Saturday, 3 March 2012

Clinoril


Generic Name: Sulindac
Class: Other Nonsteroidal Anti-inflammatory Agents
CAS Number: 38194-50-2


  • Cardiovascular Risk


  • Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).100 Risk may increase with duration of use.100 Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.100 (See Cardiovascular Effects under Cautions.)




  • Contraindicated for the treatment of pain in the setting of CABG surgery.100



  • GI Risk


  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).100 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.100 Geriatric individuals are at greater risk for serious GI events.100 (See GI Effects under Cautions.)




Introduction

Prototypical NSAIA; indeneacetic acid derivative; structurally related to indomethacin.100 a


Uses for Clinoril


Consider potential benefits and risks of sulindac therapy as well as alternative therapies before initiating therapy with the drug.100 Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.100


Inflammatory Diseases


Symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis), and acute gouty arthritis.100


Colorectal Polyps


Has been associated with a reduction of the number of adenomatous colorectal polyps in adults with familial adenomatous polyposis (FAP)†.157 158 159 160


Clinoril Dosage and Administration


General



  • Consider potential benefits and risks of sulindac therapy as well as alternative therapies before initiating therapy with the drug.100



Administration


Oral Administration


Administer orally twice daily with food.100


Dosage


To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.100 Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.100


Adults


Inflammatory Diseases

Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis

Oral

Initially, 150 mg twice daily.100 Adjust dosage based on response.100


Acute Painful Shoulder

Oral

200 mg twice daily; reduce dosage based on response.100 7–14 days of therapy usually adequate.100


Gout

Oral

200 mg twice daily; reduce dosage based on response.100 7 days of therapy usually adequate.100


Colorectal Polyps†

Oral

150 mg twice daily.158


Prescribing Limits


Adults


Inflammatory Diseases

Oral

Maximum 400 mg daily.100


Special Populations


Hepatic Impairment


Dosage reduction may be required.100


Renal Impairment


Dosage reduction may be required.100


Cautions for Clinoril


Contraindications



  • Known hypersensitivity to sulindac or any ingredient in the formulation.100




  • History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.100




  • Treatment of perioperative pain in the setting of CABG surgery.100



Warnings/Precautions


Warnings


Cardiovascular Effects

Selective COX-2 inhibitors have been associated with an increased risk of cardiovascular events in certain situations.170 Several prototypical NSAIAs also have been associated with an increased risk of cardiovascular events.173 174 175 Current data insufficient to assess risk associated with sulindac.173 174 175


Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary.100


Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).170


No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.100 (See Specific Drugs under Interactions.)


Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.100 Use with caution in patients with hypertension; monitor BP.100 Impaired response to certain diuretics may occur.100 (See Specific Drugs under Interactions.)


Fluid retention and edema reported.100 Caution in patients with fluid retention or heart failure.100


GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.100 154 156


For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;112 125 154 155 alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)112 125 154 or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).112


Renal Effects

Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.100 167


Potential for overt renal decompensation.100 109 110 111 Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.100 109 110 111 172 (See Actions.)


Symptomatic renal calculi containing sulindac metabolites reported rarely.100 121 Factors predisposing to urinary crystal formation include increased urinary excretion of sulindac metabolites (related to size of single doses as well as total daily dosage), decreased urine flow, and relatively low urinary pH.121 Formation of crystals, and presumably renal calculi, appears unlikely when urine output >240 mL/hour or pH >5.8.121 (See Renal Impairment under Cautions.)


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylactoid reactions reported.100 Hypersensitivity (e.g., severe dermatologic manifestations, hepatic abnormalities) reactions associated with fever reported.100


Immediate medical intervention and discontinuance for anaphylaxis.100 Discontinue if unexplained fever or other evidence of hypersensitivity occurs.100


Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.100


Dermatologic Reactions

Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.100 Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).100


Major Toxicities


Pancreatitis

Pancreatitis reported.100


If pancreatitis is suspected, discontinue the drug and appropriately evaluate, monitor, and treat the patient; do not reinstitute sulindac therapy.100 Rule out other possible causes of pancreatitis or conditions that may mimic pancreatitis.100


General Precautions


Hepatic Effects

Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.100 a


Elevations of serum ALT or AST reported.100


Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.100 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.100


Hematologic Effects

Anemia reported rarely.100 Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.100


May inhibit platelet aggregation and prolong bleeding time.100


Ocular Effects

Visual disturbances reported; if such effects occur, perform ophthalmic evaluation.100


