Application Nr Approved Date Route Status External Links
ANDA201807 2012-09-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Carefully Consider The Potential Benefits And Risks Of Indomethacin Extended-Release Capsules And Other Treatment Options Before Deciding To Use Indomethacin Extended-Release Capsules. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings ). Indomethacin Extended-Release Capsules Have Been Found Effective In Active Stages Of The Following: 1. Moderate To Severe Rheumatoid Arthritis Including Acute Flares Of Chronic Disease. 2. Moderate To Severe Ankylosing Spondylitis. 3. Moderate To Severe Osteoarthritis. 4. Acute Painful Shoulder (bursitis And/or Tendinitis). Indomethacin Extended-Release Capsules, Usp Are Not Recommended For The Treatment Of Acute Gouty Arthritis. Indomethacin May Enable The Reduction Of Steroid Dosage In Patients Receiving Steroids For The More Severe Forms Of Rheumatoid Arthritis. In Such Instances The Steroid Dosage Should Be Reduced Slowly And The Patients Followed Very Closely For Any Possible Adverse Effects. The Use Of Indomethacin In Conjunction With Aspirin Or Other Salicylates Is Not Recommended. Controlled Clinical Studies Have Shown That The Combined Use Of Indomethacin And Aspirin Does Not Produce Any Greater Therapeutic Effect Than The Use Of Indomethacin Alone. Furthermore, In One Of These Clinical Studies, The Incidence Of Gastrointestinal Side Effects Was Significantly Increased With Combined Therapy. (see Precautions,drug Interactions ).

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Povidones POVIDONES Unresolved
2. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
3. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Indomethacin INDOMETHACIN ZINC601283