- Indocin side effects
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- Indocin 25 mg
- Indocin uses
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What side effects can this medication cause?
Indomethacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- 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
- swelling of the eyes, face, tongue, lips, throat, or hands
- difficulty breathing or swallowing
- pale skin
- fast heartbeat
- excessive tiredness
- unusual bleeding or bruising
- lack of energy
- 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.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
How to use
Black Box Warnings
- NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
- Risk may increase with duration of use
- Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk
- NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery
- NSAIDs increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
- GI adverse events may occur at any time during use and without warning symptoms
- Elderly patients are at greater risk for serious GI events
- History of hypersensitivity (anaphylactic or serious skin reactions)
- History of urticaria, asthma, or allergic type reactions with aspirin
- Preoperative pain associated with CABG surgery
- History of proctitis or recent rectal bleeding (suppositories)
- Bleeding disorder
- Duodenal/gastric/peptic ulcer
- Ulcerative colitis
- Upper GI disease
- Late pregnancy (may cause premature closure of ductus arteriosus)
- Renal impairment
- Untreated infection
- Necrotizing enterocolitis
- Active bleeding (GI bleeding or intracranial hemorrhage)
- Congenital heart disease where patent ductus arteriosus is necessary
Use caution in patients with history of bronchospasm, cardiac disease, CHF, hypertension, hepatic or renal impairment
Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers
Prolonged use may cause corneal deposits and retinal disturbances; discontinue if visual changes observed
Risk of aggravation of psychiatric disturbances, epilepsy, fluid retention, or Parkinson disease
Reduction in cerebral blood flow associated with rapid IV infusion
Serious skin adverse events (eg, exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) reported; discontinue is symptoms occur
Platelet adhesion and aggregation may decrease; may prolong bleeding time; monitor closely patients receiving anticoagulants; patients on long-term NSAID therapy should be monitored for anemia; agranulocytosis, aplastic anemia, thrombocytopenia reported (rarely)
Transaminase elevations reported with use; patients with abnormal liver function test should be monitored closely; discontinue immediately if signs or symptoms of liver disease develop
NASAID use my increase risk of hyperkalemia, particularly in the elderly, renal disease, diabetics, when administered concomitantly with agents that can induce hyperkalemia
May increase risk of meningitis with patients with systemic lupus erythematosus and mixed connective tissue disorders being a at higher risk
Heart Failure(HF) risk
- NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
- NSAIDS should be avoided or withdrawn whenever possible
- AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134
INDOCIN (indomethacin) Oral Suspension is a nonsteroidal anti-inflammatory drug, available as an oral suspension contain 25 mg of indomethacin per 5mL, alcohol 1%, and sorbic acid 0.1% added as a preservative for oral administration. The chemical name is -(4-chlorobenzoyl)-5-methoxy-2-methyl-1Hindole- 3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure.
Indomethacin is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Indomethacin has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The suspension has a pH of 4.0-5.0.
The inactive ingredients in INDOCIN include: antifoam AF emulsion, flavors, purified water, sodium hydroxide or hydrochloric acid to adjust pH, sorbitol solution, and tragacanth. INDOCIN Oral Suspension, 25 mg per 5 mL, is an off-white suspension with a pineapple coconut mint flavor.
Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see WARNINGS AND PRECAUTIONS].
Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
For additional information about overdosage treatment contact a poison control center (1-800-222- 1222).
Where can i get more information?
Your pharmacist can provide more information about indomethacin.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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Uses for Indocin
When used for inflammatory diseases, consider potential benefits and risks of indomethacin therapy as well as alternative therapies before initiating therapy with the drug.420 Use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.420
Symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.341 420
Symptomatic relief of acute gout and acute painful shoulder (i.e., bursitis and/or tendinitis).341 420
Management of juvenile rheumatoid arthritis† in children ≥2 years of age.420
Patent Ductus Arteriosus (PDA)
Treatment of PDA in premature neonates.301 302 303 304 305 306 308 309 310 311 312 313 314 316 318 319 320 322 323 324 325 326 Used to promote closure of a hemodynamically significant PDA (i.e., left-to-right shunt large enough to compromise cardiorespiratory status) in premature neonates weighing 500–1750 g when 36–48 hours of usual medical management (e.g., fluid restriction, diuretics, cardiac glycosides, respiratory support) is ineffective.301 306 307 313
Reduction of pain, fever, and inflammation of pericarditis†;a however, in the treatment of post-MI pericarditis, NSAIAs are potentially harmful and aspirin is the treatment of choice.491 (See Cardiovascular Thrombotic Effects under Cautions.)
