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indomethacin

Pronunciation

Generic Name: indomethacin (in doe METH a sin)
Brand Name: Indocin, Indocin SR, Tivorbex

What is indomethacin?

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID). Indomethacin works by reducing hormones that cause inflammation and pain in the body.

Indomethacin is used to treat moderate to severe osteoarthritis, rheumatoid arthritis, gouty arthritis, or ankylosing spondylitis. Indomethacin is also used to treat shoulder pain caused by bursitis or tendinitis.

Extended-release indomethacin (Indocin SR) should not be used to treat gouty arthritis.

Indomethacin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about indomethacin?

Indomethacin can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Indomethacin may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using indomethacin, especially in older adults.

What should I discuss with my healthcare provider before taking indomethacin?

Indomethacin can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Indomethacin may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using indomethacin, especially in older adults.

You should not use indomethacin if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure indomethacin is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

  • a history of heart attack, stroke, or blood clot;

  • a history of stomach ulcers or bleeding;

  • asthma;

  • liver or kidney disease; or

  • fluid retention.

Taking indomethacin during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using indomethacin.

Indomethacin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Indomethacin is not approved for use by anyone younger than 14 years old.

How should I take indomethacin?

Follow all directions on your prescription label. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

If you take indomethacin for a long period of time, your doctor may want to check you on a regular basis to make sure this medicine is not causing harmful effects.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include vomiting, severe headache, dizziness, confusion, numbness, tingling, or seizure (convulsions).

What should I avoid while taking indomethacin?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking indomethacin.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain aspirin or other medicines similar to indomethacin. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Indomethacin side effects

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using indomethacin and call your doctor at once if you have:

  • changes in your vision;

  • shortness of breath (even with mild exertion);

  • swelling or rapid weight gain;

  • the first sign of any skin rash, no matter how mild;

  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • upset stomach, nausea, vomiting;

  • diarrhea, constipation;

  • headache, dizziness, drowsiness;

  • feeling tired or depressed; or

  • ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Indomethacin dosing information

Usual Adult Dose for Acute Gout:

50 mg orally or rectally 3 times a day
Duration of therapy: Until gout attack has resolved

Comments:
-Relief of pain has been observed within 2 to 4 hours; tenderness and heat usually subside within 24 to 36 hours; swelling gradually disappears in 3 to 5 days.
-Extended release capsules are not recommended for the treatment of acute gouty arthritis.

Use: For the treatment of acute gouty arthritis.

Usual Adult Dose for Bursitis:

Immediate-release capsules and suspension:
75 to 150 mg orally per day in 3 or 4 divided doses

Suppository:
50 mg rectally up to 3 times a day

Extended Release:
75 mg orally once or twice a day

Comments:
-The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
-Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days

Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).

Usual Adult Dose for Tendonitis:

Immediate-release capsules and suspension:
75 to 150 mg orally per day in 3 or 4 divided doses

Suppository:
50 mg rectally up to 3 times a day

Extended Release:
75 mg orally once or twice a day

Comments:
-The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
-Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days

Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).

Usual Adult Dose for Pain:

20 mg orally 3 times a day or 40 mg orally 2 to 3 times a day

Comment:
-The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.

Use: For the treatment of mild to moderate acute pain

Usual Adult Dose for Rheumatoid Arthritis:

Immediate-release capsules and suspension:
-Initial dose: 25 mg orally 2 or 3 times a day
-Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg

Suppository:
-Initial dose: 50 mg rectally once a day
-Maintenance dose: 50 to 200 mg rectally per day in divided doses
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg per day

Comment: For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:
-Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release at 150 mg per day:
-Initial dose: 75 mg orally twice a day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
-During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
-Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Use: For the treatment of active stages of moderate to severe rheumatoid arthritis, including acute flares of chronic disease.

Usual Adult Dose for Ankylosing Spondylitis:

Immediate-release capsules and suspension:
-Initial dose: 25 mg orally 2 or 3 times a day
-Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg

Suppository:
-Initial dose: 50 mg rectally once a day
-Maintenance dose: 50 to 200 mg rectally per day in divided doses
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg per day

Comment: For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:
-Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release at 150 mg per day:
-Initial dose: 75 mg orally twice a day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
-During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
-Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Use: For the treatment of active stages of moderate to severe ankylosing spondylitis.

Usual Adult Dose for Osteoarthritis:

Immediate-release capsules and suspension:
-Initial dose: 25 mg orally 2 or 3 times a day
-Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg

Suppository:
-Initial dose: 50 mg rectally once a day
-Maintenance dose: 50 to 200 mg rectally per day in divided doses
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg per day

Comment: For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:
-Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release at 150 mg per day:
-Initial dose: 75 mg orally twice a day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
-During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
-Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Use: For the treatment of active stages of moderate to severe osteoarthritis.