Aseptic Meningitis

Increased risk of aseptic meningitis in patients with systemic lupus erythematosus or mixed connective tissue disease.b


Other Precautions

Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.100


May mask certain signs of infection.100


Obtain CBC and chemistry profile periodically during long-term use.100


Specific Populations


Pregnancy

Category C.100 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.100


Lactation

Distributed into milk in rats; not known whether distributed into milk in humans.100 Discontinue nursing or the drug.100


Pediatric Use

Safety and efficacy not established.100


Geriatric Use

Caution advised.100 Geriatric adults appear to tolerate NSAIA-induced adverse effects less well than younger individuals.100 Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.100


Select dosage with caution because of age-related decreases in renal function.100 May be useful to monitor renal function.100


Hepatic Impairment

Monitor closely.100 (See Hepatic Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)


Renal Impairment

Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.100 (See Renal Impairment under Dosage and Administration.)


Sulindac and the sulfone metabolite eliminated principally via the kidney.100 (See Special Populations under Pharmacokinetics.)


Use with caution in patients with a history of renal lithiasis; ensure proper hydration.100 (See Renal Effects under Cautions.)


Common Adverse Effects


Dyspepsia, nausea, diarrhea, constipation, rash, dizziness, headache.100


Interactions for Clinoril


Protein-bound Drugs


Potential for sulindac and its sulfide metabolite to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs.a Observe for adverse effects (especially in patients receiving higher than recommended dosages of sulindac and those with renal impairment or other metabolic dysfunction that might increase plasma concentrations of sulindac or its sulfide metabolite).a


Specific Drugs



















































Drug



Interaction



Comments



ACE inhibitors



Reduced BP response to ACE inhibitor100


Possible deterioration of renal function in individuals with renal impairment100



Monitor BP100



Acetaminophen



Pharmacokinetic interaction unlikely100



Angiotensin II receptor antagonists



Reduced BP response to angiotensin II receptor antagonist100


Possible deterioration of renal function in individuals with renal impairment100



Monitor BP100



Antacids (magnesium- or aluminum-containing)



Change in sulindac bioavailability unlikely100



Anticoagulants, oral



Possibility of bleeding complications100


Protein binding interaction unlikely100



Caution advised; monitor PT; adjust anticoagulant dosage as needed100



Cyclosporine



Possible increase in cyclosporine-induced toxicity100



Use with caution; monitor renal function100



Dimethylsulfoxide



Decreased plasma concentrations of sulfide metabolite of sulindac100


Peripheral neuropathy reported100



Avoid concomitant use100



Diuretics (furosemide, thiazides)



Reduced natriuretic effects possible100



Monitor for diuretic efficacy and renal failure100



Hypoglycemic agents, oral



Protein binding interaction unlikely100



Lithium



Pharmacokinetic interaction unlikely135 136 137 138 139



Nevertheless, monitor for altered response to lithium when initiating or discontinuing sulindac136



Methotrexate



Possible increased plasma methotrexate concentrations100 126 127 128 129 130 131 132



Use with caution100



NSAIAs



NSAIAs including aspirin: Increased risk of GI ulceration and other complications100


Aspirin: Decreased plasma concentrations of sulfide metabolite of sulindac with aspirin 2.4 g daily100


Aspirin: No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs100


Diflunisal: Decreased plasma concentrations of the sulfide metabolite of sulindac with diflunisal100



Concomitant use not recommended100



Probenecid



Increased plasma concentrations of sulindac and its sulfone metabolite; minimal changes in plasma concentrations of the sulfide metabolite100


Reduced uricosuric action of probenecid100



Change in uricosuric action unlikely to be clinically important100



Propoxyphene



Pharmacokinetic interaction unlikely100



Thrombolytic agents



Possible bleeding complicationsa


Clinoril Pharmacokinetics


Absorption


Bioavailability


Prodrug with little pharmacologic activity until reduced to active sulfide metabolite;100 peak plasma concentrations of sulfide metabolite attained within about 5 hours.100


Special Populations


Concentrations of the sulfide metabolite are higher in patients with alcoholic liver disease than in healthy individuals.b


In patients with end-state renal disease requiring dialysis, concentrations of sulindac and the sulfone metabolite are similar to those in healthy individuals and concentrations of the sulfide metabolite are lower than those in healthy individuals.b


