Indomethacin

IMPORTANT WARNING:

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as indomethacin may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as indomethacin if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take indomethacin right before or right after the surgery.

NSAIDs such as indomethacin may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while taking indomethacin. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as diflunisal (Dolobid), ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers or bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking indomethacin and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to indomethacin. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with indomethacin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Indomethacin is used to relieve moderate to severe pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), and ankylosing spondylitis (arthritis that mainly affects the spine). Indomethacin is also used to treat pain in the shoulder caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint) and tendinitis (inflammation of the tissue that connects muscle to bone). Indomethacin immediate-release capsules and suspension (liquid) are also used to treat acute gouty arthritis (attacks of severe joint pain and swelling caused by a build-up of certain substances in the joints). Indomethacin is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Are there OTHER USES for this medicine?

Indomethacin is also sometimes used to relieve fever, pain, and inflammation caused by many types of conditions or injuries, to reduce the amount of calcium in the blood, and to treat a certain type of low blood pressure. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Indomethacin comes as a capsule, an extended-release (long-acting) capsule, and a suspension to take by mouth. Indomethacin capsules and liquid usually are taken two to four times a day. Extended-release capsules are usually taken one or two times a day. Indomethacin capsules, extended-release capsules, and suspension should be taken with food, immediately after meals, or with antacids. Take indomethacin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take indomethacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release capsules whole; do not split, chew, or crush them.

Shake the suspension well before each use to mix the medication evenly.

Your doctor may change the dose of your medication during your treatment. In some cases, your doctor may start you on a low dose of indomethacin and gradually increase your dose, not more often than once a week. In other cases, your doctor may start you on an average dose of indomethacin and decrease your dose once your symptoms are controlled. Follow these directions carefully and ask your doctor or pharmacist if you have any questions.

What SPECIAL PRECAUTIONS should I follow?

Before taking indomethacin,

• tell your doctor and pharmacist if you are allergic to indomethacin, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in indomethacin capsules, suspension, or extended-release capsules. Ask your pharmacist for a list of the inactive ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar. in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Diovan HCT, in Exforge); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); diuretics ('water pills') such as triamterene (Dyrenium, in Dyazide); lithium (Lithobid); methotrexate (Otrexup, Rasuvo, Trexall); phenytoin (Dilantin, Phenytek); and probenecid (Probalan, in Col-Probenecid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); heart failure; seizures; Parkinson's disease; depression or mental illness; or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant; or are breast-feeding. Indomethacin may harm the fetus and cause problems with delivery if it is taken around 20 weeks or later during pregnancy. Do not take indomethacin around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while taking indomethacin, call your doctor.

• you should know that indomethacin may cause fertility problems in women. Talk to your healthcare provider if you have concerns about fertility.

• talk to your doctor about the risks and benefits of taking indomethacin if you are 65 years of age or older. Older adults usually should not take indomethacin because it is not as safe as other medications that can be used to treat the same condition.

• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• talk to your doctor about the safe use of alcohol during your treatment with indomethacin. Alcohol can make the side effects of indomethacin worse.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Indomethacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• vomiting
• diarrhea
• constipation
• ringing in the ears

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment.

• unexplained weight gain
• shortness of breath or difficulty breathing
• swelling in the abdomen, ankles, feet, or legs
• fever, rash, lymph node swelling, or facial swelling
• fever
• blisters
• rash
• itching
• hives
• swelling of the eyes, face, tongue, lips, throat, or hands
• difficulty breathing or swallowing
• hoarseness
• pale skin
• fast heartbeat
• excessive tiredness
• unusual bleeding or bruising
• lack of energy
• nausea
• loss of appetite
• pain in the upper right part of the stomach
• flu-like symptoms
• yellowing of the skin or eyes
• cloudy, discolored, or bloody urine
• back pain
• difficult or painful urination
• blurred vision or other problems with sight

Indomethacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting
• headache
• dizziness
• confusion
• extreme tiredness
• feeling of numbness, pricking, burning, or creeping on the skin
• seizures

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking indomethacin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.