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Sulindac (Sulindac) - Summary

 

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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).
  • Sulindac Tablets are 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).
 

SULINDAC SUMMARY

SULINDAC TABLETS USP

Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro-2-methyl-1-[[ p -(methylsulfinyl) phenyl]methylene]-1 H -indene-3-acetic acid.

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 (see WARNINGS).

Sulindac tablets are indicated:

  1. For the relief of signs and symptoms of rheumatoid arthritis.*

  2. For the relief of signs and symptoms of osteoarthritis.

  3. For acute or long-term use in the relief of signs and symptoms of the following:

    - Ankylosing spondylitis

    - Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis)

    - Acute gouty arthritis

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* 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).

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SULINDAC NEWS HIGHLIGHTS

Published Studies Related to Sulindac

The effect of long-term treatment with sulindac on the progression of diabetic retinopathy. [2007.08]

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Clinical Trials Related to 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]

Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps [Active, not recruiting]

Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps [Active, not recruiting]

A Randomized Study of Sulindac in Oral Premalignant Lesions [Recruiting]

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Page last updated: 2007-10-18

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