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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. (See WARNINGS)
- CLINORIL is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
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. (See WARNINGS)
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CLINORIL SUMMARY
What is the most important information I should know about medicines called non-steroidal anti-inflammatory drugs (NSAIDs)?
Sulindac is a non-steroidal, anti-inflammatory indene derivative.
CLINORIL is indicated for acute or long-term use in the relief of signs and symptoms of the following:
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Osteoarthritis
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Rheumatoid arthritis **
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Ankylosing spondylitis
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Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)
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Acute gouty arthritis
**The safety and effectiveness of CLINORIL 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).
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CLINORIL NEWS HIGHLIGHTS
Published Studies Related to Clinoril (Sulindac)
The effect of long-term treatment with sulindac on the progression of diabetic retinopathy. [2007.08]
Genetic polymorphisms of human flavin monooxygenase 3 in sulindac-mediated primary chemoprevention of familial adenomatous polyposis. [2004.12.15]
A double-blind randomized study of fetal side effects during and after the short-term maternal administration of indomethacin, sulindac, and nimesulide for the treatment of preterm labor. [2003.04]
Primary chemoprevention of familial adenomatous polyposis with sulindac. [2002.04.04]
Sulindac to prevent recurrent preterm labor: a randomized controlled trial. [2001.10]
Clinical Trials Related to Clinoril (Sulindac)
Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers [Completed]
Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer [Active, not recruiting]
A Randomized Study of Sulindac in Oral Premalignant Lesions [Recruiting]
Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps [Active, not recruiting]
Melanoma Epirubicin Sulindac Trial: Sulindac in Combination With Epirubicin in Patients With Advanced Melanoma [Recruiting]
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Page last updated: 2007-10-18
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