indomethacin

What is indomethacin

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that 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 (inflammation of a fluid-filled sac in the shoulder joint) and tendinitis (inflammation of the tissue that connects muscle to bone). Indomethacin works by reducing hormones that cause inflammation, fever and pain in your body. Indomethacin inhibits cyclooxygenase, which is necessary for the formation of prostaglandins and other autacoids. Indomethacin also inhibits the motility of polymorphonuclear leukocytes (white blood cells).

Indomethacin immediate-release capsules, suspension (liquid) and 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). Extended-release indomethacin (Indocin SR) should not be used to treat gouty arthritis.

Indomethacin is also sometimes used to relieve fever, pain, and inflammation caused by many types of conditions or injuries, to reduce the amount of calcium in the blood, and to treat a certain type of low blood pressure. Talk to your doctor about the risks of using this medication for your condition.

Indomethacin may be prescribed for other uses; ask your doctor or pharmacist for more information.

Indomethacin comes as a capsule, an extended-release (long-acting) capsule, and a suspension to take by mouth and as a suppository to be used rectally. Indomethacin capsules and liquid usually are taken two to four times a day. Indomethacin suppositories usually are used two to four times daily. Extended-release capsules are usually taken one or two times a day. Indomethacin capsules, extended-release capsules, and suspension should be taken with food, immediately after meals, or with antacids. Take 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. Take indomethacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release capsules whole; do not split, chew, or crush them.

Shake the suspension well before each use to mix the medication evenly.

Your doctor may change the dose of your medication during your treatment. In some cases, your doctor may start you on a low dose of indomethacin and gradually increase your dose, not more often than once a week. In other cases, your doctor may start you on an average dose of indomethacin and decrease your dose once your symptoms are controlled. Follow these directions carefully and ask your doctor or pharmacist if you have any questions.

To use indomethacin suppositories, follow these steps:

  1. Remove the wrapper.
  2. Dip the tip of the suppository in water.
  3. 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.)
  4. Using your finger, insert the suppository about 1 inch (2.5 centimeters) into the rectum. Hold it in place for a few moments.
  5. Stand up after about 15 minutes. Wash your hands thoroughly and resume your normal activities.
  6. You should try to keep the suppository in place and avoid having a bowel movement for 1 hour after you insert the suppository.
IMPORTANT WARNING

People who take 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 take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take 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 take 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 take NSAIDs for a long time, are older in age, have poor health, or drink large amounts of alcohol while you are taking 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 taking 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 (https://www.fda.gov/Drugs/default.htm) or the manufacturer’s website to obtain the Medication Guide.

Indomethacin special precautions

Before taking indomethacin:

  • tell your doctor and pharmacist if you are allergic to indomethacin, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in indomethacin capsules, suspension, extended release capsules, or suppositories. Ask your pharmacist for a list of the inactive ingredients.
  • indomethacin can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar. in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Diovan HCT, in Exforge); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); diuretics (‘water pills’) such as triamterene (Dyrenium, in Dyazide); lithium (Lithobid); methotrexate (Otrexup, Rasuvo, Trexall); phenytoin (Dilantin, Phenytek); and probenecid (Probalan, in Col-Probenecid). 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, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); heart failure; seizures; Parkinson’s disease; depression or mental illness; or liver or kidney disease. If you will be using indomethacin suppositories, also tell your doctor if you have or have ever had proctitis (inflammation of the rectum) or have or have recently had rectal bleeding.
  • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy; you plan to become pregnant; or you are breastfeeding. If you become pregnant while taking indomethacin, call your doctor.
  • talk to your doctor about the risks and benefits of taking indomethacin if you are 65 years of age or older. Older adults should not usually take indomethacin because it is not as safe as other medications that can be used to treat the same condition.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking indomethacin.
  • 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.
  • talk to your doctor about the safe use of alcohol during your treatment with indomethacin. Alcohol can make the side effects of indomethacin worse.

Other medical problems

The presence of other medical problems may affect the use of indomethacin. 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 aspirin sensitivity—indomethacin should not be used in patients with these conditions.

