Indomethacin Rectal

IMPORTANT WARNING:

People who use 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 use these medications. These events may happen without warning and may cause death. This risk may be higher for people who use NSAIDs for a long time. Do not use 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 use 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 use NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while using 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 using 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 (swelling of a fluid-filled sac in the shoulder joint) and tendinitis (swelling of the tissue that connects muscle to bone). Indomethacin suppositories 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). It is used to treat moderate to severe rheumatoid arthritis. 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 swelling.

Are there OTHER USES for this medicine?

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 suppository to use rectally. Indomethacin suppositories usually are used two to four times daily. Use 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. Use indomethacin exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

To use indomethacin suppositories, follow these steps:

1. Wash your hands.
2. Remove the wrapper.
3. Dip the tip of the suppository in water.
4. Insert pointed end first well into rectum.
5. Lie down on your left side and raise your right knee to your chest. (A left-handed person should lie on the right side and raise the left knee.)
6. Using your finger, insert the suppository about 1 inch (2.5 centimeters) into the rectum. Hold it in place for a few moments.
7. Remain lying down for 5 minutes to prevent the suppository from coming out.
8. Wash your hands thoroughly and resume your normal activities.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using indomethacin rectal,

• tell your doctor and pharmacist if you are allergic to indomethacin, aspirin, any other medications, or any of the inactive ingredients in indomethacin suppositories. 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 while using indomethacin rectal. 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; proctitis (swelling of the rectum); or have or have recently had rectal bleeding. Your doctor will probably tell you not to use indomethacin rectal.

• 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), anemia (a lower than normal number of red blood cells), heart failure, 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 used around 20 weeks or later during pregnancy. Do not use indomethacin around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while using indomethacin rectal, call your doctor.

• talk to your doctor about the risks and benefits of using indomethacin rectal if you are 65 years of age or older. Older adults usually should not use 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.

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?

This medication is usually used as needed. If your doctor has told you to use indomethacin rectal regularly, use 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 use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• headache
• dizziness
• nausea

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

• rash
• blisters
• itching
• hives
• pale skin

Indomethacin rectal may cause other side effects. Call your doctor if you have any unusual problems while using 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 the suppositories in the refrigerator.

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:

• nausea
• vomiting
• tiredness
• dizziness
• drowsiness
• stomach pain

What OTHER INFORMATION should I know?

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

Ask your pharmacist any questions you have about indomethacin.

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.