Indocin

Name: Indocin

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:

  • 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.

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).

Precautions

Before taking indomethacin, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), bleeding or clotting problems, growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), stroke.Kidney problems can sometimes occur with the use of NSAID medications, including indomethacin. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and kidney problems.Children may be more sensitive to the side effects of this drug, especially serious liver problems. Caution is advised when this drug is used in children. Discuss the risks and benefits of treatment with your doctor.Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Notes

Do not share this medication with others.Laboratory and/or medical tests (such as complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Non-drug treatment for arthritis that is approved by your doctor (such as weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

How to use

Read the Medication Guide provided by your pharmacist before you start using indomethacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.If the suppository is too soft to insert, put it in cold water or refrigerate it for 30 minutes before removing the foil wrapper. Unwrap the foil and moisten the suppository with a little water. Lie down on your left side with right knee bent. Push the suppository into the rectum with your finger. Remain lying down for a few minutes, and avoid having a bowel movement for at least an hour to allow the drug to be completely absorbed.The dosage is based on your medical condition and response to treatment. Adults should not use more than 200 milligrams per day. For children, dosage is also based on weight. The maximum dose for children is 4 milligrams per kilogram a day or 150 to 200 milligrams a day, whichever is less. To reduce your risk of side effects (such as stomach bleeding), use this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use it more often than prescribed. For ongoing conditions such as arthritis, continue using it as directed. Discuss the risks and benefits with your doctor or pharmacist.For certain conditions (such as arthritis), it may take up to 4 weeks of using this drug regularly before you get the full benefit.If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.Tell your doctor if your condition worsens.

Warnings

Black Box Warnings

Cardiovascular risk

  • 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

Gastrointestinal risk

  • 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

Contraindications

Absolute

  • 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)

Relative

  • Bleeding disorder
  • Duodenal/gastric/peptic ulcer
  • Stomatitis
  • Ulcerative colitis
  • Upper GI disease
  • Late pregnancy (may cause premature closure of ductus arteriosus)

Neonates

  • Renal impairment
  • Untreated infection
  • Necrotizing enterocolitis
  • Active bleeding (GI bleeding or intracranial hemorrhage)
  • Thrombocytopenia
  • Congenital heart disease where patent ductus arteriosus is necessary

Cautions

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

Description

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.

Overdose

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

Inflammatory Diseases

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

Pericarditis

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

General

  • For inflammatory diseases, consider potential benefits and risks of indomethacin therapy as well as alternative therapies before initiating therapy with the drug.420

Administration

Administer orally or rectally (for inflammatory diseases or pericarditis)341 420 or by IV infusion (for PDA).301

Oral Administration

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.341 420

Conventional Capsules and Oral Suspension

Administer conventional capsules and oral suspension in 2–4 divided doses daily.420

Extended-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

Rectal Administration

Administer in 2–4 divided doses daily.420

Retain suppositories in rectum for ≥1 hour to ensure complete absorption.420

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.301

Avoid extravasation (irritating to extravascular tissues).301

Reconstitution

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.301

Rate of Administration

Optimum rate not established; may administer dose over 20–30 minutes.301

Dosage

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 Patients

Inflammatory 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.341 420

PDA 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

Dosage for the Management of PDA in Neonates

Age at First Dose

First Dose

Second Dose

Third Dose

<48 hours

0.2 mg/kg

0.1 mg/kg

0.1 mg/kg

2–7 days

0.2 mg/kg

0.2 mg/kg

0.2 mg/kg

>7 days

0.2 mg/kg

0.25 mg/kg

0.25 mg/kg

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.301

Pericarditis† Oral

50–100 mg daily in 2–4 divided doses.a

Adults

Inflammatory 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.341

Rectal

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.420

Gout Oral

Conventional capsules: 50 mg 3 times daily until pain is tolerable; then reduce dosage rapidly and discontinue.420

Painful 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.341

Rectal

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

Prescribing Limits

Pediatric Patients

Juvenile Rheumatoid Arthritis Oral

Maximum 4 mg/kg or 150–200 mg daily, whichever is less.420

Adults

Inflammatory Diseases Rheumatoid Arthritis, Osteoarthritis, or Ankylosing Spondylitis Oral

Maximum 200 mg daily.420

Rectal

Maximum 200 mg daily.420

Special Populations

Geriatric Patients

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
  • Indocin SR
  • Tivorbex

Available Dosage Forms:

  • Capsule
  • Suspension
  • Capsule, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

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