Distribution


Extent


Widely distributed in animals.a


Plasma Protein Binding


Sulindac: 93%.b


Sulfide metabolite: 98%.b


Elimination


Metabolism


Reduced to an active sulfide metabolite (reversible reaction) and oxidized to an inactive sulfone metabolite (irreversible reaction).100 Sulindac and its sulfone metabolite undergo extensive enterohepatic circulation.100


Elimination Route


Excreted in urine (50%) principally as sulindac and its conjugated sulfone metabolite and in feces (25%) as the sulfone and sulfide metabolites.100


Sulindac and its metabolites not removed by hemodialysis.b


Half-life


Sulindac: 7.8 hours.100


Sulfide metabolite: 16.4 hours.100


Stability


Storage


Oral


Tablets

15–30°C.b


ActionsActions



  • Inhibits cyclooxygenase-1 (COX-1) and COX-2.148 149 150 151 152 153




  • Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.100 a




  • Conflicting data regarding effects on renal prostaglandin synthesis and renal function.101 102 103 104 105 106 107 108 Some studies suggest no effect;101 102 105 others suggest that sulindac inhibits renal prostaglandin synthesis and impairs renal function, but possibly to lesser degree than other NSAIAs (i.e., ibuprofen, indomethacin).101 103 104 106 107



Advice to Patients



  • Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.100




  • Risk of serious cardiovascular events with long-term use.100




  • Risk of GI bleeding and ulceration.100




  • Risk of serious skin reactions.100 Risk of anaphylactoid and other sensitivity reactions.100




  • Risk of hepatotoxicity.100




  • Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.100




  • Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.100




  • Importance of discontinuing sulindac and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.100 Importance of seeking immediate medical attention if an anaphylactic reaction occurs.100




  • Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.100




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100 Importance of avoiding sulindac in late pregnancy (third trimester).100




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.100




  • Importance of informing patients of other important precautionary information.100 See Cautions.



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name




























Sulindac

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



150 mg*



Clinoril



Merck



Sulindac Tablets



200 mg*



Clinoril (scored)



Merck



Sulindac Tablets


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Sulindac 150MG Tablets (MUTUAL PHARMACEUTICAL): 60/$18.99 or 180/$49.98


Sulindac 200MG Tablets (WATSON LABS): 100/$33.91 or 200/$67.83



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



100. Merck & Co. Clinoril (sulindac) tablets prescribing information. Whitehouse Station, NJ; 2006 Feb.



101. Swainson CP, Griffiths P. Acute and chronic effects of sulindac on renal function in chronic renal disease. Clin Pharmacol Ther. 1985; 37:298-300. [IDIS 197456] [PubMed 3971654]



102. Ciabattoni G, Cinotti GA, Pierucci A et al. Effects of sulindac and ibuprofen in patients with chronic glomerular disease: evidence for the dependence of renal function on prostacyclin. N Engl J Med. 1984; 310:279-83. [IDIS 180831] [PubMed 6361565]



103. Roberts DG, Gerber JG, Barnes JS et al. Sulindac is not renal sparing in man. Clin Pharmacol Ther. 1985; 38:258-65. [IDIS 205886] [PubMed 4028619]



104. Berg KJ, Talseth T. Acute renal effects of sulindac and indomethacin in chronic renal failure. Clin Pharmacol Ther. 1985; 37:447-52. [IDIS 198821] [PubMed 3884224]



105. Sedor JR, Williams SL, Chremos AN et al. Effects of sulindac and indomethacin on renal prostaglandin synthesis. Clin Pharmacol Ther. 1984; 36:85-91. [IDIS 187558] [PubMed 6428794]



106. Brater DC, Anderson S, Baird B et al. Effects of ibuprofen, naproxen, and sulindac on prostaglandins in men. Kidney Int. 1985; 27:66-73. [PubMed 3884880]



107. Daskalopoulos G, Kronborg I, Katkov WM et al. Sulindac and indomethacin suppress the diuretic action of furosemide in patients with cirrhosis and ascites: evidence that sulindac affects renal prostaglandins. Am J Kidney Dis. 1985; 6:217-21. [PubMed 3901735]



108. Bunning RD, Barth WF. Sulindac: a potentially renal-sparing nonsteroidal anti-inflammatory drug. JAMA. 1982; 248:2864-7. [IDIS 161172] [PubMed 7143649]



