Medications and Drugs

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Brand Names: Indocin, Indocin SR

Generic Name: indomethacin (Pronunciation: in doe METH a sin)

• What is indomethacin (Indocin, Indocin SR)?
• What are the possible side effects of indomethacin (Indocin, Indocin SR)?
• What is the most important information I should know about indomethacin (Indocin, Indocin SR)?
• What should I discuss with my healthcare provider before taking indomethacin (Indocin, Indocin SR)?
• How should I take indomethacin (Indocin, Indocin SR)?
• What happens if I miss a dose (Indocin, Indocin SR)?
• What happens if I overdose (Indocin, Indocin SR)?
• What should I avoid while taking indomethacin (Indocin, Indocin SR)?
• What other drugs will affect indomethacin (Indocin, Indocin SR)?
• Where can I get more information?

What is indomethacin (Indocin, Indocin SR)?

Indomethacin is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Indomethacin works by reducing hormones that cause inflammation and pain in the body.

Indomethacin is used to treat pain or inflammation caused by many conditions such as arthritis, gout, ankylosing spondylitis, bursitis, or tendinitis.

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

Indomethacin 25 mg-MYL

green, imprinted with MYLAN 143

Indomethacin 25 mg-TEV

green, imprinted with Z 4029

Indomethacin 50 mg-ESI

pink/white, imprinted with Lederle I20

Indomethacin 50 mg-IVA

green, imprinted with Z 4030

Indomethacin 50 mg-MYL

green, imprinted with MYLAN 147

Indomethacin 50 mg-TEV

green, imprinted with Z 4030

Indomethacin 75 mg SR-EON

clear/green, imprinted with E720

What are the possible side effects of indomethacin (Indocin, Indocin SR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking indomethacin and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• swelling or rapid weight gain;
• urinating less than usual or not at all;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

• upset stomach, mild heartburn, diarrhea, constipation;
• bloating, gas;
• dizziness, nervousness, headache;
• skin rash, itching;
• blurred vision; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about indomethacin (Indocin, Indocin SR)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use indomethacin. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking indomethacin. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not drink alcohol while taking indomethacin. Alcohol can increase the risk of stomach bleeding caused by indomethacin.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to indomethacin (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

What should I discuss with my healthcare provider before taking indomethacin (Indocin, Indocin SR)?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to indomethacin, or if you have a history of allergic reaction to aspirin or other NSAIDs.

Before taking indomethacin tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart attack, stroke, or blood clot;
• heart disease, congestive heart failure, high blood pressure;
• a history of stomach ulcers or bleeding;
• liver or kidney disease,
• a seizure disorder such as epilepsy;
• asthma;
• polyps in your nose;
• a bleeding or blood clotting disorder; or
• if you smoke.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take indomethacin.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking indomethacin during the last 3 months of pregnancy may harm the unborn baby. Do not take indomethacin during pregnancy unless your doctor has told you to.

Indomethacin passes into breast milk and may affect a nursing baby. Do not take indomethacin without first talking to your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 14 years old without the advice of a doctor.

How should I take indomethacin (Indocin, Indocin SR)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take indomethacin with food or milk to lessen stomach upset.

Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

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 medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using indomethacin.

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

What happens if I miss a dose (Indocin, Indocin SR)?

If you are taking indomethacin on a regular schedule, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose.

If you are taking indomethacin as needed, take the missed dose if it is needed, then wait the recommended or prescribed amount of time before taking another dose.

What happens if I overdose (Indocin, Indocin SR)?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an indomethacin overdose may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking indomethacin (Indocin, Indocin SR)?

Do not drink alcohol while taking indomethacin. Alcohol can increase the risk of stomach bleeding caused by indomethacin.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to indomethacin (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Indomethacin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What other drugs will affect indomethacin (Indocin, Indocin SR)?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with indomethacin may cause you to bruise or bleed easily.

Before taking indomethacin, tell your doctor if you are taking any of the following drugs:

• a blood thinner such as warfarin (Coumadin);
• cyclosporine (Gengraf, Neoral, Sandimmune);
• digoxin (digitalis, Lanoxin);
• diuretics (water pills) such as furosemide (Lasix);
• lithium (Eskalith, Lithobid);
• methotrexate (Rheumatrex, Trexall);
• probenecid (Benemid);
• steroids (prednisone and others);
• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or
• a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others.

This list is not complete and there may be other drugs that can interact with indomethacin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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.

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