Indocin (Oral)

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that helps 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 only help you as long as you keep taking it.

Indomethacin is also used to treat ankylosing spondylitis, 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.

It is very important for your doctor to check your progress during regular visits. This will help your doctor see if the medicine is working correctly and decide if you should keep taking it. Blood and urine tests may be needed to check for side effects.

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

This medicine may increase your risk of having a heart attack or stroke. This risk is higher for people who already have heart disease. Those who use this medicine for a long time might also have a greater risk. Contact your doctor immediately if you or your child experiences chest pain that may spread to the arms, jaw, back, or neck, trouble breathing or speaking, headache, nausea, unusual sweating, or faintness.

This medicine can cause bleeding in your stomach or intestines. These issues can happen without warning. You are at greater risk if you have had a stomach ulcer before, smoke or drink alcohol regularly, are over 60 years old, are in poor health, or are using certain other medicines (like steroid medicine or a blood thinner).

Contact your doctor right away if you experience any symptoms of liver problems, including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of the skin or eyes.

Serious skin reactions can happen while using this medicine. Contact your doctor immediately if you notice any of the following symptoms: 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 serious side effects that can occur while taking this medicine 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 blood or material that looks like coffee grounds, or yellowing of the skin or eyes. Additionally, signs of serious heart problems may occur, such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurred speech. Contact your doctor immediately if you notice any of these warning signs.

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

Using this medicine during the later stages of pregnancy can harm your unborn baby. If you think you have become pregnant while taking this medicine, tell your doctor immediately.

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

Contact your doctor right away if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want you to see an ophthalmologist (eye doctor).

This medicine may cause some people to feel dizzy, lightheaded, drowsy, or less alert than usual. Even if taken at bedtime, it may cause some people to feel drowsy or less alert in the morning. Be sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are not alert.

Before any type of surgery or medical tests, inform your doctor that you are taking this medicine. You may need to stop using it for a while or switch to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

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

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medication or any other medicines. As well inform 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues 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 adverse effects (eg, confusion, psychosis) and age-related kidney or stomach issues, 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 drug during breastfeeding. Weigh the potential benefits against the potential chances before using this medicine while breastfeeding.

Interactions with Medications

Although certain drugs 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 physician may want to change the dose, or other precautions may be necessary. When you are taking this medication, it is especially important that your healthcare professional know if you are using any of the drugs 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 drug or change some of the other medicines you take.

• Ketorolac

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

• Abciximab
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bivalirudin
• Budesonide
• Bumetanide
• Cangrelor
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Cilostazol
• Citalopram
• Clomipramine
• Clopamide
• Clopidogrel
• Cortisone
• 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
• Fluocortolone
• 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
• Paramethasone
• 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 medications may cause an increased risk of certain adverse effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your clinician may change the dose or how frequently you use one or both of the drugs.

• 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

Interactions with Food/Tobacco/Alcohol

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 additionally cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical issues may affect the use of this medicine. Make sure you tell your doctor if you have any other medical issues, 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 prior to or following the surgery.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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. Your health care professional may also 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.

In the U.S.

• Indocin
• Indocin SR
• Tivorbex

Available Dosage Forms:

• Capsule
• Suspension
• Capsule, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

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.

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