109. The Upjohn Company. Motrin prescribing information. Kalamazoo, MI; 1985 Jul.



110. McNeil Pharmaceutical. Tolectin and Tolectin DS prescribing information. Spring House, PA; 1985 Aug.



111. Clive DM, Stoff JS. Renal syndromes associated with nonsteroidal anti-inflammatory agents. N Engl J Med. 1984; 310:563-72. [IDIS 181748] [PubMed 6363936]



112. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002; 46:328-46. [IDIS 476480] [PubMed 11840435]



113. Settipane GA. Adverse reactions to aspirin and other drugs. Arch Intern Med. 1981; 141:328-32. [IDIS 142745] [PubMed 7008734]



114. Weinberger M. Analgesic sensitivity in children with asthma. Pediatrics. 1978; 62(Suppl):910-5. [IDIS 118712] [PubMed 103067]



115. Settipane GA. Aspirin and allergic diseases: a review. Am J Med. 1983; 74(Suppl):102-9. [IDIS 171763] [PubMed 6344621]



116. VanArsdel PP Jr. Aspirin idiosyncracy and tolerance. J Allergy Clin Immunol. 1984; 73:431-3. [IDIS 183975] [PubMed 6423718]



117. Stevenson DD. Diagnosis, prevention, and treatment of adverse reactions to aspirin and nonsteroidal anti-inflammatory drugs. J Allergy Clin Immunol. 1984; 74(4 Part 2):617-22. [IDIS 193318] [PubMed 6436354]



118. Stevenson DD, Mathison DA. Aspirin sensitivity in asthmatics: when may this drug be safe? Postgrad Med. 1985; 78:111-3,116-9. (IDIS 205854)



119. Syntex Puerto Rico, Inc. Naprosyn prescribing information. Humacao, PR; 1985 Jun.



120. Pleskow WW, Stevenson DD, Mathison DA et al. Aspirin desensitization in aspirin-sensitive asthmatic patients: clinical manifestations and characterization of the refractory period. J Allergy Clin Immunol. 1982; 69(1 Part 1):11-9. [IDIS 144037] [PubMed 7054250]



121. Food and Drug Administration. Rare complication of sulindac. FDA Drug Bull. 1989; 19:4.



122. Palmer JF. Letter sent to Berger ET, of Merck Sharp & Dohme regarding labeling revisions about gastrointestinal adverse reactions to Clinoril (sulindac) Rockville, MD: Food and Drug Administration, Division of Oncology and Radiopharmaceutical Drug Products; 1988 Sep.



123. Anon. Labeling revisions for NSAIDs. FDA Drug Bull. 1989; 19:3-4.



124. Searle. Cytotec (misoprostol) prescribing information. Skokie, IL; 1989 Jan.



125. Anon. Drugs for rheumatoid arthritis. Med Lett Drugs Ther. 2000; 42:57-64. [PubMed 10887424]



126. Thyss A, Milano G, Kubar J et al. Clinical and pharmacokinetic evidence of a life-threatening interaction between methotrexate and ketoprofen. Lancet. 1986; 1:256-8. [IDIS 210465] [PubMed 2868265]



127. Ellison NM, Servi RJ. Acute renal failure and death following sequential intermediate-dose methotrexate and 5-FU: a possible adverse effect due to concomitant indomethacin administration. Cancer Treat Rep. 1985; 69:342-3. [IDIS 198404] [PubMed 3978662]



128. Singh RR, Malaviya AN, Pandey JN et al. Fatal interaction between methotrexate and naproxen. Lancet. 1986; 1:1390. [IDIS 217293] [PubMed 2872507]



129. Day RO, Graham GG, Champion GD et al. Anti-rheumatic drug interactions. Clin Rheum Dis. 1984; 10:251-75. [PubMed 6150784]



130. Daly HM, Scott GL, Boyle J et al. Methotrexate toxicity precipitated by azapropazone. Br J Dermatol. 1986; 114:733-5. [IDIS 217458] [PubMed 3718865]



131. Hansten PD, Horn JR. Methotrexate interactions: ketoprofen (Orudis). Drug Interact Newsl. 1986; 6(Updates):U5-6.



132. Maiche AG. Acute renal failure due to concomitant action of methotrexate and indomethacin. Lancet. 1986; 1:1390. [IDIS 217292] [PubMed 2872506]



133. Soll AH, Weinstein WM, Kurata J et al. Nonsteroidal anti-inflammatory drugs and peptic ulcer disease. Ann Intern Med. 1991; 114:307-19. [IDIS 277370] [PubMed 1987878]



134. Hyson CP, Kazakoff MA. A severe multisystem reaction to sulindac. Arch Intern Med. 1991; 151:387-8. [IDIS 277919] [PubMed 1992967]



135. Lithium/NSAIAs. In: Tatro DS, Olin BR, Hebel SK, eds. Drug interaction facts. St. Louis: JB Lippincott Co; 1993(April):463.



