Indomethacin Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Indomethacin is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Indomethacin extended-release capsules are indicated for: • Moderate to severe rheumatoid arthritis including acute flares of chronic disease • Moderate to severe ankylosing spondylitis • Moderate to severe osteoarthritis • Acute painful shoulder (bursitis and/or tendinitis)
What should I know before taking it?
Indomethacin extended-release capsules are contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see Warnings and Precautions (5.7, 5.9)] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)] • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)]
What important warnings are listed?
Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use . • Indomethacin extended-release capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery . Gastrointestinal Bleeding, Ulceration, and Perforation • NSAIDs cause an increased risk of serious gastrointestinal (GI) 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.
How is this medication usually taken?
Indomethacin extended-release capsules USP, 75 mg are size ‘2’, dark yellow cap and clear transparent body hard gelatin capsules, containing cream spherical pellets imprinted with ‘H’ on cap and ‘105’ on body.
What side effects are listed?
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] • GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2)] • Hepatotoxicity [see Warnings and Precautions (5.3)] • Hypertension [see Warnings and Precautions (5.4)] • Heart Failure and Edema [see Warnings and Precautions (5.5)] • Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6)] • Anaphylactic Reactions [see Warnings and Precautions (5.7)] • Serious Skin Reactions [see Warnings and Precautions (5.9)] • Hematologic Toxicity [see Warnings and Precautions (5.12)]
What interactions are listed?
See Table 2 for clinically significant drug interactions with indomethacin. Table 2 Clinically Significant Drug Interactions with Indomethacin Dr ugs That Interfere with Hemostasis C linica l Impact: Indomethacin and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of indomethacin and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=12821a3a-b5f2-4415-84c9-0a30a4725f1e
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.