Torixib Special Precautions

The selective COX-2 inhibitor class of drugs may be associated with an increased risk of thrombotic events, especially MI and stroke. These 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 and smoking, should only be treated with Etoricoxib after careful consideration.
Selective COX-2 inhibitors, including Etoricoxib, are not a substitute for aspirin for cardiovascular prophylaxis because of their lack of effect on platelets. Therefore, antiplatelet therapies should not be discontinued.
When used Etoricoxib concomitantly with aspirin (even at low dose), there is a further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications). Gastroprotective (e.g., proton pump inhibitors, misoprostol) is recommended.
Upper gastrointestinal complications including perforations, ulcers or bleedings (PUBs), some of them resulting in fatal outcome, have occurred in patients treated with Etoricoxib.
Use caution with a history or risk of gastrointestinal disease (bleeding or ulcers), concurrent therapy with aspirin or other NSAIDs, anticoagulants and/or corticosteroids, smoking, alcohol, and the elderly or debilitated patients.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Under conditions of compromised renal perfusion, administration of Etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and therapy impaired renal function. Monitoring of renal function should be considered in patients with pre-existing significantly impair 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 starting therapy with Etoricoxib.
Monitor renal function closely; discontinue use with persistent or worsening renal function; use is contraindicated with severe renal impairment (CrCl <30 mL/min).
As with other drugs known to inhibit prostaglandin synthesis, fluid retention, edema and hypertension may occur in some patients taking Etoricoxib. Etoricoxib may be associated with more frequent and severe hypertension. Therefore, maintain blood pressure <140/90 mmHg prior to initiation and special attention should be paid to blood pressure monitoring during treatment with Etoricoxib. If blood pressure rises significantly, alternative treatment should be considered.
Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) may occur, monitor hepatic function closely in patients with previous abnormal hepatic function tests or sign/symptoms of hepatic dysfunction. 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.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrosis (TEN) have been reported very rarely and serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patient receiving Etoricoxib. Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
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 measure should be taken, including discontinued 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.
The use of Etoricoxib, as with any drug known to inhibit COX-2, is not recommended in woman attempting to conceive.
Patients who experience dizziness, vertigo or somnolence while taking Etoricoxib should refrain from driving or operating machinery.