Adult Dosing
Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis
- Initial 150 mg PO bid
- Max: 400 mg/day
Acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis)
- 200 mg PO bid x 7-14 days
- Max: 400 mg/day
Acute gouty arthritis
- 200 mg PO bid x 7 days
- Max: 400 mg/day
Notes:- Use the lowest effective dose for the shortest duration possible with individual patient treatment goals
- Administer dose with food
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- NSAIDs may increase the risk of serious and potentially fatal cardiovascular thrombotic events, MI, and stroke. Risk further increases with duration of use and with the presence of cardiovascular disease or risk factors for CV disease [US Black Box Warning]
- Inform the patients about the signs/symptoms of serious CV events and the steps to take if they occur
- Therapy may cause onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Use with caution in hypertensive patients
- Use with caution in patients taking thiazides or loop diuretics as it may hamper the therapeutic response of these agents; closely monitor BP during therapy
- Use cautiously in patients with congestive heart failure, as it may cause fluid retention and edema
- Sulindac may cause potentially fatal GI adverse events such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine. Use with extreme caution in patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding
- Factors that increase the risk for GI bleeding in patients receiving NSAID therapy include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, alcohol use, older age, and poor general health status
- If a serious GI adverse event is suspected, discontinue therapy and promptly institute an alternative therapy
- Severe hepatotoxicity can occur any time during treatment; closely monitor ALT and AST levels periodically. Avoid concomitant use of hepatotoxic drugs. Use the lowest effective dose for the shortest duration possible to minimize the potential risk of hepatotoxicity
- Monitor for renal toxicity, including renal papillary necrosis and other renal injuries during long-term treatment. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, patients who are volume-depleted, and the elderly
- Therapy not recommended in patients with advanced renal disease
- As with other NSAIDs, anaphylactic reactions may occur in patients without known prior exposure to sulindac; contraindicated in patients with aspirin triad, which occurs typically in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit potentially fatal bronchospasm after taking aspirin or other NSAIDs
- Discontinue the treatment at the first appearance of skin rash or any other sign of hypersensitivity reactions like exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
- Do not administer in late pregnancy as it may cause premature closure of the ductus arteriosus in the fetus
- Sulindac cannot be used to treat corticosteroid insufficiency or to substitute for corticosteroids
- Evaluation of hemoglobin and hematocrit values at regular intervals in patients on long-term treatment with NSAIDs is recommended as therapy is associated with anemia in some cases, possibly due to fluid retention, occult or gross GI blood loss
- Sulindac inhibits platelet aggregation and prolongs bleeding time in some patients; closely monitor patients with coagulation disorders or those receiving anticoagulants
- Cautiously administer in patients with preexisting asthma or aspirin-sensitive asthma as it may cause fatal bronchospasm
- Monitor for signs of GI bleeding; perform CBC and other blood chemistries, liver function and renal function tests periodically
- Use cautiously in patients with a history of renal lithiasis, and keep them well hydrated during therapy
- Pancreatitis has been reported in some patients taking sulindac. Discontinue therapy and institute appropriate therapy if pancreatitis is suspected. Do not restart therapy with sulindac
- Perform ophthalmologic studies in patients who develop eye complaints during therapy
- Therapy may increase the risk of aseptic meningitis in patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease
Cautions: Use cautiously in
- Hepatic impairment
- Dehydration
Pregnancy Category:C (contraindicated in 3rd trimester)
Breastfeeding: Because no information is available regarding sulindac use during breastfeeding, its relatively long half-life and glucuronide metabolite, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 13 June 2011). As per manufacturer's data, because of the potential for serious adverse events in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Sulindac 150 MG TABS [Bottle] (MUTUAL PHARMACEUTICAL)
60 mg = $18.99
180 mg = $49.98 - Sulindac 200 MG TABS [Bottle] (WATSON LABS)
100 mg = $33.91
200 mg = $67.83
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
