Sandoz Indomethacin
(indomethacin)
How does this medication work? What will it do for me?
Indomethacin belongs to the class of medications known as nonsteroidal anti-inflammatories (NSAIDs). It works by reducing pain, swelling, and inflammation. Indomethacin is used for the relief of pain accompanied by inflammation. It can be used for people with conditions such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, degenerative hip disease, and gout. It does not prevent the progression of arthritis.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
How should I use this medication?
When used on a regular basis, the usual recommended adult starting dose of indomethacin for most conditions is 25 mg 2 or 3 times a day. Your doctor will gradually increase the dose until the best results are achieved with the least amount of side effects. The maximum recommended daily dose of indomethacin is 200 mg. To minimize the chance of developing serious side effects, use of indomethacin should be limited to the lowest effective dose for the shortest possible duration of time.
When treating gout, the dose of indomethacin is 50 mg taken 3 times a day, until the attack has resolved, usually about 5 days. Indomethacin should always be taken with food or antacids to reduce stomach upset.
The recommended dose of indomethacin suppositories is 100 mg to 200 mg daily. Doses higher than 100 mg must be given in 2 divided doses.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
What form(s) does this medication come in?
50 mg
Each white, opaque suppository contains indomethacin 50 mg. Nonmedicinal ingredients: suppocire.
100 mg
Each white, opaque suppository contains indomethacin 100 mg. Nonmedicinal ingredients: suppocire.
Who should NOT take this medication?
Do not take indomethacin if you:
- are or may be allergic to indomethacin or any ingredients of the medication
- have a history of asthma, itchy skin rash, or allergic reactions after taking ASA (acetylsalicylic acid) or other nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, celecoxib, diclofenac, indomethacin, etc.)
- currently have or recently had inflammatory diseases of the stomach and intestines such as stomach or intestinal ulcer or ulcerative colitis
- have bleeding in the brain or other bleeding disorders
- have severe liver or kidney disease
- have severe uncontrolled heart failure
- have high blood levels of potassium
- have recently had heart bypass surgery
- are in the third trimester of pregnancy
- are breast-feeding
Do not use indomethacin suppositories if you:
- have any of the conditions listed above
- have inflammation of the rectum or anus
- have recently had rectal or anal bleeding
Do not give indomethacin capsules to anyone under 18 years of age or indomethacin suppositories to anyone under 15 years of age.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- altered sense of taste
- burning, tickling, numb feeling
- constipation
- diarrhea
- dizziness
- dry mouth
- general feeling of being unwell
- hair loss
- headache
- heartburn
- increased sweating
- loss of appetite
- nausea
- ringing in the ears
- thirst
- vomiting
- vertigo (feeling that you or your surroundings are spinning)
A common side effect of nonsteroidal anti-inflammatory drugs (NSAIDs) is stomach upset. This can be minimized by taking the medication immediately after a meal, or with food or milk.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- blurred vision or any change in vision
- confusion, forgetfulness, mental depression, or other mood or mental changes
- difficulty breathing
- headache (severe), throbbing, or with stiff neck or back
- hearing changes
- menstrual problems
- mouth sores
- muscle pain
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
- signs of heart failure (e.g., shortness of breath; fatigue; swelling in the legs, ankles, or feet)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of kidney problems (e.g., change in the amount or colour of urine, increased urination at night, blood in the urine, swelling in the feet or legs)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- skin rash
- swelling of face, feet, or lower legs
- symptoms of increased blood pressure (e.g., chest pain, blurred vision, dizziness, excessive tiredness, headache, stronger or faster heartbeat)
- symptoms of urinary tract problems (e.g., bladder pain, pain when urinating, increased need to urinate, change in urine colour or odour or in the amount of urine)
- vomiting or persistent nausea, stomach pain, or diarrhea
Stop taking this medication and seek immediate medical attention if any of the following occur:
- signs of bleeding in the stomach or digestive system (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
- signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
- symptoms of a serious allergic reaction (e.g., hives, swelling of the face or throat, or difficulty breathing)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.
HEALTH CANADA ADVISORY
June 8, 2021
Health Canada has issued new information concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
A previous advisory on non-steroidal anti-inflammatory drugs (NSAIDs) was issued on October 30, 2020.
Allergic reactions: If you have had a reaction to acetylsalicylic acid (ASA) or other NSAIDs (e.g., ibuprofen, ketoprofen, ketorolac) that included a runny nose, itchy skin rash, nasal polyps, or shortness of breath and wheezing, you should not take this medication. If you experience symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; wheezing; swelling of the face, tongue, or throat), get immediate medical attention.
Aseptic meningitis: This medication can rarely cause symptoms of aseptic meningitis (inflammation or swelling of the membranes around the brain and spinal cord that is not caused by bacteria). If you have an autoimmune condition (e.g., systemic lupus erythematosus, mixed connective tissue disease), you are more at risk for developing this. If you experience symptoms such as stiff neck, severe headache, nausea, vomiting, fever, or changes in consciousness, stop taking this medication and get immediate medical attention.
