Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seeWARNINGS).Sulindac tablets are indicated for acute long-term use in the relief of signs and symptoms of the following:OsteoarthritisRheumatoid arthritis*Ankylosing spondylitisAcute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)Acute gouty arthritis * The safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Association classification as Functional Class IV (incapacitated, largely or wholly bedridden, or confined to wheelchair; little or no self-care).
Sulindac tablets are contraindicated in patients with known hypersensitivity to sulindac or the excipients (seeDESCRIPTION).Sulindac tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.Severe, rarely fatal, anaphylactic/anaphylactoid reactions to NSAIDs have been reported in such patients (seeWARNINGS – Anaphylactic/Anaphylactoid Reactions, andPRECAUTIONS – Preexisting Asthma).Sulindac tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS).
Cardiovascular Thrombotic EventsClinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal.
All NSAIDs, both COX-2 selective and nonselective, may have a similar risk.
Patients with known CV disease or risk factors for CV disease may be at greater risk.
To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible.
Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms.
Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.
The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (seeGI WARNINGS).Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (seeCONTRAINDICATIONS).HypertensionNSAIDs, including sulindac, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events.
Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.
NSAIDs, including sulindac, should be used with caution in patients with hypertension.
Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.Congestive Heart Failure and EdemaFluid retention and edema have been observed in some patients taking NSAIDs.Sulindac should be used with caution in patients with fluid retention or heart failure.