoricoxib is contraindicated in pregnancy. If a woman becomes pregnant during treatment, etoricoxib must be discontinued.
Use In Lactation: It is not known whether etoricoxib is excreted in human milk. Women who use etoricoxib must not breast feed.
90 mg: Etoricoxib is excreted in the milk of lactating rats.
