Pronunciation:

in-doe-METH-a-sin

Brand Names:

• Indocin
• Indocin SR
• Tivorbex

Dosage Forms:

• Capsule
• Suspension
• Capsule, Extended Release

Warnings:

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Indomethacin is contraindicated in the setting of CABG surgery. 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 .

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Indomethacin is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events .

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Indomethacin is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

NSAID

Chemical—

Acetic Acid (class)

Uses of This Medicine:

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate acute pain and relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis) or gout, such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

Indomethacin is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. This medicine may also be used to treat painful shoulder caused by bursitis or tendinitis.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of indomethacin capsules, suspension, and suppositories in children younger than 14 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Tivorbex® capsules in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indomethacin in the elderly. However, elderly patients may be more sensitive to the effects of indomethacin than younger adults, and are more likely to have unwanted side effects (eg, confusion, psychosis) and age-related kidney or stomach problems, which may require caution and an adjustment in the dose for patients receiving indomethacin.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betrixaban
• Bivalirudin
• Budesonide
• Bumetanide
• Cangrelor
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Cilostazol
• Citalopram
• Clomipramine
• Clopamide
• Clopidogrel
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Diazoxide
• Dibenzepin
• Diflunisal
• Digoxin
• Dipyridamole
• Dothiepin
• Doxepin
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Feverfew
• Fluoxetine
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Glucagon
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Inotersen
• Ketoprofen
• Lepirudin
• Levoketoconazole
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Macimorelin
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Polythiazide
• Potassium
• Potassium Citrate
• Prasugrel
• Prednisolone
• Prednisone
• Probenecid
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Vasopressin
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Gentamicin
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Bleeding problems or
• Blood clots or
• Dehydration or
• Depression or other mental changes or
• Edema (fluid retention or body swelling) or
• Heart attack, recent or
• Heart disease (eg, congestive heart failure) or
• Hypertension (high blood pressure) or
• Hyperkalemia (high potassium levels in the blood) or
• Kidney disease or
• Liver disease (eg, hepatitis), history of or
• Parkinson's disease or
• Seizures or epilepsy, history of or
• Stomach or intestinal ulcers or bleeding, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma, history of or
• Aspirin sensitivity, history of—Should not be used in patients with these conditions.

• Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

Proper Use of This Medicine:

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within 1 week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Swallow the capsule whole. Do not open, crush, break, or chew it.

Shake the oral suspension well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

It is best to take this medicine with food.

Check with your doctor first before changing dosage forms (eg, capsules, suspension). These forms are very different from each other.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules or suspension):
  • For acute gouty arthritis:
    • Adults—50 milligrams (mg) three times a day. Your doctor may decrease your dose as needed.
    • Children 15 years of age and older—Dose is based on body weight and must be determined by your doctor.
    • Children younger than 14 years of age—Use and dose must be determined by your doctor.
  • For acute painful shoulder (bursitis or tendinitis):
    • Adults—75 to 150 milligrams (mg) per day, divided into three or four equal doses, and taken for 1 to 2 weeks as determined by your doctor.
    • Children 15 years of age and older—Dose is based on body weight and must be determined by your doctor.
    • Children younger than 14 years of age—Use and dose must be determined by your doctor.
  • For mild to moderate acute pain:
    • Adults—20 milligrams (mg) three times a day, or 40 mg two or three times a day.
    • Children—Use and dose must be determined by your doctor.
  • For moderate to severe ankylosing spondylitis, osteoarthritis, or rheumatoid arthritis:
    • Adults—25 milligrams (mg) two or three times a day. Your doctor may increase your dose by 25 or 50 mg per day, as needed. However, the total dose is usually not more than 200 mg per day.
    • Children 15 years of age and older—Dose is based on body weight and must be determined by your doctor.
    • Children younger than 14 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Your doctor may recommend monitoring your blood pressure while using this medicine. .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Check with your doctor right away if you or your child has chest pain that may spread to your arms, jaw, back, or neck, trouble breathing or speaking, headache, nausea, unusual sweating, or faintness.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroid medicine or a blood thinner).

Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee ground, or yellow skin or eyes. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Acid or sour stomach

belching

diarrhea

heartburn

indigestion

nausea

stomach discomfort, upset, or pain

vomiting

Rare

Abdominal or stomach cramping, burning, or tenderness

back or leg pains

bleeding gums

blistering, peeling, or loosening of the skin

bloody or black, tarry stools

blue lips and fingernails

blurred vision

breast enlargement and tenderness

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning upper abdominal or stomach pain

canker sores

change in consciousness

change in hearing

chest pain, discomfort, or burning

clay colored stools

cloudy or bloody urine

confusion

continuing diarrhea

cough or hoarseness

coughing that sometimes produces a pink frothy sputum

cracks in the skin

dark urine

decreased appetite

decreased vision or any change in vision

depression

difficult or labored breathing

difficulty with swallowing

dilated neck veins

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position

double vision

dry mouth

extreme fatigue

false sense of well-being

feeling of unreality

feeling of warmth

fever with or without chills

flushed, dry skin

fruit-like breath odor

general body swelling

greatly decreased frequency of urination or amount of urine

hair loss

headache

heavier menstrual periods

increased hunger

increased sweating

increased thirst

increased urination

irregular breathing

irritation and swelling of the eye

jerky movements of the head, face, mouth, and neck

joint pain

large, flat, blue or purplish patches in the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

loss of balance control

loss of bladder control

loss of consciousness

loss of hearing

loss of heat from the body

lower back or side pain

mask-like face

mood swings

muscle aches, pains, or weakness

muscle spasm or jerking of all extremities

nervousness

noisy, rattling breathing

nosebleeds

numbness or tingling in the hands, feet, or lips

pain in the ankles or knees

pain or discomfort in the upper stomach or throat

pain with swallowing

painful or difficult urination

painful, red lumps under the skin, mostly on the legs

pale skin

persistent bleeding or oozing from puncture sites, mouth, or nose

personality changes

pinpoint red or purple spots on the skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

red, swollen skin

redness of the face, neck, arms and occasionally, upper chest

scaly skin

seeing double

seeing, hearing, or feeling things that are not there

seizures

sense of detachment from self or body

severe constipation

severe mental changes

severe or continuing stomach pain

shuffling walk

skin rash, hives or welts, itching

slow, fast, irregular, pounding, or racing heartbeat or pulse

slowed movements

slurred speech

small red or purple spots on the skin

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

stiffness of the arms and legs

sudden loss of consciousness

swelling of the breasts or breast soreness in both females and males

swelling of the face, fingers, feet, ankles, or lower legs

swollen or painful glands

tightness in the chest

trembling and shaking of the fingers and hands

troubled breathing at rest

troubled breathing with exertion

unexplained weight loss

unpleasant breath odor

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

vaginal bleeding

vomiting of blood or material that looks like coffee grounds

weakness in the arms, hands, legs, or feet

weight gain

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Confusion about identity, place, and time

severe headache

unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Mild headache

Less common

Continuing ringing or buzzing or other unexplained noise in the ears

difficulty having a bowel movement (stool)

discouragement

feeling sad or empty

general feeling of discomfort or illness

hearing loss

irritability

loss of interest or pleasure

sleepiness

trouble with concentrating

Rare

Anxiety

bloated or full feeling

changes in patterns and rhythms of speech

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

involuntary muscle movements

lightheadedness

passing gas

sensation of spinning

tiredness

trouble sleeping

trouble with speaking

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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