Bladder problems: This medication may cause bladder pain, painful or difficult urination, or increased frequency of urination. If these symptoms occur without an explanation (e.g., infection), stop taking this medication and contact your doctor.
Blood clotting: This medication may reduce the ability of the blood to clot. If you are taking anticoagulants (e.g., warfarin, heparin) or have hemophilia or other blood disorders (e.g., low platelets), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have a bleeding disorder, do not take this medication.
Drowsiness and reduced alertness: Headaches, sometimes combined with dizziness or lightheadedness, may occur during treatment with indomethacin. (These headaches usually occur early in the treatment.) Avoid operating motor vehicles and doing other activities that require alertness until you determine how this medication affects you.
Heart problems and stroke: Indomethacin may increase the risk of heart attacks, strokes, and high blood pressure, and may also make existing high blood pressure worse. As well, it can cause fluid buildup, especially in the feet and legs.
If you have or have had a heart condition (such as congestive heart failure), high blood pressure, high cholesterol, stroke, kidney disease, or if you have had recent surgery, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
High blood potassium: There is a risk of high blood potassium with NSAID treatment. People most at risk are seniors, people with conditions such as diabetes or kidney failure, and people who are taking beta-adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, or some diuretics (water pills). Ask your doctor whether you need to have your potassium levels checked while you are taking this medication.
Hypersensitivity reaction: Rarely, people taking indomethacin experience a severe skin reaction that can be life-threatening. These reactions may start as a skin rash that blisters, sores on the lips and eyes, or a rash that covers a large area of the body. It can develop into an exfoliating skin condition, with peeling, shedding, or scaling of the skin. These reactions may affect organ function and should be treated as an emergency. Get immediate medical attention if you have symptoms of a severe skin reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.
Kidney function: Long-term use of indomethacin may lead to a higher risk of reduced kidney function. This is most common for those who already have kidney disease, liver disease, or heart failure; for those who take diuretics (water pills); and for seniors. If you fit into one of these groups, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Indomethacin may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Stomach ulcers: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during therapy with indomethacin. These problems can happen even to people who have never had stomach problems before. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding increase for people taking higher doses of NSAIDs for longer periods of time.
If you have ever had a stomach ulcer, bloody stools, diverticulosis or other conditions affecting the stomach or intestines (such as ulcerative colitis or Crohn's disease), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: Within the first 20 weeks of pregnancy, this medication should not be used unless the benefits outweigh the risks. Use of indomethacin at 20 weeks or later in pregnancy may increase the risk of kidney damage and complications due to low amniotic fluid in the developing baby. Late use of indomethacin or other NSAIDs in pregnancy may also cause labour to be prolonged.
If you become pregnant while taking this medication, contact your doctor immediately.
This medication may reduce fertility. If you are trying to get pregnant or are having difficulty getting pregnant, you should not use this medication.
Breast-feeding: This medication passes into breast milk. If you are breast-feeding and taking indomethacin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Seniors appear to have a higher risk of side effects. They should use the lowest effective dosage under close medical supervision.
What other drugs could interact with this medication?
There may be an interaction between indomethacin and any of the following:
- ASA (acetylsalicylic acid)
- alcohol
- aliskiren
- aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
- aminosalicylate drugs (e.g., mesalamine, olsalazine, sulfasalazine)
- anagrelide
- angiotensin converting enzyme inhibitors (ACEIs; e.g., captopril, enalapril, ramipril)
- angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
- antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
- apixaban
- beta-adrenergic blockers (e.g., metoprolol, atenolol)
- birth control pills
- bismuth subsalicylate
- bisphosphonates (e.g., alendronate, risedronate)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- cholestyramine
- clopidogrel
- colesevelam
- colestipol
- corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- cyclosporine
- dabigatran
- dasatinib
- deferasirox
- desmopressin
- digoxin
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- drospirenone
- edoxaban
- eplerenone
- glucagon
- glucosamine
- haloperidol
- heparin
- herbal medications (e.g., garlic, ginger, gingko, ginseng)
- hydralazine
- icosapent ethyl
- latanoprost
- lithium
- low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- metformin
- methotrexate
- multivitamins
- other non-steroidal anti-inflammatory medications (NSAIDs; e.g., celecoxib, diclofenac, ibuprofen, ketorolac, naproxen)
- obinutuzumab
- omega-3 fatty acids
- pentoxifylline
- polyethylene glycol
- potassium supplements
- prasugrel
- prostaglandin eye drops (e.g., bimatoprost, latanoprost, travoprost)
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- rivaroxaban
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline, vortioxetine)
- serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
- sodium phosphates
- spironolactone
- tacrolimus
- tenofovir
- ticagrelor
- tipranavir
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- vaccines
- vancomycin
- Vitamin E
- warfarin
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sandoz-Indomethacin