Indomethacin

What it is and how it works

Mechanism of Action Indomethacin has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of indomethacin capsules, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Indomethacin is a potent inhibitor of prostaglandin synthesis in vitro . Indomethacin concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation.

Mechanism class: Cyclooxygenase Inhibitors

Indications

Indomethacin 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) • Acute gouty arthritis Indomethacin capsules are nonsteroidal anti-inflammatory drug 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) • Acute gouty arthritis

Dosage and administration (summary)

• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. • The dosage for moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis is indomethacin capsules 25 mg two or three times a day. • The dosage for acute painful shoulder (bursitis and/or tendinitis) is 75 to 150 mg daily in 3 or 4 divided doses. • The dosage for acute gouty arthritis is indomethacin capsules 50 mg three times a day.

Contraindications

Indomethacin 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 . • 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 . • In the setting of coronary artery bypass graft (CABG) surgery .

Warnings and precautions

• Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. • Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4 , 7 ) • Heart Failure and Edema : Avoid use of indomethacin capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Pregnancy

Pregnancy Risk Summary Use of NSAIDs, including indomethacin capsules, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Storage and supply

Product: 50090-0055 NDC: 50090-0055-0 30 CAPSULE in a BOTTLE

Source: Indomethacin (Indomethacin) — US FDA prescribing information, 2024-11-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.