sulindac (Clinoril)

Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) that is used for treating pain, fever, and inflammation. Other NSAIDs include ibuprofen (Motrin), indomethacin (Indocin), nabumetone (Relafen) as well as others. They work by reducing the levels of prostaglandins, chemicals that are produced by the body and are responsible for pain, fever, and inflammation. Sulindac blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower concentrations of prostaglandins. As a consequence, inflammation, pain and fever are reduced. Sulindac was approved by the FDA in September 1978.

What brand names are available for sulindac?

Clinoril

Is sulindac available as a generic drug?

Yes

Do I need a prescription for sulindac?

Yes

Most patients benefit from sulindac and other NSAIDs with few side effects. However, serious side effects can occur and generally tend to be dose related, that is, they occur more frequently with higher doses. Therefore, it is advisable to use the lowest effective dose to minimize side effects.

The most common side effects of sulindac involve the gastrointestinal system, and these are:

• ulcerations of the stomach and small intestine,
• abdominal pain,
• cramping,
• nausea,
• gastritis,
• serious gastrointestinal bleeding, and
• liver toxicity.

Sometimes, ulceration of the stomach and bleeding can occur without any abdominal pain, and black tarry stools, weakness, and dizziness upon standing (orthostatic hypotension) may be the only signs of internal bleeding.

Other important side effects include:

• rash,
• kidney impairment,
• ringing in the ears, and
• lightheadedness.

Sulindac should be avoided by patients with a history of exacerbation of asthma, hives, or other allergic reactions to aspirin or other NSAIDs. Rare but severe allergic reactions have been reported in such individuals. It also should be avoided by patients with peptic ulcer disease or poor kidney function, since this medication can aggravate both conditions. Fluid retention, blood clots, heart attacks, hypertension, and heart failure have also been associated with the use of NSAIDs such as sulindac.

The usual adult dose is 150 or 200 mg given twice daily with meals. The maximum dose is 400 mg daily.

Sulindac may increase the blood levels of lithium (Eskalith, Lithobid) by reducing the elimination of lithium by the kidneys. Increased levels of lithium may lead to lithium toxicity.

Sulindac may reduce the blood pressure lowering effects of blood pressure medications. This may occur because prostaglandins have a role in the regulation (reduction) of blood pressure. Combining NSAIDs such as sulindac with angiotensin receptor blockers (for example, valsartan [Diovan], losartan [Cozaar], irbesartan [Avapro]) or angiotensin converting enzyme (ACE) inhibitors (for example, enalapril [Vasotec], captopril [Capoten]) in patients who are elderly, fluid-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure. These effects usually are reversible.

When sulindac is used in combination with methotrexate (Rheumatrex, Trexall) or aminoglycoside antibiotics (for example, gentamicin) the blood levels of methotrexate or aminoglycoside may increase, presumably because the elimination of methotrexate or aminoglycosides from the body is reduced. This may lead to more methotrexate or aminoglycoside-related side effects.

Individuals taking oral blood thinners or anticoagulants, for example, warfarin, (Coumadin), should avoid sulindac because sulindac also thins the blood, and excessive blood thinning may lead to bleeding.

Persons who consume more than three alcoholic beverages per day are at increased risk of developing stomach ulcers when taking sulindac or other NSAIDs.

There are no adequate studies of sulindac in pregnant women. Therefore, sulindac is not recommended during pregnancy.

It is not known whether sulindac is excreted in breast milk.

What preparations of sulindac are available?

tablets: 150 and 200 mg

How should I keep sulindac stored?

Sulndac should be stored in a sealed container and protected from moisture at room temperature, 15-30 C (59-86 F).