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

Indomethacin in pregnancy

Taking indomethacin during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using indomethacin.

Indomethacin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Pregnancy CategoryExplanation
1st TrimesterCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd TrimesterCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Indomethacin interactions

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 indomethacin, 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 indomethacin 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 indomethacin 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
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Amiloride
  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amtolmetin Guacil
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Balsalazide
  • Bemiparin
  • Bendroflumethiazide
  • Benzthiazide
  • Betamethasone
  • Betrixaban
  • Bismuth Subsalicylate
  • Bivalirudin
  • Bromfenac
  • Budesonide
  • Bufexamac
  • Bumetanide
  • Cangrelor
  • Celecoxib
  • Certoparin
  • Chlorothiazide
  • Chlorthalidone
  • Choline Magnesium Trisalicylate
  • Choline Salicylate
  • Cilostazol
  • Citalopram
  • Clomipramine
  • Clonixin
  • Clopamide
  • Clopidogrel
  • Cortisone
  • Cyclopenthiazide
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Deflazacort
  • Desipramine
  • Desirudin
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Diazoxide
  • Dibenzepin
  • Diflunisal
  • Digoxin
  • Dipyridamole
  • Dipyrone
  • Dothiepin
  • Doxepin
  • Droxicam
  • Duloxetine
  • Edoxaban
  • Enoxaparin
  • Eplerenone
  • Epoprostenol
  • Eptifibatide
  • Escitalopram
  • Ethacrynic Acid
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Feverfew
  • Floctafenine
  • Flufenamic Acid
  • Fluocortolone
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Furosemide
  • Ginkgo
  • Gossypol
  • Heparin
  • Hydrochlorothiazide
  • Hydrocortisone
  • Hydroflumethiazide
  • Ibuprofen
  • Iloprost
  • Imipramine
  • Indapamide
  • Inotersen
  • Ketoprofen
  • Lepirudin
  • Levomilnacipran
  • Lithium
  • Lofepramine
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Macimorelin
  • Magnesium Salicylate
  • Meadowsweet
  • Meclofenamate
  • Mefenamic Acid
  • Melitracen
  • Meloxicam
  • 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
  • Pralatrexate
  • Prasugrel
  • Prednisolone
  • Prednisone
  • Probenecid
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C
  • Protriptyline
  • Reboxetine
  • Reviparin
  • Rivaroxaban
  • Rofecoxib
  • Salicylamide
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sibutramine
  • Sodium Salicylate
  • Spironolactone
  • Sulfasalazine
  • Sulindac
  • Tacrolimus
  • Tenofovir Disoproxil Fumarate
  • Tenoxicam
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tolfenamic Acid
  • Tolmetin
  • Torsemide
  • Treprostinil
  • Triamterene
  • Trichlormethiazide
  • Trimipramine
  • Trolamine Salicylate
  • Valdecoxib
  • Vasopressin
  • Venlafaxine
  • Vilazodone
  • Vorapaxar
  • Vortioxetine
  • Warfarin
  • Xipamide

Using indomethacin 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
  • Alacepril
  • Atenolol
  • Azilsartan
  • Azilsartan Medoxomil
  • Benazepril
  • Betaxolol
  • Bisoprolol
  • Candesartan Cilexetil
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Enalapril
  • Enalaprilat
  • Eprosartan
  • Esmolol
  • Fosinopril
  • Gentamicin
  • Irbesartan
  • Labetalol
  • Levobunolol
  • Lisinopril
  • Losartan
  • Metipranolol
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Olmesartan Medoxomil
  • Oxprenolol
  • Penbutolol
  • Perindopril Erbumine
  • Pindolol
  • Practolol
  • 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. Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Indomethacin uses

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that 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 (inflammation of a fluid-filled sac in the shoulder joint) and tendinitis (inflammation of the tissue that connects muscle to bone).

Indomethacin immediate-release capsules, suspension (liquid) and 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). Extended-release indomethacin (Indocin SR) should not be used to treat gouty arthritis.

