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Generic Name: indomethacin

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An NSAID - treats Tendonitis, Ankylosing Spondylitis, Cluster Headache, Acute Gout, Bursitis, Rheuma... more

FDA Alerts

Cardiovascular Risk

Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke). Risk may increase with duration of use. Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk. (See Cardiovascular Effects under Cautions.)
Contraindicated for the treatment of pain in the setting of CABG surgery.

GI Risk

Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine). Serious GI events can occur at any time and may not be preceded by warning signs and symptoms. Geriatric individuals are at greater risk for serious GI events. (See GI Effects under Cautions.)

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Indomethacin
MYLAN 147 / MYLAN 147 50 mg	Lederle I20 / Lederle I20 50 mg	MYLAN 143 / MYLAN 143 25 mg	Z 4030 / Z 4030 50 mg
Indomethacin SR
E720 75 mg

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(in doe METH a sin)

Uses

When used for inflammatory diseases, consider potential benefits and risks of indomethacin therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.

Inflammatory Diseases

Symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Symptomatic relief of acute gout and acute painful shoulder (i.e., bursitis and/or tendinitis).

Management of juvenile rheumatoid arthritis† in children ≥2 years of age.

Patent Ductus Arteriosus (PDA)

Treatment of PDA in premature neonates. Used to promote closure of a hemodynamically significant PDA (i.e., left-to-right shunt large enough to compromise cardiorespiratory status) in premature neonates weighing 500–1750 g when 36–48 hours of usual medical management (e.g., fluid restriction, diuretics, cardiac glycosides, respiratory support) is ineffective.

Pericarditis

Reduction of pain, fever, and inflammation of pericarditis†; however, other drugs (i.e., aspirin) generally are preferred.

Dosage and Administration

General

For inflammatory diseases, consider potential benefits and risks of indomethacin therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Administer orally or rectally (for inflammatory diseases or pericarditis) or by IV infusion (for PDA).

Oral Administration

In patients who have persistent night pain and/or morning stiffness, a large portion (maximum 100 mg) of the total daily dose may be given at bedtime.

Conventional Capsules and Oral Suspension

Administer conventional capsules and oral suspension in 2–4 divided doses daily.

Extended-release Capsules

Administer extended-release capsules once or twice daily.

Extended-release capsules can be used as an alternative to conventional capsules: 75 mg once daily (extended-release) as an alternative to 25 mg 3 times daily (conventional); 75 mg twice daily (extended-release) as an alternative to 50 mg 3 times daily (conventional).

Swallow extended-release capsules intact.

Extended-release capsules are not recommended for treatment of acute gouty arthritis.

Rectal Administration

Administer in 2–4 divided doses daily.

Retain suppositories in rectum for ≥1 hour to ensure complete absorption.

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.

Avoid extravasation (irritating to extravascular tissues).

Reconstitution

Reconstitute vial containing 1 mg of indomethacin with 1 or 2 mL of preservative-free 0.9% sodium chloride injection or sterile water for injection to provide a solution containing 1 mg/mL or 0.5 mg/mL, respectively. Further dilution is not recommended.

Use of bacteriostatic water for injection containing benzyl alcohol is not recommended because of potential risk of benzyl alcohol exposure if administered to a neonate.

Prepare solutions immediately before use; discard any unused solution.

Rate of Administration

Optimum rate not established; may administer dose over 20–30 minutes.

Dosage

Available as indomethacin and indomethacin sodium; dosage expressed in terms of indomethacin.

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.

Pediatric Patients

Inflammatory Diseases

Juvenile Rheumatoid Arthritis

Oral

Children ≥2 years of age: Initially, 1–2 mg/kg daily in divided doses. Increase dosage until a satisfactory response is achieved, up to maximum dosage of 3 mg/kg daily or 150–200 mg daily (whichever is less) in divided doses; limited data support the use of a maximum dosage of 4 mg/kg daily or 150–200 mg daily (whichever is less) in divided doses. As symptoms subside, reduce dosage to the lowest effective level or discontinue the drug.†

PDA

IV

Each course of therapy consists of up to 3 doses administered at 12- to 24-hour intervals.

Base dosage on neonate’s age at the time therapy is initiated.

**Dosage for the Management of PDA in Neonates**
Age at First Dose	First Dose	Second Dose	Third Dose
<48 hours	0.2 mg/kg	0.1 mg/kg	0.1 mg/kg
2–7 days	0.2 mg/kg	0.2 mg/kg	0.2 mg/kg
>7 days	0.2 mg/kg	0.25 mg/kg	0.25 mg/kg

If anuria or oliguria (urine output <0.6 mL/kg per hour) is present at the time of a second or third dose, withhold the dose until laboratory determinations indicate that renal function has returned to normal.

If ductus arteriosus closes or is substantially constricted 48 hours or longer after completion of the first course, no further doses are necessary.

If ductus reopens, a second course of 1–3 doses may be administered. Surgical ligation may be necessary if ductus is unresponsive to 2 courses of therapy.

Pericarditis

Oral

50–100 mg daily in 2–4 divided doses.†

Adults

Inflammatory Diseases

Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis

Oral

Conventional capsules or oral suspension: Initially, 25 mg 2 or 3 times daily. If needed, increase dosage by 25 or 50 mg daily at weekly intervals until a satisfactory response is obtained up to a maximum dosage of 150–200 mg daily.

Extended-release capsules: Initially, 75 mg once daily. May increase dosage to 75 mg twice daily.

Rectal

25 mg 2 or 3 times daily. If needed, increase dosage by 25 or 50 mg daily at weekly intervals until a satisfactory response is obtained up to a maximum dosage of 150–200 mg daily.

Gout

Oral

Conventional capsules: 50 mg 3 times daily until pain is tolerable; then reduce dosage rapidly and discontinue.

Painful Shoulder

Oral

Conventional capsules or oral suspension: 75–150 mg daily in 3 or 4 divided doses. Discontinue once symptoms have been controlled for several days; usual course of therapy is 7–14 days.

Extended-release capsules: 75 mg once or twice daily. Discontinue once symptoms have been controlled for several days; usual course of therapy is 7–14 days.