136. Nonsteroidal anti-inflammatory drug interactions: Lithium. In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc; 1993:610.



137. Ragheb M, Powell AL. Lithium interaction with sulindac and naproxen. J Clin Psychopharmacol. 1986; 6:150-4. [IDIS 216256] [PubMed 3711365]



138. Furnell MM, Davies J. The effect of sulindac on lithium therapy. Drug Intell Clin Pharm. 1985; 19:374-6. [IDIS 199067] [PubMed 4006726]



139. Miller LG, Bowman RC, Bakht F. Sparing effect of sulindac on lithium levels. J Fam Prac. 1989; 28:592-3.



140. Ciba Geigy, Ardsley, NY: Personal communication on diclofenac 28:08:04.



141. Reviewers’ comments (personal observations) on diclofenac 28:08:04.



142. Corticosteroid interactions: nonsteroidal anti-inflammatory drugs (NSAIDs). In: Hansten PD, Horn JR. Drug interactions and updates. Vancouver, WA: Applied Therapeutics, Inc., 1993:562.



143. Garcia Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet. 1994; 343:769-72. [IDIS 328176] [PubMed 7907735]



144. Hollander D. Gastrointestinal complications of nonsteroidal anti-inflammatory drugs: prophylactic and therapeutic strategies. Am J Med. 1994; 96:274-81. [IDIS 328041] [PubMed 8154516]



145. Schubert TT, Bologna SD, Yawer N et al. Ulcer risk factors: interaction between Helicobacter pylori infection, nonsteroidal use, and age. Am J Med. 1993; 94:413-7. [IDIS 314155] [PubMed 8475935]



146. Piper JM, Ray WA, Daugherty JR et al. Corticosteroid use and peptic ulcer disease: role of nonsteroidal anti-inflammatory drugs. Ann Intern Med. 1991; 114:735-40. [IDIS 280191] [PubMed 2012355]



147. Bateman DN, Kennedy JG. Non-steroidal anti-inflammatory drugs and elderly patients: the medicine may be worse than the disease. BMJ. 1995; 310:817-8. [IDIS 345154] [PubMed 7711609]



148. Hawkey CJ. COX-2 inhibitors. Lancet. 1999; 353:307-14. [IDIS 418284] [PubMed 9929039]



149. Kurumbail RG, Stevens AM, Gierse JK et al. Structural basis for selective inhibition of cyclooxygenase-2 by anti-inflammatory agents. Nature. 1996; 384:644-8. [PubMed 8967954]



150. Riendeau D, Charleson S, Cromlish W et al. Comparison of the cyclooxygenase-1 inhibitory properties of nonsteroidal anti-inflammatory drugs (NSAIDs) and selective COX-2 inhibitors, using sensitive microsomal and platelet assays. Can J Physiol Pharmacol. 1997; 75:1088-95. [PubMed 9365818]



151. DeWitt DL, Bhattacharyya D, Lecomte et al. The differential susceptibility of prostaglandin endoperoxide H synthases-1 and -2 to nonsteroidal anti-inflammatory drugs: aspirin derivatives as selective inhibitors. Med Chem Res. 1995; 5:325-43.



152. Cryer B, Dubois A. The advent of highly selective inhibitors of cyclooxygenase—a review. Prostaglandins Other Lipid Mediators. 1998; 56:341-61. [PubMed 9990677]



153. Simon LS. Role and regulation of cyclooxygenase-2 during inflammation. Am J Med. 1999; 106(Suppl 5B):37-42S.



154. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med. 1999; 340:1888-99. [IDIS 426864] [PubMed 10369853]



155. Lanza FL, and the members of the Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. A guideline for the treatment and prevention of NSAID-induced ulcers. Am J Gastroenterol. 1998; 93:2037-46. [IDIS 417402] [PubMed 9820370]



156. Singh G, Triadafilopoulos G. Epidemiology of NSAID induced gastrointestinal complications. J Rheumatol. 1999; 26(suppl 56):18-24.



