- Tablets 200 mg
- Tablets 150 mg
Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.
T max is 3 to 4 h. Approximately 90% of the drug is absorbed after oral administration.
93% bound to plasma proteins. Sulindac penetrates the blood-brain and placental barriers.
Recirculation of sulindac and its sulfone metabolite is more extensive than that of the active sulfide metabolite.
The t ½ is 7.8 h. The main route of excretion is via the urine. Approximately 25% is found in feces, primarily as the sulfone and sulfide metabolites. Renal Cl is 68 to 74 mL/min.
Special PopulationsRenal Function Impairment
Use a lower daily dose to avoid excessive drug accumulation.Hepatic Function Impairment
Plasma concentrations have been reported to be higher in patients with alcoholic liver disease; patients with acute and chronic hepatic disease may require reduced doses.Children
Pharmacokinetics have not been studied.Race
Pharmacokinetic differences have not been identified.
Indications and Usage
Treatment of acute and chronic rheumatoid (class I to III) and osteoarthritis, ankylosing spondylitis, acute gouty arthritis, and acute painful shoulder (tendonitis, bursitis).
Juvenile rheumatoid arthritis.
Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; treatment of perioperative pain in setting of coronary artery bypass graft (CABG) surgery; hypersensitivity to any component of the product.
Dosage and AdministrationAcute Gouty Arthritis
PO 200 mg twice daily; therapy for 7 days is usually sufficient.Acute Painful Shoulder
PO 200 mg twice daily; therapy for 7 to 14 days is usually sufficient.Ankylosing Spondylitis, Osteoarthritis, Rheumatoid Arthritis
PO 150 mg twice daily. Adjust dose as needed.
- Max dosage is 400 mg/day
- Administer dose with food.
Store at 59° to 86° F.Sulindac (Watson Laboratories)
Store at 68° to 77°F.
Drug InteractionsACE inhibitors (eg, captopril), angiotensin II antagonists (eg, losartan)
The antihypertensive effect may be decreased by sulindac.Aminoglycosides (eg, gentamicin)
Plasma levels may be elevated by sulindac.Anticoagulants
May increase effect of anticoagulants because of decreased plasma protein binding. May increase risk of gastric erosion and bleeding.Aspirin
Risk of GI adverse reactions may be increased; plasma levels of active sulindac metabolite may be reduced.Bile acid sequestrants (eg, cholestyramine)
Plasma levels of sulindac may be reduced.Cimetidine
Sulindac has increased cimetidine bioavailability.Cyclosporine
Risk of cyclosporine toxicity may be increased.Diflunisal
Plasma level of active sulindac metabolite may be reduced.Dimethyl sulfoxide
Dimethyl sulfoxide may decrease formation of active metabolite of sulindac, possibly resulting in decreased therapeutic effect. Also, topical dimethyl sulfoxide with sulindac has resulted in severe peripheral neuropathy.Diuretics
Decreased diuresis may result.Heparin
Risk of hemorrhage may be increased.Lithium
May decrease lithium Cl.Methotrexate
May increase methotrexate levels.NSAIDs (eg, ibuprofen)
Coadministration with other NSAIDs may increase the risk of GI toxicity.Probenecid
Sulindac plasma levels may be elevated.SSRI (eg, citalopram)
Risk of GI bleeding may be increased.
Laboratory Test Interactions
May prolong bleeding time.
CHF (less than 1%).
Dizziness, headache (3% to 9%); nervousness (1% to 3%).
Rash (3% to 9%); pruritus (1% to 3%).
Tinnitus (1% to 3%); erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (less than 1%).
GI pain (10%); constipation, diarrhea, dyspepsia, nausea with or without vomiting (3% to 9%); anorexia, flatulence, GI cramps (1% to 3%).
Elevated LFTs (15%).
Edema (1% to 3%).
NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with length of therapy. Patients with CV disease or risk factors for CV disease may be at greater risk. Sulindac is contraindicated for treatment of perioperative pain in the setting of CABG surgery. NSAIDs cause an increased risk of serious GI adverse reactions, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These reactions can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI events.
Monitor for fever, chills, and joint pain (symptoms of acute hypersensitivity reaction); withhold medication if noted. Monitor BP, LFTs, and renal function. Monitor vision, CBC, and chemistry profile in patients on long-term treatment. Monitor all patients for GI bleeding.
Category C . Avoid in late pregnancy. Premature closure of ductus arteriosus may occur if sulindac is used in late pregnancy.
Safety and efficacy not established.
Increased risk of adverse reactions.
May occur; use caution in aspirin-sensitive individuals because of possible cross-sensitivity. The reaction may be fatal. Fever and other evidence of hypersensitivity, including LFT abnormalities, skin reactions, and death, have occurred.
Not recommended in patients with advanced renal disease.
Delayed, elevated, and prolonged levels of sulindac metabolites may occur.
May occur in patients without known prior exposure to sulindac.
Do not use in patients with aspirin-sensitive asthma. Use with caution in patients with preexisting asthma.
Fluid retention and edema may occur.
Inhibition of platelet aggregation and prolongation of bleeding time may occur. Anemia, resulting from fluid retention, or occult or gross GI blood loss may occur.
New-onset hypertension or worsening of preexisting hypertension may occur.
Has been reported. If pancreatitis is suspected, discontinue and do not restart the drug.
Long-term administration has resulted in renal papillary necrosis and other renal injury.
Use with caution in patients with a history of renal lithiasis.
SLE and mixed connective tissue disease
Risk of aseptic meningitis may be increased in patients with SLE or mixed connective tissue disease.
Coma, death, diminished urine output, hypotension, stupor.
- Advise patient who becomes pregnant to avoid use in late pregnancy because of possible premature closure of the ductus arteriosus.
- Instruct patient to promptly report signs or symptoms of unexplained weight gain or edema to health care provider.
- Advise patient to take medication with food or after meals.
- Tell patient to take medication with full glass of water to prevent medication from lodging in esophagus.
- Emphasize importance of regular medical follow-up, even in absence of adverse reactions or problems related to drug therapy.
- Instruct patient to report the following symptoms of toxicity to health care provider immediately: blurred vision, change in urine (pattern, blood in urine), ringing in ears.
- Tell patient to avoid intake of alcoholic beverages, other NSAIDs, or aspirin during therapy (increases risk of GI irritation/bleeding), especially during long-term therapy.
- Advise patient that drowsiness or dizziness may occur and to use caution while driving or performing other activities requiring mental alertness.
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