Favocox Special Precautions

Celecoxib contains a sulfonamide moiety. In clinical trials, Celecoxib did not induce bronchospasm in patients with asthma. However, Celecoxib has not been evaluated in patients in whom attacks of asthma, urticaria or acute rhinitis have been precipitated by aspirin or nonsteroidal anti-inflammatory agents. Use in such patients should be avoided until further information is available.
(1) Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
(2) Gastrointestinal Risk: NSAIDS cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
(3) Celecoxib are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of effect on platelets function.
(4) Given the association between cardiovascular risk and exposure to celecoxib, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment.
(5) Celecoxib should be used with caution in patients with history of cardiac failure or hypertension, since it may result in fluid retention.
(6) Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of NSAIDs including celecoxib during postmarketing surveillance.
(7) Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
(8) Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of Favocox Capsule in patients with advanced renal disease. Therefore, treatment with Favocox Capsule is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.