Indomethacin is also sometimes used to relieve fever, pain, and inflammation caused by many types of conditions or injuries, to reduce the amount of calcium in the blood, and to treat a certain type of low blood pressure. Talk to your doctor about the risks of using this medication for your condition.

Indomethacin may be prescribed for other uses; ask your doctor or pharmacist for more information.

Indomethacin dosage

Indomethacin Gout dosage

Use: For the treatment of acute gouty arthritis in adults.

  • 50 mg orally or rectally 3 times a day
  • Duration of therapy: Until gout attack has resolved

Comments:

  • Relief of pain has been observed within 2 to 4 hours; tenderness and heat usually subside within 24 to 36 hours; swelling gradually disappears in 3 to 5 days.
  • Extended release capsules are not recommended for the treatment of acute gouty arthritis.

Adult dose for Bursitis

Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis) in adults.

  • Immediate-release capsules and suspension: 75 to 150 mg orally per day in 3 or 4 divided doses

Suppository:

  • 50 mg rectally up to 3 times a day

Extended Release:

  • 75 mg orally once or twice a day

Comments:

  • The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
  • Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days

Adult dose for Tendonitis

Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis) in adults.

  • Immediate-release capsules and suspension: 75 to 150 mg orally per day in 3 or 4 divided doses

Suppository:

  • 50 mg rectally up to 3 times a day

Extended Release:

  • 75 mg orally once or twice a day

Comments:

  • The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
  • Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days

Adult dose for Pain

Use: For the treatment of mild to moderate acute pain in adults

  • 20 mg orally 3 times a day or 40 mg orally 2 to 3 times a day

Comment:

  • The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.

Adult dose for Rheumatoid Arthritis

Use: For the treatment of active stages of moderate to severe rheumatoid arthritis, including acute flares of chronic disease.

Immediate-release capsules and suspension:

  • Initial dose: 25 mg orally 2 or 3 times a day
  • Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg

Suppository:

  • Initial dose: 50 mg rectally once a day
  • Maintenance dose: 50 to 200 mg rectally per day in divided doses
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg per day

Comment:

  • For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:

  • Initial dose: 75 mg orally once a day
  • For patients currently receiving immediate-release at 150 mg per day: Initial dose: 75 mg orally twice a day

Comments:

  • Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.
  • During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
  • Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Adult dose for Ankylosing Spondylitis

Use: For the treatment of active stages of moderate to severe ankylosing spondylitis.

Immediate-release capsules and suspension:

  • Initial dose: 25 mg orally 2 or 3 times a day
  • Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg

Suppository:

  • Initial dose: 50 mg rectally once a day
  • Maintenance dose: 50 to 200 mg rectally per day in divided doses
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg per day

Comment:

  • For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:

  • Initial dose: 75 mg orally once a day
  • For patients currently receiving immediate-release at 150 mg per day: Initial dose: 75 mg orally twice a day

Comments:

  • Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.
  • During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
  • Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Adult dose for Osteoarthritis

Use: For the treatment of active stages of moderate to severe osteoarthritis.

Immediate-release capsules and suspension:

  • Initial dose: 25 mg orally 2 or 3 times a day
  • Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg

Suppository:

  • Initial dose: 50 mg rectally once a day
  • Maintenance dose: 50 to 200 mg rectally per day in divided doses
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg per day

Comment:

  • For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:

  • Initial dose: 75 mg orally once a day
  • For patients currently receiving immediate-release at 150 mg per day: Initial dose: 75 mg orally twice a day

Comments:

  • Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.
  • During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
  • Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Pediatric dose for Patent Ductus Arteriosus

Use: For the closure of a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when 48 hours of usual medical management is ineffective; clear-cut clinical evidence of hemodynamically significant patent ductus arteriosus should be present (e.g., respiratory distress, continuous murmur, hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray).

Dosing depends on age of neonate at time of therapy; A course of therapy is defined as 3 IV doses given at 12 to 24 hour intervals.

