Indocin Oral Suspension

DRUG DESCRIPTION

Suspension INDOCIN for oral use contains 25 mg of indomethacin per 5 mL, alcohol 1%, and sorbic acid 0.1% added as a preservative and the following inactive ingredients: antifoam AF emulsion, flavors, purified water, sodium hydroxide or hydrochloric acid to adjust pH, sorbitol solution, and tragacanth. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It 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 structural formula is:

INDOCIN® (indomethacin) Structural Formula Illustration

What are the possible side effects of indomethacin (Indocin, Indocin SR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking indomethacin and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or...

Read All Potential Side Effects and See Pictures of Indocin Oral Suspension »


Indocin Oral Suspension Patient Information Including Side Effects

Brand Names: Indocin, Indocin SR

Generic Name: indomethacin (Pronunciation: in doe METH a sin)

  • What is indomethacin (Indocin Oral Suspension)?
  • What are the possible side effects of indomethacin (Indocin Oral Suspension)?
  • What is the most important information I should know about indomethacin (Indocin Oral Suspension)?
  • What should I discuss with my healthcare provider before taking indomethacin (Indocin Oral Suspension)?
  • How should I take indomethacin (Indocin Oral Suspension)?
  • What happens if I miss a dose (Indocin Oral Suspension)?
  • What happens if I overdose (Indocin Oral Suspension)?
  • What should I avoid while taking indomethacin (Indocin Oral Suspension)?
  • What other drugs will affect indomethacin (Indocin Oral Suspension)?
  • Where can I get more information?

What is indomethacin (Indocin Oral Suspension)?

Indomethacin is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Indomethacin works by reducing hormones that cause inflammation and pain in the body.

Indomethacin is used to treat pain or inflammation caused by many conditions such as arthritis, gout, ankylosing spondylitis, bursitis, or tendinitis.

Indomethacin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of indomethacin (Indocin Oral Suspension)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking indomethacin and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

  • upset stomach, mild heartburn, diarrhea, constipation;
  • bloating, gas;
  • dizziness, nervousness, headache;
  • skin rash, itching;
  • blurred vision; or
  • ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about indomethacin (Indocin Oral Suspension)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use indomethacin. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking indomethacin. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not drink alcohol while taking indomethacin. Alcohol can increase the risk of stomach bleeding caused by indomethacin.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to indomethacin (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

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