Sulindac Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Acute Gout

200 mg orally twice a day with food, continued for 7 to 10 days.
The dose may be reduced or discontinued after this time based on clinical response.

Usual Adult Dose for Ankylosing Spondylitis

150 to 200 mg orally twice a day with food.

The maximum daily dose should not exceed 400 mg.

Usual Adult Dose for Osteoarthritis

150 to 200 mg orally twice a day with food.

The maximum daily dose should not exceed 400 mg.

Usual Adult Dose for Pain

150 to 200 mg orally twice a day with food.

The maximum daily dose should not exceed 400 mg.

Usual Adult Dose for Rheumatoid Arthritis

150 to 200 mg orally twice a day with food.

The maximum daily dose should not exceed 400 mg.

Usual Adult Dose for Familial Adenomatous Polyposis

Studies - Suppository formulation:
Initial: 150 mg rectally twice daily for 3 months.
Maintenance: 67 mg rectally daily, given in 2 equally divided doses.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Children:
Limited information exists:
Some centers use the following: 2 to 4 mg/kg/day orally in 2 divided doses
Maximum: 6 mg/kg/day orally not to exceed 400 mg/day

Renal Dose Adjustments

A lower daily dosage is recommended in patients with significantly impaired renal function.

Liver Dose Adjustments

A lower daily dosage may be required in patients with acute or chronic hepatic disease.

Precautions

NSAIDs may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of administration. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with NSAIDs, the lowest effective dose should be used for the shortest duration possible. Prescribers and patients should remain vigilant for the development of such events, even in the absence of previous CV symptoms. Patients should be advised about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. It has been shown that the incidence of upper GI ulcers, gross bleeding, or perforation, caused by NSAIDs, increases with duration of use. However, even short-term therapy is not without risk. Patients should be informed about the signs and symptoms of serious GI toxicities and the steps to take if they occur. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or GI bleeding. Patients with a prior history of peptic ulcer disease, and/or GI bleeding, and who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Since elderly patients are at greater risk for serious GI events, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered. NSAIDs should be administered with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.

Sulindac is contraindicated for the treatment of perioperative pain in patients undergoing coronary artery bypass graft (CABG) surgery. Patients with a hypersensitivity (angioedema, bronchospasm, urticaria, or rhinitis) to aspirin or other NSAIDs may be cross sensitive to sulindac. Patients with the "triad" of asthma, nasal polyps, and aspirin or other NSAID hypersensitivity are at particular risk. The use of sulindac is considered contraindicated in these patients.

Fluid retention and edema have been observed in some patients taking NSAIDs, including sulindac. Caution should be used when using sulindac in patients with fluid retention or heart failure.

In addition to hypersensitivity reactions involving the liver, in some patients the findings are consistent with those of cholestatic hepatitis. As with other NSAIDs, borderline elevations of one or more liver tests without any other signs and symptoms have been reported in patients taking NSAIDs, including sulindac. These laboratory abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. Notable elevations in ALT or AST (approximately three or more times the upper limit of normal) have been reported in clinical trials with NSAIDs. Patients with symptoms and/or signs suggesting liver dysfunction, or in whom abnormal liver tests have occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with sulindac. Sulindac should be discontinued if patients experience signs or symptoms suggestive of liver dysfunction, because severe and sometimes fatal hepatotoxic reactions have occurred.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. In addition, renal function may be further compromised by the use of sulindac in patients with renal dysfunction, heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Renal blood flow in patients with renal dysfunction, edematous disorders, or hypovolemic states is dependent upon renal prostaglandin synthesis. No information is available from clinical studies regarding the use of sulindac in patients with advanced renal disease. Therefore, treatment with sulindac is not recommended in patients with advanced renal disease. If sulindac must be used, periodic monitoring of renal function is recommended.

Sulindac metabolites have been rarely reported as the major or a minor component in renal stones in association with other calculus components. Sulindac should be used with caution in patients with a history of renal lithiasis, and they should be kept well hydrated while receiving sulindac therapy.

NSAIDs, including sulindac, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Anemia has been reported in patients receiving NSAIDs, including sulindac. This may due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including sulindac, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving sulindac who may be adversely affected by alterations in platelet function, such as those with coagulation disorders, should be carefully monitored.

Pancreatitis has been reported in patients receiving sulindac therapy. If pancreatitis is suspected, the drug should be discontinued and not restarted, supportive medical therapy instituted, and the patient monitored closely with appropriate laboratory studies (e.g., serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, serum calcium, glucose, lipase, etc.).

A search for other causes of pancreatitis as well as those conditions which mimic pancreatitis should be conducted.

The manufacturer recommends that patients on sulindac therapy who experience visual disturbances should have an ophthalmologic examination.

Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically.

There may be an increased risk of aseptic meningitis in patients with systemic lupus erythematosus and mixed connective tissue disease.

Sulindac should be used with caution in geriatric patients 65 years of age or older since these patients may have decreased renal function. It may be necessary to monitor renal function in these patients.

Dialysis

No adjustment recommended

Other Comments

If no improvement is seen in 2 to 4 weeks of therapy, an alternative NSAID should be considered.

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