Generic Name: indomethacin (IN-doe-METH-a-sin)
Brand Name: Examples include Indocin and Tivorbex
Tivorbex is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Tivorbex for a long time. Do not use Tivorbex right before or after bypass heart surgery.
Tivorbex may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.
Tivorbex is used for:
Treating moderate to severe rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is used to treat gout, certain types of bursitis and tendonitis, or mild to moderate pain. It may also be used for other conditions as determined by your doctor.
Tivorbex is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.
Do NOT use Tivorbex if:
- you are allergic to any ingredient in Tivorbex
- you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)
- you have recently had or will be having bypass heart surgery
- you are taking diflunisal, another NSAID (eg, ibuprofen), or triamterene
- you are more than 29 weeks pregnant
Contact your doctor or health care provider right away if any of these apply to you.
Before using Tivorbex:
Some medical conditions may interact with Tivorbex. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, inflammation)
- if you have a history of swelling or fluid buildup, depression, mental or mood problems, seizures, Parkinson disease, asthma, growths in the nose (nasal polyps), or mouth inflammation
- if you have high blood pressure, a blood disorder, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases
- if you have poor health, dehydration or low fluid volume, low blood sodium levels, or high blood potassium levels; you drink alcohol; or you have a history of alcohol abuse
Some MEDICINES MAY INTERACT with Tivorbex. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), diflunisal, heparin, other NSAIDs (eg, ibuprofen), salicylates (eg, aspirin), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased
- Potassium-sparing diuretics (eg, spironolactone, triamterene) because the risk of kidney problems or increased blood potassium levels may be increased
- Cyclophosphamide because low blood sodium levels may occur
- Probenecid because it may increase the risk of Tivorbex's side effects
- Cyclosporine, digoxin, lithium, methotrexate, quinolones (eg, ciprofloxacin), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Tivorbex
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin receptor blockers (eg, losartan), beta-blockers (eg, propranolol), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Tivorbex
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tivorbex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Tivorbex:
Use Tivorbex as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tivorbex comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tivorbex refilled.
- Take Tivorbex by mouth with food. This may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor if you have persistent stomach upset.
- Take Tivorbex with a full glass of water (8 oz [240 mL]) as directed by your doctor.
- If you miss a dose of Tivorbex and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Tivorbex.
Important safety information:
- Tivorbex may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Tivorbex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Serious stomach ulcers or bleeding can occur with the use of Tivorbex. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Tivorbex with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Serious and sometimes fatal skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) may happen with Tivorbex. Get medical help right away if you develop a rash; red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Tivorbex is an NSAID. Before you start taking any new medicine, read the ingredients. If it also has an NSAID (eg, ibuprofen) in it, check with your doctor. If you are not sure, check with your doctor or pharmacist.
- Do not take aspirin while you are using Tivorbex unless your doctor tells you to.
- Tivorbex may interfere with certain lab tests. Be sure your doctor and lab personnel know that you are taking Tivorbex.
- Lab tests, including kidney function, liver function, complete blood cell counts, and blood pressure, may be performed while you use Tivorbex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Tivorbex with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding, kidney problems, confusion, or mental changes.
- PREGNANCY and BREAST-FEEDING: Tivorbex may cause harm to the fetus. Do not use it if you are more than 29 weeks pregnant. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tivorbex while you are pregnant. Tivorbex is found in breast milk. Do not breast-feed while you are taking Tivorbex.
Possible side effects of Tivorbex:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach pain or upset; vomiting.
Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; symptoms of liver problems (eg, dark urine, flu-like symptoms, right upper stomach pain, unusual nausea or tiredness, yellowing of the skin or eyes); unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Tivorbex:
Store Tivorbex at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Store in the original container. Do not store in the bathroom. Keep Tivorbex out of the reach of children and away from pets.
- If you have any questions about Tivorbex, please talk with your doctor, pharmacist, or other health care provider.
- Tivorbex is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Tivorbex or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tivorbex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Tivorbex. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Tivorbex.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.