Usual Pediatric Dose for Patent Ductus Arteriosus:

Dosing depends on age of neonate at time of therapy; A course of therapy is defined as 3 IV doses given at 12 to 24 hour intervals.

Age at first dose: Less than 48 hours:
-First dose: 0.2 mg/kg IV
-Second dose: 0.1 mg/kg IV
-Third dose: 0.1 mg/kg IV

Age at first dose: 2 to 7 days:
-First dose: 0.2 mg/kg IV
-Second dose: 0.2 mg/kg IV
-Third dose: 0.2 mg/kg IV

Age at first dose: Over 7 days:
-First dose: 0.2 mg/kg IV
-Second dose: 0.25 mg/kg IV
-Third dose: 0.25 mg/kg IV

Comments:
-Monitor urinary output; if anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) is evident at time of the second or third dose, hold drug until laboratory studies indicate renal function has returned to normal.
-If ductus arteriosus closes or has significantly reduced in size 48 hours or more after completion of the first course, no further doses are needed.
-If ductus arteriosus re-opens, a second course of 1 to 3 doses may be given.
-If neonate is unresponsive after 2 courses of therapy, surgery may be necessary.

Use: For the closure of a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when 48 hours of usual medical management is ineffective; clear-cut clinical evidence of hemodynamically significant patent ductus arteriosus should be present (e.g., respiratory distress, continuous murmur, hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray).

Usual Pediatric Dose for Rheumatoid Arthritis:

2 to 14 years:
-Initial dose: 1 to 2 mg/kg/day orally in divided doses
-Maximum dose: 3 mg/kg/day or 150 to 200 mg/day, whichever is less; limited data supports a maximum of 4 mg/kg/day

Comments:
-Safety and efficacy have not been established in patients 14 years and younger; use should be limited to patients for whom toxicity or lack of efficacy with other drugs warrants the risk.
-As symptoms subside, the dose should be reduced or discontinued.
-Use in pediatric patients have been confined to the use of capsules.

Over 14 years:
Immediate-release capsules and suspension:
-Initial dose: 25 mg orally 2 or 3 times a day
-Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg

Suppository:
-Initial dose: 50 mg rectally once a day
-Maintenance dose: 50 to 200 mg rectally per day in divided doses
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg per day

Comment:
-For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:
-Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release at 150 mg per day:
-Initial dose: 75 mg orally twice a day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
-During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
-Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Use: For the treatment of active stages of moderate to severe rheumatoid arthritis, including acute flares of chronic disease.

Usual Pediatric Dose for Ankylosing Spondylitis:

Over 14 years:
Immediate-release capsules and suspension:
-Initial dose: 25 mg orally 2 or 3 times a day
-Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg

Suppository:
-Initial dose: 50 mg rectally once a day
-Maintenance dose: 50 to 200 mg rectally per day in divided doses
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg per day

Comment:
-For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:
-Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release at 150 mg per day:
-Initial dose: 75 mg orally twice a day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
-During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
-Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Use: For the treatment of active stages of moderate to severe rheumatoid arthritis.

Usual Pediatric Dose for Osteoarthritis:

Over 14 years:
Immediate-release capsules and suspension:
-Initial dose: 25 mg orally 2 or 3 times a day
-Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg

Suppository:
-Initial dose: 50 mg rectally once a day
-Maintenance dose: 50 to 200 mg rectally per day in divided doses
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg per day

Comment:
-For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:
-Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release at 150 mg per day:
-Initial dose: 75 mg orally twice a day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
-During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
-Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Use: For the treatment of active stages of moderate to severe rheumatoid arthritis.

Usual Pediatric Dose for Bursitis:

Over 14 years:
Immediate-release capsules and suspension:
75 to 150 mg orally per day in 3 or 4 divided doses

Suppository:
50 mg rectally up to 3 times a day

Extended Release:
75 mg orally once or twice a day

Comments:
-The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
-Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days

Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).

Usual Pediatric Dose for Tendonitis:

Over 14 years:
Immediate-release capsules and suspension:
75 to 150 mg orally per day in 3 or 4 divided doses

Suppository:
50 mg rectally up to 3 times a day

Extended Release:
75 mg orally once or twice a day

Comments:
-The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
-Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days

Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).

What other drugs will affect indomethacin?

Ask your doctor before using indomethacin if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use indomethacin if you are also using any of the following drugs:

  • cyclosporine;

  • lithium;

  • methotrexate;

  • probenecid;

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • heart or blood pressure medication, including a diuretic or "water pill"; or

  • steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with indomethacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about indomethacin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 10.01. Revision Date: 2015-09-08, 10:04:35 AM.

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