Indomethacin

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Nonsteroidal anti-inflammatory drugs (including indomethacin) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while using this drug but is more likely if you use it for a long time. The risk may be greater in older adults or if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not use this drug right before or after heart bypass surgery (CABG).

Also, this drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while using this drug. Older adults may be at increased risk for this effect.

Stop using indomethacin and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes.

Talk to your doctor or pharmacist about the benefits and risks of using this drug.

Before using indomethacin, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent rectal bleeding, inflammation of the rectum/anus, asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, growths in the nose (nasal polyps), heart disease (such as history of heart attack), high blood pressure, liver disease, stomach/intestine/esophagus problems (such as bleeding, ulcers, recurring heartburn), stroke.

Kidney problems can sometimes occur with the use of NSAID medications, including indomethacin. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, stroke, and mental/mood changes while using this drug.

Children may be more sensitive to the side effects of this drug, especially serious liver problems. Caution is advised when this drug is used by children. Discuss the risks and benefits of treatment with your doctor.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to relieve pain caused by inflammation of the pouch surrounding the heart and other conditions as prescribed by your doctor.

Read the Medication Guide provided by your pharmacist before you start using indomethacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If the suppository is too soft to insert, put it in cold water or refrigerate it for 30 minutes before removing the foil wrapper. Unwrap the foil and moisten the suppository with a little water. Lie down on your left side with right knee bent. Push the suppository into the rectum with your finger. Remain lying down for a few minutes, and avoid having a bowel movement for at least an hour to allow the drug to be completely absorbed.

The dosage is based on your medical condition and response to treatment. Children's dosage is also based on weight. To reduce your risk of stomach bleeding and other side effects, use this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use this drug more often or for longer than prescribed. For ongoing conditions such as arthritis, keep using this medication as directed. Discuss the risks and benefits with your doctor or pharmacist.

For certain conditions (such as arthritis), it may take up to 4 weeks of using this drug regularly before you get the full benefit.

If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Tell your doctor if your condition gets worse.

See also Warning section.

Upset stomach, heartburn, headache, drowsiness, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: rectal irritation, bloody stools, feeling the need to have frequent bowel movements, easy bruising/bleeding, hearing changes (such as ringing in the ears), mental/mood changes (such as confusion, hallucinations), signs of kidney problems (such as change in the amount of urine), symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, dark urine, severe stomach/abdominal pain, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, corticosteroids (such as prednisone), lithium, methotrexate (high-dose treatment), "water pills" (diuretics such as furosemide).

This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, diflunisal, ibuprofen, or ketorolac). These drugs are similar to indomethacin and may increase your risk of side effects if taken together. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. If accidentally swallowed, you may experience symptoms such as: severe stomach pain, vomit that looks like coffee grounds, extreme drowsiness, slow or shallow breathing, confusion, seizures.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, complete blood count, liver/kidney function) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Lifestyle changes (such as weight loss if needed, strengthening/conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

Some brands may require refrigeration while others should not be refrigerated. Check the product package for instructions on how to store your product. If you have any questions about storage, ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.