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Basic Drug Info
Drug Name:Sulindac
Manufacturer:Watson Laboratories, Inc.
Other Info:Rx only



Clinical Trials:


Indications and Usage

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).
Physical findings -- Objective evidence of disease perceptible to the examining physician.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

GOUTY ARTHRITIS ACUTE --

Rheumatoid Arthritis -- A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.

Little's Disease --

Contraindications

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).
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Urticaria -- A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress.

Allergic Reaction --

Pain -- An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.

Warnings

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.
Branded Drugs
The following US Branded drugs contain Sulindac


CLINORIL -- MERCK RESEARCH LABORATORIES DIV MERCK CO INC


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