Indocin Dosage and Administration
For inflammatory diseases, consider potential benefits and risks of indomethacin therapy as well as alternative therapies before initiating therapy with the drug.420
Administer orally or rectally (for inflammatory diseases or pericarditis)341 420 or by IV infusion (for PDA).301
In patients who have persistent night pain and/or morning stiffness, a large portion (maximum 100 mg) of the total daily dose may be given at bedtime.341 420Conventional Capsules and Oral Suspension
Administer conventional capsules and oral suspension in 2–4 divided doses daily.420Extended-release Capsules
Administer extended-release capsules once or twice daily.341
Extended-release capsules can be used as an alternative to conventional capsules: 75 mg once daily (extended-release) as an alternative to 25 mg 3 times daily (conventional); 75 mg twice daily (extended-release) as an alternative to 50 mg 3 times daily (conventional).341
Swallow extended-release capsules intact.341
Extended-release capsules are not recommended for treatment of acute gouty arthritis.341
Administer in 2–4 divided doses daily.420
Retain suppositories in rectum for ≥1 hour to ensure complete absorption.420
For solution and drug compatibility information, see Compatibility under Stability.
Administer by IV infusion.301
Avoid extravasation (irritating to extravascular tissues).301Reconstitution
Reconstitute vial containing 1 mg of indomethacin with 1 or 2 mL of preservative-free 0.9% sodium chloride injection or sterile water for injection to provide a solution containing 1 mg/mL or 0.5 mg/mL, respectively.301 Further dilution is not recommended.301
Use of bacteriostatic water for injection containing benzyl alcohol is not recommended because of potential risk of benzyl alcohol exposure if administered to a neonate.301
Prepare solutions immediately before use; discard any unused solution.301Rate of Administration
Optimum rate not established; may administer dose over 20–30 minutes.301
Available as indomethacin and indomethacin sodium; dosage expressed in terms of indomethacin.301 341 420
To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.420 Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.420
Pediatric PatientsInflammatory Diseases Juvenile Rheumatoid Arthritis† Oral
Children ≥2 years of age: Initially, 1–2 mg/kg daily in divided doses.341 420 Increase dosage until a satisfactory response is achieved, up to maximum dosage of 3 mg/kg daily or 150–200 mg daily (whichever is less) in divided doses; limited data support the use of a maximum dosage of 4 mg/kg daily or 150–200 mg daily (whichever is less) in divided doses.341 420 As symptoms subside, reduce dosage to the lowest effective level or discontinue the drug.341 420PDA IV
Each course of therapy consists of up to 3 doses administered at 12- to 24-hour intervals.301
Base dosage on neonate’s age at the time therapy is initiated.301
Age at First Dose
If anuria or oliguria (urine output <0.6 mL/kg per hour) is present at the time of a second or third dose, withhold the dose until laboratory determinations indicate that renal function has returned to normal.301
If ductus arteriosus closes or is substantially constricted 48 hours or longer after completion of the first course, no further doses are necessary.301
If ductus reopens, a second course of 1–3 doses may be administered.301 Surgical ligation may be necessary if ductus is unresponsive to 2 courses of therapy.301Pericarditis† Oral
50–100 mg daily in 2–4 divided doses.a
AdultsInflammatory Diseases Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis Oral
Conventional capsules or oral suspension: Initially, 25 mg 2 or 3 times daily.420 If needed, increase dosage by 25 or 50 mg daily at weekly intervals until a satisfactory response is obtained up to a maximum dosage of 150–200 mg daily.420
Extended-release capsules: Initially, 75 mg once daily.341 May increase dosage to 75 mg twice daily.341Rectal
25 mg 2 or 3 times daily. If needed, increase dosage by 25 or 50 mg daily at weekly intervals until a satisfactory response is obtained up to a maximum dosage of 150–200 mg daily.420Gout Oral
Conventional capsules: 50 mg 3 times daily until pain is tolerable; then reduce dosage rapidly and discontinue.420Painful Shoulder Oral
Conventional capsules or oral suspension: 75–150 mg daily in 3 or 4 divided doses.420 Discontinue once symptoms have been controlled for several days; usual course of therapy is 7–14 days.420
Extended-release capsules: 75 mg once or twice daily.341 Discontinue once symptoms have been controlled for several days; usual course of therapy is 7–14 days.341Rectal
75–150 mg daily in 3 or 4 divided doses.420 Discontinue once symptoms have been controlled for several days; usual course of therapy is 7–14 days.420
Pediatric PatientsJuvenile Rheumatoid Arthritis Oral
Maximum 4 mg/kg or 150–200 mg daily, whichever is less.420
AdultsInflammatory Diseases Rheumatoid Arthritis, Osteoarthritis, or Ankylosing Spondylitis Oral
Maximum 200 mg daily.420Rectal
Maximum 200 mg daily.420
Careful dosage selection recommended due to possible age-related decreases in renal function.341 420
Commonly used brand name(s)
In the U.S.
- Indocin SR
Available Dosage Forms:
- Capsule, Extended Release
Therapeutic Class: Analgesic
Pharmacologic Class: NSAID
Chemical Class: Acetic Acid (class)