Age at first dose: Less than 48 hours:

  • First dose: 0.2 mg/kg IV
  • Second dose: 0.1 mg/kg IV
  • Third dose: 0.1 mg/kg IV

Age at first dose: 2 to 7 days:

  • First dose: 0.2 mg/kg IV
  • Second dose: 0.2 mg/kg IV
  • Third dose: 0.2 mg/kg IV

Age at first dose: Over 7 days:

  • First dose: 0.2 mg/kg IV
  • Second dose: 0.25 mg/kg IV
  • Third dose: 0.25 mg/kg IV

Comments:

  • Monitor urinary output; if anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) is evident at time of the second or third dose, hold drug until laboratory studies indicate renal function has returned to normal.
  • If ductus arteriosus closes or has significantly reduced in size 48 hours or more after completion of the first course, no further doses are needed.
  • If ductus arteriosus re-opens, a second course of 1 to 3 doses may be given.
  • If neonate is unresponsive after 2 courses of therapy, surgery may be necessary.

Pediatric dose for Rheumatoid Arthritis

Use: For the treatment of active stages of moderate to severe rheumatoid arthritis, including acute flares of chronic disease.

2 to 14 years:

  • Initial dose: 1 to 2 mg/kg/day orally in divided doses
  • Maximum dose: 3 mg/kg/day or 150 to 200 mg/day, whichever is less; limited data supports a maximum of 4 mg/kg/day

Comments:

  • Safety and efficacy have not been established in patients 14 years and younger; use should be limited to patients for whom toxicity or lack of efficacy with other drugs warrants the risk.
  • As symptoms subside, the dose should be reduced or discontinued.
  • Use in pediatric patients have been confined to the use of capsules.

Over 14 years:

Immediate-release capsules and suspension:

  • Initial dose: 25 mg orally 2 or 3 times a day
  • Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg

Suppository:

  • Initial dose: 50 mg rectally once a day
  • Maintenance dose: 50 to 200 mg rectally per day in divided doses
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg per day

Comment:

  • For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:

  • Initial dose: 75 mg orally once a day
  • For patients currently receiving immediate-release at 150 mg per day: Initial dose: 75 mg orally twice a day

Comments:

  • Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.
  • During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
  • Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Pediatric dose for Ankylosing Spondylitis

Use: For the treatment of active stages of moderate to severe rheumatoid arthritis.

Over 14 years:

Immediate-release capsules and suspension:

  • Initial dose: 25 mg orally 2 or 3 times a day
  • Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg

Suppository:

  • Initial dose: 50 mg rectally once a day
  • Maintenance dose: 50 to 200 mg rectally per day in divided doses
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg per day

Comment:

  • For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:

  • Initial dose: 75 mg orally once a day
  • For patients currently receiving immediate-release at 150 mg per day: Initial dose: 75 mg orally twice a day

Comments:

  • Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.
  • During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
  • Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Pediatric dose for Osteoarthritis

Use: For the treatment of active stages of moderate to severe rheumatoid arthritis.

Over 14 years:

  • Immediate-release capsules and suspension:
  • Initial dose: 25 mg orally 2 or 3 times a day
  • Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg

Suppository:

  • Initial dose: 50 mg rectally once a day
  • Maintenance dose: 50 to 200 mg rectally per day in divided doses
  • Maximum single dose: 100 mg
  • Maximum daily dose: 200 mg per day

Comment:

  • For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:

  • Initial dose: 75 mg orally once a day
  • For patients currently receiving immediate-release at 150 mg per day: Initial dose: 75 mg orally twice a day

Comments:

  • Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient’s treatment goals.
  • During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
  • Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Pediatric dose for Bursitis

Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).

Over 14 years:

Immediate-release capsules and suspension: 75 to 150 mg orally per day in 3 or 4 divided doses

Suppository:

  • 50 mg rectally up to 3 times a day

Extended Release:

  • 75 mg orally once or twice a day

Comments:

  • The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
  • Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days

Pediatric dose for Tendonitis

Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).

