INDOMETHACIN SUSTAINED-RELEASE CAPSULE - ORAL

INDOMETHACIN SUSTAINED-RELEASE CAPSULE - ORAL

PHONETIC PRONUNCIATION: (in-doh-METH-uh-sin)

COMMON BRAND NAME(S): Indocin SR

GENERIC NAME(S): indomethacin

Uses

USES: Indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis, bursitis, and tendonitis. Reducing these symptoms helps you do more of your normal daily activities. The sustained release capsule does not relieve pain quickly. Therefore, do not use it for sudden gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.


How to use INDOMETHACIN SUSTAINED-RELEASE CAPSULE - ORAL

HOW TO USE: 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. Swallow this medication whole. Do not crush or chew the capsules. Doing so can destroy the long action of the drug and may increase side effects. Take this medication by mouth as directed by your doctor, usually once or twice daily with a full glass of water (8 ounces or 240 milliliters). Do not lie down for at least 10 minutes after taking this drug. Take this medication either with food, right after meals, or with antacids to prevent stomach upset. Dosage is based on your medical condition and response to treatment. Do not take more than 150 milligrams per day. To lessen side effect risks (such as stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or take it more often than prescribed. For chronic conditions such as arthritis, continue taking it as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist. In certain conditions (such as arthritis), it may take up to 4 weeks when this drug is taken regularly before you notice the full benefits. Tell your doctor if your condition worsens.

Side Effects

SIDE EFFECTS: See also Warning section. Upset stomach, heartburn, headache, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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 any of these unlikely but serious side effects occur: hearing changes (such as ringing in the ears), mental/mood changes, difficult/painful swallowing, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Get medical help right away if any of these rare but very serious side effects occur: signs of kidney problems (such as change in the amount of urine), unexplained stiff neck. This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, severe stomach/abdominal pain, yellowing eyes or 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: 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 www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking 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: 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 previous heart attack), high blood pressure, liver disease, stomach/intestinal/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. This drug may make you dizzy or drowsy. Alcohol or marijuana 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. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 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. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and kidney problems. Children may be more sensitive to the side effects of this drug, especially serious liver problems. Caution is advised when this drug is used in 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 (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: 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 losartan, valsartan), cidofovir, lithium, methotrexate, corticosteroids (such as prednisone), "water pills" (diuretics such as furosemide). This medication may increase the risk of bleeding when taken 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 directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details. This medication can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.

Overdose

OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, vomit that looks like coffee grounds, extreme drowsiness, slow or shallow breathing, confusion, seizures.

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Faq for INDOMETHACIN SUSTAINED-RELEASE CAPSULE - ORAL

Indomethacin sustained-release capsule is used to relieve pain, swelling, and stiffness caused by conditions such as arthritis, gout, bursitis, and tendonitis.

Follow the instructions provided by your healthcare professional. Usually, indomethacin sustained-release capsule is taken with food or milk to reduce stomach upset. Swallow the capsule whole, without crushing or chewing it.

The common side effects may include upset stomach, heartburn, dizziness, drowsiness, headache, and swelling. Contact your doctor if any of these side effects persist or worsen.

It is essential to inform your doctor about all the medications you are taking, including prescription, over-the-counter, and herbal products. Some drugs may interact with indomethacin sustained-release capsule, leading to adverse effects.

Indomethacin sustained-release capsule should only be used during pregnancy if clearly needed, as it may harm the unborn baby. Consult your doctor before using this medication if you are pregnant or planning to become pregnant.

Alcohol consumption may increase the risk of stomach bleeding when combined with indomethacin sustained-release capsule. It is advisable to avoid or limit alcohol intake during treatment.

The onset of action may vary depending on the individual and the condition being treated. It is recommended to follow the prescribed dosage and give the medication enough time to show its effects.

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

Indomethacin sustained-release capsule is generally not recommended for use in children. The safety and effectiveness of this medication in pediatric patients have not been established, so consult with a healthcare professional for alternative options.


Warning

WARNING: 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 taking this drug but is more likely if you take it for a long time. The risk may be greater 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 take 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 taking this drug. Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.) Stop taking indomethacin and get medical help right away if you notice any of the following rare but serious side effects: bloody or black/tarry stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, sudden vision changes, slurred speech. Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.


Disclaimer

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.