Indications And Usage

• 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)

Administration

General Dosing Instructions:

Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin capsules. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals

After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.

Adverse reactions generally appear to correlate with the dose of indomethacin. Therefore, every effort should be made to determine the lowest effective dosage for the individual patient.

Moderate to severe rheumatoid arthritis including acute flares of chronic disease:

Indomethacin capsules 25 mg twice a day or three times a day. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. Doses above this amount generally do not increase the effectiveness of the drug.

In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.

If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and observe the patient closely.

If severe adverse reactions occur, stop the drug. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.

Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.

As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly.

Acute painful shoulder (bursitis and/or tendinitis):

Indomethacin capsules 75 mg to 150 mg daily in 3 or 4 divided doses.

The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.

Acute Gouty Arthritis:

Contraindications

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug
• 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 

Precautions

Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation, Hepatotoxicity, Hypertension, Heart Failure and Edema, Renal Toxicity and Hyperkalemia, Anaphylactic Reactions, Exacerbation of Asthma Related to Aspirin Sensitivity, Serious Skin Reactions, Premature Closure of Fetal Ductus Arteriosus, Hematologic Toxicity, Masking of Inflammation and Fever , Central Nervous System Effects, Ocular Effects

Adverse Reactions

Cardiovascular Thrombotic Events, GI Bleeding, Ulceration and Perforation, Hepatotoxicity, Hypertension, Heart Failure and Edema, Renal Toxicity and Hyperkalemia, Anaphylactic Reactions, Serious Skin Reactions, Hematologic Toxicity

Pregnancy and lactation

Use of NSAIDs, including indomethacin capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including indomethacin, in pregnant women starting at 30 weeks of gestation

Renal and liver Impairment

Elevations of ALT or AST (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported.

Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs including indomethacin.

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue indomethacin immediately, and perform a clinical evaluation of the patient.

Laboratory Tests