Over 14 years:

Immediate-release capsules and suspension: 75 to 150 mg orally per day in 3 or 4 divided doses

Suppository:

  • 50 mg rectally up to 3 times a day

Extended Release:

  • 75 mg orally once or twice a day

Comments:

  • The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
  • Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days

Renal Dose Adjustments

Advanced Renal Disease: Not recommended; if treatment is necessary, close monitoring of renal function is advised.

Neonates:

  • Contraindicated in significant renal impairment.
  • If anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) occurs after a dose of IV therapy, no additional doses should be given until renal function returns to normal.

Liver Dose Adjustments

  • Patients who have an abnormal liver test or who develop signs or symptoms of liver dysfunction should be evaluated for hepatic dysfunction.
  • If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.
  • Pediatric: If the decision is made to use this drug in patients 2 years of age or older, close monitoring and periodic assessment of liver function is recommended; there have been reports of hepatotoxicity in pediatric patients with juvenile rheumatoid arthritis, including fatalities.

What should I do if I forget a dose?

Take 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 take a double dose to make up for a missed one.

Indomethacin side effects

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

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

Some side effects can be serious. If you experience any of the following symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more indomethacin until you speak to your doctor.

  • unexplained weight gain
  • shortness of breath or difficulty breathing
  • swelling in the abdomen, ankles, feet, or legs
  • fever
  • blisters
  • rash
  • itching
  • hives
  • swelling of the eyes, face, tongue, lips, throat, or hands
  • 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

Indomethacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Indomethacin overdose

In case of indomethacin 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 your local emergency services number.
Symptoms of indomethacin overdose may include the following:

  • nausea
  • vomiting
  • headache
  • dizziness
  • confusion
  • extreme tiredness
  • feeling of numbness, pricking, burning, or creeping on the skin
  • seizures

Below are symptoms of an indomethacin overdose in different parts of the body.

EYES, EARS, NOSE, AND THROAT

  • Blurred vision
  • Ringing in the ears

BLADDER AND KIDNEYS

  • Little or no urine output

HEART AND BLOOD

  • Chest pain
  • High or low blood pressure
  • Increased heart rate

STOMACH AND INTESTINES

  • Diarrhea
  • Nausea
  • Possible loss of blood through the stomach and intestines
  • Stomach pain
  • Vomiting (sometimes with blood)

LUNGS AND AIRWAYS

  • Difficulty breathing
  • Wheezing

NERVOUS SYSTEM

  • Headache
  • Agitation
  • Coma (decreased level of consciousness and lack of responsiveness)
  • Confusion
  • Delirium (person is not making sense)
  • Drowsiness
  • Fatigue and weakness
  • Numbness and tingling
  • Seizures
  • Unsteadiness

SKIN

  • Blistering rash
  • Bruising
  • Sweating

What to expect at the emergency room

Take the container with you to the hospital, if possible.

Emergency room doctors will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure.

Tests that may done include:

  • Blood and urine tests
  • ECG (electrocardiogram or heart tracing)
  • Endoscopy — camera placed down the throat to check for burns in the esophagus and stomach

Treatment may include:

  • Fluids through a vein (by IV)
  • Medicine to treat symptoms
  • Activated charcoal
  • Laxative
  • Tube through the mouth into the stomach to empty the stomach (gastric lavage)
  • Breathing support, including a tube through the mouth into the lungs and connected to a breathing machine (ventilator)

Indomethacin overdose prognosis

How well someone does depends on how much indomethacin was swallowed and how quickly treatment is received. The faster the medical help is received, the better the chance for recovery.

A mild overdose of indomethacin does not usually cause serious problems. There may be some stomach pain and vomiting (possibly with blood).

However, a large amount of internal bleeding is possible, and a blood transfusion may be needed. Endoscopy may be needed to stop the internal bleeding.

In rare cases, there can be ringing in the ears and a bad headache. But these symptoms will likely pass as well.

If kidney damage is severe, dialysis (kidney machine) may be needed until kidney function returns. In some cases, the damage is permanent.

A large indomethacin overdose can be very harmful to children and adults. Death may occur.

Health Jade