Tivorbex

Tivorbex is a prescription medication used to relieve mild to moderate acute pain in adults.

Tivorbex belongs to a group of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). These work by stopping the body’s production of a substance that causes pain, fever, and inflammation.

This medication comes in capsule form and is taken two or three times a day.

Common side effects of Tivorbex include nausea, headache, dizziness, vomiting, constipation, diarrhea, upset stomach, rash, itching, decreased appetite, and flushing.

Tivorbex can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how tivorbex affects you.

Oral:

Oral forms of indomethacin are prescription medications most commonly used to relieve moderate to severe pain, tenderness, and swelling caused by a variety of conditions.

Topical:

Indomethacin suppositories are prescription medications most commonly used to relieve moderate to severe pain, tenderness, and swelling caused by a variety of conditions.

Injectable:

Indomethacin injection is a prescription medication used to treat a patent ductus arteriosus in infants.

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

• Iroko Pharmaceuticals, LLC

Serious side effects have been reported with indomethacin. See the “Indomethacin Precautions” section.

Oral:

Common side effects of indomethacin suspension and capsules include the following:

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

Topical:

Common side effects of indomethacin suppositories include the following:

• headache
• dizziness
• vomiting
• diarrhea
• constipation
• irritation of the rectum
• constant feeling of the need to empty the bowel
• ringing in the ears

Injectable:

Side effects of indomethacin injection in infants are uncommon, but may include:

• bleeding
• coagulation problems
• renal failure

This is not a complete list of indomethacin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• angiotensin II receptor antagonists such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• cyclosporine (Neoral, Sandimmune)
• digoxin (Lanoxin)
• diuretics ('water pills') such as triamterene (Dyrenium, in Dyazide)
• lithium (Eskalith, Lithobid); methotrexate (Rheumatrex)
• phenytoin (Dilantin)
• probenecid (Benemid)

This is not a complete list of indomethacin drug interactions. Ask your doctor or pharmacist for more information.

Oral:

Serious side effects have been reported with oral indomethacin including the following:

• unexplained weight gain
• fever
• blisters
• rash
• itching
• hives
• swelling of the eyes, face, tongue, lips, throat, hands, feet, ankles, or lower legs
• 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

Topical:

Serious side effects have been reported with indomethacin suppositories including the following:

• unexplained weight gain
• fever
• blisters
• rash
• itching
• hives
• swelling of the eyes, face, tongue, lips, throat, hands, feet, ankles, or lower legs
• 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

Injectable:

• Serious side effects have been reported with indomethacin injection including the following:
• Perforations in the stomach or intestine
• Decreased blood sugar
• Fluid retention
• Pulmonary hypertension

Indomethacin can cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how indomethacin affects you.

Do not take indomethacin if you:

• are allergic to indomethacin or to any of its ingredients
• are allergic to aspirin or other NSAIDs

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of indomethacin, there are no specific foods that you must exclude from your diet when receiving this medication.

Alcohol can worsen the side effects of indomethacin. Talk to your doctor about drinking alcohol while you are taking indomethacin.

Before taking indomethacin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to indomethacni or to any of its ingredients
• are allergic to aspirin or other NSAIDs
• have liver disease
• have kidney disease
• experience seizures
• have mental illness or depression
• have Parkinson’s disease
• have frequent stuffed or runny nose or nasal polyps
• have inflammation of the rectum, if using suppositories
• are pregnant or breastfeeding

Indomethacin may not be the safest medication choice in people who are 65 years or older. Talk to your doctor about the risks of taking indomethacin if you are over the age of 65.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Indomethacin falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

If indomethacin is taken during the third trimester of pregnancy, it can cause cardiovascular problems, bleeding problems, renal failure, and a risk of necrotizing enterocolitis in the fetus.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Indomethacin is excreted in human breast milk. Therefore, it is not recommended for use in nursing mothers.

Oral:

Take oral indomethacin exactly as prescribed.

This medication comes in oral suspension, capsule, and extended release capsule forms and is taken two or three times a day, with food.

Do not chew, divide, or break extended release indomethacin capsules. Swallow these capsules whole.

Topical:

Use indomethacin suppositories exactly as prescribed.

This medication comes in rectal suppository form and is used two or three times a day.

Injectable:

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of indomethacin at the same time.

Take indomethacin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The indomethacin dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

Oral:

The recommended dose range of oral indomethacin for the treatment of moderate to severe rheumatoid arthritis is 25 to 50 mg two or three times a day.

The recommended dose range of oral indomethacin for the treatment of shoulder bursitis and/or tendonitis is 75 to 150 mg daily divided into three or four doses. Therapy is usually continued for 7 to 14 days.

The recommended dose range of oral indomethacin for the treatment of acute gouty arthritis is 50 mg three times a day.

Topical:

The recommended dose range of indomethacin suppository for the treatment of moderate to severe rheumatoid arthritis is 25 to 50 mg two or three times a day.

The recommended dose range of indomethacin suppository for the treatment of shoulder bursitis and/or tendonitis is 75 to 150 mg daily divided into three or four doses. Therapy is usually continued for 7 to 14 days.

The recommended dose range of indomethacin suppository for the treatment of acute gouty arthritis is 50 mg three times a day.

Injectable:

The recommended dose range of indomethacin injection for the treatment of a patent ductus arteriosus 0.1 to 0.25 mg/kg, depending on the age of the newborn infant. Typically, only one course of therapy is required.

If you take too much indomethacin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If indomethacin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store indomethacin at room temperature (or whichever proper storage method applies).

Keep this and all medicines out of the reach of children.

Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

Suppositories INDOCIN are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.