Clinoril

DRUG DESCRIPTION

Sulindac is a non-steroidal, anti-inflammatory indene derivative designated chemically as (Z)-5-fluoro2-methyl-1-[[p-(methylsulfinyl)phenyl]methylene]-1H-indene-3-acetic acid. It is not a salicylate, pyrazolone or propionic acid derivative. Its empirical formula is C20H17FO3S, with a molecular weight of 356.42. Sulindac, a yellow crystalline compound, is a weak organic acid practically insoluble in water below pH 4.5, but very soluble as the sodium salt or in buffers of pH 6 or higher.

CLINORIL (Sulindac) is available in 200 mg tablets for oral administration. Each tablet contains the following inactive ingredients: cellulose, magnesium stearate, starch.

Following absorption, sulindac undergoes two major biotransformations - reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Available evidence indicates that the biological activity resides with the sulfide metabolite.

The structural formulas of sulindac and its metabolites are:

CLINORIL® (Sulindac) Structural Formula Illustration

What are the possible side effects of sulindac (Clinoril)?

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 sulindac 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;
  • urinating less than usual or not at...

Read All Potential Side Effects and See Pictures of Clinoril »

What are the precautions when taking sulindac (Clinoril)?

See also Warning section.

Before taking sulindac, 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: stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), kidney disease, kidney stones, liver disease, asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), stroke, dehydration, bleeding or clotting problems, growths in the nose (nasal polyps).

Before...

Read All Potential Precautions of Clinoril »


Clinoril Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, vomiting, gas, diarrhea, constipation, dizziness, fatigue, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: swelling of the hands or feet (edema), sudden or unexplained weight gain, hearing changes (such as ringing in the ears), mental/mood changes, difficult/painful swallowing.

Get medical help right away if any of these rare but very serious side effects occur: change in the amount of urine, unexplained stiff neck.

This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking sulindac and consult your doctor or pharmacist immediately: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes or skin, unusual/extreme tiredness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking sulindac, 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: stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), kidney disease, kidney stones, liver disease, asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), stroke, dehydration, bleeding or clotting problems, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

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.

Older adults may be more sensitive to the side effects of this drug, especially stomach bleeding and kidney effects.

This medication should be used only when clearly needed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to possible harm to an unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


Clinoril Patient Information Including Side Effects

Brand Names: Clinoril

Generic Name: sulindac (Pronunciation: sul IN dak)

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

What is sulindac (Clinoril)?

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

Sulindac is used to treat pain or inflammation caused by arthritis, ankylosing spondylitis, tendinitis, bursitis, or gout.

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

What are the possible side effects of sulindac (Clinoril)?

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 sulindac 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;
  • 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 or stomach pain, diarrhea, constipation; bloating, gas;
  • dizziness, headache, nervousness;
  • skin itching or rash;
  • dry mouth;
  • increased sweating, runny nose;
  • 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 sulindac (Clinoril)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. 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 sulindac. 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.

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