157. Giardiello FM, Yang VW, Hylind LM et al. Primary chemoprevention of familial adenomatous polyposis with sulindac. N Engl J Med. 2002; 346:1054-9. [IDIS 479514] [PubMed 11932472]



158. Giardiello FM, Hamilton SR, Krush AJ et al. Treatment of colonic and rectal adenomas with sulindac in familial adenomatous polyposis. N Engl J Med. 1993; 328:1313-6. [IDIS 313152] [PubMed 8385741]



159. Labayle D, Fischer D, Vielh P et al. Sulindac causes regression of rectal polyps in familial adenomatous polyposis. Gastroenterology. 1991; 101:635-9. [IDIS 286972] [PubMed 1650315]



160. Nugent KP, Farmer KC, Spigelman AD et al. Randomized controlled trial of the effect of sulindac on duodenal and rectal polyposis and cell proliferation in patients with familial adenomatous polyposis. Br J Surg. 1993; 80:1618-9. [PubMed 8298943]



161. in’t Veld BA, Ruitenberg A, Hofman A et al. Nonsteroidal antiinflammatory drugs and the risk of Alzheimer’s disease. N Engl J Med. 2001; 345:1515-21. [PubMed 11794217]



162. Breitner JCS, Zandi PP. Do nonsteroidal antiinflammatory drugs reduce the risk of Alzheimer’s disease? N Engl J Med. 2001; 345:1567-8. Editorial.



163. McGeer PL, Schulzer M, McGeer EG. Arthritis and anti-inflammatory agents as possible protective factors for Alzheimer’s disease: a review of 17 epidemiologic studies. Neurology. 1996; 47:425-32. [IDIS 371394] [PubMed 8757015]



164. Beard CM, Waring SC, O’sBrien PC et al. Nonsteroidal anti-inflammatory drug use and Alzheimer’s disease : a case-control study in Rochester, Minnesota, 1980 through 1984. Mayo Clin Proc. 1998; 73:951-5. [IDIS 416502] [PubMed 9787743]



165. in’t Veld BA, Launer LJ, Hoes AW et al. NSAIDs and incident Alzheimer’s disease: the Rotterdam Study. Neurobiol Aging. 1998; 19:607-11. [PubMed 10192221]



166. Stewart WF, Kawas C, Corrada M et al. Risk of Alzheimer’s disease and duration of NSAID use. Neurology. 1997; 48:626-32. [IDIS 383303] [PubMed 9065537]



167. Pharmacia. Daypro (oxaprozin) caplets prescribing information. Chicago, IL; 2002 May.



168. Chan FKL, Hung LCT, Suen BY et al. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med. 2002; 347:2104-10. [IDIS 490812] [PubMed 12501222]



169. Graham DY. NSAIDs, Helicobacter pylori, and Pandora’s box. N Engl J Med. 2002; 347:2162-4. [IDIS 490815] [PubMed 12501230]



170. Food and Drug Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. 2005 Apr 6.



171. Cush JJ. The safety of COX-2 inhibitors: deliberations from the February 16-18, 2005, FDA meeting. From the American College of Rheumatology website (). Accessed 2005 Oct 12.



172. Novartis Pharmaceuticals. Diovan (valsartan) capsules prescribing information (dated 1997 Apr). In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999:2013-5.



173. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA. 2006; 296: 1633-44. [PubMed 16968831]



174. Kearney PM, Baigent C, Godwin J et al. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006; 332: 1302-5. [PubMed 16740558]



175. Graham DJ. COX-2 inhibitors, other NSAIDs, and cardiovascular risk; the seduction of common sense. JAMA. 2006; 296:1653-6. [PubMed 16968830]



176. Chou R, Helfand M, Peterson K et al. Comparative effectiveness and safety of analgesics for osteoarthritis. Comparative effectiveness review no. 4. (Prepared by the Oregon evidence-based practice center under contract no. 290-02-0024.) . Rockville, MD: Agency for Healthcare Research and Quality. 2006 Sep. Available at: .



a. AHFS Drug Information 2003. McEvoy GK, ed. Sulindac. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1997-2001.



b. Merck & Co. Clinoril (sulindac) tablets prescribing information. Whitehouse Station, NJ; 2007 Feb.



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